Држава: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Mercaptopurine monohydrate 10mg
GlaxoSmithKline NZ Limited
Mercaptopurine monohydrate 10 mg
10 mg
Tablet
Active: Mercaptopurine monohydrate 10mg Excipient: Lactose monohydrate Magnesium stearate Starch
Bottle, 100 tablets
Prescription
Prescription
Glaxo Operations UK Limited t/a Glaxo Welcome Operations
Package - Contents - Shelf Life: Bottle, - 100 tablets - 60 months from date of manufacture stored at or below 25°C protect from light
1969-12-31
PURI-NETHOL – Data Sheet Page 1 of 17 NEW ZEALAND DATA SHEET 1. PURI-NETHOL TABLETS (MERCAPTOPURINE 50 MG) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Purinethol 50 mg Tablets: Each tablet contains 50 mg mercaptopurine BP. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pale yellow, round, biconvex tablets, marked PT above the line and 50 below the line on one side and plain on the other. Please note that the tablets should not be taken in divided doses. Breaking the tablets across the score line is to enable swallowing only. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute leukaemia in adults, adolescents and children. It may be utilised in: Acute lymphoblastic leukaemia (ALL) Acute promyelocytic leukaemia (APL)/Acute myeloid leukaemia M3 (AML M3). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE IN ADULTS AND CHILDREN For adults and children, the usual dose is 2.5 mg/kg bodyweight per day, or 50-75 mg/m2 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 PURI-NETHOL. The dosage should be carefully adjusted to suit the individual patient and in accordance with the employed treatment protocol. 6-mercaptopurine has been used in various combination therapy schedules for acute leukaemia and the literature and current treatment guidelines should be consulted for details. Studies carried out in children with acute lymphoblastic leukemia 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). PURI-NETHOL – Data Sheet Page 2 of 17 DOSAGE IN THE ELDERLY It is advisable to monitor renal and hepatic function in these patients, and if there is any impa Прочитајте комплетан документ