DOCSLIB.ORG

Subpart J—Certain Other Dosage Forms [Reserved] PART

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Subpart J—Certain Other Dosage Forms [Reserved] PART Pt. 448 21 CFR Ch. I (4±1±96 Edition) (ii) Samples required: Subpart HÐRectal Dosage Forms (a) The oxytetracycline hydro- [Reserved] chloride used in making the batch: 10 packages, each containing approxi- mately 300 milligrams. Subpart IÐ[Reserved] (b) The polymyxin B sulfate used in making the batch: 10 packages, each Subpart JÐCertain Other Dosage containing approximately 300 milli- Forms [Reserved] grams. (c) The batch: A minimum of 30 tab- PART 448ÐPEPTIDE ANTIBIOTIC lets. DRUGS (b) Tests and methods of assayÐ(1) Po- tencyÐ(i) Oxytetracycline content. Pro- Subpart AÐBulk Drugs ceed as directed in § 436.106 of this chap- ter, preparing the sample for assay as Sec. 448.10 Bacitracin. follows: Place a representative number 448.10a Sterile bacitracin. of tablets into a high-speed glass blend- 448.13 Bacitracin zinc. er jar containing sufficient 0.1N hydro- 448.13a Sterile bacitracin zinc. chloric acid to obtain a stock solution 448.15a Sterile capreomycin sulfate. of convenient concentration containing 448.20a Sterile colistimethate sodium. not less than 150 micrograms of oxytet- 448.21 Colistin sulfate. racycline per milliliter (estimated). 448.23 Cyclosporine. Blend for 3 to 5 minutes. Remove an al- 448.25 Gramicidin. iquot of the stock solution and further 448.30 Polymyxin B sulfate. dilute with sterile distilled water to 448.30a Sterile polymyxin B sulfate. the reference concentration of 0.24 448.75 Tyrothricin. microgram of oxytetracycline per mil- liliter (estimated). Subpart BÐOral Dosage Forms (ii) Polymyxin B content. Proceed as 448.121 Colistin sulfate for oral suspension. directed in § 436.105 of this chapter, pre- 448.123 Cyclosporine oral dosage forms. paring the sample for assay as follows: 448.123a Cyclosporine oral solution. Grind a representative number of tab- 448.123b Cyclosporine capsules. lets into a fine powder and place this powder, accurately weighed, into a fil- Subpart CÐInjectable Dosage Forms ter funnel with a solvent-resistant 448.210 Sterile bacitracin. membrane filter of 1.0 micrometer po- 448.215 Sterile capreomycin sulfate. rosity. Wash the powder with five 20- 448.220 Colistimethate sodium injectable milliliter portions of acetone or until dosage forms. the yellow color has disappeared. Re- 448.220a Sterile colistimethate sodium. move the filter and soak in 400 milli- 448.223 Cyclosporine for infusion. liters of 10 percent potassium phos- 448.230 Sterile polymyxin B sulfate. phate buffer, pH 6.0 (solution 6), and blend. Quantitatively transfer to a 500- Subpart DÐOphthalmic Dosage Forms milliliter volumetric flask and adjust 448.310 Bacitracin ophthalmic dosage forms. to volume with solution 6. Further di- 448.310a [Reserved] lute an aliquot with solution 6 to the 448.310b Bacitracin-neomycin sulfate- reference concentration of 10 units of polymyxin B sulfate ophthalmic oint- polymyxin B per milliliter (estimated). ment. (2) Loss on drying. Proceed as directed 448.310c Bacitracin ophthalmic ointment. in § 436.200(b) of this chapter. 448.313 Bacitracin zinc ophthalmic dosage forms. [43 FR 11174, Mar. 17, 1978, as amended at 50 448.313a Bacitracin zinc-polymyxin B sul- FR 19920, May 13, 1985] fate ophthalmic ointment. 834 VerDate 17<JUL>96 11:55 Jul 29, 1996 Jkt 167069 PO 00000 Frm 00829 Fmt 8010 Sfmt 8010 C:\CFR\21V5.001 pfrm13 Food and Drug Administration, HHS § 448.10 448.313b Bacitracin zinc-neomycin sulfate- SOURCE: 39 FR 19115, May 30, 1974, unless polymyxin B sulfate ophthalmic oint- otherwise noted. ment; bacitracin zinc-neomycin sulfate- polymyxin B sulfate hydrocortisone oph- thalmic ointment. Subpart AÐBulk Drugs 448.321 Colistin sulfate for ophthalmic solu- tion. § 448.10 Bacitracin. 