DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)90. MIDAZOLAMThe following statements shall be included in the package inserts of IVpreparations containing Midazolam:WARNINGIV Midazolam has been associated with severe respiratory depression andrespiratory arrest, especially when used for conscious sedation. In somecases, where this was not recognized promptly and treated effectively, deathor hypoxic encephalopathy resulted. IV Midazolam should be used only inhospital or ambulatory care settings that provide for continuous monitoring ofrespiratory and cardiac functions. Assure immediate availability of resuscitativedrugs, equipments, appropriate antidote and personnel trained in their use.Dosage of IV Midazolam must be individualized for each patient. Lower dosesare usually required for elderly, debilitated or higher risk surgical patients.When Midazolam is administered intravenously for conscious sedation, itshould be injected slowly (over at least 2 minutes); it should not beadministered by rapid or single bolus IV injection because of respiratorydepression and/or arrest, especially in elderly or debilitated patients. The initialdose may be as little as 1mg, but should not exceed 2.5mg in a normal healthyadult; administer over at least 2 minutes and allow additional 2 or moreminutes to fully evaluate sedative effect. If further titration is necessary, usesmall increments to the appropriate level of sedation, allowing an additional 2or more minutes after each increment to fully evaluate sedative effect. SeeDosage and Administration for complete dosing information.Please refer to SEDATIVE – HYPNOTIC products for additional information.91. MINOXIDILThe label and the package insert shall include the following statement:To be supplied only on the prescription of a registered medical practitioner.Note: The statement is exempted for external use preparation containing notmore than 5% of Minoxidil; its salts; its derivatives(Please refer latest Poison List: Preparations for external use containing not morethan 5% of Minoxidil; its salts; its derivatives, which is under Group C)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 396
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)92. MUCOLYTIC AGENTThe following warning shall be included in the package inserts of productscontaining:a) Acetylcysteineb) Carbocysteinec) Methylcarbocysteine (Mecysteine)CONTRAINDICATIONSContraindicated in children below two (2) years of age.Reference: Circular Bil (7) dlm BPFK/PPP/01/03 Jld 1: Kemaskini Kenyataan Amaran“Contraindicated In Children Under 2 Years Of Age” Yang Wajib Dimuatkan Pada SisipBungkusan Semua Produk Carbocysteine, Acetylcysteine Dan Methylcarbocysteine(Mecysteine)93. NEVIRAPINEThe following statement shall be included in the package insert of product thatcontains Nevirapine:Addition of this statement at approved Indication:“Avoid usage of Nevirapine in patient with CD4+cell count greater than250cells/mm3”.Reference: Circular Bil (43) dlm BPFK/02/5/1.3: Pendaftaran Produk Yang MengandungiNevirapine94. NIFEDIPINEThe following statement shall be included in the package inserts of “shortacting” Nifedipine products:WARNING/ PRECAUTIONSeveral well documented studies have described profound hypotension,myocardial infarction and death when immediate release nifedipine capsulesare used sublingually for acute reduction of blood pressure.DOSAGELower doses may be required in elderly patients as a result of reduceddrug clearance.For hypertension, the dose used should not exceed 60mg daily.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 397
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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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