Federal State Scientific-Industrial Company For

Federal State Scientific-Industrial Company for Immunobiological Medicines of the Ministry of Health of the Russian Federation MICROGEN is a first-rate company in Russian medical industry with leading role in development and production of immunobiological preparations, diagnosticums and drugs. Priority in company’s work is given to production of vaccines for dangerous infectious diseases, including those for the National Vaccination Schedule of Russia and influenza vaccines. Microgen is actively collaborating with leading Russian research centers in order to develop and manufacture unique products of biotechnology and immunobiology. Highly skilled staff, rigid manufacturing standards and strict control of every production stage guaranty the best quality of the company’s products.

Consortium MICROGEN was founded in May, 2003 under the aegis of Public Health Ministry of the Russian Federation in order to preserve and develop the domestic production of medical immunolobiological preparations. The newly established company was to become an advanced enterprise of medical immunobiology that could ensure the realization of national programs of biological security and preservation of epidemiologic and sanitary welfare, switching to international standards of drug production and practical application of new preparations developed by Russian scientists. The staff of the 14 subsidiaries of MICROGEN comprises more than 7500 persons, including 7 professors, 21 doctors of science and 177 candidates of science. MICROGEN subsidiaries are located in 13 cities of the Russian Federation: Moscow, Ekaterinburg, Irkutsk, Makhachkala, Nizhny Novgorod, Omsk, Perm, Stavropol, Tomsk, Tumen, Ufa, Khabarovsk and Belorechensk. MICROGEN manufactures more than 70 percent of all the domestic immunobiological products: vaccines, allergens, therapeutic and diagnostic serums, eubiotics, bacteriophages, donor blood products, human immunoglobulins and drug preparations. The total nomenclature of immunobiological products of MICROGEN exceeds 300 items. In collaboration with leading Russian scientists the company is striving to develop and manufacture new high-quality and moderately priced preparations. At present more than 15 novel preparations are being prepared for commercial production, e.g. new influenza and smallpox vaccines, diphtheria and tetanus toxoids and pertussis vaccine, hepatitis B vaccine, avian influenza vaccine, etc. By taking part in WHO international programs for eradication of smallpox, measles, rubella, tuberculosis, whooping cough, diphtheria, tetanus allows the company specialists to keep abreast of the modern developments in immunobiology. Production facilities of the MICROGEN company allow it to manufacture the whole range of vital immunobiological preparations in the necessary quantities. The main aims of the company are: • complete provision of immunobiological preparations for the maintenance of Russia epidemiologic and sanitary welfare, primarily vaccines for the National Vaccination Schedule of Russia and vaccines for socially important infectious diseases; • maintenance and development of efficient supply of immunobiological preparations to Russian Federation subjects; • development of a unified program of development, funding and modernization of production and research; • improving the international image of the Russian science and producers of immunobiological preparations. • gradual transfer of all enterprises of the consortium to the GMP international quality standard.

CONTENTS

I.MEDICAL IMMUNOBIOLOGICAL PREPARATIONS 11 Vaccines and toxoids (anatoxins) 11 Diphtheria and tetanus anatoxin (toxoid), purified, adsorbed, liquid 13 Diphtheria and tetanus anatoxin (toxoid), purified, adsorbed, with the reduced antigen content, liquid 13 Diphtheria anatoxin (toxoid), purified, adsorbed, with the reduced antigen content, liquid 14 Tetanus anatoxin (toxoid), purified, adsorbed, liquid 14 “COCAV”: antirabic tissue culture vaccine, concentrated, purified, inactivated 15 “RABIVAC-VNUKOVO-32”: rabies tissue culture vaccine, concentrated, purified, inactivated, for human immunization 15 Brucellosis vaccine, live, dry 15 Gonococcal vaccine, inactivated, liquid (gonovaccine) 16 Influenza virus vaccine, egg-derived, intranasal, live, dry 16 Influenza virus vaccine, inactivated, eluate-centrifuged, liquid 17 “GRIPPOL”®(influenza virus vaccine, trivalent, polymer-subunit, liquid) 17 Typhoid vaccine E, combined, live 18 Diphtheria and tetanus toxoids and pertussis vaccine, adsorbed, liquid (DTP-vaccine) 18 Measles virus vaccine, tissne cultured, live 18 Meningococcal vaccine of A group, polysaccharidal, dry 19 Smallpox vaccine, live, dry 19 Mumps vaccine, tissue cultured, live, dry (parotitis vaccine) 20 Mumps and measles virus vaccine, tissue cultured, live, dry (measles-mumps vaccine) 20 Hepatitis B virus vaccine, recombinant-DNA, yeast (hepatitis B vaccine) 21 Tuberculosis vaccine for sparing immunization (vaccine of Calmette and Guerin-M, BCG-M vaccine) 22 Tuberculosis vaccine (vaccine of Calmette and Guerin, BCG vaccine) 22 Tularemia vaccine, live, dry 23 Tetratoxoid, purified, adsorbed, liquid 23 Tritoxiod, purified, adsorbed, liquid 24 ENCEVIR® (tick-borne encephalitis vaccine, tissue cultured, purified, concentrated, inactivated, sorbed, liquid) 24 Human immunoglobulins 25 Normal human immunoglobulins 26 Immune globulin intravenous (human) 26 IMMUNOVENIN (immune globulin intravenous, human) 26

Immune globulin intramuscular (human) 27 IMBIOGAM® (immune globulin intramuscular, human) 27 Immunoglobulin complex preparation for enteral administration (KIP) 27 Specific human immunoglobulins 28 Antistaphylococcsus human immunoglobulin 28 Antitetanus human globulin 28 ANTIHEP (antihepatitis B human globulin) 29 Immunoglobulin human against encephalitis ixodicum 29 Antiallergic human immunoglobulins 30 Histaglobulin 30 Antiallergic human globulin, liquid 30 Heterogenous serums 31 Antibotulinic serum of A, D, E types, purified, concentrated, liquid 31 Antigangrene serum, polyvalent, purified, concentrated, horse, liquid 31 Antidiphtheric serum, horse, purified, concentrated, liquid 32 Antitetanic serum, horse, purified, concentrated, liquid 32 Anti-viper (anti-adder) venom serum, horse, purified, concentrated, liquid 32 Cytokines (interferons and interleukins) 33 AFFINOLEUKIN ® 33 SVEFERON ® (human leukocyte interferon, suppositories) 33 Human leukocyte interferon 34 Bacteriophages 35 Pseudomonas aeruginosa bacteriophage 36 Coliproteic bacteriophage 36 Staphylococcal bacteriophage 37 Dysenteric bacteriophage, polyvalent 37 Klebsiella bacteriophage, polyvalent, purified 38 Klebsiella pneumoniae bacteriophage, purified 38 Klebsiphage (Klebsiella pneumoniae bacteriophage) 38 Coli bacteriophage 39 Proteus bacteriophage 39 Salmonellosis of ABCDE groups bacteriophage 40 Streptococcal bacteriophage 40

Intesti-bacteriophage 41 Pyopolyphage (pyobacteriophage combined, liquid) 41 Pyobacteriophage polyvalent, purified® 42 SEXTAPHAGE ® (pyobacteriophage polyvalent) 42 Probiotics (Eubiotics) 43 Bifidumbacterin, dry 44 Bifidumbacterin, suppositories 45 Bificol, dry 45 Colibacterin, dry 46 Lactobacterin (Lactobacteria acidophilic, vaginal suppositories) 46 Lactobacterin, dry 47 II. BLOOD PRODUCTS 49 Plasma substitutes 50 Albumin solution, 10% 50 Protein 51 Preparations for parenteral nutrition 51 Infusamin 51 Fibrinolytic preparations 52 Fibrinolysin 52 Eye film with fibrinolysin 52 Antioxidants 53 Ceruloplasmin 53 Nonspecific biostimulators 54 Glunat 54 Plasmol 54 III. DRUGS OF OTHER PHARMACOLOGICAL GROUPS 57 Alpha-adrenomimetics 58 Naphthisin (naphazoline) solution 58 m-Cholinoblockers 58 Platiphylline hydrotartrate 58 Anticoagulants 59 Heparin 59 Fibrinolysis inhibitors 60 Inhitril® 60 Hemopoiesis stimulants 61

ERYTHROSTIM ® 61 Adenosinergetics 62 Pentoxifyllin 62 Euphyllin 62

H1 antihistamine agents 63 Dimedrol 63 Anabolics 63 Riboxin 63 Vitamins and vitamin-like preparations 64 Ascorbic acid 64 Thiamin chloride 65 Cyanocobalamin 65 Cocarboxylase hydrochloride 66 Nicotinic acid 67 Detoxifying agents 68 Glucose 68 Cartilage and bone tissue metabolism correctors 68 CHONDROLON ® 68 Minerals and trace elements 69 Potassium chloride 69 Calcium chloride 69 Magnesium sulphate 70 Sodium chloride 70 Enzymes and antienzymes 71 Lydase 71 LYRASE ® 71 Trypsin crystalline 72 Chemotrypsin 72 Metabolics 73 Sodium adenosinetriphosphate 73 Anxiolytics 73 Sibason 73 Local anesthetics 74 Lydocaine hydrochloride 74 Novocaine 74

Nootropic agents 75 Piracetam 75 Cerebrolysate 75 Non-narcotic analgesics, nonsteroid anti-inflammatory agents 76 Analgin 76 Ortophen 76 Gastrointestinal agents 77 Dalargin 77 “EQUINE”, natural gastric juice 77 Dental agents 78 Propolis tincture 78 Cardiovascular agents 78 Dibasol 78 Papaverine hydrochloride 79 Nitroglycerin 79 Agents affecting prostate metabolism 80 Prostacor ® 80 Uterotonics 80 Oxytocin 80 Antibiotics 81 Gentamycin sulphate 81 Lincomycin 81 Aids (adjuncts) 82 Water for injection 82 IV. DIAGNOSTIC IMMUNOBIOLOGICAL AGENTS 85 Allergens and allergiods 86 Allergens from tree pollens: birch, oak, maple, alder, hazel and ash for diagnosis and therapy 86 Allergens from pollens of wild and cultivated grasses: orchard grass, sheave, maize, foxtail, fowl-grass, fescue, bent, couch-grass, ryegrass, rye, timothy-grass and dandelion 86 Allergens from weed pollens: ambrosia (ragweed), wormwood, goose-foot, hemp, cyclahen, dandelion and sunflower 86 Mixt-allergen from tree pollens (birch, oak, maple, alder, hazel and ash) for diagnosis and therapy 86 Mixt-allergen from pollens of wild grasses (timothy-grass, orchard grass, ryegrass sheave, fescue, fowl-grass, couch-grass, foxtail) for diagnosis and therapy 86

Mixt-allergen from weed pollens: ambrosia, wormwood, goose-foot) and sunflower for diagnosis and therapy 86 Allergoids from wild grass (orchard grass, fecque, timothy-grass) and weed (ambrosia, wormwood) pollens for therapy 86 Mixt-allergoid of pollen orchard grass, fescue and timothy-grass for therapy 86 Mixt-allergoid of pollen alder, birch, hazel for therapy 86 House dust allergoid for therapy 86 Brucellosis allergen for intracutaneuos administration, liquid 88 Tularemia allergen for epicutaneuos administration, liquid (tularin) 88 Preparations for serum diagnostics of infectious diseases 89 Diphtheria antitoxin, purified by enzymolysis and specific sorbtion, dry 89 Tularemia diagnosticum for bulk and blood-drop agglutination reaction, liquid 89 Rickettsia Prowazekii diagnosticum for complement fixation test (CFT), dry 90 Rickettsia Siberica diagnosticum for CFT, dry 90 Rickettsia Typhi diagnosticum for CFT 90 Chlamydia diagnosticum for CFT and indirect CFT, dry 91 Salmonellosis erythrocytal diagnosticum, Vi-antigen, liquid 91 Salmonellosis erythrocytal diagnosticum, O-antigen, liquid 92 Shigellosis erythrocytal diagnosticums: dysentery 1; 2; 3-7; Flexneri 1-5; Flexneri 6 and Sonnei, antigenic, liquid 92 Meningococcal erythrocytal immunodiagnosticums, polysaccharide of A, B, C, X, Y, Z, W-135 groups and liposaccharide species-specific, liquid 93 Immunoglobulin erythrocytal immunodiagnosticums for detection of surface antigen of hepatitis B virus (HBs-Ag), dry, “ROPGA-HBs-Ag” 93 Complement, dry 94 Microtest systems for biochemical identification of microorganisms 94 Microtest system for biochemical identification of vibrios (MTS-V) 94 Microtest system for biochemical identification of diphtheria corynebacteria (MTS-CD) 94 Microtest system for rapid detection of enzyme activity of enterobacteriaceae (MTS-5H) 95 Microtest system for biochemical identification of enterobacteriaceae (MTS-M-12E) 95 Microtest system for biochemical identification of staphylococci (MTS-S) 95 Microtest system for rapid identification of vibrio groups by Heiberg test (MTS-H) 96 Paper indicator systems (PIS) for microorganism identification 96 KIT № 1. PIS for vibrio identification (13 tests) 96 KIT № 2. PIS for intergenetic and speicies identification of enterobacteriaceae (13 tests) 96 KIT № 3. PIS for water coli-index determination (2 tests) 97 KIT № 4. PIS for bacteriologic sanitary water monitoring (3 tests) 97

KIT № 5. PIS for diphtheria corynebacteria identification (4 tests) 97 Immunoenzyme test systems 98 Test systems for viral infection diagnosis 98 Enzyme immunoassay system for hepatitis B surface antigen detection (EIA- HBs-Ag) 98 Enzyme immunoassay system for hepatitis C antigen detection (EIA-anti-HCV) 99 Enzyme immunoassay system for the confirmation of positive results in testing for hepatitis C antibodies, “SPECTRUM-4” 99 Enzyme immunoassay system for the detection of class IgM antibodies against hepatitis C virus (EIA-HCV-IgM) 99 Enzyme immunoassay system for the detection of antigen of the tick-borne encephalitis 100 Immunoenzyme allergodiagnostic test systems 100 Enzyme immunoassay system for the determination of allergen specific human IgE-antibidies 100 Other diagnostic preparations 102 Rabbit plasma , citrated, dry 102 Botulinic serum of A, B, C, E, F types, native, horse or cattle, for biological neutralizing reaction, diagnostic, dry 102 Diagnostic nonspecific serum against human IgG(H+L), IgG(H), IgM(H), IgA(H), dry 103 Diagnostic nonspecific serum against kappa and lambda chains of human immunoglobulins, dry 103 Serum for immunoelectrophoresis against serum proteins of human blood, dry 104 Cattle blood serum for cultures, dry 104 Cattle blood serum for cultures, liquid 104 Culture media 105 Dry culture media 106 Culture base and growth factors – sources of nitrous supply and vitamins 106 Media for enterobacteriaceae: for isolation, accumulation and identification 106 Media for conditionally pathogenic bacteria and Pseudomonas aeruginosa: for isolation, storage and transportation 106 Media for coccal bacteria group: for isolation and cultivation 107 Media for diphtheria corynebacteria: for isolation and identification 107 Media for yeastlike fungi and protozoa: for identification and cultivation 107 Media for extremely dangerous infections 107 Media for antibioticograms: for determination of microbial sensitivity to antibiotics 107 Media for ureaplasmae: for indication and isolation 107 Media for whooping cough pathogens: for isolation and cultivation 107 Media for tubercle mycobacteria isolation 108 Media for control of sterility and microbiological purity of drugs 108

Liquid culture media 109 Culture medium 199, liquid 109 Hank’s diagnostic solution with phenol red 109 Hank’s diagnostic solution without phenol red 109 V. BIOLOGICALLY ACTIVE FOOD SUPPLEMENTS 111 “NARINE-TNC” ® 111

MEDICAL IMMUNOBIOLOGICAL PREPARATIONS

10 MEDICAL IMMUNOBIOLOGICAL PREPARATIONS

The medical immunobiological preparations are those medicinal agents that are used for immunological prophylaxis, diagnistics and therapy of human diseases.

VACCINES AND TOXOIDS (ANATOXINS)

Vaccines are “preparations containing antigen material and used for the prevention of infectious diseases. Disease prevention is implemented by the use of vaccines based on live, attenuated or inactivated microorganisms, immunogens that are isolated from them combined with adjuvants, specific microorganism RNA or microorganism genetic material (including modified one)”. Anatoxins are a type of vaccine that is produced from bacterial exotoxins and is devoid of toxicity but retains antigenic and immunogenic exotoxin properties. Anatoxins cause the development of antitoxic immunity and are used for prevention and treatment of several infectious diseases. “According to WHO data, vaccines yearly save lives of 3 million children. Modern vaccination system is a deciding factor of the decrease in children mortality and the increase of the life- span and the quality of life of all age groups of the population. Vaccines not only create the specific protection from certain types of infection but also have a strong non-specific effect by stimulating the many factors of natural resistance”. The domestic production of the greater part of vaccines and anatoxins is concentrated in the manufacturing facilities of the MICROGEN company.

1 Yarilin A.A. “Basic Immunology” (Osnovy Immunologii), Moscow, 1999. 2 Medunitzin N.V. “Vaccinology” (Vakzinologia), 2nd edition, revised and expanded. Moscow, 2004.

11 Appendix 1 To the order № 229 of the minister of Public Health of the Russian Federation of 27.06.2001

the National Vaccination Schedule of Russia

AGE VACCINATION neonates (first 12 hours of life) first vaccination against viral hepatitis B neonates (3-7 days old) vaccination against tuberculosis 1 month second vaccination against viral hepatitis B first vaccination against diphtheria, whooping 3 months cough, tetanus, poliomyelitis second vaccination against diphtheria, 4.5 months whooping cough, tetanus, poliomyelitis third vaccination against diphtheria, 6 months whooping cough, tetanus, poliomyelitis third vaccination against viral hepatitis B vaccination against measles, rubella, 12 months epidemic parotitis first booster against diphtheria, whooping 18 months cough, tetanus, poliomyelitis 20 months second booster against poliomyelitis booster against measles, rubella, epidemic 6 years parotitis booster against tuberculosis 7 years second booster against diphtheria, tetanus rubella vaccination (girls) 13 years vaccination against viral hepatitis B (without previous vaccinations) third vaccination against diphtheria, 14 years tetanus, booster against tuberculosis, third booster against poliomyelitis booster against diphtheria, tetanus – every adults 10 years counting from the last booster

NOTE: Immunization within the framework of The National Vaccination Schedule of Russia is made with vaccines of domestic and foreign manufacturing that are registered and approved for use according to the established order and the instructions for their use.

12 DIPHTHERIA AND TETANUS ANATOXIN (TOXOID), PURIFIED, ADSORBED, LIQUID suspension for injection

Administration according to the established scheme results in the specific antitoxic immunity to diphtheria and tetanus. Used as protection against diphtheria and tetanus for children up to the age of 6 years: • children who had whooping cough (aged from 3 months up to 6 years); • children with contraindications for DTP-vaccine; • children over 4 years old without previous diphtheria and tetanus vaccinations.

Produced in 1ml ampoules (two doses) in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Perm and Ufa.