448.330 Polymyxin B sulfate-trimethoprim (a) Requirements for certificationÐ (1) hemisulfate ophthalmic solution. Standards of identity, strength, quality, and purity. Bacitracin is a white to Subpart EÐOtic Dosage Forms brown, neutral water-soluble 448.421 Colistin sulfate-neomycin sulfate- polypeptide. It is so purified and dried thonzonium bromide-hydrocortisone ace- that: tate otic suspension. (i) Its potency is not less than 40 448.430 Polymyxin B sulfate-hydrocortisone units of bacitracin per milligram. otic solution. (ii) [Reserved] Subpart FÐDermatologic Dosage Forms (iii) Its loss on drying is not more than 5 percent. 448.510 Bacitracin dermatologic dosage (iv) Its pH in an aqueous solution forms. containing 10,000 units per milliliter is 448.510a Bacitracin ointment. not less than 5.5 and not more than 7.5. 448.510bÐ448.510c [Reserved] (v) It passes the identity test. 448.510d Bacitracin-neomycin sulfate oint- ment. (2) Labeling. It shall be labeled in ac- 448.510e Bacitracin±neomycin sulfate- cordance with the requirements of polymyxin B sulfate ointment. § 432.5 of this chapter. 448.510f Bacitracin-polymyxin B sulfate top- (3) Requests for certification; samples. ical aerosol. In addition to complying with the re- 448.513 Bacitracin zinc dermatologic dosage quirements of § 431.1 of this chapter, forms. each such request shall contain: 448.513a Bacitracin zinc-polymyxin B sul- fate ointment. (i) Results of tests and assays on the 448.513b Bacitracin zinc-neomycin sulfate batch for potency, loss on drying, pH, ointment. and identity. 448.513c Bacitracin zinc-neomycin sulfate- (ii) Samples required: 10 packages, polymysin B sulfate ointment; bacitracin each containing approximately 1.0 zinc-neomycin sulfate-polymyxin B sul- gram. fate hydrocortisone ointment. (b) Tests and methods of assayÐ(1) Po- 448.513d Bacitracin zinc-polymyxin B sul- fate topical powder. tency. Proceed as directed for baci- 448.513e Bacitracin zinc-polymyxin B sul- tracin zinc in § 436.105 of this chapter, fate topical aerosol. preparing the sample for assay as fol- 448.513f Bacitracin zinc ointment. lows: Dissolve an accurately weighed sample in sufficient 1.0 percent potas- Subpart GÐVaginal Dosage Forms sium phosphate buffer, pH 6.0 (solution [Reserved] 1), to obtain a stock solution of con- venient concentration. Remove an ali- Subparts H±IÐ[Reserved] quot of the stock solution, add suffi- cient hydrochloric acid so that the Subpart JÐCertain Other Dosage Forms amount of acid in the final solution 448.910 Bacitracin for prescription will be the same as in the reference compounding. concentration of the working standard 448.913 Bacitracin zinc for prescription and further dilute with solution 1 to compounding. the reference concentration of 1.0 unit 448.930 Polymyxin B sulfate in certain other of bacitracin per milliliter (estimated). dosage forms. 448.930a Polymyxin B sulfate for prescrip- (2) [Reserved] tion compounding. (3) Loss on drying. Proceed as directed 448.930b Sterile polymyxin B sulfate- in § 436.200(b) of this chapter. benzalkonium chloride urethral lubri- (4) pH. Proceed as directed in § 436.202 cant. of this chapter, using an aqueous solu- AUTHORITY: Sec. 507 of the Federal Food, tion containing 10,000 units per milli- Drug, and Cosmetic Act (21 U.S.C. 357). liter. 835 VerDate 17<JUL>96 11:55 Jul 29, 1996 Jkt 167069 PO 00000 Frm 00830 Fmt 8010 Sfmt 8010 C:\CFR\21V5.001 pfrm13.
