Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
IDARUBICIN HYDROCHLORIDE
Farmitalia Carlo Erba Ltd
5 Milligram
Pdr for Soln for Injection
1990-10-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zavedos 5 mg Powder for Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 5mg idarubicin hydrochloride. The reconstituted solution contains 1mg/ml. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Powder for solution for Injection. Orange-red, sterile, freeze-dried powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of acute non-lymphoblastic leukaemia (ANLL) in adults, for remission induction in untreated patients or for remission induction in relapsed or refractory patients. In the treatment of relapsed acute lymphoblastic leukaemia (ALL) as second line treatment in adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous use only. Not for intrathecal use. Dosage is calculated on the basis of body surface area. Acute non-lymphoblastic leukaemia (ANLL) ADULTS - 12 mg/m 2 /day x 3 days with cytosine arabinoside or - 8 mg/m 2 /day x 5 days with/without cytosine arabinoside Acute lymphoblastic leukaemia (ALL) ADULTS - 12 mg/m 2 /day x 3 days CHILDREN - 10 mg/m 2 /day x 3 days IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/03/2010_ _CRN 2079623_ _page number: 1_ The haematological status of the patient should be taken into account before treatment with any of these dosing schedules. Administration of the second course should be delayed in patients who develop severe mucositis until recovery from this toxicity has occurred and a dose reduction of 25% is recommended. The dosage should be reduced in the presence of impaired renal or liver function. For instructions on dilution of the product before administration, _see section Aqra d-dokument sħiħ