DIPHTHERIA AND TETANUS ANATOXIN (TOXOID), PURIFIED, ADSORBED, WITH THE REDUCED ANTIGEN CONTENT, LIQUID suspension for intramuscular or subcutaneous use

Administration of the preparation according to the established scheme results in the specific antitoxic immunity to diphtheria and tetanus . Used as protection against diphtheria and tetanus for children over 6 years of age, adolescents and adults in: • scheduled booster vaccinations at the ages of 7 and 14 years and then every 10 years without age limitations; • vaccinations of children over 7 years of age without previous diphtheria and tetanus vaccinations; • replacement of DTP-vaccine for children with severe general reactions (fever higher than 400C) or with post-vaccination complications for the above-mentioned preparations; • vaccination schemes for adults without previous diphtheria and tetanus immunizations; • preventive vaccinations in diphtheria high-incidence area.

Produced in 1ml ampoules (two doses) in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Perm and Ufa.

13 DIPHTHERIA ANATOXIN (TOXOID), PURIFIED, ADSORBED, WITH THE REDUCED ANTIGEN CONTENT, LIQUID suspension for intramuscular or subcutaneous use

Results in the specific antitoxic immunity to diphtheria. Used in the prophylaxis against diphtheria for children after 6 years old, adolescents and adults. The anatoxin may be administered with one month’s delay or simultaneously with poliomyelitis vaccine and other preparations of the National Vaccination Schedule of Russia.

Produced in 1ml ampoules (two doses) in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Perm and Ufa.

TETANUS ANATOXIN (TOXOID), PURIFIED, ADSORBED, LIQUID suspension for injection

Administration according to the established scheme results in the specific antitoxic immunity to tetanus. Used for active immunization against tetanus and emergency specific prophylaxis against tetanus in cases of: • traumas with the compromised integrity of skin and mucosa; • frostbites and deep burns; • out-of hospital abortions; • out-of hospital births; • gangrene and necrosis of tissues of any kind, indolent abscesses; • animal bites; • penetrating wounds of gastrointestinal tract. For emergency tetanus prophylaxis tetanus anatoxin is used in conjunction with antitetanic human immunoglobulin or antitetanic horse serum, purified, concentrated, liquid. The choice of preventive measures for emergency specific prophylaxis is made according to the scheme.

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Perm and Ufa.

14 “COCAV”: ANTIRABIC tissue culture VACCINE, CONCENTRATED, PURIFIED, INACTIVATED lyophilizate for solution preparation for intramuscular injection

Inactivated vaccine virus of rabies, strain Vnukovo-32. Administration according to the established scheme results in immunity to rabies pathogen. Used for preventive health care against rabies.

Produced in kits of 1 ampoule of vaccine (not less than 2.5 IU) and 1 ampoule of solvent (1ml of injection water) in 5-kit packs. Period of validity: 1.5 years. Manufacturer: MICROGEN subsidiary in Ufa.

“RABIVAC-VNUKOVO-32”: RABIES TISSUE CULTURE VACCINE, CONCENTRATED, PURIFIED, INACTIVATED, FOR HUMAN IMMUNIZATION lyophilizate for intramuscular and subcutaneous use

Administration according to the established scheme results in immunity to rabies pathogen. Used for preventive health care against rabies.

Produced in kits of 1 ampoule of vaccine (not less than 0.5 IU) and 1 ampoule of solvent (3ml of injection water) in 5-kit packs. Period of validity: 1.5 years. Manufacturer: MICROGEN subsidiary in Ufa.

BRUCELLOSIS VACCINE, LIVE, DRY lyophilizate for solution preparation for epicutaneous and subcutaneous use

Results in immunity to brucellosis. In 20 – 30 days the vaccination provides immunity that persists for 10 – 12 months. Used for prevention of brucellosis of goat and sheep type in adults. Vaccinations are indicated for people employed in: • purchase, storage and processing of agricultural products from the farms with registered cases of animal brucellosis; • slaughter of brucellar animals, storage and processing of their meet, as well as farm workers and veterinarians in establishments that are enzootic for brucellosis; persons working with live cultures of brucella.

Produced in 1ml ampoules (4–10 cutaneous tests) in 5-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Omsk and Perm.

15 GONOCOCCAL VACCINE, INACTIVATED, LIQUID (GONOVACCINE) suspension for intramuscular use

Increases specific reactivity. Used for diagnostic purposes (establishing recovery from gonorrhea: provocation test) and as a supplementary therapy for gonococcal infections from 3 years of age. Administration of gonococcal vaccine is indicated for patients after unsuccessful antibiotic therapy in sluggish recurrences, new torpid and chronic forms of disease, for males with complicated gonorrhea and females with ascending gonorrhea (after reduction of acute inflammatory symptoms), in obstetrical practice in inflammation treatment.

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 1 year. Manufacturer: MICROGEN subsidiaries in Perm and Tomsk.

INFLUENZA VIRUS VACCINE, EGG-DERIVED, INTRANASAL, LIVE, DRY lyophilizate for solution preparation for intranasal administration

Recombinant flu viruses of A and B types obtained from virus-infected allantois liquid of chick embryos (strain content of the vaccine is changed yearly according to WHO recommendations). Results in specific immunity to influenza viruses of A and B types. Protective effect is typically achieved in 3 weeks after vaccination and persists for 10 – 12 months. Used for active flu prophylaxis for adults without limitations and for children over 3 years of age, once a year in autumn or winter time.

The vaccination is recommended to people with high complication risk and to professionals with high risk of contacting and spreading the infection: • people over 60, people with chronic somatic diseases and prone to URI; • pre-school and schoolchildren, medical care workers, workers in consumer services, transport and education system.

Produced in 0.5ml ampoules (one dose) with a disposable atomizer. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Irkutsk.

16 INFLUENZA VIRUS VACCINE, INACTIVATED, ELUATE-CENTRIFUGED, LIQUID suspension for subcutaneous use

Results in specific immunity to influenza viruses of A and B types (antigen content of the vaccine is changed yearly according to epidemic situation and WHO recommendations). Protective effect is typically achieved in 3 weeks after vaccination and persists for 10–12 months. Used for active flu prophylaxis and in after-flu complications and also for alleviation of disease course in adults over 18.

Produced in 0.5ml ampoules (one dose) in 10-ampoule packs. Period of validity: 1 year Manufacturer: MICROGEN subsidiary in Ufa.

“GRIPPOL”® (INFLUENZA VIRUS VACCINE, TRIVALENT, POLYMER-SUBUniT, LIQUID) solution for intramuscular and subcutaneous use

Contains surface glycoproteins (hemagglutinin and neuraminidase) obtained from purified flu viruses of A and B type in complex with water-soluble high-molecular weight immunostimulant N-oxidized derivative of poly-1,4-ethylentpiperazine (Polyoxidonium). Results in high specific immunity to influenza viruses of A and B types (antigen content of the vaccine is changed yearly according to epidemic situation and WHO recommendations). Used for active flu prophylaxis in infants from 6 months of age, children, adolescents and adults without age limitations. Vaccination is provided yearly in autumn or winter time. Vaccination at the start epidemic outbreak is possible. Vaccine is injected intramuscularly (into deltoid muscle) or deeply subcutaneously into the upper third of exterior shoulder, young children are injected into exterior thigh surface. Infants from 6 months to 3 years of age: • 0.25ml twice with a 4-week interval; • 0.5ml once if the child was vaccinated against flu during previous season. Children over 3 years of age and adults without age limitations are vaccinated once with 0.5ml. Immunodeficient patients may be vaccinated twice with 0.5ml with a 4-week interval.

Produced in ampoules and injectors of 0.5ml (one dose) in packs of 1, 5 or 10 ampoules. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Ufa.

17 TYPHOID VACCINE E, COMBINED, LIVE lyophilizate for suspension preparation for subcutaneous use

One dose of vaccine produces specific immunity to typhus pathogen. Used for specific typhus prophylaxis. Vaccination and boosters are possible for people from 18 to 60 years of age.

Produced in kits: an ampoule with 20 doses of vaccine and solution vial (0.9% sodium chloride solution, 5 ml). A pack contains 5 kits. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Perm.

DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSUS VACCINE, ADSORBED, LIQUID (DTP-vaccine) suspension for injection

Results in specific immunity to whooping cough, diphtheria and tetanus. Used for prevention of whooping cough, diphtheria and tetanus in children. DTP immunization is made from 3 months of age until 3 years 11 months and 29 days (children who had whooping cough are immunizes by diphtheria and tetanus toxoids).

Produced in ampoules of 0.5ml (one dose) or 1ml (two doses) in 10-ampoule packs. Period of validity: 1.5 years. Manufacturer: MICROGEN subsidiary in Ufa.

MEASLES VIRUS VACCINE, TISSUE CULTUREd, LIVE lyophilizate for solution preparation for subcutaneous use

Induces measles antibodies production in seronegative children in 21–28 days after vaccination. Used for planned and emergency measles prophylaxis. Planned vaccinations are made twice: at the ages of 12–15 months and 6 years to children who did not have measles. Emergency prophylaxis is provided to children from one year of age, adolescents and adults exposed to measles who had not had measles and had not been immunized against the infection. In the absence of contraindications the vaccine is administered not later than 72 hours after the exposure.

Produced in ampoules with 1, 2 or 5 doses in 10-ampoule packs. Period of validity: 15 months. Manufacturer: MICROGEN subdivision in Moscow.

18 MENINGOCOCCAL VACCINE OF A GROUP, POLYSACCHARIDAL, DRY lyophilizate for solution preparation for subcutaneous use

Results in active specific immunity to meningococcal meningitis pathogen (Neisseria meningitidis) of group A serum. Used for prevention of meningitis of serum group A in endemic areas or during epidemics.

Produced in ampoules with 250 micrograms of polysaccaride of serum group A (5 – 10 doses depending on the age of immunized persons). A pack contains 5 vaccine ampoules and 5 ampoules of potassium chloride for injection. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Moscow.

SMALLPOX VACCINE, LIVE, DRY lyophilizate for solution preparation for epicutaneous use

Results in specific immunity to smallpox that persists no less than 5 years. Used for natural smallpox prevention according to epidemiological indications as well as for immunization of persons working with smallpox vaccine viruses and animal smallpox pathogenic to humans.

Produced in 0.1 or 0.2ml ampoules (10 or 20 doses respectively). Solvent is produced in two-ended capillary ampoules of 0.2ml for 0.1ml of vaccine, or 0.3 for 0.2ml of vaccine. One pack contains: 5 ampoules of vaccine and 5 ampoules of solvent; 10 ampoules of vaccine and 10 ampoules of solvent. Or 10 ampoules of vaccine and 10 ampoules of solvent (in separate packs). Period of validity: for vaccine – 2 years, for the solvent – 3 years. Manufacturer: MICROGEN subsidiary in Tomsk.

19 MUMPS VACCINE, TUSSUE CULTURED, LIVE, DRY (PAROTITIS VACCINE) lyophilizate for solution preparation for subcutaneous use

Induces parotitis antibodies in seronegative children the level of which reaches maximum level in 6–7 weeks after vaccination. Used for planned and emergency prophylaxis against epidemic parotitis in children. Planned vaccinations are administered twice: at 12 month and 6 years of age to children who did not have mumps. Emergency vaccinations are administered to children from 12 months of age, adolescents and adults exposed to parotitis who had not had parotitis and had not been immunized. In the absence of contraindications vaccine should be administered not later than 72 hours after the exposure.

Produced in ampoules of 1, 2 or 5 doses in 10-ampoule packs. Period of validity: 15 months. Manufacturer: MICROGEN subdivision in Moscow.

MUMPS AND MEASLES VIRUS VACCINE, TISSSUE CULTURED, LIVE, DRY (MEASLES-MUMPS VACCINE) lyophilizate for solution preparation for subcutaneous use

Results in immunity to measles and epidemic parotitis. Used for prophylaxis against epidemic parotitis and measles. Vaccine is administered twice: at 12 months and 6 years of age to children who did not have measles and mumps. Emergency prophylaxis is provided to children from the age of 12 months, adolescents and adults exposed to measles or mumps who had not had these diseases and had not been immunized.

Produced in ampoules of one vaccination dose in 10-ampoule packs with solvent. Period of validity: 12 months. Manufacturer: MICROGEN subdivision in Moscow.

20 HEPATITIS B VIRUS VACCINE, RECOMBINANT-DNA, YEAST (HEPATITIS B VACCINE) suspension for intramuscular use

Vaccination course results in specific antibodies to hepatitis B virus, found in protection titer in over 90 percent of vaccinated persons. Used for hepatitis B prophylaxis in children within the national vaccination program and in the high risk group for hepatitis B: • children and adults in families with HBsAg-carrier or a patient with chronic hepatitis B; • children in orphanages and boarding schools; • children and adults who regularly receive whole blood or blood products as well as hemodialysis and oncohematologic patients; • persons exposed to material infected by hepatitis B virus; • health care workers in contact with blood; • persons involved in production of immunobiological preparations from donor and placental blood; • students of medical colleges and medical vocational schools (primarily graduates); • intravenous drug abusers. Besides the above-mentioned categories vaccinations may be given to all population groups. Vaccination course may be provided according to standard or emergency scheme.

Produced in ampoules of 1ml (one adult dose) and 0.5ml (one dose for a child) in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Tomsk.

21 TUBERCULOSIS VACCINE FOR SPARING IMMUNIZATION (VACCINE OF CALMETTE AND GUERIN-M, BCG-M VACCINE) lyophilizate for suspension preparation for intracutaneous use

Results in lasting immunity to tuberculosis due to the use of living strain of micobacterium tuberculosis of the BCG-1 strain (immunization dose contains 0.025mg of BCG cells in 0.1 ml of solvent). Used for active specific prophylaxis of tuberculosis. BCG-M vaccine is administered: • in maternity departments to all healthy neonates with the birth weight of 2000 grams and more on the 3rd – 7th day of life or on the day of the discharge from the hospital in areas with tuberculosis morbidity not higher than 80 in 100000; • in maternity departments to premature neonates with birth weight of 2000 grams and more after the recovery of the initial weight on the eve or on the day of discharge; • in neonatal intensive care department of hospitals (2nd stage of care) to infants with body weight of 2300g or more before the discharge; • in child clinics to children who were not immunized in maternity departments due to medical contraindications but who need the immunization after contraindication removal.

Produced in kits with 0,5mg ampoules of the preparation (20 doses) and 2ml ampoule of solvent (0.9% solution of potassium chloride for injections), in 5-kit packs. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Stavropol.

TUBERCULOSIS VACCINE (VACCINE OF CALMETTE AND GUERIN, BCG VACCINE) lyophilizate for suspension preparation for intracutaneous use

Results in lasting immunity to tuberculosis due to the use of living strain of micobacterium tuberculosis of the BCG-1 strain (immunization dose contains 0.05mg of BCG cells in 0.1ml of solvent). Used for active specific prophylaxis of tuberculosis: • primary vaccination of healthy neonates on the 3rd – 7th day of life; boosters at 7 and 14 years of age.

Produced in kits with ampoules with 0,5mg of the preparation (10 doses) or 1mg (20 doses) and 1 or 2ml ampoule of solvent respectively (0.9% solution of potassium chloride for injections), in 5-kit packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Stavropol.

22 TULAREMIA VACCINE, LIVE, DRY lyophilizate for solution preparation for intracutaneous or cutaneous use

Results in immunity to tularemia up to 5 years duration. Used for tularemia prevention from 7 years of age (from 14 in high-incidence area). Immunization are provided to population in the tularemia enzootic areas and persons who come to these territories and working in: • agricultural, irrigation or drainage, building jobs, or other jobs connected with soil removal and replacement, purchasing, commercial fishing or hunting, geological, survey, dispatch, deratization and disinfecting jobs; • logging, or forestry jobs or in improvements of public recreational zones.

Produced in kits. Each kit consists in one ampoule of vaccine (15-60 doses) and 1 ampoule of water for injection. A pack contains 5 kits. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Omsk.

TETRATOXOID, PURIFUED, ADSORBED, LIQUID suspension for subcutaneous use

Results in specific antitoxic immunity to botulism and tetanus toxoids that persists no less than 5 years. Used for prevention of botulism and tetanus in persons from 16 to 60 years of age (women to 55).

Produced in 3ml ampoules (3 doses) in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Ufa.

23 TRITOXOID, PURIFUED, ADSORBED, LIQUID suspension for subcutaneous use

Results in specific antitoxic immunity to anatoxins of botulism and tetanus that persists no less than 5 years. Used for prevention of botulism and tetanus in persons from 16 to 60 (women to 55).

Produced in 3ml ampoules (3 doses) in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Ufa.

ENCEVIR® (TICK-BORNE ENCEPHALITIS VACCINE, TISSUE CULTURED, PURIFIED, CONCENTRATED, INACTIVATED, SORBED, LIQUID) suspension for intramuscular use

Results in specific immunity to tick-borne encephalitis, produced from virus strain isolated in Russia. Protects against all subtypes of tick-borne encephalitis. Used for active prophylaxis against of tick-borne encephalitis in persons from 3 years of age. Vaccination is indicated to: • population of areas endemic to tick-born encephalitis; • persons who come to these territories to work in agricultural, irrigation or drainage, building, purchasing, commercial fishing or hunting, geological, survey, dispatch, deratization and disinfecting jobs; as well as in soil removal or replacement, logging, or forestry jobs or in improvements of public recreational zones; • persons working with live cultures of tick-borne encephalitis pathogen; • donors whose blood is used for specific immunoglobulin production. Results in specific immunity to tick-borne encephalitis virus; protects from both Asian and European viral strains.

Produced in 0.5ml ampoules (one dose) in 3, 5 or 10 ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Tomsk

24 HUMAN IMMUNOGLOBULINS

The acting agents of human immunoglobulin preparations produced by the MICROGEN subsidiaries are highly purified immunoglobulins isolated from blood plasma of healthy donors. In order to rule out the use of blood plasma from donors in incubation period of some infectious disease all doses of received plasma go through an obligatory quarantine for the minimal time of 3 months. Blood plasma used for the production goes through additional three tests to establish the absence of human immunodeficience virus (HIV-1 and HIV-2), and during the production additional stages ensure the high level of viral safety of the end products. According to the antibody spectrum, human immunoglobulin preparations can be used for prevention and treatment of dangerous infections, allergies and immunodeficiencies, as well as for increasing organism immunocompetence in reconvalescence periods after infectious diseases. Normal human immunoglobulins are produced from blood plasma of more than 1000 donors. They contain high concentrations of antibodies against infectious agents that are more common to Russia and posses a high range of antiviral and antibacterial activity. Specific immunoglobulins contain the highest concentration of antibodies against a certain pathogen and are meant for the therapy of the corresponding infectious disease.

25 NORMAL HUMAN IMMUNOGLOBULINS

immune globulin intravenous (HUMAN) solution for intravenous use

Produced in 25ml vials. Period of validity: 1 year. Manufacturer: MICROGEN subsidiaries in Nishny Novgorod and Khabarovsk.

