DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)interference with uterine contractibility. During IV infusion ofterbutaline, the maternal pulse should be monitored and notnormally allowed to exceed a steady rate of 140 beats per minute.133.2 The following information shall be included in the package insert andproduct literature of products containing Terbutaline 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 to fluidbalance and cardio-respiratory function, including ECG monitoring. Ifsigns of pulmonary oedema and myocardial ischaemia develop,discontinuation of treatment should be considered.Due to the risk of pulmonary oedema and myocardial ischaemia thathas been observed during the use of beta2-agonists in the treatmentof premature labour, before these products are given to any patientwith known heart disease, an adequate assessment of the patients‟scardiovascular status should be made by a physician experienced incardiology.133.3 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 havebeen reported after administration of terbutaline/ salbutamol towomen in labor. In the mother, these include increased heartrate, transient hyperglycaemia, hypokalaemia, cardiacarrhythmias, pulmonary oedema and myocardial ischaemia.Increased fetal heart rate and neonatal hypoglycaemia mayoccur as a result of maternal 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 | 416
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)134. TETRACYCLINE SYRUPThe following boxed warning shall be included on the label and in the packageinserts of products containing Tetracycline (syrup)NOT TO BE GIVEN TO CHILDREN UNDER 12 YEARS OF AGE135. THIOMERSALNote: Thiomersal is not allowed in ophthalmic preparations as preservative.The following statement shall be included on the label and package inserts ofproducts containing thiomersal for preparations other than ophthalmicpreparation:WARNING„RISK OF SENSITIZATION IN RELATION TO THIOMERSAL AND OTHERPRESERVATIVES‟Reference: Circular Bil (34)dlm BPFK/02/5/1.3: Penggunaan Thiomersal Dalam PersediaanVaksinNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 417
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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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