DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)109. PIROXICAMThe following additional information shall be included in the package inserts ofproducts containing Piroxicam:WARNING AND PRECAUTIONTreatment should always be initiated by a physician experienced inthe treatment of rheumatic diseases.Use the lowest dose (no more than 20mg per day) and for theshortest duration possible. Treatment should be reviewed after 14days.Always consider prescribing a gastro-protective agent.CONTRAINDICATIONPiroxicam should not be prescribed to patient who is more likely todevelop side effects, such as those with a history of gastro-intestinaldisorders associated with bleeding, or those who have had skinreactions to other medicines.Piroxicam should not be prescribed in association with any otherNSAID or an anticoagulant.Reference: Circular Bil (80) dlm BPFK/02/5/1.3: Menghadkan Indikasi bagi Produk untukKegunaan Systemic yang Mengandungi Piroxicam kepada 'For the symptomatic relief of painand inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis'dan Tambahan Amaran dan Kontraindikasi terkini pada sisip bungkusan110. PRAMIPEXOLEPlease refer to DOPAMINERGIC INGREDIENTNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 406
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)111. PROMETHAZINE HCLThe following additional information shall be included on the label and in thepackage insert of liquid oral products containing Promethazine HCl:WARNINGWhen used for treatment of cough and cold(a) “It (brand or generic names) should not be used in pediatric patientsless than 2 years of age because of the potential for fatal respiratorydepression”.(b) To be used with caution and doctor‟s/ pharmacist‟s advice in children 2to 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)112. PROPAFENONEThe following warning shall be included in the package insert of productscontaining propafenone:Propafenone is not recommended for treatment of less severearrhythmias such as nonsustained ventricular tachycardias or frequentpremature ventricular contractions even if the patients are symptomatic,because of recent evidence in the US of increase mortality in patientswith non-lifethreatening arrhythmias who were treated with encainideand flecainide.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 407
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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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