DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)49. DIPHENHYDRAMINEThe following statement shall be included on the labels and in the packageinserts of products containing Diphenhydramine:WARNINGWhen used for treatment of cough and cold:(a) Not to be used in children less than 2 years of age(b) To be used with caution and doctor‟s/ pharmacist‟s advice in children2 to 6 years of age.Reference: Circular Bil (34) dlm. BPFK/PPP/01/03: Kenyataan Amaran Pada Label danSisip Bungkusan Produk Persediaan Cecair Oral Untuk Rawatan Batuk dan Selsema (Coughand Cold) yang Mengandungi Antihistamin, Antitusif dan Dekongestan (Sebagai Bahan AktifTunggal atau Kombinasi)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 370
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)50. DIPHENOXYLATE50.1 The following boxed warning shall be included on the labels of productscontaining Diphenoxylate:NOT RECOMMENDED FOR CHILDREN UNDER 6 YEARS OF AGE.50.2 The following statement shall be included in the package insert ofproducts containing Diphenoxylate:WARNINGNot recommended for children under 6 years of age.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 detention in theintestine, which may aggravate and mask dehydration and depletion ofelectrolytes, especially in young children. If severe dehydration ofelectrolyte imbalance is present, diphenoxylate should be withheld untilappropriate corrective therapy has been initiated.National 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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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