DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)125. SEDATIVE – HYPNOTIC PRODUCTSThe following statement shall be included in the package inserts under sectionon „Warning‟ and „Precaution‟ of products containing:a. Alprazolamb. Bromazepamc. Clobazamd. Diazepame. Flurazepam hydrochloridef. Lorazepamg. Midazolamh. Nitrazepami. Triazolamj. Zolpidem tartratek. ZopicloneWARNING/ PRECAUTIONAnaphylaxis (severe allergic reaction) and angioedema (severe facialswelling) which can occur as early as the first time the product is takenComplex sleep – related behaviors which may include sleep driving,making phone calls, preparing and eating food while asleepReference: Circular Bil (75) dlm BPFK/02/5/1.3: Pernyataan Amaran Pada Sisip BungkusanSemua Produk Sedatif-Hipnotik Oral Berkaitan dengan Risiko Complex Sleep - RelatedBehaviors Which May Include Sleep Driving, Making Phone Calls, Preparing and Eating Food(While Asleep)126. SELENIUM SULPHIDEThe following statement shall be included on the labels of products containingSelenium sulphide:WARNINGDo not use on broken skin or inflamed. Avoid contact with eyes.(AMARAN: Selenium sulphide tidak boleh digunakan pada kulit yang pecahdan radang. Elakkan daripada terkena mata.)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 412
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)127. SENNA LEAF (CASSIA) AND RHUBARB/ RADIX et RHIZOMA RHEIThe following statement shall be included on the labels of products containingsenna leaf (cassia) and rhubarb/ radix et rhizoma rhei:Do not use when abdominal pain, nausea or vomiting are presentFrequent or prolong use of this preparation may result independence towards the product and „Imbalanced electrolytes‟128. SODIUM METABISULPHITE (EXCIPIENT)The following statement shall be included in the package inserts of productscontaining Sodium metabisulphite:WARNINGThis preparation contains Sodium metabisulphite that may cause seriousallergic type reactions in certain susceptible patients. Do not use if known tobe hypersensitive to bisulphites.129. SODIUM VALPROATEThe following boxed warning shall be included in the package inserts ofproducts containing Sodium valproate:PANCREATITIS:CASES OF LIFE-THREATENING PANCREATITIS HAVE BEENREPORTED IN BOTH CHILDREN AND ADULTS RECEIVINGVALPROATE. SOME OF THE CASES HAVE BEEN DESCRIBED ASHEMORRHAGIC WITH A RAPID PROGRESSION FROM INITIALSYMPTOMS TO DEATH. CASES HAVE BEEN REPORTED SHORTLYAFTER INITIAL USE AS WELL AS AFTER SEVERAL YEARS OF USE.PATIENTS AND GUARDIANS SHOULD BE WARNED THATABDOMINAL PAIN, NAUSEA, VOMITING, AND/OR ANOREXIA CAN BESYMPTOMS OF PANCREATITIS THAT REQUIRE PROMPT MEDICALEVALUATION. IF PANCREATITIS IS DIAGNOSED, VALPROATESHOULD BE DISCONTINUED.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 413
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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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