DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)113. PROPOFOLThe following statement shall be included in the package inserts of productscontaining Propofol:WARNINGPropofol is not recommended for paediatric general anaesthesia and sedationbecause its safety and effectiveness in these patients have not beenestablished. There have been recent reports of adverse cardiac events anddeaths associated with its use in paediatric intensive care. Although there is noevidence of a causal link of death with propofol in these cases, the drug couldnot be ruled out as a contributing factor. Until further data establishing itssafety and delineating its appropriate dose range are available, propofolshould not be used in paediatric intensive care.There have been very rare reports of epileptiform movement in epileptics andnon-epileptics occurring during induction orbemergence from anaesthesiainduced by propofol.114. PROPOLIS (TOPICAL)The following information shall be included on the labels and/ or packageinserts of products containing Propolis (for topical use):WARNINGSPropolis may cause allergic skin reaction.Reference:a) Circular Bil (48) dlm BPFK/02/5/1.3: Pernyataan Amaran Pada Label Dan SisipBungkusan Produk Yang Mengandungi Propolis (Topikal) dan Royal Jelly (SemuaBentuk)b) Bil (56) dlm BPFK/02/5/1.3: Pernyataan Amaran pada Label dan Sisip BungkusanProduk yang Mengandungi Propolis (topikal) dan Royal Jelly (Semua Bentuk)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 408
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)115. PROPYLTHIOURACIL115.1 The following statement shall be included in the package inserts ofproducts containing propylthiouracil:1 WARNING AND PRECAUTIONPotential risk of serious hepatoxicity or liver injury including liver failureand death. Patients who are initiated with propylthiourasil should beclosely monitored for signs and symptoms of liver injury (e.g. fatigue,weakness, vague abdominal pain, loss of appetite, itching, easybruising or yellowing of the eyes or skin) especially during the first sixmonths. If liver injury is suspected, promptly discontinuepropylthiouracil therapy.Propylthiouracil should not be used in pediatric patients unless thepatient is allergic to or intolerant of the alternatives available.115.2 2 The following boxed warning shall be included in the package insertsof products containing propylthiouracil:BOXED WARNINGSevere liver injury and acute liver failure, in some cases fatal, havebeen reported in patients treated with propylthiouracil. These reportsof hepatic reactions include cases requiring liver transplantation inadult and pediatric patients.Propylthiouracil should be reserved to patients who cannot toleratecarbimazole/ methimazole and in whom radioactive iodine therapy orsurgery are not appropriate treatments for management ofhyperthyroidism.Because of the risk of fetal abnormalities associated withcarbimazole/ methimazole, propylthiouracil may be the treatment ofchoice when an antithyroid drug is indicated during or just prior to thefirst trimester of pregnancy (See Warnings & Precautions).Reference:Circular 1 Bil (41) dlm. BPFK/PPP/01/03: Kenyataan Amaran Berkaitan Dengan “Potential foran Increase in Risk of Hepatotoxicity” yang Perlu Dimuatkan Pada Sisip Bungkusan ProdukPropylthiouracilCircular 2 Bil (55) dlm. BPFK/PPP/01/03: Kenyataan Amaran Berbentuk “Boxed Warning”Yang Wajib Dimuatkan Pada Sisip Bungkusan Produk Propylthiouracil Dengan “Severe LiverInjury”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 409
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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