DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)56. FLUORIDEAll toothpastes containing Fluorides should be labeled with the followingadditional information:a. DIRECTIONS ON USEDo not swallow – spit and rinse after use.b. FOR CHILDREN BELOW 6 YEARSUse a pea-sized amount of toothpaste (less than 5mm).Supervise child‟s brushing.c. DIRECTIONS ON DENTAL HEALTHBrush at least twice a day.Restrict the amount and frequency of sugary food.Visit your dentist at least once a year.d. GRAPHICS AS SHOWNChild‟s useAdult‟s useNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 384
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)57. FLUOROQUINOLONESThe following statement shall be included in the package inserts of productscontaining fluoroquinolones:WARNING AND PRECAUTIONExacerbation of myasthenia gravisFluoroquinolones have neuromuscular blocking activity and may exacerbatemuscle weakness in person with myasthenia gravis. Post marketing seriousadverse events, including deaths and requirement for ventilator support havebeen associated with flouroquinolones use in persons with myasthenia gravis.Avoid flouroquinolones in patients with known history of myasthenia gravisADVERSE REACTIONS/SIDE EFFECTSExacerbation of myasthenia gravisPost Marketing ExperienceReference: Circular Bil (20) dlm BPFK/PPP/01/03 Jld 1: Direktif untuk MemperkukuhkanAmaran Berkaitan dengan Exacerbation of Myasthenia Gravis dalam Sisip Bungkusan SemuaProduk Antibiotik dalam Kumpulan Fluoroquinolones58. FLURAZEPAM HYDROCHLORIDEPlease refer to SEDATIVE – HYPNOTIC PRODUCTS59. GADOBENIC ACIDPlease refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETICRESONANCE IMAGING60. GADOBUTROLPlease refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETICRESONANCE IMAGINGNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 385
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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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