DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)136. THROMBOLYTIC AGENTSThe following caution shall be disclosed prominently in the package inserts ofproducts containing “systemic thrombolytic agent” in particular “the tissueplasminogen activators”:WARNINGSevere bleeding such as intracranial haemorrhage may occur followingadministration of the drug, particularly in the elderly patients. The risk must bebalanced against the potential benefit of thrombolysis.The following precautions need to be observed:Patients should be carefully observed for clinical signs during and followingadministration of the drug for early detection of bleeding. Frequenthaematological tests such as blood coagulation tests are mandatory.To prevent bleeding at the site of centesis or other regions, caution must beexercised concerning procedures and management of arterial/ venuspuncture.The use of heparin in conjunction with the thrombolytic agent for the purposeof prevention of reocclusion may increase the risk of intracranial haemorrhage.Close monitoring of patients is strongly recommended.137. TIAPROFENIC ACIDThe following statement shall be included in the package inserts of productscontaining Tiaprofenic acid:PRECAUTIONUrinary symptoms (bladder pain, dysuria, and frequency), haematuria orcystitis may occur. In certain exceptional cases, the symptoms have becomesevere on continued treatment. Should urinary symptoms occur, treatmentwith tiaprofenic acid must be stopped.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 418
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)138. TRETINOIN TOPICALThe following statement shall be included in the package inserts of productscontaining Tretinoin used topically:USE IN PREGNANCY:Studies in animal have shown that oral tretinoin is fetotoxic in rats given500 times the topical human dose and teratogenic in rats given 1,000times the topical human dose. Topical tretinoin has caused delayedossification in a number of bones in the offspring of rats and rabbits given100 to 320 times the topical human dose, respectively. There has beenincreasing incidence of foetal malformation following topical administrationof tretinoi. Use of topical tretinoin is not recommended during pregnancy,especially the first trimester.139. TRIAZOLAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTS140. TRIPROLIDINEThe following statement shall be included on the label and in the packageinserts of liquid oral products containing Triprolidine: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 inchildren 2 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 | 419
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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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