DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)2. ACE INHIBITORSThe following statement shall be included in the package inserts of productscontaining ACE inhibitors:WARNINGINCREASED RISK OF BIRTH DEFECTS, FOETAL AND NEONATALMORBIDITY AND DEATH WHEN USED THROUGHOUT PREGNANCYUSE IN PREGNANCYINCREASED RISK OF BIRTH DEFECTS, FOETAL AND NEONATALMORBIDITY AND DEATH WHEN USED THROUGHOUT PREGNANCYReference: Circular Bil (65) dlm BPFK/02/5/1.3: Produk yang Mengandungi 'ACE Inhibitors'3. ACETYLSALICYLIC ACID (ASPIRIN)For products containing Acetylsalicylic acid, the following warning shall beincluded on the labels in two languages (Bahasa Malaysia and English):AMARANTIDAK BOLEH DIBERI KEPADA KANAK-KANAK BERUMUR KURANGDARIPADA 16 TAHUN.WARNINGNOT TO BE GIVEN TO CHILDREN UNDER 16 YEARS OF AGE.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 358
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)4. ACTIVATED CHARCOAL/ ATTAPULGITE4.1 The following boxed warning shall be included on the labels of productscontaining Activated charcoal/ attapulgite:NOT RECOMMENDED FOR TREATMENT OF DIARRHOEAIN CHILDREN UNDER 6 YEARS OF AGE4.2 The following statements shall be included in the package inserts ofproducts containing Activated charcoal/ attapulgite:Not recommended for treatment of diarhoeain children under 6 years of ageWARNINGActivated charcoal/ attapulgite may interfere with the absorption of otherdrugs, including antibiotics, when administered concurrently.PRECAUTIONAppropriate fluid and electrolyte therapy should be given to protect againstdehydration. Oral rehydration therapy which is the use of appropriate fluidsincluding oral rehydration salts remains the most effective treatment fordehydration due to diarrhoea. The intake of as much of these fluids aspossible is therefore imperative.5. ALBENDAZOLE & BENZIMIDAZOLE ANTIHELMINTICSThe following statement shall be included on the labels and in the packageinserts of products containing Albendazole or Benzimidazole antihelmintics:SHOULD NOT BE ADMINISTERED DURING CONFIRMED OR SUSPECTEDPREGNANCY6. ALFALFA (MEDICO SATIVA)The following boxed warning shall be included on the labels of productscontaining Alfalfa (Medico sativa):This product contains Alfalfa (Medico sativa).Individual with a predisposition to systemic lupus erythematosusshould consult their physician before consuming this product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 359
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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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