DOCSLIB.ORG

Product Data Sheet

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Product Data Sheet Product data sheet MedKoo Cat#: 300270 Name: Retapamulin CAS#: 224452-66-8 Chemical Formula: C30H47NO4S Exact Mass: 517.32258 Molecular Weight: 517.76 Product supplied as: Powder Purity (by HPLC): ≥ 98% Shipping conditions Ambient temperature Storage conditions: Powder: -20°C 3 years; 4°C 2 years. In solvent: -80°C 3 months; -20°C 2 weeks. 1. Product description: Retapamulin, also known as SB-275833, is a newer topical agent of pleuromutilin class approved by the Food and Drug Administration for treatment of impetigo in children. It has been demonstrated to have low potential for the development of antibacterial resistance and a high degree of potency against poly drug resistant Gram-positive bacteria found in skin infections including Staphylococcus aureus strains. The drug is safe owing to low systemic absorption and has only minimal side-effect of local irritation at the site of application. 2. CoA, QC data, SDS, and handling instruction SDS and handling instruction, CoA with copies of QC data (NMR, HPLC and MS analytical spectra) can be downloaded from the product web page under “QC And Documents” section. Note: copies of analytical spectra may not be available if the product is being supplied by MedKoo partners. Whether the product was made by MedKoo or provided by its partners, the quality is 100% guaranteed. 3. Solubility data Solvent Max Conc. mg/mL Max Conc. mM DMSO 30.0 57.9 Ethanol 30.0 57.9 4. Stock solution preparation table: Concentration / Solvent Volume / Mass 1 mg 5 mg 10 mg 1 mM 1.93 mL 9.66 mL 19.31 mL 5 mM 0.39 mL 1.93 mL 3.86 mL 10 mM 0.19 mL 0.97 mL 1.93 mL 50 mM 0.04 mL 0.19 mL 0.39 mL 5. Molarity Calculator, Reconstitution Calculator, Dilution Calculator Please refer the product web page under section of “Calculator” 6. Recommended literature which reported protocols for in vitro and in vivo study In vitro study 1. Saravolatz LD, Pawlak J, Saravolatz SN, Johnson LB. In Vitro Activity of Retapamulin against Staphylococcus aureus Resistant to Various Antimicrobial Agents. Antimicrob Agents Chemother. 2013 Sep;57(9):4547-4550. doi: 10.1128/AAC.00282-13. Epub 2013 Jun 24. PMID: 23796931; PMCID: PMC3754297. 2. Candel FJ, Morales G, Picazo JJ. In vitro activity of retapamulin against linezolid and methicillin-resistant Staphylococcus aureus isolates. Rev Esp Quimioter. 2011 Sep;24(3):127-30. PMID: 21947094. In vivo study 1. Guo Y, Ramos RI, Cho JS, Donegan NP, Cheung AL, Miller LS. In vivo bioluminescence imaging to evaluate systemic and topical antibiotics against community-acquired methicillin-resistant Staphylococcus aureus-infected skin wounds in mice. Antimicrob Agents Chemother. 2013 Feb;57(2):855-63. doi: 10.1128/AAC.01003-12. Epub 2012 Dec 3. PMID: 23208713; PMCID: PMC3553733. 2. Rittenhouse S, Singley C, Hoover J, Page R, Payne D. Use of the surgical wound infection model to determine the efficacious dosing regimen of retapamulin, a novel topical antibiotic. Antimicrob Agents Chemother. 2006 Nov;50(11):3886-8. doi: 10.1128/AAC.00183-06. PMID: 17065626; PMCID: PMC1635196. MedKoo Biosciences || http://www.medkoo.com || [email protected] 2500 Gateway Centre Blvd Suite 400, Morrisville, NC27560, USA. Tel: 919-636-5577, Fax: 919-980-4831 Product data sheet 7. Bioactivity Biological target: Retapamulin(SB-275833) is a topical antibiotic, which binds to both E. coli and S. aureus ribosomes with similar potencies with Kd of 3 nM. In vitro activity The purpose of this study was to determine the in vitro activity of retapamulin against methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant S. aureus (MRSA), and linezolid and methicillin-resistant S. aureus.The minimum inhibitory concentrations (MICs) were determined on Mueller-Hinton agar. Retapamulin inhibited all the isolates of MSSA and MRSA at 0.125 mg/L, but the 18 linezolid-resistant-MRSA strains proved resistant, with MICs over 32 mg/L. Retapamulin demonstrated excellent in vitro activity against MSSA and MRSA strains, but not against MRSA isolates harbouring the cfr gene. The results of this in vitro study support cut-off values for retapamulin of ≤ 0.5, 1, and ≥ 2 mg/L for susceptible, intermediate, and resistant strains, respectively. Reference: Rev Esp Quimioter. 