IMMUNOVENIN (immune globulin intravenous HUMAN) lyophilized porous mass

Concentrate of immunologically active protein fraction of blood plasma from healthy donors that contains antibodies of various specificity. The preparation is also endowed with nonspecific activity which is realized in raised general resistance. Used in treatment of children and adults with inborn or acquired immunodeficiency, hypogammaglobulinemia, severe forms of bacteriotoxic and viral infections, postoperative complications with bacteremia and sepsis.

Preparation lyophilized from 25 or 50ml volume is presented in 25 or 50ml vials and solvent (25 or 50ml, water for injection). Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Ufa.

26 immune globulin intramuscular (HUMAN) solution for intramuscular injection

Concentrate of immunologically active protein fraction of blood plasma from healthy donors that contains antibodies of various specificity. The preparation is also endowed with nonspecific activity which is realized in raised general resistance. The immunoglobin series is produced from the plasma from 1000 healthy donors who are individually tested for the absence of surface antigen of viral hepatitis B (HBsAg) antibodies against hepatitis C and HIV-1 and HIV-2. Used for profylaxis of viral hepatitis A, measles, flu, whooping cough, meningococcal infection, poliomyelitis; for therapy of hypo- and agammaglobulinemia and in order to increase general resistance during convalescence period of infectious diseases.

Produced in 1.5ml ampoules (1 dose) in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Ekaterinburg, Irkutsk, Omsk, Perm, Tomsk, Ufa and Khabarovsk.

IMBIOGAM® (immune globulin intramuscular HUMAN) solution for intramuscular injection

Manufacturer: MICROGEN subsidiary in Nishny Novgorod.

IMMUNOGLOBULIN COMPLEX PREPARATION FOR ENTERAL ADMINISTRATION (KIP) lyophilizate for solution preparation for oral administration

Immunologically active protein fractions of human blood serum from healthy donors. Used for therapy of acute intestinal infections caused by enterobacteria in children from 1 month to 14 years of age.

Produced in vials with 300±25mg of protein (1 dose) in 5-vial packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Moscow.

27 SPECIFIC HUMAN IMMUNOGLOBULINS

ANTISTAPHYLOCOCCUS HUMAN IMMUNOGLOBULIN solution for intramuscular injection

Concentrate of immunologically active protein fraction of blood plasma from healthy donors with antibodies against staphylococcal exotoxins. Used in various diseases of staphylococcal etiology in children and adults. In generalized staphylococcal infection minimal single dose of the preparation is 5 IU for 1kg of weight, in localized forms no less than 100 IU. The preparation is intended for intramuscular injection only.

Produced in ampoules of 100 IU (1 dose) with 3 to 5ml volume. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Perm, Nishny Novgorod, Omsk, Tomsk, Ufa, Ekaterinburg, Irkutsk and Khabarovsk.

ANTITETANUS HUMAN GLOBILIN solution for intramuscular injection

Purified concentrate of immunologically active protein fraction of blood plasma from healthy donors immunized with tetanus toxoid. 1 ml contains not less than 50 IU of antibodies against tetanus toxin. Maximum concentration of antibodies in blood is achieved in 24 hours after the preparation administration. Used in emergency tetanus prophylaxis in adults and children who had not recieved the complete course of tetanus toxoid immunization or have an unknown immunization history.

Produced in 1-dose ampoules not larger than 5ml, in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Perm.

28 ANTIHEP (ANTIHEPATITIS B HUMAN GLOBULIN) solution for injection

Produced from blood serum (plasma) of healthy donors immunized by hepatitis B vaccine (recombinant, yeast, liquid). Used for emergency prophylaxis of hepatitis B in children and adults: • neonates of mothers who carry HbsAg or have acute hepatitis B; • persons without previous hepatitis B vaccination or with HBs-antibody levels lower than the protective one after an inadvertent infection because of the contact with an infected material; • persons from risk groups for hepatitis B infection.

Produced in 2ml ampoules (200 IU one dose), in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Perm.

Immunoglobulin human against encephalitis ixodicum solution for intramuscular injection

Produced from blood plasma from healthy donors. Acting agents are immunoglobulins of class G that have active antibodies neutralizing tick-borne encephalitis virus. The preparation also has non-specific properties that increase immunocompetence. Used for emergency prophylaxis and therapy of tick- borne encephalitis in adults and children. For emergency prophilaxis after a tick bite (not later than the 4th day) the preparation is administered to persons without immunization against tick-borne encephalitis or with an incomplete immunization course as well as in suspected laboratory infection by the virus. In cases of high infection risk the immunoglobulin is administered to immunized persons. The preparation can be used before possible contact with the virus of tick-borne encephalitis. The protective action appears in 24 - 48 hours and persists for about 4 weeks. For therapeutic purposes the immunoglobulin is administered as early as possible after the disease onset in various doses depending on body mass, clinical infection form, severity and disease stage.

Produced in 1ml and 3ml ampoules (with titer 1:320, 1:160; 1:80) in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Tomsk, Perm, Ufa, Ekaterinburg, Irkutsk, Omsk, Khabarovsk, Nizhny Novgorod.

29 ANTIALLERGIC HUMAN IMMUNOGLOBULINS

HISTAGLOBULIN lyophilizate for solution preparation for subcutaneous use

Complex of human blood serum immunoglobulin and histamine dihydrochloride on administration increases blood serum ability to activate free histamine. Used in therapy of allergic states in adults and children: chronic recurrent urticaria, allergic (atopic) dermatitis, eczemas, allergic migraines, bronchial asthma, asthmatic bronchitis, allegric rhinosinusopathy, allergic conjunctivitis, pollinosis (recommended use before flowering season), recurrent Quincke’s edema (excluding inherited angioneurotic edema). Therapy course is implemented in remission period.

Produced in kits of 1 histaglobulin ampoule (one dose) and 1 ampoule of solvent (isotonic solution of sodium hydrochlorate for injections) in 5-kit packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Tomsk and Ufa.

ANTIALLERGIC HUMAN GLOBULIN, LIQUID solution for intramuscular use

Purified concentrate of immunologically active protein fraction of blood plasma from healthy donors (not less than 1000 persons per every preparation batch). Used in therapy of immediate-type allergy, of mild to medium severity in remission stage in adults and children over 1 year of age: pollinosis with various clinical manifestations, atopical bronchial asthma, allergic recurrent urticaria and Quincke’s edema, allergic dermatosis.

Produced in ampoules of 1ml (1 dose) and 2ml (2 doses) in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod and Ufa.

30 HETEROGENOUS SERUMS

These are preparations of blood serum obtained from animals immunized by certain antigen and containing specific antibodies against these antigens. Heterologous serums are used for specific passive immunotherapy of several dangerous infections, i.e. botulism, tetanus, gas gangrene, diphtheria. The condition necessary for a heterologous serum use is the determination of the patient sensitivity. It is ascertained by intracutaneous test with a diluted preparation. The effectiveness of the preparation administration is the higher the earlier it is introduced into the organism of the person with the diagnosed or suspected disease.

ANTIBOTULINIC SERUMS OF A, D, E TYPES, PURIFIED, CONCENTRATED, LIQUID suspension for injections

Preparations of antibotulinic serums contain antitoxins that neutralise botulinic toxins of corresponding type. Used for therapy and prevention of botulism.

Monovalent antibotulinic serums are produced in ampoules containing one treatment dose for every botulinic toxin. A pack contains 5 ampoules of antibotulinic serum of one type and 5 ampoules of horse serum diluted 1:100 for determining a person’s sensitivity to foreign protein. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Stavropol and Ufa.

ANTIGANGRENE SERUM, POLYVALENT, PURIFIED, CONCENTRATED, HORSE, LIQUID solution for injection

Neutralizes toxins of anaerobic microbes Clostridium perfingens type A, edomatiens and septicum. Used for therapy and prevention of gas gangrene. Preventive administration of the serum is intramuscular, whereas the therapeutic one is performed by intravenous infusion.

Produced in ampoules with 30000 IU (one dose) of serum packaged with horse serum diluted 1:100. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Perm.

31 ANTIDIPHTHERIC SERUM, HORSE, PURIFIED, CONCENTRATED, LIQUID solution for intramuscular and subcutaneous use

Neutralizes toxins of diphtheria bacteria. Used for therapy of patients with diphtheria.

Produced in ampoules with 10000 IU (1 dose). A pack contains 5 ampoules of antidiphtheric serum and 5 ampoules of serum diluted 1:100. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Stavropol, Perm and Ufa.

ATNITETANIC SERUM, HORSE, PURIFIED, CONCENTRATED, LIQUID solution for intramuscular use

Neutralizes tetanus toxin. Used for emergency specific prophylaxis and therapy of tetanus.

Produced in 1ml ampoules (3000 IU) with 1ml of horse serum diluted 1:100, in 5-kit packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Ufa.

ANTI-VIPER (ANTI-ADDER) VENOM SERUM, HORSE, PURIFIED, CONCENTRATED, LIQUID solution for injection

Contains antitoxins neutralizing adder (Vipera bents) venom. Used for treating persons after a snakebite.

Produced in ampules (150 IU – one dose) in kits with sterile syringe and needle. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Stavropol.

32 CYTOKINES (INTERFERONS AND INTERLEUKINS)

Cytokines are “protein products of predominantly activated immune system cells devoid of specificity in respect to antigens and providing intercellular communication in hemopoiesis, inflammation, immune response and intersystem interactions”1. These proteins act by means of receptor interaction. Cytokines include interferons, interleukins, tumor necrosis factors, growth and colony-stimulating factors and chemokines. Cytokines were the basis for the development of immunotherapeutic preparations that are used in conjunction with other treatments for many pathologic processes that are accompanied by the reduced activity of the organism immune system. The MICROGEN company produces several drugs of this group.

______1 A.A. Yarilin, “Basic Immunology”, Moscow, 1999.

33 AFFINOLEUKIN ® lyophilizate for solution preparation for subcutaneous use

Immunostimulator. Complex of low molecular weight proteins isolated from human leukocytes containing antigenspecific cytokines of T-cell origin. Therapeutic indications. Deep forms of acute and recurrent ophthalmoherpes in protracted cases and secondary infections (as an addition to etiotropic medication) in adults and children over 4 years of age.

Produced in ampoules with 0.5; 1.0 or 2.0 IU in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Perm.

SVEFERON ® (HUMAN LEUKOCYTE INTERFERON) suppositories

Group of proteins produced by blood leukocytes of healthy donors in response to the action of interferonogenic virus. Has antiviral and immunostimulation effect. Therapeutic indications. Acute form of hepatitis B in children from 2 to 12 years of age (as part of a complex therapy).

Produced in 10-suppositories packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Perm.

HUMAN LEUKOCYTE INTERFERON (α-interferon), lyophilizate for solution preparation for intranasal administration

Contains proteins produced by donor blood leukocytes in response to the action of a interferon inductor virus. Therapeutic indications. Prevention and treatment of influenza and other acute respiratory viral infections. Preparation is most effective in early therapy.

Produced in 1000 IU ampoules (4 doses) in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Perm, Tomsk and Ufa.

34 BACTERIOPHAGES

Bacteriophages (phages) are viruses that are able to infect bacterial cells, reproduce there and cause lysis or the transference into lysogenic state. The process of bacteria destruction by phages (phagolysis) takes place in spontaneous recovery from a bacterial infection. Drugs containing bacteriophages act against certain types of bacterias, produce antibacterial effect, but do not affect human cells and do not destroy normal intestinal microflora (as opposed to most antibiotics). At present in this country the production of bacteriophages for prevention and treatment of enteric infections and also “wound” bacteriophages against main pathogens of pyoinflammatory diseases has been organized. Chances of the development of microbe flora resistance to bacteriophages are very low because bacteriophages are constantly adapting to circulating bacteria strains by means of renewal of phage races. Due to decreased therapeutic effectiveness of antibiotics barteriophage preparations are used in clinical practice as an alternative to other antibacterial agents. Bacteriophages do have no contraindications and can be combined with any other medicines. The absence of contraindications and complications in the therapeutic use of bacteriophage preparations, their combinability with other medicines (including antibiotics), their effectiveness against antibiotic-resistant strains characterize bacteriophage preparations as highly effective and promising therapeutic means of treatment of pyoinflammatory and enteral diseases. The necessary condition of effective phagotherapy is a preliminary determination of the pathogen phagosensitivity.

At present the subsidiaries of the MICROGEN company produce a wide range of bacteriophages for the therapy of various infectious diseases.

35 PSEUDOMONAS AERUGINOSA BACTERIOPHAGE solution for oral, local and external use

Possesses the ability to lyse Pseudomonas aeruginosa bacilli. Therapeutic indications. Treatment and prevention of pyoinflammatory and intestinal diseases caused by the Pseudomonas aeruginosa bacillus. Used in therapy of ear, nose and throat diseases, respiratory and pulmonary diseases, surgical infections (septic wounds, burns, abscess, phlegmon, furuncles, carbuncles, hydradenitis, felons, paraproctitis, mastitis, bursitis, osteomyelitis); urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis); enteral infections (gastroenterocolitis, cholecystitis); dysbacteriosis, generalized septic diseases, pyoinflammatory diseases of neonates (omphalitis, pyodermia, conjunctivitis, gastroenterocolitis, sepsis, etc.); other diseases caused by Pseudomonas aeruginosa. In prophylaxis the preparation is used in debridement of surgical and newly infected wounds as well as for prevention of hospital infections according to epidemic indications.

Produced in 20ml vials (4 or 10 vials per package) and in 100ml vials. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Perm, Ufa and Nizhny Novgorod.

COLIPROTEIC BACTERIOPHAGE solution for oral, local and external use

Possesses the ability to lyse enteropathogenic and Proteeae rods. Therapeutic indications. Treatment and prevention of pyoinflammatory and enteric diseases caused by enteropathogenic and Proteeae rods. Used in therapy of ear, nose and throat diseases, respiratory and pulmonary diseases (inflammation of frontal sinuses and middle ear, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleuritis); surgical infections (septic wounds, burns, abscess, phlegmon, furuncles, carbuncles, hydradenitis, felons, paraproctitis, mastitis, bursitis, osteomyelitis); urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis); enteric infections (gastroenterocolitis, cholecystitis, dysbacteriosis); generalized septic processes; pyoinflammatory diseases of neonates (omphalitis, pyodermia, conjunctivitis, gastroenterocolitis, sepsis, etc.); other diseases caused by Proteus and colibacillus. In prophylaxis the preparation is used in debridement of surgical and newly infected wounds as well as for prevention of hospital infections according to epidemic indications.

Produced in 20ml vials (4 or 10 vials per package) and in 100ml vials. Period of validity: 1 year. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod and Ufa.

36 STAPHYLOCOCCAL BACTERIOPHAGE solution for oral, local and external use

Possesses the ability to specifically lyse staphylococci. Therapeutic indications. Treatment and prevention of pyoinflammatory and enteric diseases caused by staphylococci. Used in therapy of ear, nose and throat diseases, respiratory and pulmonary diseases (inflammation of frontal sinuses and middle ear, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleuritis); surgical infections (septic wounds, burns, abscess, phlegmon, furuncles, carbuncles, hydradenitis, felons, paraproctitis, mastitis, bursitis, osteomyelitis); urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis); enteric infections (gastroenterocolitis, cholecystitis, dysbacteriosis); generalized septic processes; pyoinflammatory diseases of neonates (omphalitis, pyodermia, conjunctivitis, gastroenterocolitis, sepsis, etc.); other diseases caused by staphylococci. In prophylaxis the preparation is used in debridement of surgical and newly infected wounds as well as for prevention of hospital infections according to epidemic indications.

Produced in 20ml vials (4, 8 or 10 vials per package) and in 100ml vials. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod, Perm, Khabarovsk and Ufa.

1. DYSENTERIC BACTERIOPHAGE, POLYVALENT tablets

2. DYSENTERIC BACTERIOPHAGE, POLYVALENT tablets with enteric coating

3. DYSENTERIC BACTERIOPHAGE, POLYVALENT solution for oral and rectal use

Cause specific lysis of Schigellae Zonnei and Flexneri. Therapeutic indications. Prevention and treatment of bacterial dysentery. Prescribed to children (from 6 months of age) and adults. The use of the preparation is recommended for group diseases in institutions and families.

Produced in tablet form with 25; 50 or 100 tablets in glass or plastic vials, in 50-tablet blister packs or in 20ml vials (in 4 or 10 vial packages) or in 100ml vials. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod, Khabarovsk and Ufa.

37 KLEBSIELLA BACTERIOPHAGE, POLYVALENT, PURIFIED solution for oral, local and external use

Possesses the ability to specifically lyse bacteria Klebsiella pneumoniae, ozena and rhinoscleromatis. Therapeutic indications. Ozena, scleroma, and pyoinflammatory and enteric diseases caused by Klebsiella pneumoniae, ozena and rhinoscleromatis.

Produced in 10 or 20ml vials in 4 or 10-vial packages. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Ufa.

KLEBSIELLA PNEUMONIAE BACTERIOPHAGE, PURIFIED solution for oral, local and external use

Possesses the ability to specifically lyse bacteria Klebsiella pneumoniae. Therapeutic indications. Surgical infections (septic wounds, peritonitis, pleuritis, burns, mastitis, abscess), urogenital infections (cystitis, pyelonephritis, endometritis, salpingo-oophoritis); pyoinflammatory ENT diseases (ozena, rhinoscleroma); enteric infections (gastroenterocolitis, cholecystitis, dysbacteriosis); pyoinflammatory diseases of neonates and infants (omphalitis, pyodermia, conjunctivitis, gastroenterocolitis, sepsis).

Produced in 10 or 20ml vials in 4 or 10-vial packages. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Ufa.

KLEBSIPHAGE (KLEBSIELLA PNEUMONIAE BACTERIOPHAGE) solution for internal and topical use

Sterile filtrate of Klebsiella pneumoniae phagolysate. Therapeutic indications. Prevention and treatment of pyoinflammatory diseases caused by Klebsiella pneumoniae.

Produced in 20ml vials in 4 or 10-vial packages. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Perm.

38 COLI BACTERIOPHAGE solution for oral, local and external use

Possesses the ability to specifically lyse Escherichia coli bacillus. Therapeutic indications. Treatment and prevention of pyoinflammatory and enteric diseases caused by enteropathogenic colibacillus. Used in therapy of ear, nose and throat diseases, respiratory and pulmonary diseases (inflammation of frontal sinuses and middle ear, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleuritis); surgical infections (septic wounds, burns, abscess, phlegmon, furuncles, carbuncles, hydradenitis, felons, paraproctitis, mastitis, bursitis, osteomyelitis); urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis); gastroenteric infections (gastroenterocolitis, cholecystitis, dysbacteriosis); generalized septic processes; pyoinflammatory diseases of neonates (omphalitis, pyodermia, conjunctivitis, gastroenterocolitis, sepsis) and other diseases caused by colibacillus. In prophylaxis the preparation is used in debridement of surgical and newly infected wounds as well as for prevention of hospital infections according to epidemic indications.

Produced in 20ml vials (4 or 10 vials per package) and in 100ml vials. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Perm, Khabarovsk and Ufa.

