Zavedos

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Idarubicin hydrochloride 5mg; Idarubicin hydrochloride 5mg; Idarubicin hydrochloride 5mg

Available from:

Pfizer New Zealand Limited

INN (International Name):

Idarubicin hydrochloride 5 mg

Dosage:

5 mg

Pharmaceutical form:

Capsule

Composition:

Active: Idarubicin hydrochloride 5mg Excipient: Gelatin Glyceryl palmito-stearate Iron oxide red Microcrystalline cellulose Opacode black S-1-27794 Titanium dioxide Active: Idarubicin hydrochloride 5mg Excipient: Gelatin Glyceryl palmito-stearate Iron oxide red Microcrystalline cellulose Titanium dioxide Active: Idarubicin hydrochloride 5mg Excipient: Gelatin Glyceryl palmito-stearate Iron oxide red Microcrystalline cellulose TekPrint black SW-9008 Titanium dioxide

Units in package:

Bottle, glass, 1 capsule

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Olon SpA

Therapeutic indications:

ZAVEDOS is an antimitotic and cytotoxic agent. It 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 is also an effective agent for use in the second line treatment of advanced breast cancer either as a single agent or in a combination regimen.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, - 1 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1992-11-19

Patient Information leaflet

ZAVEDOS
 CAPSULES
_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
CAPSULES ARE USED
FOR
ZAVEDOS is used to treat:
•
a type of leukaemia in adults
known as AML (acute
myelogenous leukaemia).
•
advanced breast cancer.
ZAVEDOS 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 YOU TAKE
ZAVEDOS CAPSULES
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE ZAVEDOS IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
idarubicin hydrochloride
•
other similar medicine 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
•
pr

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ZAVEDOS
®
5 mg, 10 mg Powder for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of ZAVEDOS Powder for Injection contains 5 mg or
10 mg of idarubicin
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for Injection.
ZAVEDOS 5 mg and 10 mg Powder for Injection is a sterile, orange-red
lyophilised powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZAVEDOS is an antimitotic and cytotoxic agent. It 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 is also an effective agent for use in the second line
treatment of advanced breast
cancer either as a single agent or in a combination regimen.
4.2 DOSE AND METHOD OF ADMINISTRATION
ZAVEDOS
treatment
should
be
initiated
or
overseen
by
personnel
experienced
in
chemotherapy. Dosage is usually calculated on the basis of body
surface area.
DOSE
For
induction
therapy
in
adult
patients
with
AML,
the
following
dose
schedule
is
recommended:
ZAVEDOS
12 mg/m
2
daily
for
3 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.
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For reconstitution of the freeze-dried formulation, see Method of
administration below.
Also
refer
to
Section
6.4
Special
precautions
for
storage
for
storage
conditions
for
the
unreconstituted Powder for injection and the reconstituted solution.
All dosage schedules should take into accou