DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)21. BLACK COHOSH (CIMICIFUGAE RACEMOSAE)The following statement shall be included on the labels and in the packageinserts of products containing Black Cohosh (Cimicifugae Racemosae):WARNINGStop taking this product if signs and symptoms suggestive of liver injurydevelop such as tiredness, loss of appetite, yellowing of the skin and eyes orsevere upper stomach pain with nausea and vomiting or dark urine andconsult your doctor immediately.Patients using herbal medicinal products should tell their doctor about it.Reference: Circular Bil (61) dlm BPFK/02/5/1.3: Pernyataan Amaran Produk Mengandungi'Black Cohosh'22. BROMAZEPAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTS23. BROMOCRIPTINEPlease refer to DOPAMINERGIC INGREDIENT24. BROMPHENIRAMINEThe following statement shall be included on the labels and in the packageinserts of liquid oral products containing Brompheniramine: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 in children2 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)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 368
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)25. CAMPHOR25.1 The following boxed warning shall be included on the labels of productscontaining Camphor:CAN CAUSE CONVULSIONCONTRAINDICATED IN CHILDREN BELOW 2 YEARS OF AGE.CAUTION MUST BE EXERCISED WHEN OLDER CHILDREN ARETREATEDAVOID DIRECT APPLICATION INTO THE NOSTRILS25.2 The following warning and precaution shall be included in the packageinsert of products containing Camphor:WARNINGThis product is contraindicated in children below 2 years of age. Cautionmust be exercised when older children are treated.PRECAUTION:It is dangerous to place any camphor containing product into the nostrilof children. A small amount applied this way may cause immediatecollapse.26. CARBAMAZEPINEThe following statement shall be included in the package insert of productscontaining Carbamazepine:Severe dermatologic reactions including Stevens - Johnson syndrome andtoxic epidermal necrolysis (Lyell‟s Syndrome) have been reported withcarbamazepine. Patients treated with carbamazepine should closely bemonitored for signs of hypersensitivity reactions, particularly during the firstmonth of therapy. Immediate discontinuation of therapy should be madewhen cutaneous reactions occur.Potential for an increase in risk of suicidal thoughts or behaviours.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 369
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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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