WHO Model List of Essential Medicines
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Additions and Deletions to the Drug Product List
Prescription and Over-the-Counter Drug Product List 40TH EDITION Cumulative Supplement Number 09 : September 2020 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> AA STRIDES PHARMA 325MG;50MG;40MG A 203647 001 Sep 21, 2020 Sep NEWA ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION;ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE >D> AA WOCKHARDT BIO AG 120MG/5ML;12MG/5ML A 087006 001 Jul 22, 1981 Sep DISC >A> @ 120MG/5ML;12MG/5ML A 087006 001 Jul 22, 1981 Sep DISC TABLET;ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE >A> AA NOSTRUM LABS INC 300MG;15MG A 088627 001 Mar 06, 1985 Sep CAHN >A> AA 300MG;30MG A 088628 001 Mar 06, 1985 Sep CAHN >A> AA ! 300MG;60MG A 088629 001 Mar 06, 1985 Sep CAHN >D> AA TEVA 300MG;15MG A 088627 001 Mar 06, 1985 Sep CAHN >D> AA 300MG;30MG A 088628 001 Mar 06, 1985 Sep CAHN >D> AA ! 300MG;60MG A 088629 001 Mar 06, 1985 Sep CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> @ CEROVENE INC 325MG;5MG A 211690 001 Feb 07, 2020 Sep CAHN >A> @ 325MG;7.5MG A 211690 002 Feb 07, 2020 Sep CAHN >A> @ 325MG;10MG A 211690 003 Feb 07, 2020 Sep CAHN >D> AA VINTAGE PHARMS 300MG;5MG A 090415 001 Jan 24, 2011 Sep DISC >A> @ 300MG;5MG A 090415 001 Jan 24, 2011 Sep DISC >D> AA 300MG;7.5MG A 090415 002 Jan 24, 2011 Sep DISC >A> @ 300MG;7.5MG A 090415 002 Jan 24, 2011 Sep DISC >D> AA 300MG;10MG A 090415 003 Jan 24, 2011 Sep DISC >A> @ 300MG;10MG A 090415 003 Jan 24, 2011 Sep DISC >D> @ XIROMED 325MG;5MG A 211690 -
Lipid-Based Depots: Manufacturing, Administration and Interactions of Protein Drugs with Lipid Formulations
Dissertation zur Erlangung des Doktorgrades der Fakultät für Chemie und Pharmazie der Ludwig-Maximilians-Universität München Lipid-based depots: manufacturing, administration and interactions of protein drugs with lipid formulations Michaela Maria Breitsamer aus Starnberg, Deutschland 2019 II ERKLÄRUNG Diese Dissertation wurde im Sinne von § 7 der Promotionsordnung vom 28. November 2011 von Herrn Prof. Dr. Gerhard Winter betreut. EIDESSTATTLICHE VERSICHERUNG Diese Dissertation wurde eigenständig und ohne unerlaubte Hilfe erarbeitet. Wolfratshausen, den 20.05.2019 ________________________________ (Michaela Breitsamer) Dissertation eingereicht am: 20.05.2019 1. Gutachter: Prof. Dr. Gerhard Winter 2. Gutachter: Prof. Dr. Wolfgang Frieß Mündliche Prüfung am: 25.06.2019 III IV FOR MY FAMILY “The way to get started is to quit talking and begin doing” Walt Disney (1901 – 1966) V VI ACKNOWLEDGEMENTS The present thesis was prepared between March 2015 and December 2018 at the Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics at the Ludwig-Maximilians Universität (LMU) in Munich under the supervision of Prof. Dr. Gerhard Winter. First of all, I would like to express my deepest gratitude to my supervisor Prof. Dr. Gerhard Winter for giving me the opportunity to join his research group and to work on this extremely interesting and interdisciplinary project. I really appreciated his scientific input throughout all phases of this work, his elaborate advice and his guidance, which also contributed to my personal development over the last years. Furthermore, I would like to thank him for the outstanding working and team atmosphere, which he created at the chair, for supporting my participation in scientific conferences and for initiating and motivating me to the numerous collaborations which contributed to a successful thesis. -
National Antibiotic Consumption for Human Use in Sierra Leone (2017–2019): a Cross-Sectional Study
Tropical Medicine and Infectious Disease Article National Antibiotic Consumption for Human Use in Sierra Leone (2017–2019): A Cross-Sectional Study Joseph Sam Kanu 1,2,* , Mohammed Khogali 3, Katrina Hann 4 , Wenjing Tao 5, Shuwary Barlatt 6,7, James Komeh 6, Joy Johnson 6, Mohamed Sesay 6, Mohamed Alex Vandi 8, Hannock Tweya 9, Collins Timire 10, Onome Thomas Abiri 6,11 , Fawzi Thomas 6, Ahmed Sankoh-Hughes 12, Bailah Molleh 4, Anna Maruta 13 and Anthony D. Harries 10,14 1 National Disease Surveillance Programme, Sierra Leone National Public Health Emergency Operations Centre, Ministry of Health and Sanitation, Cockerill, Wilkinson Road, Freetown, Sierra Leone 2 Department of Community