Load more

Recommended publications
  • Antibiotic Assay Medium No. 3 (Assay Broth) Is Used for Microbiological Assay of Antibiotics. M042
    HiMedia Laboratories Technical Data Antibiotic Assay Medium No. 3 (Assay Broth) is used for M042 microbiological assay of antibiotics. Antibiotic Assay Medium No. 3 (Assay Broth) is used for microbiological assay of antibiotics. Composition** Ingredients Gms / Litre Peptic digest of animal tissue (Peptone) 5.000 Beef extract 1.500 Yeast extract 1.500 Dextrose 1.000 Sodium chloride 3.500 Dipotassium phosphate 3.680 Potassium dihydrogen phosphate 1.320 Final pH ( at 25°C) 7.0±0.2 **Formula adjusted, standardized to suit performance parameters Directions Suspend 17.5 grams in 1000 ml distilled water. Heat if necessary to dissolve the medium completely. Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes. Advice:Recommended for the Microbiological assay of Amikacin, Bacitracin, Capreomycin, Chlortetracycline,Chloramphenicol,Cycloserine,Demeclocycline,Dihydrostreptomycin, Doxycycline, Gentamicin, Gramicidin, Kanamycin, Methacycline, Neomycin, Novobiocin, Oxytetracycline, Rolitetracycline, Streptomycin, Tetracycline, Tobramycin, Trolendomycin and Tylosin according to official methods . Principle And Interpretation Antibiotic Assay Medium is used in the performance of antibiotic assays. Grove and Randall have elucidated those antibiotic assays and media in their comprehensive treatise on antibiotic assays (1). Antibiotic Assay Medium No. 3 (Assay Broth) is used in the microbiological assay of different antibiotics in pharmaceutical and food products by the turbidimetric method. Ripperre et al reported that turbidimetric methods for determining the potency of antibiotics are inherently more accurate and more precise than agar diffusion procedures (2). Turbidimetric antibiotic assay is based on the change or inhibition of growth of a test microorganims in a liquid medium containing a uniform concentration of an antibiotic. After incubation of the test organism in the working dilutions of the antibiotics, the amount of growth is determined by measuring the light transmittance using spectrophotometer.
    [Show full text]
  • Infant Antibiotic Exposure Search EMBASE 1. Exp Antibiotic Agent/ 2
    Infant Antibiotic Exposure Search EMBASE 1. exp antibiotic agent/ 2. (Acedapsone or Alamethicin or Amdinocillin or Amdinocillin Pivoxil or Amikacin or Aminosalicylic Acid or Amoxicillin or Amoxicillin-Potassium Clavulanate Combination or Amphotericin B or Ampicillin or Anisomycin or Antimycin A or Arsphenamine or Aurodox or Azithromycin or Azlocillin or Aztreonam or Bacitracin or Bacteriocins or Bambermycins or beta-Lactams or Bongkrekic Acid or Brefeldin A or Butirosin Sulfate or Calcimycin or Candicidin or Capreomycin or Carbenicillin or Carfecillin or Cefaclor or Cefadroxil or Cefamandole or Cefatrizine or Cefazolin or Cefixime or Cefmenoxime or Cefmetazole or Cefonicid or Cefoperazone or Cefotaxime or Cefotetan or Cefotiam or Cefoxitin or Cefsulodin or Ceftazidime or Ceftizoxime or Ceftriaxone or Cefuroxime or Cephacetrile or Cephalexin or Cephaloglycin or Cephaloridine or Cephalosporins or Cephalothin or Cephamycins or Cephapirin or Cephradine or Chloramphenicol or Chlortetracycline or Ciprofloxacin or Citrinin or Clarithromycin or Clavulanic Acid or Clavulanic Acids or clindamycin or Clofazimine or Cloxacillin or Colistin or Cyclacillin or Cycloserine or Dactinomycin or Dapsone or Daptomycin or Demeclocycline or Diarylquinolines or Dibekacin or Dicloxacillin or Dihydrostreptomycin Sulfate or Diketopiperazines or Distamycins or Doxycycline or Echinomycin or Edeine or Enoxacin or Enviomycin or Erythromycin or Erythromycin Estolate or Erythromycin Ethylsuccinate or Ethambutol or Ethionamide or Filipin or Floxacillin or Fluoroquinolones
    [Show full text]
  • Neomycin and Polymyxin B Sulfates and Gramicidin
    NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN- neomycin sulfate, polymyxin b sulfate and gramicidin solution/ drops A-S Medication Solutions ---------- Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP (Sterile) Rx only DESCRIPTION: Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP is a sterile antimicrobial solution for ophthalmic use. Each mL contains: ACTIVES: Neomycin Sulfate, (equivalent to 1.75 mg neomycin base), Polymyxin B Sulfate equal to 10,000 Polymyxin B units, Gramicidin, 0.025 mg; INACTIVES: Sodium Chloride, Alcohol (0.5%), Poloxamer 188, Propylene Glycol, Purified Water. Hydrochloric Acid and/ or Ammonium Hydroxide may be added to adjust pH (4.7-6.0). PRESERVATIVE ADDED: Thimerosal 0.001%. Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formulae are: Polymyxin B Sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are: Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillus brevis Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are: CLINICAL PHARMACOLOGY: A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin.
