Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
MERCAPTOPURINE
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
L01BB02
TABLETS
MERCAPTOPURINE 50 MG
PER OS
Required
ASPEN PHARMA TRADING LTD, IRELAND
MERCAPTOPURINE
MERCAPTOPURINE
For the treatment of acute Leukemia and also in cases of chronic myelogenous Leukemia.
2020-09-30
ةعرجلا ديدحت متيس .طقف بيبطلا لبق نم ناددحت جلاعلا ةقيرطو ةيئاودلا ةعرجلا مهملا نم .ضيرملل ىطع ُ ت يتلا ىرخلأا تاجلاعلا ىلع ً ادامتعإو يدرف لكشب ةيئاودلا .ةمظتنم تاقوأ يف ءاودلا لوانت ىلع صرحلا .بيلحلا برش وأ لكلأا دعب تاعاس 3 وأ لبق لقلأا ىلع ةعاس ءاودلا لوانت بجي ● .ءاملا نم بوك عم هلماكب ءاودلا علب بجي ● ،رطشب ىصوي لا .صرقلا رطشل صصخم ريغ صرقلا ىلع دوجوملا رطشلا طخ ● .صارقلأا غضم وأ قحس ايلاخلل ماس رضحتسملا .ةروسكم صارقأ كب صاخلا جلاعملا وأ تنأ تسملا اذإ ً لااح نيديلا لسغ بجي ةعباتملاو تاصوحفلا اذهو .ةينيتور مد تاصوحف بيبطلا يرجي فوس لوتن-يروپ ـب جلاعلا ةرتف للاخ ءارجإب بيبطلا موقي نأ لمتحملا نم .دبكلا فئاظوو كمد يف ايلاخلا دادعت صحفل نكمي يذلا )لوبلا ضمح( كيرويلا ضمح ةبسن ةعباتمل ىرخأ لوبو مد تاصوحف جلاعلا للاخ ةيئاودلا ةعرجلا بيبطلا ريغي دق .لوتن-يروﭙ ـب جلاعلا ءانثأ عفتري نأ :تاصوحفلا جئاتنل ً اقفو فئاظو جئاتنل ً اقفو ةيئاودلا ةعرجلا ضفخ زئاجلا نم – نيغلابلا ىضرملا ىدل ● .دبكلاو ىلكلا .ةيئاودلا ةعرجلا ضفخ زئاجلا نم – دبكلا وأ ىلكلا يف لكاشم عم ىضرملا ىدل ● .ةيئاودلا ةعرجلا ضفخ زئاجلا نم – TPMT ميزنإ يف صقن كيدل ناك اذإ ● .اهب ىصوملا ةيئاودلا ةعرجلا زواجت زوجي لا ربكأ ةيئاود ةعرج أطخلاب تلوانت اذإ تلوانت اذإ .لاهس Leggi il documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Puri-Nethol Tablets 50 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mercaptopurine. Each tablet contains 50 mg of the active substance mercaptopurine. Excipients with known effect: Lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets A pale yellow, round, biconvex tablet, marked PT above the score line and 50 below the score line on one side and plain on the other. The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications For the treatment of acute leukaemia and also in cases of chronic myelogenous leukemia. 4.2 Posology and Method of Administration Posology Mercaptopurine should be administered at least 1 hour before or 3 hours after food or milk (see sections 5.2 Pharmacokinetic properties: Absorption). Populations • Adults and children For adults and children the usual dose is 2.5 mg/kg bodyweight per day, or 50 to 75 mg/m 2 body surface area per day, but the dose and duration of administration depend on the nature and dosage of other cytotoxic agents given in conjunction with mercaptopurine. The dosage should be carefully adjusted to suit the individual patient. Mercaptopurine has been used in various combination therapy schedules for acute leukaemia and the literature should be consulted for details. Studies carried out in children with acute lymphoblastic leukaemia suggested that administration of mercaptopurine in the evening lowered the risk of relapse compared with morning administration. Children considered to be overweight may require doses at the higher end of the dose range and therefore close monitoring of response to treatment is recommended (see section 5.2 Pharmacokinetic properties: Special patient populations; Overweight children). 2 • Elderly It is advisable to monitor renal and hepatic function in these patients, and if there is any impairment, consideration should be given to reducing the mercaptopurine dosage. • Renal impairment Leggi il documento completo