PROTEUS BACTERIOPHAGE solution for oral, local and external use

Possesses the ability to lyse Proteus vulgaris and mirabilis bacteria. Therapeutic indications. Ear, nose and throat diseases, respiratory and pulmonary diseases (inflammation of frontal sinuses and middle ear, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleuritis); surgical infections (septic wounds, burns, abscess, phlegmon, furuncles, carbuncles, hydradenitis, felons, paraproctitis, mastitis, bursitis, osteomyelitis); urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis); enteric infections (gastroenterocolitis, cholecystitis, dysbacteriosis); generalized septic processes; pyoinflammatory diseases of neonates (omphalitis, pyodermia, conjunctivitis, gastroenterocolitis, sepsis); other diseases caused by Proteus. In prophylaxis the preparation is used in debridement of surgical and newly infected wounds as well as for prevention of hospital infections according to epidemic indications. The therapy of pyoinflammatory diseases with localized lesions should be provided both topically and orally for 7 – 20 days (according to clinical indications).

Produced in 20ml vials (4 or 10 vials per package) and in 100ml vials. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Perm, Khabarovsk and Ufa.

39 1. SALMONELLOSIS OF ABCDE GROUPS BACTERIOPHAGE, LIQUID solution for oral use

2. SALMONELLOSIS OF ABCDE GROUPS BACTERIOPHAGE tablets with enteric coating

3. SALMONELLOSIS OF ABCDE GROUPS BACTERIOPHAGE tablets

The preparations are based on sterile phagolysate filtrate of the more common salmonellae: group A – paratyphoid A, group B – paratyphoid B, group C – typhimurium, heidelberg, newport, choleraesuis, oranienburg, infantum; group D – dublin, enteritidis; group E – anatum, newlands. Bacteriophage preparations are able to lyse salmonellae of the above serotypes. Therapeutic indications. Prevention and treatment of salmonellosis.

Produced in 100ml vials; in tablet form (50 in a vial or blister pack, one package containing 10 vials or 5 blister packs); in 25; 50 or 100-tablet glass or plastic vials. Period of validity: 1 year. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod and Ufa.

STREPTOCOCCAL BACTERIOPHAGE solution for oral, local and external use

Sterile filtrate of phagolysed streptococcal strains. Therapeutic indications. Prevention and treatment of diseases caused by streptococci.

Produced in 20ml vials (in 4 or 10 vial packages) and in 100ml vials. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Perm and Ufa.

40 INTESTI-BACTERIOPHAGE solution for oral and rectal use

Mixture of filtrates of phagolysates active against Shigella flexneri 1, 2, 3, 4, 6 serovars and Zonnei, salmonellae of paratyphoid A and B, typhimurium, cholerae suis, infantum, oranienburg, enteritidis; enteropathogenic colibacillus of etiologically significant serovariants, enterococci, staphylococci, Pseudomonas aeruginosa, Proteus vulgaris and mirabilis. Intesti-bacteriophage possesses the ability to specifically lyse the above-mentioned bacteria. Therapeutic indications. Prevention and treatment of gastro-intestinal diseases caused by the above-mentioned pathogens or their combinations.

Produced in 20ml vials (in 4 or 10-vial packages) and in 100ml vials. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Perm, Nizhny Novgorod and Ufa.

PYOPOLYPHAGE (PYOBACTERIOPHAGE COMBINED, LIQUID) solution for oral and topical use

Possesses the ability to specifically lyse bacteria of staphylococci, streptococci (including enterococci), Proteus, pyocyaneus and coli-bacillus. Therapeutic indications. Prevention and treatment of pyoinflammatory diseases as well as dysbacterioses caused by the above-mentioned pathogens. Used in treatment of ear, nose and throat diseases, respiratory and pulmonary diseases (inflammation of frontal sinuses and middle ear, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleuritis); surgical infections (septic wounds, burns, abscess, phlegmon, furuncles, carbuncles, hydradenitis, felons, paraproctitis, mastitis, bursitis, osteomyelitis); urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis); enteric infections (gastroenterocolitis, cholecystitis); generalized septic processes; pyoinflammatory diseases of neonates (omphalitis, pyodermia, conjunctivitis, gastroenterocolitis, sepsis) and other diseases caused by the sensitive bacteria. In prophylaxis the preparation is used in debridement of surgical and newly infected wounds as well as for prevention of hospital infections according to epidemic indications.

Produced in 20ml vials (in 4 or 10-vial packages) and in 100ml vials. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Ufa.

41 PYOBACTERIOPHAGE POLYVALENT, PURIFIED solution for oral, local and external use

Possesses the ability to specifically lyse bacteria of staphylococci, streptococci, Proteus (mirabilis and vulgaris), Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli bacillus. Therapeutic indications. Prevention and treatment of various pyoinflammatory and gastrointestinal diseases caused by the above-mentioned pathogens. Used in treatment of surgical infections (septic wounds, pustulous skin lesions, burns, peritonitis, pleuritis, mastitis, bursitis, osteomyelitis); urogenital infections (cystitis, pyelonephritis, endometritis, vulvitis, bartholinitis, colpitis, salpingo-oophoritis); enteric infections (gastroenterocolitis, cholecystitis, pancreatitis, intestinal dysbacteriosis); pyoinflammatory diseases of ear, nose and throat, lungs and pleura (otitis, tonsillitis, pharyngitis, stomatitis, parodontitis, sinusitis, pneumonia, pleuritis); post-traumatic conjunctivitis, keratoconjunctivitis, purulent corneal ulcers and iridocyclitis; inflammatory diseases of neonates and infants, septicemias, septicopyemias of various localizations, omphalitis, pyodermia, enteritis, intestinal dysbacterioses.

Produced in 10 or 20ml vials in 4 or 10-vial packages. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Ufa.

SEXTAPHAGE ® (PYOBACTERIOPHAGE POLYVALENT) solution for oral, local and external use

Mixture of sterile filtrates of bacteria phagolysates of staphylococci, streptococci, Proteus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli bacillus. The preparation has the ability to specifically lyse bacteria of staphylococci, streptococci, Proteus (mirabilis and vulgaris), Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli (of various serogroups). Therapeutic indications. Prevention and treatment of various diseases caused by staphylococci, streptococci, Proteus (mirabilis and vulgaris), Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli (of various serogroups) as well as dysbacteriosis.

Produced in 20ml vials in 4 or 10-vial packages. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Perm.

42 PROBIOTICS (EUBIOTICS)

Probiotics are biological preparations of live strains of symbiotic intestinal microflora aimed at human microflora correction (in gastrointestinal tract and mucous linings). Probiotics have the ability to increase organism resistance during infectious diseases, in many cases they produce an antiallergic effect and normalize digestion. These preparations are prescribed for intestinal dysbacterioses, including those produced by antibacterial agents, in complex therapy of some allegric diseases, metabolic disbalance, obesity, etc. Many probiotics have an immunotropic effect. Lactobacteria and bifidobacteria affect various components of the immune system and normalize nonspecific and specific, cell and humoral immunity. Such probiotics as Lactobacterin and Bifidobacterin are necessary components of birth preparation of pregnant women, especially from the risk group for pyoseptic diseases. At present the Russian pharmaceutical market demands are met both by the domestic and foreign manufacturers. Domestic preparations have wider range of indications and can be used in various forms: for oral, rectal, intravaginal and external administration. Probiotics have practically no contraindications and can be used as preventive agents by persons of both sexes and all ages and of all social groups.

The subsidiaries of the MICROGEN company produce a number of the most popular probiotics.

43 BIFIDUMBACTERIN, DRY lyophilizate for solution preparation for topical and oral use

Contains live bifidobacteria that possess antagonistic activity against wide range of pathogenic and conditionally pathogenic microorganisms of the intestine (including staphylococci, proteus, enteropathogenic colibacillus, Schigellae, some yeastlike fungi). Restores the balance of intestinal and vaginal microflora, improves GI tract functioning, activates metabolism, enhances non-specific body resistance. Therapeutic indications. Solution for oral administration: Dysbacteriosis of GI tract of various ethiologies (prevention and treatment), including ulcers of the stomach and duodenum, pancreatitis and other gastro-intestinal diseases; allergic diseases, use of antimicrobial preparations, hormones and non-steroid anti- inflammatory drugs; acute intestinal infections (schigellosis, salmonellosis, staphylococcal enterocolitis, rotaviral infection, etc.), food toxicoinfection, malabsorption syndrome, chronic constipation or diarrhea in long-term antibacterial therapy; microbiocenosis correction before and after the surgery on the intestine, liver, pancreas; prevention of hospital infection and dysbacteriosis in patients with frequent URI. Solution for topical administration: Dysbacteriosis of urogenitary tract, acute and chronic inflammatory diseases of urogenitary tract (uncluding sexually transmitted urogenitary infections); preparation for obstetric surgery (in order to prevent postoperative complications); antepartum preparation of pregnant women from risk group for inflammatory diseases (for prevention and treatment of vaginal dysbacteriosis); prevention of mastitis in breastfeeding mothers from the risk group.

Produced in vials of 5 or 10 doses in 10-vial packages: in 5-dose ampoules in 10-ampoule packs. Period of validity: 1 year. Manufacturer: MICROGEN subsidiaries in Moscow, Nizhny Novgorod, Omsk, Perm, Stavropol, Tomsk, Ufa and Tumen.

44 BIFIDUMBACTERIN suppositories

The preparation contains live bifidobacteria with antagonistic activity against a wide range of pathogenic and conditionally pathogenic microorganisms. Normalizes microflorae of the intestine and vagina, improves metabolism, prevents protracted forms of intestinal diseases, enhances non-specific resistance of the organism. Therapeutic indications. Dysbacteriosis and inflammatory processes in the large intestine and vagina.

Produced in 5-suppository contour packs, in 2-pack packages. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

BIFICOL, DRY lyophilizate for solution preparation for oral use

Contains live bifidobarteria and colibacillus with antagonistic activity against pathogenic and conditionally pathogenic microorganisms, as well as immunomodulating and adjuvant activity due to bacterial antigens affecting the production of specific and non-specific protective factors (including local ones); stimulates local reparation processes in the intestine. Therapeutic indications. Treatment of intestinal dysfunction due to dysbacterioses of various ethiology and chronic colitis, states after acute intestinal infections accompanied by the ecxretion of conditionally pathogenic microorganisms. Acute intestinal infections (in complex therapy).

Produced in 5-dose vials (10 vials per package). Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

45 COLIBARTERIN, DRY lyophilizate for solution preparation for oral use

Microbial cells of strain M-17 colibacillus contained in the preparation have antagonistic action against pathogenic and conditionally pathogenic microorganisms. Therapeutic indications. Chronic colitis of various ethiologies. Reconvalescence after acute intestinal infections, intestinal dysfunction, pronounced dysbacteriosis, excretion of pathogenic and conditionally pathogenic bacteria.

Produced in 5-dose vials (10 vials per package). Period of validity: 1 year. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod, Stavropol, Tyumen.

LACTOBACTERIN (LACTOBACTERIA ACIDOPHILIC) vaginal suppositories

Lactobacilli from the preparation have antagonistic action against pathogenic and conditionally pathogenic microorganisms and create favorable conditions for normal vaginal microflora development. Lactobacterin suppositories are applied intravaginally. Therapeutic indications. Dysbacteriosis of various ethiology in children and adults.

Produced in packs of 10 suppositories. Period of validity: 1 year. Manufacturer: MICROGEN subsidiaries in Perm and Nizhny Novgorod.

46 LACTOBACTERIN, DRY lyophilizate for solution preparation for topical application and oral use

Lactobacilli from the preparation have antagonistic action against pathogenic and conditionally pathogenic microorganisms and create favorable conditions for normal intestinal microflora development. Is administered orally and intravaginally. Therapeutic indications. Chronic colitis of various ethiologies including non-specific ulcerative colitis, somatic diseases complicated by dysbarteriosis due to the antibiotics, sylfanilamide preparations and other causes; acute intestinal infections (in reconvalescence period) in intestinal dysfunction and excretion of pathogenic and conditionally pathogenic bacteria; nonspecific inflammatory diseases of genitalia and antepartum preparation of pregnant women from the risk group with III-IV stage of vaginal secretion composition abnormality; colpitis and vaginal dysbacteriosis after antibiotics.

Produced in 5-dose vials, in 10-vial packages. Period of validity: 1 year. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod, Omsk, Perm, Tomsk, Tyumen, Ufa.

47 BLOOD PRODUCTS

48 BLOOD PRODUCTS

Medicinal human blood products manufactured by MICROGEN facilities are highly purified proteins produced from blood plasma of healthy donors. The preparations are produced from blood plasma tested for the absence of human immunodeficiency virus (HIV-1 and HIV-2), viruses of hepatitis C and hepatitis B. In order to safeguard the production process against plasma from donors who gave their blood during incubating period of an infectious disease, all portions of plasma go through a mandatory quarantine of minimum 3 month duration. Production technologies include stages that provide additional viral safety of the end product. The end product is again tested for the absence of human immunodeficiency virus (HIV-1 and HIV-2), viruses of hepatitis C and hepatitis B. Blood products are generally used in various critical states that require emergency measures for the recovery of the vital functions. Depending on the main effect all products are used as plasma substitutes, fibrinolytics, antioxydants, mixtures for parenteral nutrition and as nonspecific biostimulants.

49 PLASMA SUBSTITUTES

ALBUMIN SOLUTION, 10%

Plasma substitute produced from the blood plasma of human donors. The preparation compensates the lack of plasma albumin and maintains oncotic blood pressure and hemodynamic indices, possesses detoxifying effect. In transfusion 10 g of albumin are equivalent to 200 ml of blood plasma. The preparation is administered by instillation with the rate of 40 drops per minute or in a stream. Indications: • albumin content in blood plasma below 3g/l, or colloid-osmotic pressure below 15 mm Hg, or overall protein level less than 5g/l; • hypoalbuminemia of various genesis (hemorrhagic, traumatic or thermal shock; acute blood loss – decrease of circulating blood volume more than by 25–30 percent; pyoseptic conditions; liver diseases with the impairment of albumin-synthesizing function; kidney diseases – nephritises and nephrotic syndrome; burn disease; • surgery with extracorporeal circulation; • therapeutic plasmophereses; • hemolitic disease of newborns in exchange transfusion; • pre-surgery hemodilution and autoblood component storage; • cerebral edema.

Produced in 100 and 200ml glass bottles for blood and transfusion products. Period of validity: 5 years. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod, Ekaterinburg, Omsk, Perm, Tomsk, Ufa and Khabarovsk.

50 PROTEIN solution for infusion

Protein product of isogenous human blood plasma. This hyperoncotic preparation promotes tissue fluid retention in blood circulation and produces antianemic effect. Indications: • traumatic and postoperative shock; • burns accompanied by dehydration and hemoconcentration; • hypoproteinemia and hypoalbuminemia of various ethiology including gastrointestinal tract pathologies with the nutrition disturbances (ulcerative disease, tumors, impeded gastrointestinal anastomosis patency); • hypoproteinemia developed in nutritional dystrophy, liver cirrhosis, prolonged suppurative processes, etc.; • clinical conditions whose genesis allows to suppose a decrease in erythropoiesis; • iron deficiency (in conjunction with an iron preparation).

Produced in 200ml bottles for transfusion preparations. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod, Ekaterinburg, Omsk.

PREPARATIONS FOR PARENTERAL NUTRITION

INFUSAMIN solution for injection

Contains all the essential and nonessential amino-acids, necessary for protein biosynthesis in the organism, does not contain proteins and peptides. Possesses anabolic, desintoxicating effect. Used for parenteral nutrition in conditions accompanied by protein deficit: • period before surgery operation and in postoperative period; • sluggish wounds, fractures, burns; • acute infections, inflammatory processes in the lungs; • gastritis and gastroduodenitis; • inflammations of the rectum (administered in microenemas). Absence of sugar makes it possible to use the preparation for diabetic patients. Infusamin is administered intravenously by instillator.

Produced in 100 and 450ml vials. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod and Ekaterinburg.

51 FIBRINOLYTIC PREPARATIONS

FIBRINOLYSIN powder for preparation of infusion solution

Fibrinolytic agent that promotes dissolving of fresh fibrin clots. Used for: • pulmonary embolism and embolism of peripheral arteries and cerebral vessels; • myocardial infarction; • acute thrombophlebitis and exacerbation of chronic thrombophlebitis; • thrombosis of the central retinal vein and its branches; • thrombosis of the central retinal artery (during first 24 hours); • hemorrhages into the anterior chamber of the eye, vitreous body of both the traumatic and endogenic nature.

Produced in dry form in bottles for blood, transfusion and infusion preparations with 20000 units. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

EYE FILMS WITH FIBRINOLYSIN

Fibrinolytic agent that promotes dissolving of fresh hemorrhages in various eye tissues. Fibrinolysin is slowly released from the polymeric base and acts for 24 hours. Used for: • hemorrhages into the anterior chamber of the eye (hyphema), vitreous body (hemophthalmus), retina of both the traumatic and endogenic nature; • thrombosis of the central retinal vein and its branches; • occlusion of the central retinal artery and its branches (during first 24 hours). The film is introduced into the conjunctival sac once a day after local anesthesia.

Produced in 10-film blister packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

52 ANTIOXIDANTS

CERULOPLASMIN lyophilizate for solution preparation for intravenous infusion

Ceruloplasmin is a copper-containing enzyme of α2-globulin fraction of human blood serum. It is a principal blood antioxidant and prevents peroxidation of cell membrane lipids, stimulates hemopoiesis, reduces intoxication and immunodepression. Used for: • hemopoiesis stimulation; • intoxication reduction and immunologic correction in complex therapy of oncologic patients; • pre-surgery preparation for weakened patients with anemia; • early postoperative period in cases of massive blood loss during surgical procedure; • pyoseptical complications in early postoperative period; • combined chemotherapy of oncologic patients including those with hemoblastosis with non-acute intoxication; • complex therapy of patients with acute and chronic osteomyelitis.

Produced in ampoules with 0.1g of the preparation in 5-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Nizhny Novgorod and Ufa.

53 NONSPECIFIC BIOSTIMULATORS

GLUNAT solution for injection

The preparation of human blood plasma or serum with the addition of glucose and sodium hydrocarbonate. Glunat enhances metabolic processes and accelerates tissue regeneration. Used in order to accelerate regeneration processes and stimulate body defense in persistent skin ulcers, gastric and duodenal ulcers, pneumonia and other diseases.

Produced in 5ml ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Tomsk.

PLASMOL solution for injection

Human blood preparation. Used as a nonspecific tissue therapy agent for: • diseases of peripheral nervous system (neuralgia, neuritis, radiculitis, etc.) with pain symptom; • gastric and duodenal ulcers; • chronic inflammatory processes; • bronchial asthma; • nonspecific arthritis and chronic rheumatoid arthritis.

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Ufa.

54 55 DRUGS OF OTHER PHARMACOLOGICAL GROUPS

56 DRUGS OF OTHER PHARMACOLOGICAL GROUPS

This drug group consists of about 40 preparations with stable pharmaceutical demand. The list of drugs is constantly changed and improved towards more effective preparations that have convincing factual base in the form of controlled clinical studies that comply with modern requirements. Drugs that are manufactured by the MICROGEN subsidiaries are characterized by high quality and prices more attractive than those of the foreign analogues. The produced preparations belong to the different groups of drugs.