    [Show full text]
  • AMEG Categorisation of Antibiotics
    12 December 2019 EMA/CVMP/CHMP/682198/2017 Committee for Medicinal Products for Veterinary use (CVMP) Committee for Medicinal Products for Human Use (CHMP) Categorisation of antibiotics in the European Union Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals Agreed by the Antimicrobial Advice ad hoc Expert Group (AMEG) 29 October 2018 Adopted by the CVMP for release for consultation 24 January 2019 Adopted by the CHMP for release for consultation 31 January 2019 Start of public consultation 5 February 2019 End of consultation (deadline for comments) 30 April 2019 Agreed by the Antimicrobial Advice ad hoc Expert Group (AMEG) 19 November 2019 Adopted by the CVMP 5 December 2019 Adopted by the CHMP 12 December 2019 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Categorisation of antibiotics in the European Union Table of Contents 1. Summary assessment and recommendations .......................................... 3 2. Introduction ............................................................................................ 7 2.1. Background ........................................................................................................
    [Show full text]
  • Biological Function of Gramicidin: Studies on Gramicidin-Negative Mutants (Peptide Antibiotics/Sporulation/Dipicolinic Acid/Bacillus Brevis) PRANAB K
    Proc. NatS. Acad. Sci. USA Vol. 74, No. 2, pp. 780-784, February 1977 Microbiology Biological function of gramicidin: Studies on gramicidin-negative mutants (peptide antibiotics/sporulation/dipicolinic acid/Bacillus brevis) PRANAB K. MUKHERJEE AND HENRY PAULUS Department of Metabolic Regulation, Boston Biomedical Research Institute, Boston, Massachusetts 02114; and Department of Biological Chemistry, Harvard Medical School, Boston, Massachusetts 02115 Communicated by Bernard D. Davis, October 28,1976 ABSTRACT By the use of a rapid radioautographic EXPERIMENTAL PROCEDURE screening rocedure, two mutants of Bacillus brevis ATCC 8185 that have lost the ability to produce gramicidin have been iso- lated. These mutants produced normal levels of tyrocidine and Bacterial Strains. Bacillus brevis ATCC 8185, the Dubos sporulated at the same frequency as the parent strain. Their strain, was obtained from the American Type Culture Collec- spores, however, were more heat-sensitive and had a reduced tion. Strain S14 is a streptomycin-resistant derivative of B. brevis 4ipicolinic acid content. Gramicidin-producing revertants oc- ATCC 8185, isolated on a streptomycin-gradient plate without curred at a relatively high frequency among tie survivors of mutagenesis. It grows well at 0.5 mg/ml of streptomycin, but prolonged heat treatment and had also regained the ability to produce heat-resistant spores. A normal spore phenotype could growth is retarded by streptomycin at 1.0 mg/ml. Strain B81 also be restored by the addition of gramicidin to cultures of the is a rifampicin-resistant derivative of strain S14, isolated on mutant strain at the end of exponential growth. On the other rifampicin-gradient plates after mutagenesis of spores with hand, the addition of dipicolinic acid could not cure the spore ethyl methanesulfonate (11).
    [Show full text]
  • Conjunctivitis Or Worse?