2011 Sep;24(3):127-30. https://pubmed.ncbi.nlm.nih.gov/21947094/ In vivo activity The purpose of this study was to evaluate the effect of topically applied retapamulin ointment using various dosing regimens in the Staphylococcus aureus and Streptococcus pyogenes wound infection model. Therapy was administered topically (0.1 ml/mouse) b.i.d. (beginning at 1 and 7 h postinfection) or t.i.d. (beginning at 1, 4, and 7 h postinfection) and continued for 3, 4, or 6 days (4, 5, or 7 days of therapy). Additional groups of mice received petrolatum ointment or remained untreated to act as placebo or infected controls. Following infection with S. aureus J1225 (5 days postinfection), bacterial numbers from untreated control animals were 6.3 ± 0.3 log10 CFU/wound. Retapamulin administered t.i.d. for 4 days demonstrated significant efficacy (P ≤ 0.01) compared with untreated animals at all concentrations tested. A maximum 4.6 log10 reduction in bacterial counts was achieved at 2% (wt/wt) (1.7 ± 0.1 log10 CFU/wound; 7/8 wounds cleared to the limit of detection). All retapamulin concentrations evaluated produced a potent effect compared with untreated or placebo-treated animals (P ≤ 0.01). The effect obtained with 4-day t.i.d. application of 0.5%, 1%, and 2% wt/wt were similar, reducing bacterial counts by >5 log10 (1.9 ± 0.4, 2.3 ± 1.3, and 2.3 ± 1.5 log10 CFU/wound, respectively). Overall, these results demonstrate the potential benefit of retapamulin over existing topical antibiotics, particularly against isolates resistant to currently used agents. Reference: Antimicrob Agents Chemother. 2006 Nov; 50(11): 3886–3888. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1635196/ Note: The information listed here was extracted from literature. MedKoo has not independently retested and confirmed the accuracy of these methods. Customer should use it just for a reference only. MedKoo Biosciences || http://www.medkoo.com || [email protected] 2500 Gateway Centre Blvd Suite 400, Morrisville, NC27560, USA. Tel: 919-636-5577, Fax: 919-980-4831 .
Load more

Recommended publications
  • What Is the Best Treatment for Impetigo?
    Evidence-based answers from the Family Physicians Inquiries Network clinical inquiries Jae Shim, MD; Jeffrey Lanier, MD What is the best treatment Martin Army Community Hospital, Fort Benning, Ga for impetigo? Maylene (Kefeng) Qui, MLIS Biomedical Library, University of Pennsylvania, EvidEncE-basEd answEr Philadelphia AssistAnt EDItOR Although evidence is lack- als [RCTs] and a single RCT of retapamulin). Paul Crawford, MD A ing to support a single best treat- Topical bacitracin and fusidic acid are Nellis Family Medicine ment for impetigo, topical mupirocin, 15% more likely than disinfectant solu- Residency, Nellis Air Force Base, Nev fusidic acid, gentamicin, and retapamu- tions to cure or improve impetigo (SOR: a, lin are all at least 20% more likely than systematic review of RCTs). The opinions and assertions con- tained herein are the private views placebo to produce cure or improvement Oral antibiotics may be as effective as of the authors and are not to be (strength of recommendation [SOR]: a, topical antibiotics (SOR: b, RCTs with dif- construed as official or as reflecting the views of the US Army or the meta-analysis of randomized controlled tri- ferent results). Department of Defense. Evidence summary A 2012 Cochrane review of various inter- Most data on the effectiveness of topical an- ventions included 68 RCTs with a total of 5708 tibiotics focus on bacitracin, fusidic acid (not participants, primarily from pediatric or der- available in the United States), and mupiro- matology hospital outpatient clinics in North cin. Retapamulin
    [Show full text]
  • In Vitro Activity of Retapamulin
    Correspondence: Abstract 2338 B. Johnson In Vitro Activity of Retapamulin (SB-275833), a Novel Topical Antimicrobial, against 3721 Gram-Positive IHMA (F-2050) 2122 Palmer Drive Schaumburg Isolates Associated with Skin and Skin Structure Infections (SSSIs) From 17 Sites in North America IL 60173 USA 1 1 1 1 2 2 1 1 Tel: +1 847 303 5003 B. Johnson, A. Jordan, S. Bouchillon, D. Hoban, N. Scangarella, R. Shawar, J. Johnson & R. Badal Fax: +1 847 303 5601 1International Health Management Associates, Schaumburg, IL, USA; 2GlaxoSmithKline, Collegeville, PA, USA E-mail: [email protected] Table 3. MIC (µg/mL) Summary for Retapamulin and Comparators against S. aureus from Table 6. MIC (µg/mL) Summary For Retapamulin and Comparators against Viridans Revised Abstract Materials and Methods North America (n = 1182) Streptococci from North