DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)72. HYDROQUINONEThe following warning shall be included on the outer labels of productscontaining Hydroquinone:WARNING:Some users of this product may experience skin irritations. Should this occur,stop using and consult a medical doctor.For hydroquinone products that do not contain any sun screening agent, astatement should be included in the package insert to advise users to eitheruse a sun screening agent or protect themselves from sunlight or to use theproducts only at night.Reference: Circular (bil 26) dlm bpfkweb.bpkp.3.2000: Amaran bagi Produk MengandungiHydroquinone73. IMMUNOSUPPRESANTSThe following information shall be included in the package inserts of productscontaining the following immunosuppressants:a) Sirolimusb) Cyclosporinc) Mycophenolate mofetild) Mycophenolic acide) TacrolimusWARNINGS AND PRECAUTIONSImmunosuppressed patients are at increased risk for opportunistic infections,including activation of latent viral infections. These include BK virus associatednephropathy which has been observed in patients receivingimmunosuppressants. These infections may lead to serious, including fataloutcomes.Reference: Circular Bil (44) dlm. BPFK/PPP/01/03: Kenyataan Amaran Berkaitan Dengan“Increased Risk For Opportunistic Infections Such As Activation of Latent Viral InfectionsIncluding BK Virus – Associated Nephropathy” Yang Perlu Dimuatkan Pada Sisip BungkusanProduk Immunosuppressant74. INSULINThe label of the product shall state clearly the source of insulin.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 390
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)75. INGREDIENTS DERIVED FROM SEAFOODThe following statement shall be included on the labels and package inserts ofproducts.“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'76. KAOLIN, PECTIN, KAOLIN-PECTINThe following boxed warning shall be included on the labels:NOT RECOMMENDED FOR CHILDREN UNDER 6 YEARS OF AGE.The following statement shall be included in the package inserts of productscontaining kaolin and/ or pectin:WARNINGNot recommended for children under 6 years of age.Severe constipation, which may lead to faecal impaction, may rarely occur inchildren and the elderly patients taking kaolin and pectin. Kaolin and pectinmay interfere with the absorption of other drugs, including antibiotics,administered concurrently.PRECAUTIONAppropriate fluid and electrolyte therapy should be given to protect againstdehydration. Oral rehydration therapy with the use of appropriate fluidsincluding oral rehydration salts - remains the most effective treatment fordehydration due to diarrhoea. The intake of as much of these fluids aspossible is therefore imperative.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 391
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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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