Zavedos

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Idarubicin hydrochloride 10mg

Beschikbaar vanaf:

Pfizer New Zealand Limited

INN (Algemene Internationale Benaming):

Idarubicin hydrochloride 10 mg

Dosering:

10 mg

farmaceutische vorm:

Powder for injection

Samenstelling:

Active: Idarubicin hydrochloride 10mg Excipient: Lactose monohydrate

Eenheden in pakket:

Vial, glass, 1 x 10mg, 1 dose unit

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Olon SpA

therapeutische indicaties:

Latest Regulatory Activity

Product samenvatting:

Package - Contents - Shelf Life: Vial, glass, - 1 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Autorisatie datum:

1990-01-17

Bijsluiter

ZAVEDOS
®
1
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 treating you with
ZAVEDOS against the benefits they
expect it will have for you.
ASK YOUR DOCTOR OR PHARMACIST, IF
YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
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).
•
advanced breast cancer.
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 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

Productkenmerken

Version: pfdzavea11121
Supersedes: pfdzavea11220
Page 1 of 14
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.
Version: pfdzavea11121
Supersedes: pfdzavea11220
Page 2 of 14
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