Health, Faculty of Clinical Sciences, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone 3 Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, 1211 Geneva, Switzerland; [email protected] 4 Sustainable Health Systems, Freetown, Sierra Leone; [email protected] (K.H.); [email protected] (B.M.) 5 Unit for Antibiotics and Infection Control, Public Health Agency of Sweden, Folkhalsomyndigheten, SE-171 82 Stockholm, Sweden; [email protected] 6 Pharmacy Board of Sierra Leone, Central Medical Stores, New England Ville, Freetown, Sierra Leone; [email protected] (S.B.); [email protected] (J.K.); [email protected] (J.J.); [email protected] (M.S.); [email protected] (O.T.A.); [email protected] (F.T.) Citation: Kanu, J.S.; Khogali, M.; 7 Department of Pharmaceutics and Clinical Pharmacy & Therapeutics, Faculty of Pharmaceutical Sciences, Hann, K.; Tao, W.; Barlatt, S.; Komeh, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown 0000, Sierra Leone 8 J.; Johnson, J.; Sesay, M.; Vandi, M.A.; Directorate of Health Security & Emergencies, Ministry of Health and Sanitation, Sierra Leone National Tweya, H.; et al. -
(12) Patent Application Publication (10) Pub. No.: US 2013/0253056A1 Nemas Et Al
US 20130253 056A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0253056A1 Nemas et al. (43) Pub. Date: Sep. 26, 2013 (54) CONTINUOUS ADMINISTRATION OF (60) Provisional application No. 61/179,511, filed on May LEVODOPA AND/OR DOPA 19, 2009. DECARBOXYLASE INHIBITORS AND COMPOSITIONS FOR SAME Publication Classification (71) Applicant: NEURODERM, LTD., Ness-Ziona (IL) (51) Int. Cl. A63L/216 (2006.01) (72) Inventors: Mara Nemas, Gedera (IL); Oron (52) U.S. Cl. Yacoby-Zeevi, Moshav Bitsaron (IL) CPC .................................... A6 IK3I/216 (2013.01) USPC .......................................................... 514/538 (73) Assignee: Neuroderm, Ltd., Ness-Ziona (IL) (57) ABSTRACT (21) Appl. No.: 13/796,232 Disclosed herein are for example, liquid aqueous composi (22) Filed: Mar 12, 2013 tions that include for example an ester or salt of levodopa, or an ester or salt of carbidopa, and methods for treating neuro Related U.S. Application Data logical or movement diseases or disorders such as restless leg (63) Continuation-in-part of application No. 12/961,534, syndrome, Parkinson's disease, secondary parkinsonism, filed on Dec. 7, 2010, which is a continuation of appli Huntington's disease, Parkinson's like syndrome, PSP. MSA, cation No. 12/836,130, filed on Jul. 14, 2010, now Pat. ALS, Shy-Drager syndrome, dystonia, and conditions result No. 7,863.336, which is a continuation of application ing from brain injury including carbon monoxide or manga No. 12/781,357, filed on May 17, 2010, now Pat. No. nese intoxication, using Substantially continuous administra 8,193,243. tion of levodopa and/or carbidopa or ester and/or salt thereof. -
Expert Review 2
2021 Expert Committee on Selection and Use of Essential Medicines Application review I.1 Albendazole, mebendazole and praziquantel for the indication of treatment of (item number) taeniid cestode cysts Does the application adequately ☒ Yes address the issue of the public health ☐ need for the medicine? No ☐ Not applicable Comments: The larval stages of three taeniid cestode parasites, Echinococcus granulosus, Echinococcus multilocularis and Taenia solium, produce cysts in humans that are of medical relevance. The diseases caused by these parasitic cysts are called cystic echinococcosis (CE), alveolar echinococcosis (AE), and cysticercosis (being neurocysticercosis (NCC) the most common form) respectively, and they are recognised by WHO as neglected tropical diseases. NCC is mainly a disease of poverty that predominantly affects rural populations in Africa, Asia and Latin America. Access to diagnostic and treatment, to better manage epilepsy and other NCC is a challenge for the people affected in these communities due to the availability and costs of specialised diagnostic and care. Stigma and social discrimination also mean that many people try to “hide” the disease. Briefly summarize the role of the The only real options for treatment of CE are albendazole (ALB) and Mebendazole proposed medicine(s) relative to other (MEB). ALB is the drug of choice as it has better bioavailability. ALB is also preferred to therapeutic agents currently included in MEB, because MEB requires a higher dose and a higher pill burden, for example, an the Model List, or available in the adult patient would require 8 tablets/day of MEB compared with 2 tablets/day ALB. market. ALB and praziquantel ( PZQ) are the only drugs used for the antiparasitic treatment of NCC. -
