DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 382
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)61. GADODIAMIDEPlease refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETICRESONANCE IMAGING62. GADOLINIUM OXIDEPlease refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETICRESONANCE IMAGING63. GADOTERIC ACIDPlease refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETICRESONANCE IMAGING64. GADOVERSETAMIDEPlease refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETICRESONANCE IMAGING65. GADOXETIC ACIDPlease refer to GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETICRESONANCE IMAGING66. GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETICRESONANCE IMAGINGThe following boxed warning and warning shall be included in the packageinserts of products containing:a. Gadobenate Dimeglumineb. Gadobenic acidc. Gadobutrold. Gadodiamidee. Gadolinium oxidef. Gadoteric acidg. Gadoversetamideh. Gadoxetic acidNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 383
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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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