Puri-nethol

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Mercaptopurine monohydrate 10mg

Tilgjengelig fra:

GlaxoSmithKline NZ Limited

INN (International Name):

Mercaptopurine monohydrate 10 mg

Dosering :

10 mg

Legemiddelform:

Tablet

Sammensetning:

Active: Mercaptopurine monohydrate 10mg Excipient: Lactose monohydrate Magnesium stearate Starch

Enheter i pakken:

Bottle, 100 tablets

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Glaxo Operations UK Limited t/a Glaxo Welcome Operations

Produkt oppsummering:

Package - Contents - Shelf Life: Bottle, - 100 tablets - 60 months from date of manufacture stored at or below 25°C protect from light

Autorisasjon dato:

1969-12-31

Preparatomtale

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