Food and Drugs Regulations
LAWS OF TRINIDAD AND TOBAGO 22 Chap. 30:01 Food and Drugs SUBSIDIARY LEGISLATION FOOD AND DRUGS REGULATIONS ARRANGEMENT OF REGULATIONS REGULATION 1. Citation. 2. Requirements prescribed by regulation. 3. Interpretation. 4. Request to Director. 5. Functions, duties, responsibilities of Inspectors. 6. Certificate of appointment. 7. Taking of photographs. 8. Taking samples and detention pending further examination. 9. Violation of Act or Regulations and relabelling or recondition ing of food, drug, cosmetic or device. 10. Issue of certificate. 11. Taking a sample, notification of intention and division of sample. 12. Division an interference and objection to procedure by owner or person. 13. Certificate of Analysis. 14. Definition of terms in Part II. 15. Offence to sell unlabelled food. 16. Labelling of package. 17. Declaration of net contents not required on certain labels. 18. List of ingredients not required on certain labels. 19. Declaration not required. 20. Declaration not required to indicate presence of flavouring. 21. Dried or dehydrated products. 22. Food from vending machine. 23. Non application of regulation 16. 24. Standard for a food. 25. Name of designation given to standard, grade or definition. 26. Adulteration of food. 27. Non-adulteration. 28. Contents of package. 29. Display of information on label. 30. First Schedule. 31. Offence. 32. Definition of terms in Part III. 33. Labelling of drug. 34. Contents of label. 35. Label on bulk package. 36. Drug sold on prescription. 37. Packing cases. LAWS OF TRINIDAD AND TOBAGO Food and Drugs Chap. 30:01 23 Food and Drugs Regulations [Subsidiary} REGULATION 38. Name and proportion of drug to be stated on label. -
ALBENDAZOLE (Extrapolation to All Ruminants)
European Medicines Agency Veterinary Medicines and Inspections EMEA/MRL/865/03-FINAL June 2004 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE ALBENDAZOLE (Extrapolation to all ruminants) SUMMARY REPORT (3) 1. Albendazole is a benzimidazole carbamate, used for the treatment of gastrointestinal infestations with roundworms, lungworms and tapeworms and adult flukes of Fasciola hepatica. Albendazole is currently entered into Annex I of Council Regulation (EEC) No. 2377/90 in accordance with the following table: Pharmacologically Marker residue Animal MRLs Target Other active substance(s) species tissues provisions Albendazole Sum of albendazole Bovine, 100 µg/kg Muscle sulphoxide, ovine 100 µg/kg Fat albendazole sulphone 1000 µg/kg Liver and albendazole 2- 500 µg/kg Kidney amino sulphone 100 µg/kg Milk expressed as albendazole 2. In reviewing the availability of endo- and ectoparasiticides for sheep and goats, albendazole was considered for extrapolation from bovine and ovine species to all ruminants. The considerations and criteria leading to the identification of albendazole are described in the Position Paper Regarding Availability of Veterinary Medicines – Extrapolation of MRLs (EMEA/CVMP/457/03-FINAL). 3. The scientific justification for this extrapolation was assessed in accordance with the Notes for Guidance on Risk Analysis Approach for Residues of Veterinary Medicinal Products in Food of Animal Origin (EMEA/CVMP/187/00-FINAL) and on the Establishment of Maximum Residue Limits for Minor Animal Species (EMEA/CVMP/153a/97-FINAL). 4. In setting the ADI in the original assessment of albendazole, the data summarised on the paragraphs below were considered. 5. The mode of action of albendazole is by binding strongly with the tubulin in the cells of nematodes. -
Neonatal Intensive Care Drug Therapy Update: a Bibliography
