DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)50. DIPHENOXYLATE50.1 The following boxed warning shall be included on the labels of productscontaining Diphenoxylate:NOT RECOMMENDED FOR CHILDREN UNDER 6 YEARS OF AGE.50.2 The following statement shall be included in the package insert ofproducts containing Diphenoxylate:WARNINGNot recommended for children under 6 years of age.PRECAUTIONAppropriate fluid and electrolyte therapy should be given to protectagainst dehydration in all cases of diarrhoea. Oral rehydration therapywhich is the use of appropriate fluids including oral rehydration saltsremains the most effective treatment for dehydration due to diarrhoea.The intake of as much of these fluids as possible is therefore imperative.Drug-induced inhibition of peristalsis may result in fluid detention in theintestine, which may aggravate and mask dehydration and depletion ofelectrolytes, especially in young children. If severe dehydration ofelectrolyte imbalance is present, diphenoxylate should be withheld untilappropriate corrective therapy has been initiated.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 380
Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)51. DOPAMINERGIC INGREDIENTThe following warning/ statement related to “Sudden sleep onset” shall beincluded in the package insert and product literature of products containingdopaminergic ingredients:a. alpha-dihydroergocryptineb. apomorphinec. bromocriptined. cabergolinee. levodopaf. lisurideg. piribedilh. pramipexolei. quinagolidej. ropiniroleSPECIAL WARNING & SPECIAL PRECAUTIONS FOR USE……. has been associated with somnolence and episodes of sudden onset,particularly in patients with Parkinson‟s diseases. Sudden onset of sleepduring daily activities, in some cases without awareness or warning signs, hasbeen reported very rarely. Patients must be informed of this and advised toexercise caution while driving or operating machines during treatment with……. Patients who have experienced somnolence and/or an episode ofsudden sleep onset must refrain from driving or operating machines.Furthermore a reduction of dosage or termination of therapy may beconsidered.EFFECTS ON ABILITY TO DRIVE AND USE MACHINESPatients being treated with ……. and presenting with somnolence and/orsudden sleep episodes must be informed to refrain from driving or engaging inactivities where impaired alertness may put themselves or others at risk ofserious injury or death (e.g. operating machines) until such recurrent episodesand somnolence have resolved (see also section on special warnings andspecial precautions for use).UNDESIRABLE EFFECTS……. is associated with somnolence and has been associated very rarely withexcessive daytime somnolence and sudden sleep onset episodes.Reference: Circular (bil 14) dlm bpfk02/5/1.3: keluaran yang mengandungi bahan aktifdopaminergik- tanda amaran berkaitan dengan ' sudden sleep onset'National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 381
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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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