Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
magnesium phosphate pentahydrate,Manganese amino acid chelate,pyridoxine hydrochloride,retinol acetate,zinc amino acid chelate
Blackmores Ltd
magnesium phosphate pentahydrate,Manganese amino acid chelate,pyridoxine hydrochloride,retinol acetate,zinc amino acid chelate
Medicine Listed (Export Only)
Version: pfpzavea10221 Supersedes: pfpzavea10220 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION – ZAVEDOS (IDARUBICIN HYDROCHLORIDE) 1. NAME OF THE MEDICINE Idarubicin hydrochloride. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION POWDER FOR INJECTION Each vial contains 5 mg, 10 mg or 20 mg of idarubicin hydrochloride. SOLUTION FOR INJECTION Each vial contains 5 mg/5 mL, 10 mg/10 mL or 20 mg/20 mL of idarubicin hydrochloride. CAPSULES Each capsule contains 5 mg or 25 mg of idarubicin hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM POWDER FOR INJECTION Porous, red-orange freeze dried powder, cake or mass. The reconstituted solution is an orange-red, mobile solution, free from particles. SOLUTION FOR INJECTION Red-orange, clear, mobile solution, free from particles. CAPSULES The 5 mg capsule is a hard gelatin capsule, self-locking, with opaque red-orange cap & body, size No.4, with a radial imprint on the cap “idarubicin 5” with black ink. The capsules contain an orange powder. The 25 mg capsule is a hard gelatin capsule, self-locking, with opaque white cap and body, size No.2, with a radial imprint on the cap “idarubicin 25” with black ink. The capsules contain an orange powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZAVEDOS is indicated for use in acute myelogenous leukaemia (AML) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. Version: pfpzavea10221 Supersedes: pfpzavea10220 Page 2 of 17 ZAVEDOS capsules are indicated whenever the intravenous route is not considered suitable. ZAVEDOS may be used in combination chemotherapy regimens involving other cytotoxic agents. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE For induction therapy in adult patients with AML, the following dose schedules are recommended: CAPSULES In adult AML the recommended dose schedule is 30 mg/m2 orally given daily for 3 days as a single agent, or between 15 and 30 mg/m2 orally daily for three day Läs hela dokumentet