ZAVEDOS CS 5MG5ML INJECTION VIALS

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

IDARUBICIN HCL/DEMETHOXY DAUNORUBICIN H*

Available from:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

IDARUBICIN HCL/DEMETHOXY DAUNORUBICIN H*

Units in package:

5ml0 mL

Manufactured by:

PFIZER (PERTH) PTY. LTD.

Patient Information leaflet

NOT APPLICABLE

Summary of Product characteristics

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