Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IDARUBICIN HCL/DEMETHOXY DAUNORUBICIN H*
PFIZER (MALAYSIA) SDN. BHD.
IDARUBICIN HCL/DEMETHOXY DAUNORUBICIN H*
10ml mL
PFIZER (PERTH) PTY. LTD.
NOT APPLICABLE Izlasiet visu dokumentu
Pfizer Confidential 1 1. NAME OF THE MEDICINAL PRODUCT ZAVEDOS CS ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Idarubicin hydrochloride is available as: Solution for injection containing 1 mg/mL idarubicin hydrochloride. 3. PHARMACEUTICAL FORM Sterile solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antimitotic and cytotoxic agent. Acute non-lymphocytic leukemia (ANLL) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients, Acute lymphocytic leukemia (ALL) as second line treatment in adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Idarubicin hydrochloride, either as the reconstituted solution or the ready to use solution must be administered only by the intravenous (IV) route (SEE SECTION 6.6: SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING). A slow administration over 5 to 10 minutes via the tubing of a freely running intravenous infusion of 0.9% sodium chloride or 5% dextrose, must be followed. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration (SEE SECTION 4.4: SPECIAL WARNINGS AND PRECAUTIONS FOR USE). _ACUTE NON-LYMPHOCYTIC LEUKEMIA (ANLL)_ In adult ANLL, the recommended intravenous dose schedule suggested is 12 mg/m 2 IV daily for 3 days in combination with cytarabine. Idarubicin hydrochloride may also be administered as a single agent and in combination, at a dose of 8 mg/m 2 IV daily for 5 days. _ACUTE LYMPHOCYTIC LEUKEMIA (ALL)_ In adult ALL, the recommended single-agent intravenous dose is 12 mg/m 2 daily for 3 days. In children with ALL, the recommended single-agent intravenous dose is 10 mg/m 2 daily for 3 days. All of these dosage schedules should, however, take into account the haematological status of the patient and the dosages of other cytotoxic drugs when used in combination. _DOSE MODIFICATIONS_ _HEPATIC OR RENAL DYSFUNCTION. _While no specific dose recommendation can be made Izlasiet visu dokumentu