57 Alpha-adrenomimetics

NAPHTHISIN SOLUTION nasal drops 0.1% INN: NAPHAZOLINE

Alpha-adrenostimulating agent; topical application causes vasoconstriction in the mucosa (reduces congestion and exudation), facilitates nasal breathing during rhinitis. Therapeutic indications. Acute rhinitis, allergic rhinitis, sinusitis, eustachitis, laryngitis, allergic laryngeal edema, post-radiation laryngeal edema, mucosal hyperemia after surgery on upper respiratory tract, chronic conjunctivitis, astenotopic disorders (accomodation abnormalities in excessive eye work), as additional medication in bacterial conjunctivitis. For epistaxis. For rhinoscopy facilitation.

Produced in 5ml or 10ml vials; in 10ml or 20ml vial-droppers. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Ekaterinburg.

m-Cholinoblockers

PLATIPHYLLINE HYDROTARTARATE solution for injection

Blocks m-choline receptors (similar to atropine) and also has direct myotropic spasmolytic effect. The preparation produces relaxation of smooth muscles of viscera and blood vessels, reduces gastrointestinal secretions, causes pupil dilation. Therapeutic indications. Gastric and duodenal ulcers, pylorospasm, intestinal, renal and hepatic colic, biliary dyskinesia, pain syndrom in pancreatitis. Bronchial asthma; spasm of cerebral arteries; arterial hypertension, angina pectoris (as part of combined therapy); algodysmenorrhea. Acute inflammatory eye diseases (iritis, iridocyclitis, keratitis), eye traumas; for pupil dilation in eye disease diagnostics and treatment.

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 5 years. Manufacturer: MICROGEN subsidiary in Perm.

58 Anticoagulants

HEPARIN solution for injection, 5000 units of activity/ml INN: HEPARIN SODIUM

Direct-action anticoagulant that belongs to the group of medium-molecular weight heparins, retards fibrin formation. Therapeutic indications. Thrombosis of deep veins, pulmonary embolism, coronary thrombosis, thrombophlebitis, unstable angina, acute myocardial infarction, fibrillating arrhythmia, prevention and therapy of microthrombosis and microcirculation disruption, renal vein thrombosis, hemolytic-uremic syndrome, mitral valvular disease (clottage prevention), bacterial endocarditis, glomerulonephritis, lupus nephritis. Prevention of clotting in surgery with extracorporeal blood circulation, in hemodialysis, hemosorption, peritoneal dialysis, cytopheresis, forced diuresis, in venous catheter washing.

Prodused in 5ml ampoules or vials in packs of 5, in 1ml ampoules or vials in packs of 5 or 10, in 2ml ampoules or vials in packs of 5 or 10. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Tomsk.

59 Fibrinolysis inhibitors

INHITRIL ® lyophilizate for solution preparation for intravenous injection INN: APROTININ

Polyvalent protease inhibitor with antiproteolytic, antifibrinolytic and hemostatic effect. The preparation inactivates main proteases (trypsin, chymotrypsin, kininogenase, kallikrein, including those that activate fibrinolysis). Therapeutic indications. Pancreatitis (acute and exacerbated chronic ones), pancreonecrosis. Diagnostic tests and surgeries on pancreas (as a preventive measure against pancreas autolysis). Prevention of acute nonspecific postoperative parotitis. Hemorrhage in hyperfibrinolytic states: posttraumatic, postoperative, pre- and postpartum and during birth (including amniotic fluid embolism), polymenorrhea. Angioneurotic edema. Shock (toxic, traumatic, burn and hemorrhagic ones). Extensive and deep traumatic tissue damage. As an additional therapy – in coagulopathies characterized by secondary hyperfibrinolysis (at initial stage, before the effect of heparin administration and replacement of clotting factors); massive hemorrhage (during thrombolytic therapy), in extracorporeal circulation. Prevention of postoperative pulmonary embolisms and hemorrhages, fat embolism in multiple traumas, especially those of lower extremities and cranial bones.

Produced in ampoules with 15 units of activity (15 units of activity = 10000 AtpU), in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Tomsk and Omsk.

60 Hemopoiesis stimulants

ERYTHROSTIM ® solution for injection INN: EPOETIN BETA

The agent stimulates erythropoiesis. Purified glycoprotein produced by genetic engineering techniques identical to human erithropoietin. Promotes red blood cell formation from precursor cells of erythrocytic series. Causes the increase in hemoglobin level and hematocrit, improves tissue blood supply and heart function. Effective in anemias connected with insufficient endogenic erythropoietin production. The most pronounced effect is observed in anemias caused by chronic renal diseases. Therapeutic indications. Anemia: • in chronic renal failure both after hemodialysis and before it: • after kidney transplantation; • in myeloblastosis; • with chemotherapy and radiation therapy of oncological patients; • after radiation exposure; • in neonates and premature infants; • in chemotherapy of HIV infection; • in rheumatoid arthritis.

Produced in 1ml ampoules with 500; 2000; 3000; 4000 or 10000 IU in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subdivision in Moscow.

61 Adenosinergetics

PENTOXIFYLLINE solution for injection, 2% INN: PENTOXIFYLLINE

Spasmolytic, antiaggregation, angioprotective, vasodilating and improving microcirculation agent. Therapeutic indications. Peripheral circulation problems (atherosclerosis obliteration of limb vessels, diabetic angiopathy, endarteritis obliterans, Raynaud’s syndrome); brain circulation disruption (ischemic stroke, cerebrovascular failure, discirculatory encephalopathy), viral neuroinfection (prevention of possible microcirculation problems); states after myocardial infarction; acute circulatory disruption in retina and choroid; otosclerosis, degeneration with pathology of inner ear vessels and gradual hearing impairment: obstructive bronchitis, bronchial asthma, pulmonary emphysema; impotence of vascular origin.

Produced in 5ml ampoules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Tomsk.

EUPHYLLINE solution for intravenous use INN: AMINOPHYLLINE

Relaxes bronchial musculature, rapidly relieves bronchial spasm. Produces moderate inotropic and diuretic effect, reduces vascular resistance, reduces vascular tone (mainly in brain, skin and renal vessels), dilates coronary vessels, reduces pressure in pulmonary artery system, improves diaphragm contraction, increases mucocyliary clearance, inhibits mediator release (histamine and leukotriens) from mast cells, stimulates respiratory center, enhances adrenaline release, inhibits platelet aggregation, improves microcirculation. Therapeutic indications. Bronchoobstructive syndrome in bronchial asthma, bronchitis, pulmonary emphysema, cardiac asthma (mainly for attack relief); hypertension of pulmonary circulation. Ischemic type brain circulation disturbance (as part of complex therapy). Left ventricle failure with bronchospasm and Cheyne-Stokes repsiration (as part of complex therapy).

Produced in 5ml or 10ml ampoules with 24mg in 1ml of solution. A pack contains 10 ampoules. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Tomsk.

62 H1 antihistamine agents

DIMEDROL solution for injection, 1% INN: DIPHENHYDRAMINE

Antihistamine agent, blocker of H1-type histamine receptors. Has antiallergic, sedative- somnolent and antiemetic action; in high doses blocks ganglia and decreases arterial pressure. Has some m-cholinoblocking effect. Therapeutic indications. Acute allergic reactions (urticaria, hay fever, angioneurotic edema, capillary toxicosis), allergic conjunctivitis, acute iridocyclitis, vasomotor rhinitis, rhinosinusopathy, allegric dermatitis, itching dermatoses. Insomnia. Pregnancy vomiting, Meniere’s syndrome, sea and motion sickness, radiation sickness. Extensive traumatic injuries of skin and soft tissuies, hemorrhagic vasculitis, serum sickness. Premedication.

Produced in 1ml ampoules of 1% solution, in 10-ampoule packs. Period of validity: 5 years. Manufacturer: MICROGEN subsidiaries in Stavropol and Ufa.

Anabolics

RIBOXIN solution for injection, 2% INN: INOSINE

Has anabolic, antihypoxic and anti-arrhythmic effect. Positively influences myocardial metabolism, improves coronary circulation, inhibits platelet aggregation, stimulates regenerative processes in tissues (particularly in myocardium and gastrointestinal lining). Therapeutic indications. Myocardial infarction, coronary deficiency, arrhythmias; cardiomyopathies of various etiologies, congenital and acquired heart diseases, myocarditis, coronary atherosclerosis, glycoside intoxication, myocardial dystrophy after great physical exertions and infections and due to endocrine disorders. Liver cirrhosis, acute and chronic hepatitis, alcohol and drug liver damages, fatty degeneration of liver , gastric and duodenal ulcer, porphyria. Drug poisoning; alcoholism; prophylaxis of leukopenia during radiation treatments.

Produced in 5ml or 10ml ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Stavropol, Ufa, Perm, Tomsk.

63 Vitamins and vitamin-like preparations

ASCORBIC ACID solution for injection, 5% INN: ASCORBIC ASID

Vitamin preparation with wide range of biological effects. Takes part in redox processes, hydrocarbon metabolism, blood clotting, tissue regeneration. Enhances immunocompetence, reduced vascular permeability, has antioxidative effect. Therapeutic indications. Vitamin deficiency and avitaminosis, increased vitamin C requirement (formula feeding and intensive growth period, hard work); for immune activation; prevention of URIs; fatigue; anemia; tissue regeneration stimulation; reconvalescence after serious ilness; liver diseases (hepatitis A, chronic hepatitis, liver cirrhosis), GI diseases (achylia, gastric and duodenal ulcer, especially after hemorrhage, enteritis, colitis, helminthiasis), cholecystitis, adrenal gland hypofunction (Addison’s disease), dystrophy, pregnancy and lactation period, hemosiderosis, erythrodermia, psoriasis, chronic extensive dermatosis. As an antioxidant the preparation is indicated in atherosclerosis, bronchial asthma, diffuse diseases of connective tissue (rheumatoid arthritis, scleroderma); anticoagulant overdose: poisoning by foxbane, benzocaine, aniline, disulfiram, barbiturates, benzene, dichlorethane, potassium permanganate, methanol, arsenic, carbon oxide, prussic acid, sulphanilamides, thallium, phenols, quinine.

Produced in 2ml ampoules in 10-ampoule packs. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Tomsk.

64 THIAMINE CHLORIDE solution for injection, 5% INN: THIAMINE

Vitamin B1. As the result of phosphorylation turns into cocarboxylase that serves as a coenzyme for many enzymatic reactions. Plays an important role in carbohydrate, protein and fat metabolism as well as in transmission of synaptic stimulation. Therapeutic indications.

Vitamin deficiency and avitaminosis of B1 vitamin, including patients on enteral feeding, hemodialisis, with malabsorption syndrome. Forms part of complex therapy of burns, prologned fever, neuritis and polyneuritis, radiculitis, neuralgia, peripheral pareses and paralyses, Wernicke encephalopathy, Korsakoff’s psychosis, chronic liver damages, various intoxications, myocardiodystrophy, coronary circulation disruption, gastric and duodenal ulcers, atonic constipation, intestinal atony, sprue, thyrotoxicosis, diabetes mellitus, endarteritis, dermatoses with neurotrophic lesions and dysbolism, pyodermia. The preparation is used in prolonged physical and psychological stress, during pregnance and breastfeeding, in dieting.

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Perm and Tomsk.

CYANOCOBALAMIN solution for injection INN: CYANOCOBALAMIN

Vitamin B12. Has hemopoietic and metabolic effects. In the form of coenzyme (adenosincobalamin) this agent is a part of many enzymes. It favorably influences hepatic and cardiac function and enhances tissue regeneration. Therapeutic indications.

Chronic anemias with vitamin B12 deficiency (Addison-Birmer’s disease, alimentary macrocytal anemia) as part of complex anemia therapy. Chronic hepatitis, liver cyrrhosis, liver failure. Alcoholism, prolonged fever. Polyneuritis, radiculitis, neuralgia, hypotrophy, funicular myelosis, trauma of peripheral nerves, amyotrophic lateral sclerosis, infantile cerebral paralysis, Down’s syndrome. Skin diseases.

Produced in 1ml ampoules in 10-ampoule packs. Manufacturer: MICROGEN subsidiary in Perm.

65 COCARBOXYLASE HYDROCHLORIDE for injection, 0.05g INN: COCARBOXYLASE

This substance is thiamine (vitamin B1) coenzyme, promotes acetyl-coenzyme A formation and takes part in carbohydrate metabolism regulation. Therapeutic indications. Cocarboxylase is prescribed in complex therapy of kidney and liver failure, diabetic pre-coma and coma, diabetic ketoacidosis, acute and chronic cardiovascular collapse and and arrhythmias, peripheral neuritis, various cataleptic states that require carbohydrate metabolism improvement. For children the preparation is prescribed with similar indications. For neonates the preparation is used in complex therapy of states connected with hypoxia and acidosis, including asphyxia during neonatal period, hypoxic encephalopathy, circulatory insufficiency, pneumonia, sepsis, etc.

Produced in 5ml ampoules with 0.05 g of the preparation in 10-ampoule packs. In kits with solvent – 5 ampoules of the preparation and 5 ampoules of water for injection (2ml ampoules). Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Stavropol, Ekaterinburg, Ufa, Omsk.

66 NICOTINIC ACID solution for injection, 1% INN: NICOTINIC ACID

Vitamin and hypolipidemic agent. Takes part in the metabolism of fats, proteins, purins, in tissue respiration, glycogenolysis, synthetic processes. Makes up vitamin PP (B3) deficiency, is a specific antipellagric (vitamin PP avitaminosis) agent. Has a wide range of hypolipidemic activity. Dilates small blood vessels, improves microcirculation, produces mild anticoagulatory effect (enhances fibrinolytic blood activity). Therapeutic indications. Vitamin PP deficiency and avitaminosis as well as states with increased vitamin PP requirement (pellagra, malnutrition and poorly balanced diet, malabsorption, fast weight loss), diabetes mellitus and its complications (diabetic polyneuropathy, microangiopathy), prolonged fever, gastroectomy, Hartnup disease, hepatobiliary diseases, hyperthyroidism, chronic infections, pregnancy, lactation period. Primary hyperlipidemia (Types IIa, IIb, III, IV, V), ischemic disruptions of brain circulation, obliterating diseases of blood vessels of extremities (endarteritis obliterans, Raynaud’s syndrome), spasm of blood vessels of extremities, biliary and urinary tracts, atherosclerosis, liver diseases (acute and chronic hepatitis), neuritis of facial nerve, hypoacid gastritis, enterocolitis, colitis, sluggish wounds and trophic ulces.

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 5 years. Manufacturer: MICROGEN subsidiaries in Ufa and Perm.

67 Detoxifying agents

GLUCOSE solution for infusion, 5% GLUCOSE solution for injection, 40%

Takes part in various metabolic processes, enhances redox processes, improves antitoxic liver function. Glucose solution infusion makes up water deficit. 5% solution has detoxifying, metabolic effect, acts as a source of easily metabolized nutrition. Hypertonic solutions increase osmotic blood pressure, improve metabolism; increase myocardial contractivity; improve antitoxic liver function, dilate blood vessels, increase diuresis. Therapeutic indications. Hypoglycemia, deficit of dietal carbohydrates, toxicoinfections, intoxications of liver diseases (hepatitis, liver dystrophy and atrophy, including liver failure), hemorrhagic diathesis; dehydration (vomiting, diarrhea, postoperative period); intoxication; collapse, shock. Serves as a component of blood substitutes and anti-shock fluids; in preparing solutions of drugs for intravenous injection.

Produced in 10ml ampoules (40% solution) in 10-ampoule packs; in 200ml vials for blood substitutes (5% solution). Period of validity: 6 years. Manufacturer: MICROGEN subsidiaries in Stavropol (40% solution) and Ufa (5% solution).

Cartilage and bone tissue metabolism correctors

CHONDROLON ® lyophilizate for injection solution preparation INN : CHONDROITIN SULFATE

High-molecular weight mucopolysaccharide produced from cattle cartilage tissue. Inhibits degenerative processes and promotes regeneration of joint cartilage and connective tissue, increases intraarticular fluid production, reduces joint pain. Therapeutic indications. Degenerative diseases of joints and spine: primary arthrosis, osteoarthrosis, arthropathies, vertebral osteochondrosis.

Produced in 100 mg ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Ufa.

68 Minerals and trace elements

POTASSIUM CHLORIDE solution for injection, 4%

Potassium preparation restores fluid balance. Reduces excitation, automatism and conduction as well as cardiac contractility. Therapeutic indications. Hypokalemia of various genesis (including diabetes mellitus, prologned diarrhea or vomiting, certain hypotensive and diuretic medications). Overdose of cardiac glycosides. Arrhythmia prevention in acute myocardial infarction.

Produced in 10ml ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Stavropol.

CALCIUM CHLORIDE solution for injection, 10%

Calcium preparation with antiallergic, anti-inflammatory, hemostatic, antiintoxicating effect. Replenishes the deficiency of calcium which is necessary for various biochemical and physiological processes. Therapeutic indications. Higher calcium requirements during growth period, lactation, pregnancy; hemorrhages of various etiology and localization, (pulmonary, gastrointestinal, nose, uteral, etc.); allergic diseases (serum disease, urticaria, fever syndrome, itching, angioneurotic edema); bronchial asthma, dystrophic alimentary edema, spasmophilia, tetany, pulmonary tuberculosis, rickets, osteomalacia, lead colic; hypoparathyroidism, hypocalcemia, vascular hyperpermeability (hemorrhagic vasculitis, radiation sickness), parenchymatous hepatitis, toxic hepatitis, nephritis, eclampsia, powerless labor, poisoning by magnesium salts, oxalic and fluoric acids; paroxysmal myoplegia (hypercaliemic form); inflammatory and exudative processes (pneumonia, pleuritis, adnexitis, endometritis, etc.); eczema, psoriasis. Insufficient dietary calcium, calcium malabsorption (pancreas enzyme insufficiency, achlorhydria, after gastroectomy and extensive intestinal resections) or increased excretion (chronic diarrhea, certain diuretics and antispasmodics). As antishock preparation in reanimation procedures in hyperkalemia, hypocalcemia or overdose of calcium-blocking preparations; in intoxication with magnesium salts, oxalates, phosphates or fluorides, chlorine or other irritating gases; chlororganics, radioactive phosphorus, strontium or radium; for hypocalcemia prevention.

Produced as a 10% solution in 5 or 10ml ampoules. Period of validity: 5 years. Manufacturer: MICROGEN subsidiary in Ufa.

69 MAGNESIUM SULPHATE solution for injection, 25%

On parenteral administration produces sedative, hypnotic, antispasmodic, tocolytic (myometrium relaxation) effect, in high doses has general anesthetic and curare-like (inhibition of neuromuscular transmission) effect. Magnesium is calcium physiological antagonist. Therapeutic indications. Hypertension stroke (including that with brain edema signs), eclampsy, encephalopathy, myocardial infarction, acute hypomagnesemia, convulsive syndrome, premature labour, some cardiac arrhythmias, heavy metal poisoning (mercury, arsenic, tetraethyl lead).

