ZAVEDOS idarubicin hydrochloride 5mg capsule bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

idarubicin hydrochloride

Tilgængelig fra:

Pfizer Australia Pty Ltd

Autorisation status:

Registered

Indlægsseddel

ZAVEDOS
®
_Idarubicin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE TREATMENT WITH ZAVEDOS.
This leaflet answers some common
questions about this medicine.
It does not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ZAVEDOS
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE KEEP THIS LEAFLET.
You may need to read it again.
WHAT ZAVEDOS IS
USED FOR
ZAVEDOS is used to treat a type of
leukaemia in adults known as AML
(acute myelogenous leukaemia). It
works by stopping cancer cells from
growing and multiplying.
ZAVEDOS may be used alone or in
combination with other
chemotherapy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZAVEDOS
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
ZAVEDOS is only available with a
doctor's prescription.
It is not addictive.
BEFORE TREATMENT WITH
ZAVEDOS
_WHEN ZAVEDOS MUST NOT_
_BE USED_
DO NOT TAKE ZAVEDOS IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
idarubicin hydrochloride
•
other similar medicines for
cancer, e.g., daunorubicin,
doxorubicin, epirubicin,
mitozantrone
•
any of the ingredients listed at the
end of this leaflet
Symptoms of an allergic reaction to
ZAVEDOS may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THE MEDICINE IF YOU
HAVE:
•
severe kidney problems
•
severe liver problems
•
severe heart problems including
heart failure, abnormal heart beat
or a recent heart attack
•
a severe infection, with signs
such as fever, severe chills, sore
throat or mouth ulcers
•
reduced number of red or white
blood cells or platelets
•
previously received the full
course of treatment with the
maximum

Produktets egenskaber

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