America (n = 471) Background: Retapamulin is a novel pleuromutilin currently in development as a topical G MIC endpoints were determined by broth microdilution according to MIC (µg/mL) MIC (µg/mL) antimicrobial for the treatment of skin and skin structure infections (SSSIs) that shows no Clinical and Laboratory Standards Institute (CLSI) guidelines3 for retapamulin a a Compound %Sus %Int %Res Range MIC50 MIC90 Compound %Sus %Int %Res Range MIC50 MIC90 target specific cross-resistance to other classes of antibiotics and exhibits a unique mode of and 14 comparators in customized dried broth microdilution panels (Trek action. Methods: A total of 3721 clinical isolates of staphylococci (Staphylococcus aureus and Retapamulin NA NA NA 0.015–0.5 0.06 0.12 Retapamulin NA NA NA 0.004–0.5 0.06 0.25 Diagnostic Systems Ltd, West Sussex, UK).
    [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]
  • ALTABAX (Retapamulin)
    HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------- DOSAGE FORMS AND STRENGTHS -------------- These highlights do not include all the information needed to use 10 mg retapamulin/1g of ointment in 15-, and 30-gram tubes (3) ALTABAX safely and effectively. See full prescribing information for -------------------------------CONTRAINDICATIONS------------------------ ALTABAX. None. (4) ® ----------------------- WARNINGS AND PRECAUTIONS ---------------- ALTABAX (retapamulin ointment), 1% Discontinue in the event of sensitization or severe local irritation. (5.1) For Dermatological use only Not intended for ingestion. Not for intraoral, intranasal, ophthalmic, or Initial U.S. Approval: 2007 intravaginal use. (5.2) ----------------------------INDICATIONS AND USAGE--------------------- ------------------------------ ADVERSE REACTIONS ----------------------- ALTABAX, a pleuromutilin antibacterial, is indicated for the topical The most common drug-related adverse reaction was application site irritation treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible (≤2% of patients). (6) isolates only) or Streptococcus pyogenes in patients aged 9 months or older. (1) Safety in patients younger than 9 months has not been established. To report SUSPECTED ADVERSE REACTIONS, contact ----------------------- DOSAGE AND ADMINISTRATION ---------------- GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or Apply a thin layer of ALTABAX to the affected area (up to 100 cm2 in www.fda.gov/medwatch. total area in adults or 2%
    [Show full text]
  • New Antibiotics for the Treatment of Acute Bacterial Skin and Soft Tissue Infections in Pediatrics
    pharmaceuticals Review New Antibiotics for the Treatment of Acute Bacterial Skin and Soft Tissue Infections in Pediatrics Nicola Principi 1, Alberto Argentiero 2, Cosimo Neglia 2, Andrea Gramegna 3,4 and Susanna Esposito 2,* 1 Università degli Studi di Milano, 20122 Milan, Italy; [email protected] 2 Pediatric Clinic, Pietro Barilla Children’s Hospital, Department of Medicine and Surgery, University of Parma, 43121 Parma, Italy; [email protected] (A.A.); [email protected] (C.N.) 3 Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, 20122 Milan, Italy; [email protected] 4 Department of Pathophysiology and Transplantation, University of Milan, 20122 Milan, Italy * Correspondence: [email protected]; Tel.: +39-052-190-3524 Received: 29 September 2020; Accepted: 19 October 2020; Published: 23 October 2020 Abstract: Acute bacterial skin and soft tissue infections (aSSTIs) are a large group of diseases that can involve exclusively the skin or also the underlying subcutaneous tissues, fascia, or muscles. Despite differences in the localization and severity, all these diseases are due mainly to Gram-positive bacteria, especially Staphylococcus aureus and Streptococcus pyogenes. aSSTI incidence increased considerably in the early years of this century due to the emergence and diffusion of community-acquired methicillin-resistant S. aureus (CA-MRSA). Despite the availability of antibiotics effective against CA-MRSA, problems of resistance to these drugs and risks of significant adverse events have emerged. In this paper, the present knowledge on the potential role new antibiotics for the treatment of pediatric aSSTIs is discussed. The most recent molecules that have been licensed for the treatment of aSSTIs include ozenoxacin (OZ), ceftaroline fosamil (CF), dalbavancin (DA), oritavancin (OR), tedizolid (TD), delafloxacin (DL), and omadacycline (OM).
