DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)141. VARENICLINEThe following statement shall be included in the package inserts of productscontaining Varenicline:SPECIAL WARNINGS AND PRECAUTIONS FOR USEEffect of smoking cessation:Smoking cessation, with or without pharmacotherapy has been associatedwith the exacerbation of underlying psychiatric illness (eg. depression). Careshould be taken with patients with a history of psychiatric illness and patientsshould be advised accordingly.Depression, rarely including suicidal ideation and suicide attempt, has beenreported in patients undergoing a smoking cessation attempt.UNDESIRABLE EFFECTSPost marketing cases of MI, depression and suicidal ideation have beenreported in patients taking varenicline.Reference: Circular Bil (83) dlm. BPFK/17/FV/28: Maklumat dari European MedicinesAgency (EMEA) berkaitan penggunaan produk Champix (Varenicline) untuk rawatan berhentimerokok (smoking cessation).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 420
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)142. VITAMIN K142.1 The following statement shall be included in the label and package insertof health supplement products containing Vitamin K as combinedingredients with other vitamins and minerals in oral preparation:„Consult a healthcare practitioner if you are on anticoagulant/blood thinner products.142.2 The following statement shall be included in the package inserts ofproducts containing Vitamin K1 (phytomenadione) as single ingredientused intravenously:WARNINGSevere reactions, including fatalities, have occurred during andimmediately after intravenous injection of Vitamin K1. Restrictintravenous use to emergency case. When intravenous administration isnecessary, the rate of injection should not exceed 1mg per minute.ADMINISTRATION:In severe bleeding, or situations where other routes are not feasible,Vitamin K1 may be given by very slow intravenous injection, at a ratenot exceeding 1mg per minute.143. WARFARINThe following statement shall be included in the package inserts of productscontaining Warfarin:CAUTIONTopical preparations containing methyl salicylate should be used with care inpatients on Warfarin and excessive usage is to be avoided as potentiallydangerous drug interaction can occur.144. ZIPRASIDONEPlease refer to ANTIPSYCHOTIC AGENTNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 421
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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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