Produced in 5 and 10ml ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Ufa.

SODIUM CHLORIDE isotonic solution for infusion, 0.9% SODIUM CHLORIDE isotonic solution for injection, 0.9%

Plasma substitute. Has antiintoxicating and rehydrating effects. Replenishes sodium ion deficit in various pathologic states. Therapeutic indications. Massive losses of interstitial fluid or its insufficient uptake (toxic dyspepsia, cholera, diarrhea, uncontrollable vomiting, extensive burns with massive exudation, etc.), hypochloremia and hyponatremia with dehydration, ileus, intoxications; irrigation of wounds, eyes, nasal mucosa. Solution and dilution of drugs and moistening of dressings.

Produced in 5ml ampoules in 10-ampoule packs. In 200ml and 400ml vials for blood substitutes. Period of validity: for ampoules – 5 years, for vials – 1 year. Manufacturer: MICROGEN subsidiaries in Ufa (vials), Stavropol, Tomsk, Perm (ampoules).

70 Enzymes and antienzymes

LYDASE lyophilizate for injection solution preparation, 64 units INN: Hyaluronidase

Enzyme proteolytic agent. Possesses hyaluronidase activity, increases tissue and vascular permeability, enhances scar tissue resorption, reduces contractures. Therapeutic indications. Scars after burns, traumas and surgery; joint contractures, ankylosing spondilarthritis; surface soft tissue hematomas, chronic tendovaginitis, scleroderma, sluggish trophic ulcers. Complex therapy of myocardial infarction, hydrocephaly, rheumatoid arthritis, arachnoiditis, bronchial asthma, allergic rhinitis, pulmonary tuberculosis. Keratitis (for finer scarring of corneal lesions). Improves drug absorption in subcutaneous and intramuscular injection.

Produced in ampoules of 64 units of activity in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Tomsk, Perm, Omsk, Stavropol.

LYRASE ® lyophilized powder for injection solution preparation, 64 units INN: Hyaluronidase

This enzyme preparation breaks up primary component of connective tissue interstitial substance, i.e. hyaluronic acid. It increases tissue and vascular permeability, facilitates fluid motion in interspaces of tissues; reduces tissue swelling, softens and flattens scars, increases joint motion range, reduced contractures and prevents their formation. Therapeutic indications. Scars after burns, traumas and surgery; sluggish ulcers (including those after radiation); Dupuytren’s contractures, joint rigidity and contracture (after inflammation or traumas), osteoatrthrosis, ankylosing spondilarthritis; severe diseases of lumbar disks; chronic tendovaginitis, scleroderma (skin manifestations), surface soft tissue hematomas; preparation for plastic surgery on scar contractures, myocardial infarction, hydrocephaly, pulmonary tuberculosis (complicated by nonspecific bronchial lesions), inflammations of upper respiratory tract and bronchi with obstruction signs. Allergic rhinitis, rheumatoid arthritis, arachnoiditis (as part of complex therapy). Traumatic lesions of nerve plexus and peripheral nerves (plexitis, neuritis). Improves drug absorption in subcutaneous and intramuscular injection. Keratitis (for finer scarring of corneal lesions).

Produced in ampoules with 64 units of activity in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Ufa.

71 TRYPSIN CRYSTALLINE powder for solution preparation for injection and external application

Proteolytic enzyme. On topical administration promotes necrotic tissue rejection, thins purulent masses and facilitates their secretion, enhances wound regeneration. Thins viscous secretions. Therapeutic indications. Burns, bedsores, purulent wounds, iritis and iridocyclitis; hemorrhages into anterior chamber of the eye; respiratory tract diseases with viscous secretion and exudate accumulation, destructive forms of pulmonary and cervical lymph nodes tuberculosis, pneumonia, postoperation atelectasis , pleural empyema, tracheitis, bronchitis.

Produced in 10mg ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Perm and Tomsk.

CHYMOTRYPSIN lyophilizate for solution preparation for local and external application INN: CHYMOTRYPSIN

Proteolytic agent of protein structure. Manufactured from cattle pancreas. On intramuscular injection has antiinflammatory effect. On topical application breaks up necrotic tissues and fibrinous masses, thins viscous secretions, exudate, liquefies blood clots. Therapeutic indications. Thrombophlebitis, periodontosis (inflammatory-dystrophic forms), osteomyelitis, sinusitis, otitis, iritis, iridocyclitis, intracapsular cataract extraction, hemorrhages into anterior chamber of the eye, periorbital edema after surgery or trauma; thracheitis, bronchitis, pleural empyema, exudative pleuritis; burns, purulent wounds, bedsores (topically).

Produced in 10mg ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Tomsk.

72 Metabolics

SODIUM ADENOSINETRIPHOSPHATE solution for injection 1% INN: TRIPHOSADENIN

Metabolic agent, natural macroenergic compound with hypotensive and antiarrhythmic action. Dilates coronary and cerebral arteries. Improves tissue metabolism and enegry supply. Therapeutic indications. Paroxysmal tachycardia – for rapid relief of attacks.

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Perm.

Anxiolytics

SIBAZON solution for injection 0.5% INN: DIAZEPAM

Anxiolytic (tranquilizer) of benzodiazepine family. Decreases the level of anxiety, fear, emotional tension, also has a sedative, hypnotic, amnestic, antispasmodic and central muscle-relaxing effect. Relieves sympathoadrenal and parasympathetic (vestibular including) paroxysms. In withdrawal syndrome of chronic alcoholism produces decrease of agitation, tremor, negativism. Therapeutic indications. Anxiety disorders, epileptic status, insomnia. Dysphoria (combined with other medication). Spastic states of skeletal muscles of various etiologies (in local trauma, brain and spinal cord injuries, arthritis, arthrosis, myositis, bursitis). Vertebral syndrome, tension headache, angina pectoris (as an adjuvant). Alcohol withdrawal syndrome. Meniere’s disease. Premedication before surgical and endoscopy procedures, general anesthesia, as a component of combined general anesthesia. Prolonged agitation of various etiologies in neurology and psychiatry.

Produced in 2ml ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Tomsk.

73 Local anesthetics

LIDOCAINE HYDROCHLORIDE solution for injection 2% INN: LIDOCAINE

Local anesthetic and antiarrhythmic agent of IB class. Produces membrane stabilizing effect, inhibits ectopic excitation sites in conduction system of the heart. Therapeutic indications. As local anesthetic – for infiltration, conduction, spinal (epidural) anesthesia in various surgical procedures, blocking of peripheral nerves and plexuses. As antiarrhythmic agent – in prevention and treatment of ventricular arrhythmias (tachycardia, extrasystole, flutter, fibrillation) in myocardial infarction, anesthesia, pacemaker implantation, overdose of cardiac glycosides.

Produced in 2ml ampoules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Stavropol and Tomsk.

NOVOCAINE solution for injection 0.5% INN: PROCAINE

Local anesthetic. Inhibits nerve transmission of pain impulses and impulses of other modality. Therapeutic indications. Infiltration anesthesia in various surgical procedures; paranephral block, circulatory and paravertebral intracutaneous block in eczema and neurodermitis.

Produced in 2 and 5ml ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Ekaterinburg, Perm, Stavropol, Tomsk and Ufa.

74 Nootropic agents

PIRACETAM solution for injection 20% INN: PIRACETAM

This nootropic agent has good effect on metabolic processes in the brain. Improves integrative function, promotes memory consolidation, facilitates learning, provides protection in brain injuries due to hypoxia, intoxication, electric shock. Increases efficiency of mental work, improves cerebral circulation. Therapeutic indications. Chronic cerebrovascular insufficiency (impairment of memory, attention, speech, vertigo, headache); residual effects of brain circulation disruption; nervous system diseases with reduced intellective-mnestic function and abnormalities in emotional-volitional sphere. Neurotic syndrome, asteno-depressive syndrome of various genesis; apathetic defective states (schizophrenia, psychoorganic syndrome); depressive states resistant to antidepressants, low tolerance of antipsychotic medication (in order to reduce their side effects). Alcohol withdrawal syndrome, predelirious and delirious states, morphine withdrawal syndrome, acute poisoning with ethanol, morphine, barbiturates, benzedrine; chronic alcoholism. Sickle-cell anemia (as part of complex therapy). In pediatrics – when necessary to accelerate learning process and eliminate perinatal brain defects caused by hypoxia, birth trauma, in oligophrenia, mental retardation, cerebral palsy.

Produced in 5ml ampoules in 10-ampule packs. Period of validity: 5 years. Manufacturer: MICROGEN subsidiary in Perm.

CEREBROLYSATE solution for intramuscular injection

Concentrate of biologically active neuropeptides manufactured from animal brains. Stimulates protein synthesis in neural cells, increases brain tissue resistance to toxic effects, hypoxia, hypoglycemia. Enhances integrative processes in CNS, has positive effect on cognitive and emotional spheres. Therapeutic indications. CNS function disorders in adults caused by disruption of cerebral circulation; dyscirculatory encephalopathy; post-traumatic astenic syndrome. Used in complex therapy.

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Ufa.

75 Nonnarcotic analgetics, nonsteroid anti-inflammatory agents

ANALGIN solution for intravenous and intramuscular use INN: METAMIZOL SODIUM

This nonsteroid anti-inflammatory agent, pyrazolon derivative has an analgesic, antipyretic and mild anti-inflammatory effect. Therapeutic indications. Pain syndrome of mild and medium intensity of various origin (headache, migraine, toothache, neuralgia, myalgia, dysmenorrhea). Visceral pains: combined with spasmolytics for renal, intestinal and biliary colic. Pain relief after surgical and diagnostic procedures, traumas, burns, in decompression sickness. Febrile states in infectious inflammatory diseases, insect bites, posttransfusion complications. Drug administration advisability is established according to the pain intensity, character and tolerance.

Produced in 2ml ampoules of 50% solution in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Tomsk.

ORTOPHEN solution for injection 2.5% INN: DICLOPHENAC

Nonsteroid anti-inflammatory agent, phenylacetic acid derivative. Effective as anti- inflammatory, analgesic, antirheumatic, antipyretic and anti-aggregation, mostly for pains of inflammatory character. Therapeutic indications. Inflammatory and degenerative diseases of skeletal-muscular system: arthrites of various genesis (rheumatic, rheumatoid, psoriatic, gouty, etc.), ankylosing spondilitis, osteochondrosis, osteochondrosis deformans. Lumbago, sciatica, neuralgia, myalgia. Extraarticular tissue diseases (bursitis, tendovaginitis, rheumatic lesions of soft tissues). Posttraumatic and postoperative pain syndrome. Pain syndrome of cancer patients (combined with other analgesics). Renal and hepatic colic. Algodysmenorrhea, inflammatory processes in pelvis minor organs (adnexitis). Infectious inflammatory diseases of ENT-organs with pronounced pain syndrome (as part of complex therapy): pharyngitis, tonsillitis, otitis.

Produced in 3ml ampoules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Perm.

76 Gastrointestinal agents

DALARGIN lyophilizate for injection solution preparation

This is a synthetic hexapeptide, leucine enkephaline analog. Inhibits proteolysis and facilitates gastric and duodenal ulcer healing. Possesses moderate antisecretional activity, decreases gastric juice acidity. Inhibits external pancreatic secretion in response to various irritants (food, secretin, etc.). Has mild hypotensive effect. Therapeutic indications. Gastric and duodenal ulcer in exacerbation stage, acute pancreatitis, acute necrotic pancreatitis. The preparation is injected intravenously or intramuscularly.

Ptroduced in ampoules with 0.001g of the preparation in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Perm and Ufa.

“EQUINE”-natural gastric juice solution for oral administration

Enzyme preparation of animal origin with proteolytic effect. Contains all enzymes of gastric juices; free hydrochloric acid content equals 0.45–0.51%. Therapeutic indications. Achylia, hypoacidic and anacidic gastritis, dyspepsias.

Produced in 100ml vials. Period of validity: 1 year. Manufacturer: MICROGEN subsidiaries in Stavropol and Ufa.

77 Dental agents

PROPOLIS TINCTURE

The preparation contains bee glue and has anti-inflammatory, antimicrobial, antipruritic, analgesic (local) and wound healing effect. Therapeutic indications. Microtraumas, surface lesions of skin and mucosa, otitis, pharyngitis, tonsillitis. Catarrhal gungivitis, aphthous stomatitis, periodontosis. Infected wounds, persistent wounds, trophic wounds (in complex therapy). Itching dermatitis, atopic dermatitis.

Produced in 25 and 50ml vials. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Tomsk and Ufa.

Cardiovascular agents

DIBASOL solution for injection 1% INN: BENDAZOL

Vasodilating agent with direct spasmolytic action upon smooth muscles of blood vessels and internal organs; lowers arterial pressure, stimulates spinal cord function, effects moderate immunostimulation. Therapeutic indications. Spasm of peripheral arteries, coronary spasm, arterial hypertension (including hypertensive stroke); smooth muscle spasm of internal organs; gastric and duodenal ulcer, intestinal, renal and hepatic colic; residual effects of poliomyelitis, facial nerve peripheral paralysis, polyneuritis.

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 4 years. Manufacturer: MICROGEN subsidiaries in Stavropol and Ufa.

78 PAPAVERINE HYDROCHLORIDE solution for injection 2%

Spasmolytic hypotensive agent causing relaxation of smooth muscles of internal organs and blood vessels. Therapeutic indications. Spasm of smooth muscles of abdominal organs (hepatic colic, pylorospasm, renal colic), of peripheral vessels (endarteritis), coronary vessels. Angina pectoris (as part of complex therapy). Bronchial spasm (mild manifestation). For premedication in combination with other preparations.

Produced in 2ml ampoules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Stavropol, Perm and Ufa.

NITROGLYCERIN solution for injection 0.1%

Antianginal, vasodilatory, coronary vasodilatory agent of nitrate group. Relaxes smooth muscles of blood vessels (mostly veins), bronchi, gastrointestinal organs, ureters. Produces fast reduction of myocardium oxygen requirement (by means of reduction of cardiac preload and afterload). Therapeutic indications. Acute myocardial infarction, unstable and postinfarction angina, angina pectoris refractory to other therapies, central retinal artery occlusion.

Produced in 10ml ampoules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Stavropol.

79 Agents affecting prostate metabolism

PROSTACOR ® lyophilized powder for injection solution preparation

Extract of cattle prostate with positive organotropic effect on human prostate (reduces swelling, leukocytal infiltration and venule thrombosis, normalizes secretory function of epithelial cells), stimulates muscle tone of the bladder, has antiaggregant effect. Therapeutic indications. Chronic prostatitis (in complex therapy); after prostate surgery.

Produced in ampoules with 5mg of active agent in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Ufa.

Uterotonics

OXYTOCIN solution for injection 5 IU/ml INN: OXYTOCIN

Synthetic polypeptide analogue of the hormone of the posterior lobe of the pituitary that increases the uterine tonus, stimulates labor and has lactotropic effect. Therapeutic indications. Primary or secondary uterine inertia, necessity of pre-term birth due to gestosis, rhesus incompatibility, fetal death; postmature pregnancy (for labor induction), early moving of waters, labor with pelvic presentation, cesarean section (during operation). Uterine hypotonia after birth or abortion. Postpartum hypolactation. Painful premenstrual syndrome with edema and body weight increase.

Produced in 1ml (5 IU) ampoules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Ufa.

80 Antibiotics

GENTAMYCIN SULPHATE solution for injection 4% INN: GENTAMYCIN

Wide-range antibiotic of the animoglycoside group, inhibitor of intracellular protein synthesis. Has bactericidal properties: in high concentrations reduces barrier functions of cytoplasmic membrane and cause microorganism destruction. Bacterial resistance to gentamycin develops slowly, however, strains resistant to neomycin and canamycin can also demonstrate resistance to gentamycin. It does not affect fungi, viruses and protozoa. Therapeutic indications. Bacterial infections caused by sensitive microflora: upper and lower respiratory infections (bronchitis, pneumonia, pleural empyema), complicated urogenitary infections (pyelonephritis, cistitis, urethritis, prostatitis, gonorrhea, endometritis), infections of bones and joins, infections of skin and soft tissues, abdominal infections (peritonitis, pelvioperitonitis), CNS infections (meningitis, etc.) sepsis, wound infection, burn infection, otitis.

Produced in 2ml ampules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Tomsk.

LINCOMYCIN solution for injection 30% INN: LINCOMYCIN

Antibarterial agent, antibiotic of lincosamide group. Inhibits protein synthesis in bacterial cells. Effective mostly against aerobic gram-positive bacteria (staphylococci, including those resistant to several other antibiotics, streptococci, pneumococci, diphtheria bacillus) as well as clostridia, bacteroides, mycoplasmas. Lincomycin resistance develops slowly. Therapeutic indications. Bacterial infections caused by sensitive microorganisms: sepsis, subacute septic endocarditis, chronic pneumonia, pulmonary abscess, pleural empyema, pleuritis, otitis, osteomyelitis (acute and chronic), purulent arthritis, postoperative purulent complications, wound infection, infections of skin and soft tissues (pyodermia, furunculosis, phlegmon, erysipelas).

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Tomsk.

81 Aids (Adjuncts)

WATER FOR INJECTION solution for injection preparation

Used as a carrier or dosing vehicle for preparation of sterile infusion (injection) solutions from powders, lyophilizates and concentrates. Used in preparation of sterile solutions for subcutaneous, intramuscular, intravenous and other injections.

Produced in 2 or 5ml ampoules in 10-ampoule packs. Period of validity: 4 years. Manufacturer: MICROGEN subsidiaries in Tomsk (2ml ampoules) and Stavropol (2 and 5ml ampoules).

82 83 DIAGNOSTIC IMMUNOBIOLOGICAL AGENTS

84 DIAGNOSTIC IMMUNOBIOLOGICAL AGENTS

Modern diagnostics of infectious diseases requires new techniques that could allow to determine the genus, species or strain of the pathogen with high specificity, reliability and reproducibility. At present the MICROGEN facilities produce standardized diagnostic microbiological preparations that make it possible to diagnose most of the widespread and dangerous infections, which comprise viral, ricketsial, salmonellial, shigellial, tularemic, chlamidic and some other diagnosticums. The diagnosticum action is based on serological test methods where specific reactions result in antigen-antibody complexes with the subsequent visualized agglutination and precipitation. Microtest systems for the biochemical microorganism identification are systems of rapid diagnosing of infectious diseases used for differentiation of various pathogen groups. Microtest systems ensure reliability, constancy and comparability of bacteriologic test results with minimal labor expenditure. The reliability of these handy and simple testing is 98% and more. A microtest system is disposable and consists of a polystyrene container with compartments. The bottom part of it is filled with dehydrated (dried in place) culture medium without agar. The tablet is freed from the film and bacteriologic inoculation is performed. After several hours of incubation the microorganisms can be identified according to the color map. The immunobiologic diagnostic means also include preparations for disgnosis and therapy of allergic diseases – allergens and allergoids as well as the immunoenzyme allergodiagnostic systems.