    [Show full text]
  • New Drugs of 2007 by Amy P
    CONTINUING EDUCATION New Drugs of 2007 By Amy P. Witte, PharmD; Jodie V. Mahlhotra, PharmD; and Trevor McKibbin, PharmD, MSc, BCPS pon successful completion of this There have been no reported contraindications with article, the pharmacist should be the use of retapamulin. A thin layer should be applied to able to: the affected area (up to 100 cm2 in total area in adults or 1. Identify the new molecular entities 2 percent total body surface area in pediatric patients) approved by the Food and Drug twice daily for five days. Administration (FDA) in 2007. The most common adverse effect seen with re- U2. Review approved indications, mechanism of tapamulin use was application site irritation. Patients action, and pharmacokinetic profile for each should discontinue the use of retapamulin in the event agent. of severe local irritation or sensitization. It is not intend- 3. List the available dosage forms and ed for ingestion or for intraoral, intranasal, ophthalmic, strengths, dosing schedules, and routes of or intravaginal use. Patients should also be aware of administration for the new agents. the potential for microbial overgrowth while using reta- 4. Describe the potential adverse effects, drug pamulin. If a superinfection is suspected during treat- interactions, precautions, and contraindica- ment, the patient should contact their physician. The tions associated with routine use. effect of retapamulin in combination with other topical 5. Identify medications that have been with- agents to the same area of skin has not been studied. drawn from the market in 2007. Retapamulin is a pregnancy category B agent. How- ever, it is not known whether retapamulin is excreted In 2007, the FDA approved 15 new molecular in breast milk.
    [Show full text]
  • In Vitro Activity of Retapamulin Against Staphylococcus Aureus and Streptococcus Pyogenes James A
    In Vitro Activity of Retapamulin against Staphylococcus aureus and Streptococcus pyogenes James A. Karlowsky, PhD #019 University of Manitoba Isolated from Skin and Skin Structure Infections Winnipeg, Canada J. A Karlowsky1, S. Bouchillon2, M. Hackel2, N. E. Scangarella-Oman3 1University of Manitoba, Winnipeg, Canada; 2IHMA, Schaumburg, IL, USA; 3GSK, Collegeville, PA, USA Table 3. Activity of retapamulin against resistant phenotypes Figure 2. MIC frequency distribution for retapamulin against Abstract Methods Results of methicillin-susceptible S. aureus and S. pyogenes 254 isolates of S. pyogenes • The in vitro activities of retapamulin and 14 comparative Background: Retapamulin (RP) is a semisynthetic pleuromutilin, 50S protein synthesis Table 1. Activity of retapamulin and 14 comparative agents inhibitor (PSI) approved in 2007 for the topical treatment of impetigo in the USA and agents were evaluated against 986 methicillin-susceptible against 986 isolates of methicillin-susceptible S. aureus uncomplicated skin infections and impetigo in Europe caused by methicillin-susceptible S. aureus and 254 S. pyogenes isolated from patients with Retapamulin MIC (µg/ml) 200 80% Staphylococcus aureus (MSSA) and Streptococcus pyogenes (SP). 180 (71%) 50% 90% Range %S* 180 Methods: The in vitro activities of RP and 14 comparators were assessed by CLSI broth skin and skin structure infections from selected centers in 6 Species Phenotype (n) 70% microdilution against 986 MSSA and 254 SP isolates prospectively collected from adult countries in Europe (Belgium, France, Germany, Italy, MSSA All(986) 0.12 0.12 0.004-4 99.8 160 and pediatric patients with skin and skin structure infections in 25 sites in Belgium, (µg/ml) 60% Gentamicin-R(41) 0.12 0.25 0.06-0.25 100 140 France, Germany, Italy, Spain, and the UK between October 2008 and December 2009.
