DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)BOXED WARNING- Exposure to gadolinium – based contrast agents (GBCAs) increasesthe risk for Nephrogenic Systemic Fibrosis (NSF) in patients with:acute or chronic severe renal insufficiency (glomerular filtrationrate < 30mL/min/1.73m²), oracute renal insufficiency of any severity due to the hepato-renalsyndrome or in the perioperative liver transplantation period.- NSF is a debilitating and sometimes fatal disease affecting the skin,muscle, and internal organs- Avoid use of GBCAs unless the diagnotic information is essential andnot available with non-contrast enhanced magnetic resonance imaging(MRI).- Screen all patients for renal dysfunction by obtaining a history and/ orlaboratory tests.- When administering a GBCA, do not exceed the dose recommendedin product labelling. Allow sufficient time for elimination of the GBCAprior to any readministration.WARNINGAmong the factors that may increase the risk for NSF are repeated orhigher than recommended doses of a GBCA.For patients receiving haemodialysis, healthcare professionals mayconsider prompt haemodialysis following GBCA administration in orderto enhance the contrast agent‟s elimination. However, it is unknown ifhaemodialysis prevents NSF.Determine the renal function of patients by obtaining a medical historyof conducting laboratory tests that measure renal function prior to usingGBCA.The risk, if any, for developing NSF among patients with mild tomoderate renal insufficiency or normal renal function is unknown.Post-marketing reports have identified the development of NSFfollowing single and multiple administrations of GBCAs.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 384
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)Reference: Circular Bil (2) dlm. BPFK/PPP/01/03 Jld. 1: PENAMBAHAN AMARANBERKOTAK DAN AMARAN TERKINI KE DALAM SISIP BUNGKUSAN SEMUA AGEN"CONTRAST MEDIUM" YANG BERASASKAN GADOLINIUM (GADOLINIUM BASED)UNTUK TUJUAN 'MAGNETIC RESONANCE IMAGING' "67. GENTAMICIN TOPICAL PREPARATIONSThe following boxed statement shall be included in the package inserts oftopical Gentamicin preparations:Use of topical gentamicin preparations in closed hospital settings isactively discouraged68. GINKGO BILOBA/ GINKGO EXTRACTThe following statements shall be included on the labels and in the packageinserts of products containing Gingko biloba/ Gingko extract:As the use of Ginkgo may increase the tendency of bleeding, please consultyour physician/ pharmacist if you are on or intend to start using any othermedicines and before you undergo any surgical/dental procedure.(Memandangkan Ginkgo boleh meningkatkan kemungkinan pendarahan, silarujuk kepada doktor/ ahli farmasi sekiranya anda sedang atau akanmenggunakan ubat lain dan sebelum prosedur pembedahan / dentaldijalankan).Reference: Circular Bil (47) dlm BPFK/02/5/1.3: Pernyataan Amaran Pada Label Dan SisipBungkusan Produk Yang Mengandungi Ginkgo Biloba / Ginkgo Ekstrak69. GINSENGThe following statements shall be included on the labels and in the packageinserts of products containing Ginseng (including all Panax genus):Contraindicated in pregnant women.Safe use in lactating women and children has not been established.Do not exceed the stated dose.Safety on long term use has not been established.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 385
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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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