DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)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 | 424
Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)145. ZOLPIDEM TARTRATEPlease refer to SEDATIVE – HYPNOTIC PRODUCTS146. ZOPICLONEPlease refer to SEDATIVE – HYPNOTIC PRODUCTSNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 425
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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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