DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)115. PROPYLTHIOURACIL115.1 The following statement shall be included in the package inserts ofproducts containing propylthiouracil:1 WARNING AND PRECAUTIONPotential risk of serious hepatoxicity or liver injury including liver failureand death. Patients who are initiated with propylthiourasil should beclosely monitored for signs and symptoms of liver injury (e.g. fatigue,weakness, vague abdominal pain, loss of appetite, itching, easybruising or yellowing of the eyes or skin) especially during the first sixmonths. If liver injury is suspected, promptly discontinuepropylthiouracil therapy.Propylthiouracil should not be used in pediatric patients unless thepatient is allergic to or intolerant of the alternatives available.115.2 2 The following boxed warning shall be included in the package insertsof products containing propylthiouracil:BOXED WARNINGSevere liver injury and acute liver failure, in some cases fatal, havebeen reported in patients treated with propylthiouracil. These reportsof hepatic reactions include cases requiring liver transplantation inadult and pediatric patients.Propylthiouracil should be reserved to patients who cannot toleratecarbimazole/ methimazole and in whom radioactive iodine therapy orsurgery are not appropriate treatments for management ofhyperthyroidism.Because of the risk of fetal abnormalities associated withcarbimazole/ methimazole, propylthiouracil may be the treatment ofchoice when an antithyroid drug is indicated during or just prior to thefirst trimester of pregnancy (See Warnings & Precautions).Reference:Circular 1 Bil (41) dlm. BPFK/PPP/01/03: Kenyataan Amaran Berkaitan Dengan “Potential foran Increase in Risk of Hepatotoxicity” yang Perlu Dimuatkan Pada Sisip Bungkusan ProdukPropylthiouracilCircular 2 Bil (55) dlm. BPFK/PPP/01/03: Kenyataan Amaran Berbentuk “Boxed Warning”Yang Wajib Dimuatkan Pada Sisip Bungkusan Produk Propylthiouracil Dengan “Severe LiverInjury”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 400
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)116. PSEUDOEPHEDRINEThe following statement shall be included on the labels and in the packageinserts of liquid oral products containing Pseudoephedrine:WARNINGWhen used for treatment of cough and cold:(a) Not to be used in children less than 2 years of age(b) To be used with caution and doctor‟s/ pharmacist‟s advice inchildren 2 to 6 years of age.Reference: Circular Bil (34) dlm. BPFK/PPP/01/03: Kenyataan Amaran Pada Label danSisip Bungkusan Produk Persediaan Cecair Oral Untuk Rawatan Batuk dan Selsema (Coughand Cold) yang Mengandungi Antihistamin, Antitusif dan Dekongestan (Sebagai Bahan AktifTunggal atau Kombinasi)117. PSYCHOTROPIC PRODUCTSThe following statement shall be included conspicuously on the labels of allpsychotropic products:CAUTION:This preparation may be habit forming on prolonged use.118. QUETIAPINEPlease refer to ANTIPSYCHOTIC AGENT119. QUINAGOLIDEPlease refer to DOPAMINERGIC INGREDIENT120. RISPERIDONEPlease refer to ANTIPSYCHOTIC AGENTNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 401
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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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