    Red Eye in Dogs and CatS: Conjunctivitis or Worse? Tracy Revoir, DVM Senior Manager of Veterinary Support, Dechra Veterinary Products It should come as no surprise that conjunctivitis is Common Causes of Conjunctivitis the most common ophthalmic disorder in dogs and cats. But because the clinical signs of conjunctivitis If you do confirm conjunctivitis, the next step is can mimic those of more serious ophthalmic identifying the cause. If both eyes are affected and diseases (glaucoma and uveitis), it’s important to abnormal clinical signs are apparent in other body confirm your diagnosis. systems, think underlying systemic disease. If only one eye is affected, rule out infection, tear film What are important clues to the severity of the deficiencies, an irritant, anatomical abnormality, condition? With conjunctivitis, the inflammation or deeper ocular disease. should be limited to the conjunctiva. Hyperemic conjunctival vessels are superficial, branching, In dogs, conjunctivitis can result from anatomical and bright red. They are movable over the deeper disorders, irritants, infection (usually bacterial), or episcleral vessels and can be blanched with topical atopy. Most bacterial infections are secondary dilute phenylephrine. With glaucoma and uveitis, the conditions, most often to allergies. In cats, herpes- episcleral vessels are engorged; they are dark red, virus and Chlamydophila felis are the most common deep, straight, and immobile and do not blanch with causes of conjunctivitis. Atopy can also be topical dilute phenylephrine. With conjunctivitis, an issue in cats. the Schirmer tear test and intraocular pressures are normal. And the cornea should be clear and no aqueous flare should be present. The pupil and Addressing the Problem pupillary responses are normal and intraocular structures should be visible.
    [Show full text]
  • Topical Antibiotics for Impetigo: a Review of the Clinical Effectiveness and Guidelines
    CADTH RAPID RESPONSE REPORT: SUMMARY WITH CRITICAL APPRAISAL Topical Antibiotics for Impetigo: A Review of the Clinical Effectiveness and Guidelines Service Line: Rapid Response Service Version: 1.0 Publication Date: February 21, 2017 Report Length: 23 Pages Authors: Rob Edge, Charlene Argáez Cite As: Topical antibiotics for impetigo: a review of the clinical effectiveness and guidelines. Ottawa: CADTH; 2017 Feb. (CADTH rapid response report: summary with critical appraisal). ISSN: 1922-8147 (online) Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document.
    [Show full text]
  • Farrukh Javaid Malik
    I Farrukh Javaid Malik THESIS PRESENTED TO OBTAIN THE GRADE OF DOCTOR OF THE UNIVERSITY OF BORDEAUX Doctoral School, SP2: Society, Politic, Public Health Specialization Pharmacoepidemiology and Pharmacovigilance By Farrukh Javaid Malik “Analysis of the medicines panorama in Pakistan – The case of antimicrobials: market offer width and consumption.” Under the direction of Prof. Dr. Albert FIGUERAS Defense Date: 28th November 2019 Members of Jury M. Francesco SALVO, Maître de conférences des universités – praticien hospitalier, President Université de Bordeaux M. Albert FIGUERAS, Professeur des universités – praticien hospitalier, Director Université Autonome de Barcelone Mme Antonia AGUSTI, Professeure, Vall dʹHebron University Hospital Referee Mme Montserrat BOSCH, Praticienne hospitalière, Vall dʹHebron University Hospital Referee II Abstract A country’s medicines market is an indicator of its healthcare system, the epidemiological profile, and the prevalent practices therein. It is not only the first logical step to study the characteristics of medicines authorized for marketing, but also a requisite to set up a pharmacovigilance system, thus promoting rational drug utilization. The three medicines market studies presented in the present document were conducted in Pakistan with the aim of describing the characteristics of the pharmaceutical products available in the country as well as their consumption at a national level, with a special focus on antimicrobials. The most important cause of antimicrobial resistance is the inappropriate consumption of antimicrobials. The results of the researches conducted in Pakistan showed some market deficiencies which could be addressed as part of the national antimicrobial stewardship programmes. III Résumé Le marché du médicament d’un pays est un indicateur de son système de santé, de son profil épidémiologique et des pratiques [de prescription] qui y règnent.
    [Show full text]
  • Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP)
    NDA 50-417/S-011 Page 3 NEOSPORIN® Ophthalmic Ointment Sterile (neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment, USP) Description: NEOSPORIN Ophthalmic Ointment (neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment) is a sterile antimicrobial ointment for ophthalmic use. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units, and white petrolatum, q.s. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 µg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are: [Structure] Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are: [Structure] Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula is: [Structure] CLINICAL PHARMACOLOGY: A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin. Neomycin is bactericidal for many gram-positive and gram-negative organisms.