    [Show full text]
  • 208945Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208945Orig1s000 CLINICAL REVIEW(S) 1. Benefit-Risk Assessment Benefit-Risk Summary and Assessment I concur with the Benefit-Risk Assessment written by the Division Director and include it here with my additional summary comments. The Applicant Ferrer Internacional, S.A. has demonstrated the safety and efficacy of ozenoxacin cream, 1%, (Xepi) in two adequate and well- controlled superiority trials for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in patients two months of age and older. The NDA cannot be approved during this review cycle due to outstanding issues regarding manufacturing facilities. The NDA will receive a Complete Response letter. Satisfactory resolution of these issues will be needed before the NDA can be approved. Impetigo is a common, generally self-limited, superficial bacterial skin infection caused by S. aureus and S. pyogenes. Impetigo may be treated with topical or systemic antibacterial drugs. Systemic (oral) therapy is recommended for patients with multiple lesions or during outbreaks. There are FDA-approved topical therapies for impetigo including mupirocin ointment, retapamulin ointment, and gentamicin sulfate cream and ointment. FDA-approved oral therapies for impetigo and uncomplicated skin and skin structure infections (includes impetigo) include anti- staphylococcal penicillins, cephalosporins, clindamycin, and fluoroquinolones. Study P-110880-01 (Trial 880) was a three-arm trial comparing ozenoxacin cream with placebo; a third arm, retapamulin 1% ointment, was included to test internal validity; all treatments were administered twice daily for 5 days. Clinical response rates (success/cure) at the end of therapy were 34.8% for ozenoxacin, 19.2% for placebo, and 37.7% for retapamulin.
    [Show full text]
  • S. Aureus Belonging to a Single Pulsed-Field Gel Electrophoresis Molecular Typing: the 1848L Index Strain Was Subjected to PFGE Table 1
    C1-1462 Decreased-linezolid Susceptibility Due to cfr in a Community-associated ICAAC 2010 JMI Laboratories Methicillin-resistant Staphylococcus aureus Clone (USA300) North Liberty, IA, USA www.jmilabs.com 1 1 1 2 2 1 ph. 319.665.3370, fax 319.665.3371 RE MENDES , LM DESHPANDE , JE ROSS , T TEKLE , K CARROLL , RN JONES 1 2 [email protected] JMI Laboratories, North Liberty, IA; Johns Hopkins Hospital Microbiology Laboratory, Baltimore, MD S. aureus belonging to a single pulsed-field gel electrophoresis Molecular typing: The 1848L index strain was subjected to PFGE Table 1. Antimicrobial susceptibility profile and molecular findings for S. aureus Figure 2. PFGE profiles of Cfr-producing S. aureus 1848L (lane 2) and reference Abstract type (PFGE; USA300; multilocus sequence type [MLST] 8) has and the profile obtained was compared to USA clonal types using 1848L, RN4220 (p1848L) transformant and wildtype RN4220. NRS384 strain (USA300-0114; lane 3). Lane 1 represents S. aureus NCTC 8325 a been the predominant cause of community-associated methicillin- the GelCompar II software (Applied Math, Kortrijk, Belgium). S. S. aureus MIC (µg/mL) [susceptibility category] used as PFGE standard. Background: Cfr causes post-transcriptional methylation in 23S resistant S. aureus (CA-MRSA) infections in the USA. Recently, aureus 1848L was further characterized by SCCmec, spa, and Parameters 1848L (index strain) RN4220 (p1848L) RN4220 rRNA (A2503), conferring resistance to several antimicrobial USA300 isolates have also emerged as a cause of health-care MLST typing. In addition, this strain was screened for Panton- Antimicrobial agent Linezolid 4 [S] 4 [S] 1 [S] classes, including oxazolidinones and lincosamides.
