DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)43. CYTOTOXIC AGENTThe following boxed statement shall be included on the label of productscontaining Cytotoxic agents:CAUTION : CYTOTOXIC AGENTNote: The label caution should be printed prominently on the label.44. DEXBROMPHENIRAMINEThe following statement shall be included on the labels and package inserts ofliquid oral products containing Dexbrompheniramine: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)45. DEXTROMETHORPHANThe following statement shall be included on the labels and package inserts ofliquid oral products containing Dextromethorphan: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 | 368
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)46. DIAZEPAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTS47. DICLOFENAC SODIUMThe following statement shall be included in the package inserts of productscontaining Diclofenac sodium:PRECAUTIONSevere cutaneous reactions, including Stevens - Johnson syndrome and toxicepidermal necrolysis (Lyell‟s syndrome), have been reported with diclofenacsodium. Patients treated with diclofenac sodium should be closely monitoredfor signs of hypersensitivity reactions. Discontinue diclofenac sodiumimmediately if rash occurs.Adverse effects: Dermatological: Occasional - rashes or skin eruptions Casesof hair loss, bullous eruptions, erythema multiforme, Stevens- Johnsonsyndrome, toxic epidermal necrolysis (Lyell‟s syndrome), and photosensitivityreactions have been reported.48. DICYCLOMINEThe following boxed warning shall be included on the labels and in thepackage inserts of products containing Dicyclomine:WARNINGDicyclomine is not recommended for use in infantsunder the age of six monthNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 369
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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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