DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)40. COLCHICINEThe following statement shall be included in the package inserts of productscontaining Colchicines:INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHERFORMS OF INTERACTION:Potential risk of severe drug interactions, including death, in certainpatients treated with colchicine and concomitant P-glycoprotein or strongCYP3A4 inhibitors such as clarithromycin, cyclosporin, erythromycin, calciumchannel antagonists (e.g Verapamil and Diltiazem), telithromycin,ketoconazole, itraconazole, HIV protease inhibitors and nefazodone.P-Glycoprotein or strong CYP3A4 inhibitors are not to be used in patientswith renal or hepatic impairment who are taking colchicine.A dose reduction or interruption of colchicine treatment should beconsidered in patients with normal renal and hepatic function if treatment witha P-glycoprotein or a strong CYP3A4 inhibitor is required. Avoid consuminggrapefruit and grapefruit juice while using colchicine.Reference: Circular Bil (45) dlm. BPFK/PPP/01/03: Kenyataan Amaran Berkaitan Dengan“Severe Drug Interaction Between Colchicine and P-Glycoprotein or Strong CYP3A4Inhibitors” Yang Perlu Dimuatkan Pada Sisip Bungkusan Produk ColchicineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 366
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)41. COX-2 INHIBITORSThe following statement shall be included in the package insert for COX-2Inhibitors products containing Celecoxib and Etoricoxib:Contraindication for patients who have increased risk of cardiovasculardisease (ischeamic heart disease and stroke).Warning to prescriber when prescribing COX-2 Inhibitors to patients withrisk factors of heart disease, hypertension (high blood pressure),hyperlipidemia, diabetes, smoking patient and patient with peripheralarterial disease.Statement on limiting the period and dosing is written as „Given theassociation between cardiovascular risk and exposure to COX-2Inhibitors, doctors are advised to use the lowest effective dose for theshortest possible duration of treatment‟.Contraindication for patient using Etoricoxib is written as „Contraindicationfor Etoricoxib in patients with hypertension (high blood pressure) whoseblood pressure is not under control‟.Reference: Circular Bil (46) dlm BPFK/02/5/1.3: Keputusan Mesyuarat PBKD - Tindakantindakanregulatori terhadap Cox-2 Inhibitors: Celecocib dan Etoricoxib42. CYPROTERONE ACETATEThe following statement shall be included in the package inserts of productscontaining Cyproterone acetate:WARNINGDirect hepatic toxicity, including jaundice, hepatitis and hepatic failure, whichhas been fatal in some cases, has been reported in patients treated with100mg or more of cyproterone acetate. Most reported cases are in men withprostatic cancer. Toxicity is dose-related and develops, usually, severalmonths after treatment has begun. Liver function tests should be performedpre-treatment and whenever any symptoms or signs suggestive ofhepatotoxicity occur. If hepatotoxicity is confirmed, cyproterone acetate shouldnormally be withdrawn, unless the hepatotoxicity can be explained by anothercause, e.g. metastatic disease, in which case cyproterone acetate should becontinued only if the perceived benefit outweighs the risk.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 367
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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