85 ALLERGENS AND ALLERGOIDS

The MICROGEN company is the sole producer of pollen allergen preparation in The Russian Federation. According to leading diagnosticians and clinicians in the field of the diagnostics and therapy of allergic diseases, the allergens offered by the company possess high specific activity wich ensures their diagnistic and therapeutic efficiency in skin tests and specific hyposensitization procedures. The Stavropol MICROGEN subsidiary offers a wide range of pollen allergens and allergoids of the most common in Russia plants: 1. Allergens from tree pollens: birch, oak, maple, alder, hazel and ash for diagnosis and therapy. 2. Allergens from pollens of wild and cultivated grasses: orchard grass, sheave, maize, foxtail, fowl-grass, fescue, bent, couch-grass, ryegrass, rye, timothy-grass and dandelion. 3. Allergens from weed pollens: ambrosia (ragweed), wormwood, goose-foot, hemp, cyclahen, dandelion and sunflower. 4. Mixt-allergen from tree pollens (birch, oak, maple, alder, hazel and ash) for diagnosis and therapy. 5. Mixt-allergen from pollens of wild grasses (timothy-grass, orchard grass, ryegrass sheave, fescue, fowl-grass, couch-grass, foxtail) for diagnosis and therapy. 6. Mixt-allergen from weed pollens: ambrosia, wormwood, goose-foot and sunflower for diagnosis and therapy. 7. Allergoids from wild grass (orchard grass, fecque, timothy-grass) and weed (ambrosia, wormwood) pollens for therapy. 8. Mixt-allergoid of pollen orchard grass, fescue and timothy-grass for therapy. 9. Mixt-allergoid of pollen alder, birch, hazel for therapy.

Besides pollen allergoids MICROGEN produces house dust allergoid for the therapy of patients with house dust allergy.

Allergen preparations are water-salt extracts of plant pollen, their active substance being the protein-polysaccharide complex that provides for specific diagnostics and therapy of allergic diseases. The allergen ability to interact with specific antibodies (reagins) of pollinosis patient and cause reaction of the sensitized organism is the basis of the preparation diagnostic potential in both diagnostic tests in vivo and reactions in vitro. For diagnosis the preparation is used in skin tests (by scarification, intracutaneously and by prick test) as well as in challenge tests (nasal, conjunctival, inhalation). Among laboratory test methods are immunoenzymic, immunofluorescent analyses as well as the reaction of non-direct degranulation of rat mast cells. The organism ability to form immunologic tolerancy in response to small doses of allergen is the basis for the use of these preparation in the therapy of allergic diseases (allergic rhinitis, bronchial asthma). Prolonged specific stimulation of the patient’s immune system by subcutaneous administration of small doses of allergen produces hyposensitizing effect by means of production of blocking antibodies and results in the control of the disease.

Produced in kits for diagnosis and therapy: 1 vial with 5 ml of allergen (10000 PNU/ml), 1 vial with 4.5 ml of test-control fluid, 7 vials of diluent (4.5 ml each), 1 empty sterile vial. Period of validity: 2 years.

86 Allergoids differ from allergens in that the protein-polysaccharide complex extracted from the defatted pollen of a plant has been subjected to mild processing with formaldehyde. This process results in the protein molecule agglomeration and blocking of some portion of allergen determinants, the preparation possessing a reduced allergenicity but retaining its immunogenic properties. Allergoids can produce great therapeutic effect with less frequent administration than allergens do, causing fewer side effects even in hypersensitive patients. This allows to give higher doses of the preparation in shorter time periods and to greatly increase the allergoid total dose of the patient (as compared to immunotherapy with the corresponding allergen). As well as allergens, allergoids are used in specific immunotherapy of patients with allergic rhinitis and bronchial asthma sensitive to a plant pollen or house dust.

Mixt-allergens are produced in kits that contain 5ml of the mixt-allergen (10000 PNU/ml) in two vials, 4.5ml of diluent in seven vials and 4.5 ml of test-control fluid in one vial. Mixt-allergoids are produced in kits that contain one 5ml vial of the allergoid (10000 PNU/ml), eight 5ml vials of diluent and 1 empty sterile vial. Period of validity: 2 years.

Allergens and allergoids are administered subcutaneously in the upper third of the shoulder. The use of mixt-allergens is especially convenient in screening diagnosis and specific immunotherapy in polyvalent sensitization, and the use of allergoids makes possible speedy specific pre-seasonal therapy even of the highly sensitive patients without the risk of increased allergic complications. The allergic preparation nomenclature is being constantly increased. New commercial products include the mixt-allergoid of pollens of alder, birch, hazel as well as the mixt-allergoid of pollen of orchard grass, fescue and timothy-grass for therapy. Manufacturer: MICROGEN subsidiary in Stavropol.

Besides the allergens used for diagnosis and treatment of atopic diseases, MICROGEN produces infectious allergens for tularemia and brucellosis diagnosis.

87 BRUCELLOSIS ALLERGEN, FOR INTRACUTANEOUS ADMINISTRATION, LIQUID

Used for specific diagnosis of heightened sensitivity to brucella.

Produced in 1ml ampoules (10 doses) in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Omsk.

TULAREMIA ALLERGEN, FOR EPICUTANEOUS ADMINISTRATION, LIQUID (TULARIN) suspension for external scarification application

Used to determine immunity against tularemia and the disease diagnostics.

Prodused in 1ml ampoules (20 doses) in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Omsk.

88 PREPARATION FOR SERUM DIAGNOSTICS OF INFECTIOUS DISEASES

DIPHTHERIA ANtiTOXIN, PURIFIED BY ENZYMOLYSIS AND SPECIFIC SORPTION, DRY powder for diagnostics

Contains antibodies isolated by immunosorption-desorption on immobilized diphtheria toxoid from horse diphtheria serum, liquid, concentrated. Used for the determination of diphtheria germ toxicogenity in precipitation reaction in dense gel.

Produced in 1ml ampoules (minimum 500 IU) in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Perm.

TULAREMIA DIAGNOSTICUM FOR BULK AND BLOOD-DROP AGGLUTINATION REACTION, LIQUID diagnostic kit

In agglutination reaction minimal 2/3 volume of diluted serum titer should be agglutinated with diagnostic tularemic serum (serum titer should not be less than 1:1600). In blood-drop agglutination reaction (with serum blood content of agglutinins in 1:100 titer and more) after mixing of the hemolysed blood with tularemia diagnosticum the reaction should be immediate. Used for serum diagnostics of tularemia and discovery of specific antibodies in immunized persons or in those who had tularemia.

Produced in 1ml ampoules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Omsk.

89 RICKETTSIA PROWAZEKII DIAGNOSTICUM FOR complement fixation test (CFT), DRY lyophilizate for diagnosis

Lyophilized antigen complexes inactivated by phenol. Used for serum diagnostics of epidemic typhus and Brill’s disease.

Produced: diagnosticum-lyophilizate in 0.5ml ampoules and immune serum in 0.1ml ampoules in packs with 10 diagnosticum ampoules and 3 serum ampoules. Period of validity: 5 years. Manufacturer: MICROGEN subsidiary in Perm.

RICKETTSIA SIBERICA DIAGNOSTICUM FOR CFT, DRY lyophilizate for diagnosis

Lyophilized antigen complexes isolated by ether treatment from Rickettsia siberica grown in yolk sacs of developing chick embryos and inactivated by phenol. Used for serum diagnostics of Siberian tick typhus of North Asia.

Produced: diagnosticum in 1ml ampoules; serum in 0.1ml ampoules in packs with 10 diagnosticum ampoules and 3 ampoules of serum. Period of validity: 5 years. Manufacturer: MICROGEN subsidiary in Perm.

RICKETTSIA TYPHI DIAGNOSTICUM FOR CFT lyophilizate for diagnosis

Lyophilized antigen complexes isolated by ether treatment from Rickettsia typhi virulent strain “Isahanian” grown in yolk sacs of chick embryos and inactivated by phenol. The preparation working dilution contains not less then 4 antigen units in 1ml. The diagnosticum reveals complement-fixating antibodies against endemic flea-born typhus.

Produced: diagnosticum in 0.5ml ampoules; serum in 0.1ml ampoules in packs with 10 diagnosticum ampoules and 3 ampoules of serum. Period of validity: 5 years. Manufacturer: MICROGEN subsidiary in Perm.

90 CHLAMYDIA DIAGNOSTICUN FOR CFT AND indirect-CFT, DRY diagnostic multicomponent kit

Lyophilized specific antigen complexes of Chlamydia psittaci isolated by ether-acetone extraction from warmed at 1000C homogenate of yolk sacs of chick embryos infected by Chlamydia psittaci. Used for serum diagnostics of chlamydia infections of people and animals (including birds) by the detection of serum chlamydia antibodies in CFT and indirect-CFT.

Produced: dry chlamydia diagnosticum in 0.5ml ampoules with control diagnosticum in ampoules and chlamydia serum in ampoules. The kit contains 3 ampoules of chlamydia diagnosticum, 3 ampoules of control diagnosticum and 2 ampoules of chlamydia serum. Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Perm.

SALMONELLOSIS ERYTHROCYTAL DIAGNOSTICUM, Vi-ANTIGEN, LIQUID diagnostic suspension

The active agent of the diagnosticum is Vi-antigen fixed on erythrocyte surface. On contact with serums that contain antibodies against Vi-antigen erythrocytal agglutination occurs. Used for detecting antibodies against Vi-antigen of Salmonella typhi in human blood in passive hemoagglutination reaction.

Produced in 20ml ampoules in packs with 5 diagnosticum ampoules and 1 ampoule of diagnostic salmonellosis serum adsorbed receptor-Vi, liquid. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Moscow.

91 SALMONELLOSIS ERYTHROCYTAL DIAGNOSTICUM, O-ANTIGEN, LIQUID diagnostic suspension

The active agent of the diagnosticum are specific salmonella antigens fixed on erythrocyte surface. On interaction with serums containing antibodies against salmonellae erythrocytal agglutination occurs. O-antigen diagnosticums are produced for basic serum groups: A(1, 2, 12); B(1, 4, 12); C1(6, 7); C2(6, 8); D(1, 9, 12); E(3,10) as well as complex salmonellosis diagnosticum 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12. Used for detection of antibodies against salmonellial O-antigens in human blood by means of passive agglutination reaction.

Produced in 20ml ampoules in packs with 4 ampoules of diagnosticum of one serum group and 1 ampoule (1ml) with homologous diagnostic unadsorbed salmonellosis serum for passive hemagglutination reaction (PHAR); or with 4 ampoules with the complex diagnosticum and 6 ampoules (1ml) of diagnostic nonadsorbed salmonellosis serum for PHAR for separate O serum groups and 1 ampoule (20ml) with 1% suspension of non-sensitized ram erythrocytes (control). Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Moscow.

SHIGELLOSIS ERYTHROCYTAL DIAGNOSTICUMS: DISENTERY 1; 2; 3-7; FLEXNERI 1-5; FLEXNERI 6 AND SONNEI, ANTIGENIC, LIQUID diagnostic suspension

Suspension of formalinized ram erythrocytes sensitized by Shigella liposaccharide antigens in phosphate buffer solution. Formalin is used as a preservative. The active part of the diagnosticum are specific Shigella antigens fixed on erythrocyte surface. On contact with serums that contain antibodies against shigallae the erythrocyte agglutination phenomenon (PHAR) occurs. Used for detection of specific antibodies against various shigella types in passive hemagglutination reaction (PHAR).

Produced in 20ml ampoules. A pack contains 4 ampoules of diagnosticum and 1 ampoule with 1% nonsensitized formalinized ram erythrocytes (control erythrocytes), 1 ampoule (1ml) with dry nonadsorbed diagnostic shigellosis serum. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Moscow.

92 MENINGOCOCCAL ERYTHROCYTAL IMMUNODIAGNOSTICUMS, POLYSACCHARIDAL OF A, B, C, X, Y, Z, W-135 GROUPS AND LIPOSACCHARIDAL SPECIES-SPECIFIC, LIQUID diagnostic suspension

1% suspension of human erythrocytes of 0 (1) blood type formalinized in phosphate buffer solution and sensitized by group-specific meningococcal antigens of serum groups A, B, C, X, Y, Z, W-135. Formalin is used as a preservative. The active part of the diagnosticum are meningococcal antigens of serum groups A, B, C, X, Y, Z, W-135 fixed on erythrocyte surface. On contact with serums that contain antibodies against the above-mentioned antigens the erythrocyte agglutination phenomenon (PHAR) occurs. Used for detection of specific antibodies against polysaccharide meningococcal antigens in human blood serums in passive hemagglutination reaction (PHAR).

Produced in 20ml ampoules in 5-ampoule packs. The pack also contains 1 ampoule (1ml) of homologous meningococcal diagnostic serum. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Moscow.

IMMUNOGLOBULIN ERYTHROCYTAL IMMUNODIAGNOSTICUMS FOR DETECTION OF SURFACE ANTIGEN OF HEPATITIS B VIRUS (HBs-Ag), DRY “ROPGA-HBs-Ag” diagnostic kit for 450 tests

A kit contains lyophilized chicken erythrocytes sensitized by goat antibodies (anti-HBs), reactants for test confirmation (Ig-1, Ig-2), and positive control specimen (C+). Used for rapid detection of HBs-Ag in the blood serum of donors, patients with hepatitis B, medical personnel and other persons for carrier determination by means of reverse passive hemoagglutination reaction (RPHAR). Minimal detectible HBs-Ag concentration is 10 ng/ml and higher, while test time does not exceed 30 minutes. The kit for 400 tests and specificity confirmation of 50 specimens consists of 6 ampoules of sensitized erythrocytes, 2 Ig-1 ampoules, 2 Ig-2 ampoules, 1 C+ ampoule, ampoule blade and instruction.

Period of validity: 2 years. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

93 COMPLEMENT, DRY lyophilizate for diagnostics

Has the property of adsorbing on antigen-antibody complex. Used as an ingredient in complement fixation test (CFT).

Produced in 1ml ampoules in 10-ampoule packs; or in 5ml vials in 4-vial packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiaries in Tomsk, Perm and Ufa.

MICROTEST SYSTEMS FOR BIOCHEMICAL IDENTIFICATION OF MICROORGANISMS

Manufacturer: MICROGEN subsidiary in Makhachkala.

MICROTEST SYSTEM FOR BIOCHEMICAL IDENTIFICATION OF VIBRIOS (MTS-V)

Used for detection of enzyme activity of Vibrio genus microorganisms and species identification

Produced in 10-container polyethylene packages. container has 12 isolated compartments filled with substrate-indicator culture medium. The color of compartment contents depends on the indicator used and substrate pH. Period of validity: 1 year.

MICROTEST SYSTEM FOR BIOCHEMICAL IDENTIFICATION OF DIPHTHERIA CORYNEBACTERIA (MTS-CD)

Used for detection of biochemical activity of corynebacteria by testing glucose, saccharose and starch utilization and urease presence and for their differentiation by species.

Produced in 10-container polyethylene packages. The container is 88x13x14 mm large and has 12 isolated compartments with dry culture substrate. Their numbers are marked on the container wall. Period of validity: 1 year.

94 MICROTEST SYSTEM FOR RAPID DETECTION OF ENZYME ACTIVITY OF ENTEROBACTERIAceae (MTS-5E)

MTS compartments contain dried culture media with different hydrocarbons. The MTS hydrocarbons are: glucose, lactose, saccharose, mannitol, maltose. MTS-5E is intended for the detection of Enterobacteria family isolated during bacteriologic testing.

Produced in 10-container polyethylene packages. The container is 88x13x14 mm large and has 12 isolated compartments filled with substrate-indicator culture medium. One container holds 2 similar hydrocarbon lines. Period of validity: 1 year.

MICROTEST SYSTEM FOR BIOCHEMICAL IDENTIFICATION OF ENTEROBACTERIAceae (MTS-M-12E)

Used for detection of biochemical activity of enterobacteria by means of 12 tests: utilization of sodium citrate, mannitol, sodium malonate, glucose, lactose, production of hydrogen sulphide, indol, presence of urease, β-galactosidase, lysine decarboxylase, phenylalanine deaminase and for their differentiation by species.

MICROTEST SYSTEM FOR BIOCHEMICAL IDENTIFICATION OF STAPHYLOCCOCCI (MTS-S)

Used for detection of biochemical activity of staphylococci by means of 12 tests: fermentation of glucose and mannitol, oxydation of glucose and mannitol, utilization of lactose, xylose, saccharose, maltose, mannose, galactose, presence of urease, arginindehydrolase and for their differentiation by species.

Produced in 10-container polyethylene packages. The container has 12 isolated compartments with substrate-indicator culture media that contain one of the test-indicators. Period of validity: 1 year.

95 MICROTEST SYSTEM FOR RAPID IDENTIFICATION OF VIBRIO GROUPS BY HEIBERG TEST (MTS-H)

Used for detection of vibrio enzyme activity and their differentiation according to enzyme groups (Heiberg test).

Produced in 10-container polyethylene packages. The container has 12 isolated compartments with substrate-indicator culture media that contain one of the test-indicators: D-saccharose, D-mannose, L(+)-arabinose. Each container has 3 similar hydrocarbon lines with compartments. Period of validity: 1 year.

PAPER INDICATOR SYSTEMS (PIS) FOR MICROORGANISM IDENTIFICATION

Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

KIT №1. PIS for vibrio identification (13 tests)

Used for Vibrio genus identification and rapid cholera diagnosis. Allows to determine the following biochemical properties: utilization of glucose, lactose, saccharose, mannose, arabinase, mannitol, inositol; presence of lysine and ornitine decarboxylase, arginine dehydrolase, usease, oxydase; indole production.

KIT №2. PIS for intergenetic and speicies identification of enterobacteriaceae (13 tests).

Used for identification of microorganisms of Enterobecteria family by genus and species. Allows to determine the following biochemical properties: utilization of sorbitol, inositol, sodium citrate, sodium malonate; presence of lysine and ornitine decarboxylase, β-galactosidase, urease, phenylalanindeaminase, oxydase, acetylmethyl-carbinol (Foges-Proskauer reaction); production of indole and hydrogen sulphide.

96 KIT №3. PIS for water coli-index determination (2 tests).

Used for bacteriologic sanitary water monitoring: to determine the presence of Enterobecteria family in water by titration technique. Allows to determine the following biochemical properties: glucose utilization and oxydase presence.

KIT №4. PIS for bacteriologic sanitary water monitoring (3 tests).

Used for bacteriologic sanitary drinking water monitoring: to determine the presence of Enterobecteria family and heat tolerant coliform bacteria in water by membrane filtration technique. Allows to determine the following biochemical properties: glucose and lactose utilization and oxydase presence.

KIT №5. PIS for diphtheria corynebacteria identification (4 tests).

Used for the determination of biochemical properties of diphtheria corynebacteria isolated during bacteriological testing and their biologic variant identification. Allows to determine the following biochemical properties: utilization of glucose, saccharose and starch and urease presence. Disk is placed in the test tube with the proper testing medium (0.9% solution of sodium chloride, phosphate-salt buffer) where a full loop of 24-hour agar culture is suspended and incubated at +370C. Reaction is recorded according to the color change of the substrate solution.

