DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)84. LORATADINEThe following boxed warning shall be included in the package inserts ofproducts containing Loratadine:WARNINGDrugs known to inhibit hepatic metabolism should be co-administered withcaution until definitive interaction studies can be completed. The numberof subjects who concomitantly received macrolide antibiotics,ketoconazole, cimetidine, ranitidine, or theophylline along with loratadinein controlled clinical trials is too small to rule out possible drug interactions.85. LORAZEPAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTS86. METHYL SALICYLATEThe following statements shall be included in the package inserts and productliterature of topical preparations containing methyl salicylate ≥5%:CAUTIONThis product contains methyl salicylate and when applied or rub on to the skin,can be absorbed through the skin into the blood. For patients taking warfarin,excessive application on to the skin for muscle or joint pains may increase thechances of bleeding.87. METHYLPHENIDATE HCLThe following boxed statement shall be included on the labels and in thepackage insert of products containing Methylphenidate HCl:FOR SPECIALIST‟S USE ONLYNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 394
Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)88. METOCLOPRAMIDEThe following statements shall be included in the package inserts of productscontaining Metoclopramide:DOSAGETotal daily dose of metoclopramide, especially for children and young adults,should not normally exceed 0.5mg/kg body weight.WARNINGAvoid doses exceeding 0.5mg/kg/day.Extrapyramidal effects, especially dystonic reaction of metoclopramideare more likely to occur in children shortly after initiation of therapy, andusually with doses higher than 0.5mg per kg of body weight per day.89. MICONAZOLEThe following boxed warning shall be included on the labels and in thepackage inserts of intravaginal preparations containing Miconazole:Sila dapatkan nasihat doktor atau ahli farmasi sebelum menggunakankeluaran ini jika anda mengambil ubat warfarin, iaitu sejenis ubatantipembekuan darah, kerana lebam/ pendarahan pada gusi/ hidungboleh berlaku secara spontan.(Please consult your physician/ pharmacist before using this product ifyou are on the anticoagulant medicine warfarin, because bleeding fromnose/ gums or bruising may accur spontaneously).Reference: Circular (bil 45) dlm bpfkweb.bpkp.2.2001: Keputusan Mesyuarat Pihakberkuasa Kawalan Dadah (PBKD) ke 122 Berhubung Amaran Berkaitan Interaksi Ubat BagiSemua Keluaran ANTIFUNGAL INTRAVAGINAL Yang Mengandungi MiconazoleNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 395
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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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