DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)27. CARBIMAZOLEThe following statement shall be included in the package inserts of productscontaining Carbimazole:WARNINGCarbimazole may cause white cell disorders such as neutropenia andagranulocytosis, which may be fatal if treatment with carbimazole is notstopped promptly. These reactions usually occur during the first 3 months oftherapy, and in most cases, are reversible on stopping treatment. Sinceagranulocytosis can develop very rapidly, periodic leucocyte counts alone maynot be effective in the early detection of these reactions.28. CABERGOLINEPlease refer to DOPAMINERGIC INGREDIENT29. CEFTRIAXONEThe following statement shall be included in the package inserts of productscontaining Ceftriaxone:CONTRAINDICATIONCeftriaxone is contraindicated in neonates (≤28 days of age) if they require (orare expected to require) treatment with calcium-containing intravenoussolutions, including calcium-containing infusions such as parenteral nutrition,because of the risk of precipitation of ceftriaxone-calcium.WARNINGIn patients other than neonates, Ceftriaxone and calcium-containingsolutions may be administered sequentially to one another if the infusionlines are thoroughly flushed between infusions with a compatible fluid.Diluents containing calcium, such as Ringer‟s solution or Hartmann‟ssolution, are not to be used to reconstitute Ceftriaxone vials or to furtherdilute a reconstituted vial for intravenous administration because aprecipitate can form. Ceftriaxone must not be administeredsimultaneously with calcium-containing intravenous solutions, includingcontinuous calcium-containing infusions such as parenteral nutrition via aY-site, because precipitation of ceftriaxone-calcium can occur.Reference: Circular Bil (48) dlm. BPFK/PPP/01/03: Pindaan Pada Kenyataan AmaranBerkaitan Dengan "Potential Risk Associated With Concomitant Use Of Ceftriaxone WithCalcium - Containing Intravenous Solutions" Yang Perlu Dimuatkan Pada Sisip BungkusanProduk CeftriaxoneNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 370
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)30. CETIRIZINEThe following statement shall be included in the package insert of productscontaining Cetirizine:PRECAUTIONActivities Requiring Mental Alertness: In clinical trials the occurrence ofsomnolence has been reported in some patients taking Cetirizine: due cautionshould therefore be exercised when driving a car or operating potentiallydangerous machinery.31. CHELIDONIUM MAJUSThe following statement shall be included on the label of products containingChelidonium majus in 2 languages (Bahasa Melayu and English) in bold font:WARNINGThis product may cause adverse reaction to the liver.AMARANProduk ini mungkin boleh menyebabkan kesan sampingan pada hepar (hati).Reference: Circular (bil 17) dlm bpfk02/5/1.3: Label Amaran Tentang Penggunaan BahanChelidonium majus32. CHITOSANThe following statement shall be included on the labels and package inserts ofproducts containing chitosan.“DERIVED FROM SEAFOOD”Reference: Circular Bil (52) dlm BPFK/02/5/1.3: Muatkan Kenyataan 'Derived FromSeafood' Pada Label Produk Jika Bahan AKtif Adalah Dari Sumber Laut'National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 371
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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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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