DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)36. CLINDAMYCINThe package insert must emphasize the possibility of pseudomembranouscolitis with the use of the drug.The package insert must include the following boxed or emphasizedstatements/ warning:Clindamycin therapy has been associated with severe colitis which mayend fatally.It should be reserved for serious infections where less toxic antimicrobialagents are inappropriate.It should not be used in patients with nonbacterial infections, such asmost upper respiratory tract infections.Its use in newborns is contraindicated.37. CLOBAZAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTSNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 370
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)38. CLOPIDOGRELThe following statement shall be included in the package inserts of productscontaining Clopidogrel:SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USEPharmacogenetics: Based on literature data, patients with genetically reducedCYP22C19 function (intermediate or poor metabolisers) have lower systemicexposure to the active metabolite of clopidogrel and diminished antiplateletresponses, and generally exhibit higher cardiovascular event rates followingmyocardial infarction than do patients with normal CYP2C19 function.INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHERFORMS OF INTERACTIONSince clopidogrel is metabolised to its active metabolite by CYP2C19, use ofdrugs that inhibit the activity of this enzyme would be expected to result inreduced drug levels of the active metabolite of clopidogrel and a reduction inclinical efficacy. Concomitant use of drugs that inhibit CYP2C19 (e.g protonpump inhibitors) should be discouraged.PHARMACOKINETIC PROPERTIESThe oxidative step is regulated primarily by Cytochrome P450 ISOENZYMES2B6, 3A4, 1A1, 1A2 and 2C19.Reference: Circular Bil (42) dlm. BPFK/PPP/01/03: Kenyataan Amaran Berkaitan Dengan“Possible Interaction Between Clopidogrel and Proton Pump Inhibitors” yang Perlu DimuatkanPada Sisip Bungkusan Produk Clopidogrel39. CLOZAPINEPlease refer to ANTIPSYCHOTIC AGENTNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 371
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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