DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)80. LINCOMYCINFor all products containing Lincomycin:The package insert must emphasize the possibility of pseudomembranouscolitis with the use of the drug and must include the following boxed oremphasized statement/ warning:a. Lincomycin therapy has been associated with severe colitis which mayend fatally.b. It should be reserved for serious infections where less toxicantimicrobial agents are inappropriate.c. It should not be used in patients with nonbacterial infections, such asmost upper respiratory tract infections.d. Its use in newborns is contraindicated.81. LISURIDEPlease refer to DOPAMINERGIC INGREDIENT82. LIQUID PARAFFINThe following statement shall be included on the labels of products containingLiquid paraffin as laxative:Not recommended for use in children below 3 years of age;Not recommended for use in pregnant women;Repeated use is not advisable;Consult your doctor if laxatives are needed every day, if you havepersistent abdominal pain or have a condition which makes swallowingdifficult.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 392
Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)83. LOPERAMIDE83.1 The following boxed warning shall be included on the labels of productscontaining Loperamide:NOT RECOMMENDED FOR CHILDREN UNDER 6 YEARS OF AGE83.2 The following statement shall be included in the package inserts ofproducts containing Loperamide:WARNINGNot recommended for children under 6 years of age. Its use has beenassociated with fatal episodes of paralytic ileus in infants and youngchildren.PRECAUTIONAppropriate fluid and electrolyte therapy should be given to protectagainst dehydration in all cases of diarrhoea. Oral rehydration therapywhich is the use of appropriate fluids including oral rehydration saltsremains the most effective treatment for dehydration due to diarrhoea.The intake of as much of these fluids as possible is therefore imperative.Drug-induced inhibition of peristalsis may result in fluid retention in theintestine, which may aggravate and mask dehydration and depletion ofelectrolytes. If severe dehydration or electrolyte imbalance is presentLoperamide should be withheld until appropriate corrective therapy hasbeen initiated.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 393
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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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