DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)Reference: Circular Bil (6) dlm BPFK/PPP/01/03 Jld 1: Direktif MemperketatkanPenggunaan Rosiglitazone dan Memperkukuhkan Amaran Berkaitan Dengan Risiko KesanAdvers Kardiovaskular Pada Sisip Bungkusan Semua Produk Rosiglitazone Termasuk ProdukKombinasi123. ROYAL JELLYThe following information shall be included on the labels and/or packageinserts of products containing Royal jelly:WARNINGSThis product contains royal jelly and may cause severe allergic reactionsincluding fatal anaphylactic reactions in susceptible individuals. Asthma andallergy sufferers may be at the greater risk.Reference:a) Circular Bil (48) dlm BPFK/02/5/1.3: Pernyatan Amaran Pada Label Dan SisipBungkusan Produk Yang Mengandungi Propolis (Topikal) dan Royal Jelly (SemuaBentuk)b) Circular Bil (56) dlm BPFK/02/5/1.3: Pernyataan Amaran pada Label dan SisipBungkusan Produk yang Mengandungi Propolis (topikal) dan Royal Jelly (SemuaBentuk)c) Circular Bil (12) dlm. BPFK/PPP/01/03: Pernyataan amaran pada label dan sisipbungkusan produk yang mengandungi royal jelly (produk kosmetik)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 412
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)124. SALBUTAMOL124.1 The following information shall be included in the package inserts ofproducts containing Salbutamol in injection dosage form:As maternal pulmonary oedema and myocardial ischaemia havebeen reported during or following premature labour in patientsreceiving beta2 – agonists, careful attention should be given to fluidbalance and cardio-respiratory function, including ECG monitoring.If signs of pulmonary oedema and myocardial ischaemia develop,discontinuation of treatment should be considered.Due to the risk of pulmonary oedema and myocardial ischaemiathat has been observed during the use of beta2-agonists in thetreatment of premature labour, before these products are given toany patient with known heart disease, an adequate assessment ofthe patients‟s cardiovascular status should be made by a physicianexperienced in cardiology.Cautious use of salbutamol injections is required in pregnantpatients when it is given for relief of bronchospasm so as to avoidinterference with uterine contractibility. During IV infusion ofsalbutamol, the maternal pulse should be monitored and notnormally allowed to exceed a steady rate of 140 beats per minute.124.2 The following information shall be included in the package inserts andproduct literature of products containing Salbutamol in oral tablet/capsule dosage form:As maternal pulmonary oedema and myocardial ischaemia havebeen reported during or following premature labour in patientsreceiving beta2 – agonists, careful attention should be given tofluid balance and cardio-respiratory function, including ECGmonitoring. If signs of pulmonary oedema and myocardialischaemia develop, discontinuation of treatment should beconsidered.Due to the risk of pulmonary oedema and myocardial ischaemiathat has been observed during the use of beta2-agonists in thetreatment of premature labour, before these products are givento any patient with known heart disease, an adequateassessment of the patients‟s cardiovascular status should bemade by a physician experienced in cardiology.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 413
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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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