DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)54. FIBRATESThe following statement shall be included in the package inserts of productscontaining Fibrates:a. Clofibrate,b. Bezafibratec. Ciprofibrate, Etofibrated. Fenofibratee. Simfibratef. etc.DRUG INTERACTIONConcurrent use of fibates with HMG-CoA reductase inhibitors may causesevere myositis and myoglobinuria.55. FLUCLOXACILLINThe following warning shall be included in the package insert of productscontaining Flucloxacillin:WARNINGLiver ToxicityFlucloxacillin can cause severe hepatitis and cholestatic jaundice,which may be protracted. This reaction is more frequent in olderpatients and those who take the drug for prolonged periods (seePrecaution, Adverse Reactions)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 380
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)56. FLUORIDEAll toothpastes containing Fluorides should be labeled with the followingadditional information:a. DIRECTIONS ON USEDo not swallow – spit and rinse after use.b. FOR CHILDREN BELOW 6 YEARSUse a pea-sized amount of toothpaste (less than 5mm).Supervise child‟s brushing.c. DIRECTIONS ON DENTAL HEALTHBrush at least twice a day.Restrict the amount and frequency of sugary food.Visit your dentist at least once a year.d. GRAPHICS AS SHOWNChild‟s useAdult‟s useNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 381
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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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