    [Show full text]
  • Estonian Statistics on Medicines 2013 1/44
    Estonian Statistics on Medicines 2013 DDD/1000/ ATC code ATC group / INN (rout of admin.) Quantity sold Unit DDD Unit day A ALIMENTARY TRACT AND METABOLISM 146,8152 A01 STOMATOLOGICAL PREPARATIONS 0,0760 A01A STOMATOLOGICAL PREPARATIONS 0,0760 A01AB Antiinfectives and antiseptics for local oral treatment 0,0760 A01AB09 Miconazole(O) 7139,2 g 0,2 g 0,0760 A01AB12 Hexetidine(O) 1541120 ml A01AB81 Neomycin+Benzocaine(C) 23900 pieces A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+Thymol(dental) 2639 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+Cetylpyridinium chloride(gingival) 179340 g A01AD81 Lidocaine+Cetrimide(O) 23565 g A01AD82 Choline salicylate(O) 824240 pieces A01AD83 Lidocaine+Chamomille extract(O) 317140 g A01AD86 Lidocaine+Eugenol(gingival) 1128 g A02 DRUGS FOR ACID RELATED DISORDERS 35,6598 A02A ANTACIDS 0,9596 Combinations and complexes of aluminium, calcium and A02AD 0,9596 magnesium compounds A02AD81 Aluminium hydroxide+Magnesium hydroxide(O) 591680 pieces 10 pieces 0,1261 A02AD81 Aluminium hydroxide+Magnesium hydroxide(O) 1998558 ml 50 ml 0,0852 A02AD82 Aluminium aminoacetate+Magnesium oxide(O) 463540 pieces 10 pieces 0,0988 A02AD83 Calcium carbonate+Magnesium carbonate(O) 3049560 pieces 10 pieces 0,6497 A02AF Antacids with antiflatulents Aluminium hydroxide+Magnesium A02AF80 1000790 ml hydroxide+Simeticone(O) DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 34,7001 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 3,5364 A02BA02 Ranitidine(O) 494352,3 g 0,3 g 3,5106 A02BA02 Ranitidine(P)
    [Show full text]
  • Extract from the Clinical Evaluation Report for Retapamulin
    AusPAR Attachment 2 Extract from the Clinical Evaluation Report for retapamulin Proprietary Product Name: Altargo Sponsor: GlaxoSmithKline Australia Pty Ltd Date of CER: 31 October 2012 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices. · The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website <http://www.tga.gov.au>. About the Extract from the Clinical Evaluation Report · This document provides a more detailed evaluation of the clinical findings, extracted from the Clinical Evaluation Report (CER) prepared by the TGA. This extract does not include sections from the CER regarding product documentation or post market activities. · The words [Information redacted], where they appear in this document, indicate that confidential information has been deleted. · For the most recent Product Information (PI), please refer to the TGA website <http://www.tga.gov.au/hp/information-medicines-pi.htm>.
    [Show full text]
  • Antibiotics Act
    MINISTRY OF LEGALLAWS AFFAIRS OF TRINIDAD AND TOBAGO www.legalaffairs.gov.tt ANTIBIOTICS ACT CHAPTER 30:02 Act 18 of 1948 Amended by 190/1950 46/1964 178/1951 55/1964 219/1951 9/1965 123/1952 34/1965 59/1954 47/1965 71/1954 113/1968 147/1954 4 of 1988 76/1955 55/2003 128/1955 12/2005 173/1955 174/1956 213/2005 17/1957 154/2008 48/1957 188/2008 106/1958 88/2009 13/1960 147/2009 20 of 1960 26/2011 31/1961 40/2011 Current Authorised Pages Pages Authorised (inclusive) by L.R.O. 1–2 .. 3–8 .. 9–12 .. 13–16 .. 17–30 .. 31–38 .. UNOFFICIAL VERSION L.R.O. UPDATED TO DECEMBER 31ST 2013 MINISTRY OF LEGAL AFFAIRS LAWS OF TRINIDAD AND TOBAGOwww.legalaffairs.gov.tt 2 Chap. 30:02 Antibiotics Index of Subsidiary Legislation Page Importation of Antibiotics Preparations Order … … … … 12 Approved Pharmaceutical Firms Order … … … … 32 Antibiotics (Conditions for Use) Order (LN 29/1989) … … … 38 Note on the above Orders The amendments to the above Orders are long and frequent, and in view of their very limited use by the general public they will not be updated annually (following the policy adopted with respect to the Approval of New Drugs Notification under the Food and Drugs Act— See page 2 of Ch. 30:01). For amendments to these Orders—See the Current Edition of the Consolidated Index of Acts and Subsidiary Legislation. Note on Adaptation Under paragraph 6 of the Second Schedule to the Law Revision Act (Ch. 3:03) the Commission amended certain references to public officers in this Chapter.
    [Show full text]