PIS are produced in the form of slips in test tubes, disks in vials, 50 or 100 pieces for 50 or 100 tests respectively. On the consumer request kits №1 and №2 are supplemented by phosphate- salt buffer solution pH 5.4–5.6. Period of validity: 2 years.

97 IMMUNOENZYME TEST SYSTEMS

Test systems for viral infection diagnosis

These test systems are reactant kits for enzyme immunoassay (EIA) supplemented by polystyrene tablet with indentations where synthetic or recombinant viral antigens or viral-specific monoclonal antibodies are sorbed. Test systems manufactured by MICROGEN are intended for the detection of viral hepatitis B and C and tick-borne encephalitis. Test kits for the detection of hepatitis antigens and antibodies against these viruses are used mainly in screening of donors and risk groups in laboratories of hemotransfusion stations, State Health Monitoring centres and AIDS centres. Test system for tick-borne encephalitis diagnosis allows to detect the antigen of tick-born encaphalitis virus in suspension of carriers (ticks) as well as in the blood of persons with the disease and in the blood and organ suspension of laboratory animals, culture fluid and infected cell cultures. Immunoassay enzyme systems are highly sensitive and specific, are user-friendly and are widely used in virologic tests.

ENZYME IMMUNOASSAY SYSTEM FOR HEPATITIS B virus SURFACE ANTIGEN DETECTION (EIA-HBs-Ag) kit №1, kit №2, diagnostic kit

Kit №1 is aimed at detecting hepatitis B virus sufrace antigen (HBs-Ag) in blood serum and plasma of donors, hepatitis B patients, and persons from risk groups.

Kit №2 is additionally provided with reactants for the confirmation of positive result specificity and therefore can be used both for screening purposes similar to Kit №1, and for confirmation test. It allows to make either 192 screening tests or 96 confirmation tests. The system can detect and confirm the specificity of positive results for specimens with HBs-Ag concentrations of 0.5 ng/ml and higher.

Period of validity: 6 months. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

98 ENZYME IMMUNOASSAY SYSTEM FOR HEPATITIS C ANTIGEN DETECTION (EIA-anti-HCV) kit for 192 tests (kit C-04), strips

Allows to detect antibodies against hepatitis C virus in blood serum or plasma of donors and patients with hepatitis C. Test system sensitivity and specificity is 100% when a standard serum panel of serums for hepatitis C virus antibodies certified by the State Research Facility named after L.A.Tarasevich is used.

Period of validity: 6 months. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

ENZYME IMMUNOASSAY SYSTEM FOR THE CONFIRMATION OF POSITIVE RESULTS IN TESTING FOR HEPATITIS C virus ANTIBODIES “SPECTRUM-4” diagnostic kit for 48 specimens

Intended for the confirmation of positive immunoassay for hepatitis C virus antibodies in blood serum and plasma of donors and patients with hepatitis C. Test system sensitivity and specificity is 100% when a standard serum panel of serums for hepatitis C virus antibodies certified by the State Research Facility named after L.A.Tarasevich is used.

Period of validity: 6 months. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

ENZYME IMMUNOASSAY SYSTEM FOR THE DETECTION OF CLASS IgM ANTIBODIES AGAINST HEPATITIS C VIRUS (EIA-HCV-IgM) diagnostic kit

The test system is intended for detection of class IgM antibodies against hepatitis C virus in in blood serum and plasma of donors and patients with hepatitis C. The kit allows to test 48 specimens including control ones. Test system sensitivity and specificity is 100% when a standard serum panel of serums for hepatitis C virus antibodies certified by the State Research Facility named after L.A.Tarasevich is used. Test duration is not longer than 1.5 hours.

Period of validity: 6 months. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

99 ENZYME IMMUNOASSAY SYSTEM FOR THE DETECTION OF virus ANTIGEN OF THE TICK-BORNE ENcEPHALITIS diagnostic kit, kit №1 – 176 tests, kit №2 – 98 tests, including controls

Used for detection of antigens of virus tick-borne encephalitis in carrier suspensions (ticks) as well as in ill person blood, in blood and organ suspension of infected laboratory animals, culture broth of infected cell cultures. Produced in kits.

Period of validity: of kit №1 – 12 months, kit №2 – 6 months. Manufacturer: MICROGEN subsidiary in Tomsk.

Immunoenzime allergodiagnostic test systems

Manufacturer: MICROGEN subsidiary in Stavropol.

Allergodiagnostic test systems are used in the specific diagnosis complex for allergic diseases (bronchial asthma, atopic dermatitis, etc.).

Enzyme immunoassay system for the determination of allergen specific human IgE-antibidies

Is intended for semi-quantitative detection of allergen-specific IgE antibodies in blood serum by means of solid-phase immunoenzyme assay. Allows testing with the 30 most common allergens with blood serums of eight patients.

100 The following standard allergen panels are offered:

1st kit: pollen house, epidermal food

ragweed house dust chicken egg wormwood library dust milk goose-foot pillow feathers beef timothy-grass horse dandruff pork orchard grass guinea-pig fur chicken meat fescue cat fur duck meat birch dog fur hake alder rabbit fur cod hazel D. pteronissinus wheat flour sunflower D. farina maize

2nd kit:

pollen pollen, epidermal food

brome oak tangerine ash rye lemon fowl-grass couch-grass orange cyclahenum weed mixt chicken egg white dandelion wild grass mixt chicken egg yolk maple tree mixt barley bent human hair rye foxtail sheep wool rice hemp optional buckwheat ryegrass optional oatmeal

The kit consists of three plates with sorbed allergens and reactant set for testing. Period of validity: 6 months.

101 OTHER DIAGNOSTIC PREPARATIONS

RABBIT PLASMA, CITRATED, DRY lyophilizate for diagnosis

This preparation is a vacuum lyophilizate of citrated rabbit plasma obtained from rabbit blood by means of mixing it with 5% solution of sodium citrate. Rabbit plasma of 1:5 dilution should clot on contact with (18+2)hour culture of coagulase-positive staphylococci and should not clot when mixed with coagulase-negative staphylococci. Intended for identification of staphilococcal species in plasmocoagulation reaction.

Produced in 1ml ampules in 10-ampoule packs. Period of validity: 2 years. Manufacturer: MICROGEN subsidiaries in Stavropol and Tomsk.

BOTULINIC SERUMS OF A, B, C, E, F TYPES, NATIVE, HORSE OR CATTLE, FOR BIOLOGIC NEUTRALISING REACTION, DIAGNOSTIC, DRY diagnostic kits

These preparations are produced from the blood of horses hyperimmunized with botulinic monoatoxins and toxins of the respective types. Intended for diagnosis and identification of botulism pathogen type. Am ampoule contains not less than 200 IU for type A, 100 IU for type B, 150 IU for type C, 200 IU for type E, 200 IU for type F.

Produced in 1ml ampoules in 5-ampoule packs. Period of validity: 5 years. Manufacturer: MICROGEN subsidiary in Stavropol.

102 DIAGNOSTIC MONOSPECIFIC SERUMS AGAINST HUMAN IgG(H+L), IgG(H), IgM(H), IgA(H), DRY lyophilizate for diagnosis

These are blood serums of rabbits, goats or sheep that were hyperimmunized by human immunoglobulins IgG, IgM, IgA and containing antibodies against heavy chains of the respective immunoglobulins. The serum against IgG(H+L) also contains antibodies against light immunoglobulin chains. Control serum is a mixture of human blood serums (not less than 500 donors) with the set content of immunoglobulins IgG, IgM, IgA. Monospecific serums are intended for qualitative and quantitative detection of the respective immunoglobulins in norm and pathology in serum products and biologic fluids. The serums are used for diagnosis of various diseases as well as the assesment of immunoglobulin content of immunologically active preparations produced from human blood.

Produced in dry form in 1ml ampoules. A kit consists of 3 ampoules of each serum type against IgG(H+L), IgG(H), IgM(H), IgA(H) and one ampoule of control human blood serum (10 ampoules altogether). Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

DIAGNOSTIC MONOSPECIFIC SERUMS AGAINST KAPPA AND LAMBDA CHAINS OF HUMAN IMMUNOGLOBULINS, DRY lyophilizate for diagnosis

The preparations are manufactured from the blood of sheep, goats or rabbits immunized by normal IgG, myelogenic human IgG, or Bence Jones proteins (kappa and lambda types) containing antibodies against light chains of immunoglobulins. Intended for qualitative and quantitative detection of the respective immunoglobulin type proportion in blood serum and free light chains (Bence Jones proteins) in human urine. Monospecific serums against kappa and lambda chains of human immunoglobulins for qualitative test are used in immunoelectrophoresis and precipitation reaction; and for quantitative assessment of kappa and lambda immunoglobulin types – in reaction of radial immunodiffusion in gel.

Produced in dry form in 1ml ampoules in kits of one ampoule of each serum type (2 ampoules altogether). Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

103 SERUM FOR IMMUNOELECTROPHORESIS AGAINST SERUM PROTEINS OF HUMAN BLOOD, DRY lyophilizate for diagnosis

Blood serum product from sheep or rabbits hyperimmunized by normal serum of human blood. In reaction of immunoelectrophoresis with normal human blood serum it should demonstrate not less than 15 precipitin lines. They are detected visually. Intended for immunoelectrophoretic assay of immunoglobulins and other proteins in serum products and biologic fluids, as well as for the control of commercial preparations produced from human blood serum.

Produced in dry form in 1ml ampoules in 10-ampoule packs. Period of validity: 3 years. Manufacturer: MICROGEN subsidiary in Nizhny Novgorod.

CATTLE BLOOD SERUM FOR CULTURES, DRY lyophilizate for the preparation of diagnostic solutions

Growth-stimulating component of culture media for cell cultures. Lyophilized cream colored porous mass; hygroscopic, sterile.

Produced in 500ml glass bottles containing 200g of the serum. Period of validity: 5 years. Manufacturer: MICROGEN subsidiary in Ekaterinburg.

CATTLE BLOOD SERUM FOR CULTURES, LIQUID diagnostic solution

This native serum is produced from cattle blood by means of clotting, decanting of blood clots and erythrocytes and subsequent sterilizing filtration. Used as a growth-stimulating component of culture media for cell cultures. Added to the culture medium in quantities from 5 to 20% depending on the cell type and culturing conditions.

Produced in 400ml glass bottles. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Ekaterinburg.

104 CULTURE MEDIA

Microbiologic studies play an important part in diagnosis and modern therapy of infectious diseases as well as in bacteriologic sanitary monitoring of environment. The most important stage of the microbiologic study is pathogen isolation and identification, the use of culture media for the determination of genus, species and type of a microorganism. Culture media (CM) are biologic preparations used for growing microorganism cultures and studying their morphological, cultural and biochemical properties, susceptibility to bacteriophages and antibacterial agents, including antibiotics. CM are complex multicomponent systems that contain a substrate that acts as a source of nitrous supply and organic and inorganic elements. The substrate (base) is formed by a protein hydrolysate, the product of protein breakup. To it growth factor or vitamin source (yeast extract) is added. Gelforming agar serves as a skeleton and influences microorganism growth. Depending on the CM purpose it is mixed with carbohydrates, indicators, inhibitors, organic or inorganic salts. Dry culture media produced by the MICROGEN company are characterized by their high quality and stability that are guaranteed by the long production history and constant monitoring of all the technological stages of production process. In contrast to media produced in laboratories, commercial CM ensure reliability and uniformity of results as well as better quality and comparability of bacteriologic studies. Depending on bacteria groups and application spheres CM are divided into groups. Below is the list of culture media manufactured at present.

The main manufacturer of culture media is the MICROGEN subsidiary in Makhachkala. Several culture media are produced by the subsidiaries in Stavropol and Ekaterinburg.

105 Dry culture media

Culture base and growth factors – sources of nitrous supply and vitamins

▶ Culture agar for microorganism culturing, dry ▶ Culture broth for microorganism culturing, dry ▶ Culture yeast extract for microbiological culture media, dry ▶ Casein hydrolyzate of medium breakup degree, enzymatic, dry

Media for enterobacteriaceae: for isolation, accumulation and identification

▶ Culture medium for isolation of shigellae and salmonellae, dry (Ploskirev’s bactoagar) ▶ Culture medium for salmonellae isolation, dry (bismuth sulphite agar) ▶ Culture medium for enteric bacilli isolation, dry (Endo agar) ▶ Culture medium for isolation and differentiation of enteric bacilli, dry (Kod’s medium) ▶ Culture medium for salmonellae accumulation, dry (Leifson’s selenite broth) ▶ Culture medium for primary identification of enteric bacilli, dry (Ressel’s medium) ▶ Culture medium for identification of enteric bacilli, dry (Hiss medium with glucose) ▶ Culture medium for identification of enteric bacilli, dry (Hiss medium with lactose) ▶ Culture medium for identification of enteric bacilli, dry (Hiss medium with maltose) ▶ Culture medium for identification of enteric bacilli, dry (Hiss medium with mannitol) ▶ Culture medium for identification of enteric bacilli, dry (Hiss medium with saccharose) ▶ Culture medium for generic identification of enteric bacilli, dry (Simmons’ citrate agar) ▶ Culture medium for generic identification of enteric bacilli, dry (malonate agar) ▶ Culture medium for generic identification of enteric bacilli, dry (phenylalanin agar) ▶ Culture medium for generic identification of enteric bacilli, dry (glucose-phosphate broth) ▶ Culture medium for generic identification of enteric bacilli, dry (iron-glucose-lactose agar)

Media for conditionally pathogenic bacteria and Pseudomonas aeruginosa: for isolation, storage and transportation

▶ Culture medium for campilobacteria transportation, dry ▶ Culture medium for isolation and differentiation of aerobic infection pathogens, dry ▶ Culture medium for pseudomonas aeruginosa isolation, dry (CPCH-agar) ▶ Culture medium for pseudomonas aeruginosa identification, dry ▶ Culture medium for isolation of bacteria of Proteus, Providencia, Morganella genera, dry

106 Media for coccal bacteria group: for isolation and cultivation

▶ Culture medium base for isolation and cultivation of gonococci, dry (arginine agar)

Media for diphtheria corynebacteria: for isolation and identification

▶ Culture medium for isolation and differentiation of corynebacteria, dry (Buchin’s medium) ▶ Culture medium for determination of diphtheria microbe toxigenicity, dry ▶ Culture medium for corynebacteria identification by cystin breakup test, dry

Media for yeastlike fungi and protozoa: for identification and cultivation

▶ Culture medium for isolation of Candida fungi, dry (candida agar) ▶ Culture medium for isolation of Candida albicans fungi (Chlamydospore agar) ▶ Culture medium base for isolation of vaginal trichomonas

Media for extremely dangerous infections

▶ Culture medium for brucellae isolation and cultivation, dry (erythrite agar) ▶ Culture medium for isolation and cultivation of cholera vibrio, dry (alkaline agar) ▶ Culture medium for brucellae accumulation, dry (erythrite broth) ▶ Basic pepton, dry

Media for antibioticograms: for determination of microbial sensitivity to antibiotics

▶ Culture medium for determination of microbial sensitivity to antibiotics, dry (АGВ medium)

Media for ureaplasmae: for indication and isolation

▶ Culture medium base for Ureaplasma urealiticum indication, dry ▶ Culture medium base for ureaplasmae isolation (sulphate manganese agar)

Media for whooping cough pathogens: for isolation and cultivation

▶ Culture medium for whooping cough microbe isolation and cultivation, dry

107 Media for tubercle mycobacteria isolation

▶ Culture medium for tubercle mycobacteria isolation, dry (Löwenstein-Jensen culture), lyophilizate for diagnosis ▶ Culture medium for tubercle mycobacteria isolation, dry (Finn-2 culture), lyophilizate for diagnosis

Media for control of sterility and microbiological purity of drugs

▶ Culture medium for sterility control, dry (thioglycol medium) ▶ Culture medium №1 for microbial contamination control ▶ Culture medium №2 for microbial contamination control (Sabouraud agar) ▶ Culture medium №3 for microbial contamination control ▶ Culture medium №4 for microbial contamination control, dry (Endo agar) ▶ Culture medium №5 for microbial contamination control, dry (bismuth sulphite agar) ▶ Culture medium №8 for microbial contamination control ▶ Culture medium №10 for microbial contamination control

DESCRIPTION: Dry media are fine powders, while media for tubercle mycobacteria isolation are lyophilizates (fine-pored mass).

USAGE: A specified quantity of the preparation (stated on the label) is solved in 1 l of distilled water, filtered, autoclaved and poured out into Petri dishes or test tubes.

PACKAGING: Polyethylene vials with 200g, 370g or 400g, or 200g bags of three-layered laminate.

PERIOD OF VALIDITY: 2–5 years depending on the medium composition.

108 Liquid culture media

CULTURE MEDIUM 199, LIQUID

Water-solved mixture of inorganic salts, amino acids, vitamins, glucose and phenol red indicator (or without the indicator), sterilized by filtration. Used for the cultivation of the wide range of primary and reinoculated human and animal cells.

Produced in 450ml glass bottles. Manufacturer: MICROGEN subsidiary in Ekaterinburg.

HANK’S DIAGNOSTIC SOLUTION WITH PHENOL RED HANK’S DIAGNOSTIC SOLUTION WITHOUT PHENOL RED

Water-solved mixture of inorganic salts, glucose, phenol red (or without it), sterilized by filtration through filters with 0.22 μm. Used for producing culture media for the work with cell cultures and as a solvent of dry preparations.

Produced in 450ml glass bottles. Manufacturer: MICROGEN subsidiary in Ekaterinburg.

109 BIOLOGICALLY ACTIVE FOOD SUPPLEMENTS

110 BIOLOGICALLY ACTIVE FOOD SUPPLEMENTS

BIOLOGICALLY ACTIVE FOOD SUPPLEMENT “NARINE-TNC” ®

Health-improving effect of “Narine-TNC” is produced by acidophilic lactobacteria that are contained in the preparation. They enhance the production of vital amino acids, enzymes that provide digestion of proteins, fats and carbohydrates, vitamin synthesis of B-group, C, folic acid, etc. Bactericidal effect of lactobacteria is caused by the fact that during carbohydrate fermentation in the intestine they produce lactic acid, alcohol, lysozyme. As the result of lactobacteria interaction with other microorganisms, putrefactive and pyogenic enteric flora is inhibited thus reducing the possibility of pathogen penetration of the intestinal mucosa. The preparation is recommended for normalization of intestinal microflora, dysbacteriosis prevention and for enhancing nonspecific resistance of children and adults, in therapy of chronic gastrointestinal diseases, and when it is desirable to increase immune competence of people exposed to adverse ecological and climatic factors. “Narine-TNC” can be used either as an independent product or in conjunction with other agents (their effect is then enhanced). “Narine-TNC” is recommended for the industrial production of sour dairy products, in commercial production of formulas and dietetic products by infant milk kitchens of the State Health System. “Narine-TNC” is effective in dry, water-soluble and sour-milk forms.

Produced in glass vials or in combined packaging with 0.3g of the supplement; in 10-vial (or packet) packs. Period of validity: 1 year. Manufacturer: MICROGEN subsidiary in Tomsk.

111