DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)2.7.2 SPECIFIC LABELLING STATEMENTS/ WARNING &PRECAUTIONSFor products containing the following active ingredients, specific cautionarystatement(s) as specified shall be included:For product containing Alfalfa (Medicago sativa), please state:This product contains Alfalfa (Medicago sativa).Individuals with a predisposition to systemic lupus erythematosus shallconsult their physician before consuming this product.For product containing „Anti-diarrhoea‟, please state:“Contraindicated in children below 1 year old.”For product containing Aspartame, please state:WARNING:“Unsuitable for phenylketonurics”For products containing BEE POLLEN, please state:- This product contains Bee Pollen and may cause severe allergicreactions, including fatal anaphylactic reactions in susceptible individuals.- Asthma and allergy sufferers may be at greater risks.For product containing Benzyl Alcohol/ Phenylmethanol (as preservative),please state:As this preparation contains benzyl alcohol, its use shall beavoided in children under 2 years of age. Not to be used inneonates.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 278
Drug Registration Guidance Document (<strong>DRGD</strong>)For product containing Black Cohosh (Cimicifuga racemosa), please state:Warning:- Stop taking this product if signs and symptoms suggestive ofliver injury develop such as tiredness, loss of appetite, yellowingof the skin and eyes or severe upper stomach pain with nauseaand vomiting or dark urine and consult your doctor immediately.- Patients using herbal medicinal products shall tell their doctorabout it.For products containing Camphor:i) The following warning shall be stated on the label:WARNING:CAN CAUSE CONVULSIONCONTRAINDICATED IN INFANTS BELOW 2 YEARS OF AGE.CAUTION MUST BE EXERCISED WHEN OLDER CHILDREN ARETREATED.AVOID DIRECT APPLICATION INTO NOSTRILSPRECAUTION:It is dangerous to place any camphor – containing product into the nostrilof children. A small amount applied this way may cause immediatecollapse.- Avoid contact with the eyes.- Do not apply to wounds or damaged skin.ii) The following warning and precaution shall be stated on product leaflet:WARNING: “This product is contraindicated in infants under 2years of age. Caution must be exercised when older children aretreated”PRECAUTION: “It is dangerous to place any camphor containingproduct into the nostrils of children. A small amount applied thisway may cause immediate collapse”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 279
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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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Page 228 and 229: Drug Registration Guidance Document
Page 230 and 231: APPENDIX 5:Drug Registration Guidan
Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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