DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)124.3 The following warning statement shall be included in the packageinserts of products containing Salbutamol in injection and oral dosageform under section of Warning & Precautions:Tocolysis: Serious adverse reactions including death have beenreported after administration of terbutaline/ salbutamol to womenin labor. In the mother, these include increased heart rate,transient hyperglycaemia, hypokalaemia, cardiac arrhythmias,pulmonary oedema and myocardial ischaemia. Increased fetalheart rate and neonatal hypoglycaemia may occur as a result ofmaternal administration.Reference:a) Circular Bil (6) dlm. BPFK/PPP/01/03: Kenyataan Amaran Mengenai InsidenMyocardial Ischaemia pada Wanita Mengandung yang Menerima Rawatan BetaAgonist bagi Rawatan Melambatkan Kelahiran Pramatang pada Sisip BungkusanKumpulan Produk Inib) Circular Bil (18) dlm BPFK/PPP/01/03 Jld 1: Direktif untuk MemperkukuhkanAmaran Berkaitan dengan Risiko Kesan Advers Serius pada Jantung TermasukKematian dengan Penggunaan Produk Suntikan dan Oral Beta Agonis dalamRawatan Kelahiran Pra-MatangNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 414
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 | 415
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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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