ZAVEDOS idarubicin hydrochloride 10mg/10mL injection vial

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

idarubicin hydrochloride, Quantity: 1 mg/mL

Հասանելի է:

Pfizer Australia Pty Ltd

Դեղագործական ձեւ:

Injection, solution

Կազմը:

Excipient Ingredients: glycerol; hydrochloric acid; water for injections

Կառավարման երթուղին:

Intravenous

Միավորները փաթեթում:

1 X 10mL vial

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

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. Zavedos capsules are indicated whenever the intravenous route is not considered suitable. Zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents.

Ապրանքի ամփոփագիր:

Visual Identification: Plastic vials containing a red-orange, clear, mobile solution and practically free from particles.; Container Type: Vial; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

1999-08-19

Տեղեկատվական թերթիկ

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,
mitoxantrone
•
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 heartbeat
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

Ապրանքի հատկությունները

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Supersedes: pfpzavea10221
Page 1 of 14
AUSTRALIAN
PRODUCT
INFORMATION
–
ZAVEDOS
 (IDARUBICIN HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Idarubicin hydrochloride.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 5 mg/5 mL or 10 mg/10 mL of idarubicin
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
SOLUTION FOR INJECTION
.
Red-orange, clear, mobile solution, free from particles.
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.
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:
ZAVEDOS 12 mg/m
2
daily for three days by slow (10-15 min) intravenous injection in
combination with cytarabine 100 mg/m
2
daily given by continuous infusion for seven days. In
patients with unequivocal evidence of leukaemia after the first
induction course, a second
course may be administered. Administration of the second course should
be delayed in patients
who experienced severe mucositis, until recovery from this toxicity
has occurred, and a dose
reduction of 25% is recommended.
DOSAGE ADJUSTMENT
HEPATIC AND RENAL IMPAIRMENT
ZAVEDOS should not be administered in patients with severe renal and
liver impairment (see
Section 4.3 Contraindications). Dose adjustment should be considered
in patients with
moderate liver and renal impairment (refer to Sections 5.2
Pharmacokinetic properties and 4.4
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Supersedes: pfpzavea10221
Page 2 of 14
Special warnings and precautions for use). With anthracyclines a 50%
dose reduction is
generally employed if bilirubin levels are in the range 20.4-51.0
micromoles/litre.
All dosage schedules should take into account the haematological