LWW/JPNN AS310-13 July 28, 2004 23:11 Char Count= 0 J Perinat Neonat Nurs Vol. 18, No. 3, pp. 292–306 c 2004 Lippincott Williams & Wilkins, Inc. Neonatal Intensive Care Drug Therapy Update: A Bibliography Jason Sauberan, PharmD BIBLIOGRAPHY I. Overview A. Clark RH, Bloom BT, Gerstmann DR Medications Used in Neonatal Intensive Care Units—A Descriptive Study [abstract 3047]. In: Program and abstracts of the 2004 Pediatric Academic Societies’ Annual Meeting, San Francisco, CA. B. Barr J, Brenner-Zada G, Heiman E, Pareth G, Bulkowstein M, Greenberg R, Berkovitch M. Unlicensed and off-label medication use in a neonatal intensive care unit: a prospective study. Am J Perinatol. 2002 Feb;19(2):67–72. C. O’Donnell CP, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics. 2002 Nov;110(5):e52. D. Committee on Drugs. American Academy of Pediatrics. Uses of drugs not described in the package insert (off-label uses). Pediatrics. 2002 Jul;110(1 Pt 1):181–3. II. Anti-infectives A. Linezolid 1. Deville JG, Adler S, Azimi PH, Jantausch BA, Morfin MR, Beltran S, Edge-Padbury B, Naberhuis-Stehouwer S, Bruss JB. Linezolid versus vancomycin in the treatment of known or suspected resistant gram-positive infections in neonates. Pediatr Infect Dis J. 2003 Sep;22(9 Suppl):S158–63. 2. Vo M, Cirincione BB, Rubino CM, Jungbluth GL. Pharmacokinetics of Linezolid in Neonates and Young Infants [abstract A-1409]. In: Program and abstracts of the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA. -
Efficacy and Tolerability of Quinacrine Monotherapy and Albendazole Plus Chloroquine Combination Therapy in Nitroimidazole-Refractory Giardiasis: a Tropnet Study
Klinik für Infektiologie & Spitalhygiene Efficacy and tolerability of quinacrine monotherapy and albendazole plus chloroquine combination therapy in nitroimidazole-refractory giardiasis: a TropNet study Andreas Neumayr, Mirjam Schunk, Caroline Theunissen, Marjan Van Esbroeck, Matthieu Mechain, Manuel Jesús Soriano Pérez, Kristine Mørch, Peter Sothmann, Esther Künzli, Camilla Rothe, Emmanuel Bottieau Journal Club 01.03.21 Andreas Neumayr Background on giardia treatment: • 1st-line treatment: 5-nitroimidazoles: metronidazole (1957), tinidazole, ornidazole, secnidazole • cure rate of 5NIs in 1st-line treatment: ~90% • in the last decade, an increase of 5NI-refractory giardia cases has been observed in travel medicine clinics across Europe: Hospital for Tropical Diseases, London: 2008: 15% --> 2013: 40% 70% of 5NI-refractory cases imported from India • 2nd-line treatment: effectiveness of a 2nd round with a 5NI: ~17% alternative drugs: albendazole, mebendazole, nitazoxanide, quinacrine, furazolidone, chloroquine, paromomycin 2012 TropNet member survey: 53 centres use 39 different treatment regimens, consisting of 7 different drugs in mono- or combination-therapy in various dosages and durations JC 01.03.21 Nabarro LE et al. Clin Microbiol Infect. 2015;21:791-6. • by 2013, there were only 13 reports of 2nd-line therapy for giardiasis (8 case series, 5 individual case reports): n=110 Cure rates Albendazole 6/32 18.7% Paromomycin 5/17 29.4% Nitazoxanide 2/5 40.0% Albendazole + 5-NI 42/53 79.2% Quinacrine 19/21 90.5% Quinacrine + 5-NI 14/14 100% Quinacrine + Paromomycin 2/2 100% • 2013: TropNet "GiardiaREF" study kick-off: Study on efficacy and tolerability of two 2nd-line regimens in nitroimidazole-refractory giardiasis: Quinacrine JC 01.03.21 Meltzer E et al. -
PSP: Some Answers
PSP: Some Answers Lawrence I. Golbe, MD Professor of Neurology, Rutgers Robert Wood Johnson Medical School Director of Clinical Affairs and Scientific Advisory Board Chairman, CurePSP October 2017 What is Progressive Supranuclear Palsy (PSP)? Of the approximately five to seven of every 100,000 people in Canada with progressive supranuclear palsy (PSP), few, if any, had ever heard of the disease before their diagnosis. In fact, most patients with PSP report that their family doctors knew nothing about it until a neurologist made the diagnosis. As of now, three of every four people with a diagnosis of PSP could have been diagnosed earlier, if their doctor had suspected it and performed the appropriate examination. However, it is appearing in medical journals more and more often, which will help doctors become familiar with PSP. This pamphlet should help patients and their families do the same. Why has no one heard of PSP? PSP is rare: no one even realized it existed until 1963, when several patients were first described at a national neurology research convention and the disease was given its name. In retrospect, at least 12 cases of PSP had appeared in the medical literature between 1909 and 1962, but because of its resemblance to Parkinson’s, it wasn’t recognized as a distinct disease. The brain under the microscope is almost identical to that of “post-encephalitic parkinsonism,” a common condition in the early 20th century but now nearly extinct, which also made for erroneous diagnoses during that era. Although PSP is slightly more common than the well-known amyotrophic lateral sclerosis (called ALS, or Lou Gehrig’s disease in the U.S. -
Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals
Journal of Clinical Medicine Review Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals Carlotta Cocchetti 1, Jiska Ristori 1, Alessia Romani 1, Mario Maggi 2 and Alessandra Daphne Fisher 1,* 1 Andrology, Women’s Endocrinology and Gender Incongruence Unit, Florence University Hospital, 50139 Florence, Italy; [email protected] (C.C); jiska.ristori@unifi.it (J.R.); [email protected] (A.R.) 2 Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, 50139 Florence, Italy; [email protected]fi.it * Correspondence: fi[email protected] Received: 16 April 2020; Accepted: 18 May 2020; Published: 26 May 2020 Abstract: Introduction: To date no standardized hormonal treatment protocols for non-binary transgender individuals have been described in the literature and there is a lack of data regarding their efficacy and safety. Objectives: To suggest possible treatment strategies for non-binary transgender individuals with non-standardized requests and to emphasize the importance of a personalized clinical approach. Methods: A narrative review of pertinent literature on gender-affirming hormonal treatment in transgender persons was performed using PubMed. Results: New hormonal treatment regimens outside those reported in current guidelines should be considered for non-binary transgender individuals, in order to improve psychological well-being and quality of life. In the present review we suggested the use of hormonal and non-hormonal compounds, which—based on their mechanism of action—could be used in these cases depending on clients’ requests. Conclusion: Requests for an individualized hormonal treatment in non-binary transgender individuals represent a future challenge for professionals managing transgender health care. For each case, clinicians should balance the benefits and risks of a personalized non-standardized treatment, actively involving the person in decisions regarding hormonal treatment. -
IV-23 N. Hydroxocobalamin (Cyanokit®)
N. Hydroxocobalamin (Cyanokit®) I. Classification •Cyanide antidote II. Actions •Binds cyanide ions with more affinity than hemoglobin molecule •Cyanide ion and hydroxocobalamin form cyanocobalamin (Vitamin B12) which is then excreted in the urine. III. Indications •Known or suspected cyanide poisoning - patients at high risk (industrial accidents, fire victims with smoke inhalation, known overdose, etc) with one more more of the following symptoms: - Altered mental status, confusion, seizures, coma - Headache - Chest pain or tightness - Shortness of breath, bradypnea, tachypnea - Hypertension (early), hypotension (late), cardiovascular collapse - Nausea, vomiting - Cardiac arrest - Mydriasis (dilated pupils) IV. Contraindications •Known allergic reaction to hydroxocobalamin or cyanocobalamin V. Adverse effects A. Cardiovascular •Ventricular extrasystoles •Tachycardia •Transient hypertension B. Neurological •Memory impairment •Dizziness •Restlessness C. Respiratory •Dyspnea •Dry Throat •Throat tightness D. Gastrointestinal •Abdominal discomfort •Dysphagia •Vomiting, diarrhea •Hematochezia E. General •Allergic reaction, pruritis, anaphylaxis •Hot flush SUBJECT : PATIENT CARE GUIDELINES AND STANDING ORDERS FOR BLS AND ALS UNITS REFERENCE NO. III-01 PUBLICATION : 1/11/21 IV-23 VI. Administration A. Do not administer hydroxocobalamin through the same IV site/set as the following medications: dopamine, fentanyl, dobutamine, diazepam, nitroglycerin, pentobarbital, propofol, thiopental, sodium thiosulfate, sodium nitrite and ascorbic acid. You must start a second IV to administer hydroxocobalamin in patient’s receiving these medications. B. Adult: •5 grams IV/IO over 15 minutes (Stocked as single 5gm bottle, or two 2.5 gm bottles) -Single 5 gm Bottle - Reconstituted with 200 ml Normal Saline. -Two 2.5 gm Bottles, give over 7.5 minutes each. - Each vial reconstituted with 100 ml Normal Saline. C. Pediatric •100 mg/kg IV/IO of hydroxocobalamin (reconstituted with Normal Saline the same as adults) over 15 minutes.