ZAVEDOS Idarubicin hydrochloride 20mg powder for injection

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

idarubicin hydrochloride

제공처:

Pfizer Australia Pty Ltd

승인 상태:

Registered

제품 특성 요약

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