    [Show full text]
  • Identification Product Identifier Product Name Neomycin Sulfate
    Neomycin Sulfate & Polymyxin B Sulfates & Gramicidin Ophthalmic Solution Safety Data Sheet Section 1: Identification Product identifier Neomycin Sulfate & Polymyxin B Sulfates & Gramicidin Product Name Ophthalmic Solution Product Code AB03409; Core No. 034; NDC 24208-0790-62 Relevant identified uses of the substance or mixture and uses advised against Recommended use Finished Pharmaceutical Product; Indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Restrictions on use Refer to the product insert and/or prescribing information for restrictions on use and contraindications. Details of the supplier of the safety data sheet Manufacturer Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609 United States bausch.com Telephone (General) 1-800-553-5340 Emergency telephone number Manufacturer 1-800-535-5053 - Infotrac This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product in the workplace. It is not intended to provide information relevant to consumer use of the product. Section 2: Hazard Identification UN GHS According to: UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Classification of the substance or mixture UN GHS Skin Sensitization 1B Label elements UN GHS WARNING Hazard statements May cause an allergic skin reaction Precautionary statements Preparation Date: 07/September/1994 Format: GHS Language: English (US) Revision Date: 24/April/2015 UN GHS Page 1 of 10 Neomycin Sulfate & Polymyxin B Sulfates & Gramicidin Ophthalmic Solution Prevention Wash thoroughly after handling. Response IF ON SKIN: Wash with plenty of soap and water. If skin irritation or rash occurs: Get medical advice/attention.
    [Show full text]
  • Antibiotics & Common Infections ABX-2
    - - Summaries: Trial SSTI Related toxicity rare - Evidence/Safety, Q&As/Extras: Nitrofurantion documents/GeriRxFiles-UTI.pdf http://www.rxfiles.ca/rxfiles/uploads/ Adults: UTIinOlder Geri-RxFiles RxFILES EXTRAS FROM lookup/59/2/e10 https://academic.oup.com/cid/article- Infections Tissue Skin &Soft IDSA2014: U.S. TISSUEINFECTIONS SKIN &SOFT assets/files/guidelines/en/1121.pdf https://www.cua.org/themes/web/ UTI Recurrent 2011: CUA 2163(16)34717-X/pdf http://www.jogc.com/article/S1701- UTI Recurrent SOGC 2010: 19April2013.pdf photos/custom/UTI%20Guidelines%20 https://saskpic.ipac-canada.org/ Settings Care UTI inContinuing 2013: SK MOH lookup/52/5/e103 https://academic.oup.com/cid/article- (UTI) Pylonephritis Cystitisand Acute Uncomplicated IDSA2010: U.S. CYSTITIS / UTI http://www.mumshealth.com MUMS Guidelines: http://www.bugsanddrugs.ca/ &Drugs: Bugs CANADIAN LINKS ABX-2 RELATED Skin Abscess: I&D +/- ABX I&D +/-ABX Skin Abscess: Clindamycin vs TMP/SMX vsTMP/SMX Clindamycin GUIDELINES/REFERENCES GUIDELINES/REFERENCES - Antibiotics & Common Infections &CommonInfections Antibiotics Stewardship, Effectiveness, Safety & Clinical Pearls-April2017 & Stewardship, Effectiveness,Safety ( Susceptibility of of Susceptibility 1) CYSTISIS UNCOMPLICATED CAUGHTOUREYE... FROMINSIDE THAT ABX-2: AFEWPEARLS Pad”. “Viral Prescription at allavailable These are friendly postersandthepatient suchasthe“GoneViral?”office/clinic extra supporttools on discussions inSaskatchewan. withproviders discussions detailing our springacademic Our tissue(SSTI)infections. and skin&soft willsupport The newchartsinthisnewsletter cystitis uncomplicated of onthetreatment topic tobringouttheABX-2 excited are We ONABX RxFILES ACADEMIC DETAILING pg9) (see Know youroptions! anaphylaxis). (e.g. allergy mediated atrueIgE will have ___ only “allergy”, penicillin 7) ALLERGY LACTAM BETA cellulitis. of treatment successful inthe essential -often 5) verywell.
    [Show full text]
  • (ESVAC) Web-Based Sales and Animal Population
    16 July 2019 EMA/210691/2015-Rev.2 Veterinary Medicines Division European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) Sales Data and Animal Population Data Collection Protocol (version 3) Superseded by a new version Superseded Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. Table of content 1. Introduction ....................................................................................................................... 3 1.1. Terms of reference ........................................................................................................... 3 1.2. Approach ........................................................................................................................ 3 1.3. Target groups of the protocol and templates ......................................................................... 4 1.4. Organization of the ESVAC project ...................................................................................... 4 1.5. Web based delivery of data ................................................................................................ 5 2. ESVAC sales data ............................................................................................................... 5 2.1.
    [Show full text]