Zavedos 10mg capsules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Idarubicin hydrochloride

Tillgänglig från:

Pfizer Ltd

ATC-kod:

L01DB06

INN (International namn):

Idarubicin hydrochloride

Dos:

10mg

Läkemedelsform:

Oral capsule

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 08010200; GTIN: 5012882008482

Bipacksedel

Package leaflet: Information for the patient
Zavedos
®
5 mg and 10 mg Capsules
idarubicin hydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for you.
•
Keep this leaflet. You may need to read it again
•
If you have any questions ask your doctor or pharmacist
•
This medicine has been prescribed for you only. Do not pass it to
others. It may harm them, even if their signs of
illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Zavedos is and what it is used for
2.
What you need to know before you take Zavedos
3. How to take Zavedos
4. Possible side effects
5. How to store Zavedos
6. Contents of the pack and other information
1. What Zavedos is and what it is used for
•
Zavedos contains an active ingredient called idarubicin hydrochloride,
which belongs to a group of medicines called
anthracyclines. Zavedos interferes with ways in which the cells of
your body grow and increase in number and is
used in the treatment of cancers (chemotherapy).
•
Zavedos is used for the treatment of acute non-lymphoblastic leukaemia
(ANLL) also referred to as acute
myelogenous leukaemia (AML), or advanced breast cancer.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
What you need to know before you take Zavedos
Do not take Zavedos if:
•
You have ever had an allergic (hypersensitivity) reaction to
idarubicin or any of the other ingredients of this medicine
(listed in section 6) or other anthracyclines.
•
You have an infection which is not under control.
•
Your liver or kidneys are not working properly.
•
You have had previous or current history of bone marrow depression
caused by previous therapy.
•
You have had a previous or current history of heart disease.
•
You have had a previous or current history of abnormal heart rhythms.
•
You have previo

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zavedos 10 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Idarubicin Hydrochloride 10.0 mg HSE
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Opaque red cap and white body, self-locking, hard gelatin capsule,
size no. 4,
containing an orange powder.
4.1
THERAPEUTIC INDICATIONS
Acute non-lymphocytic leukaemia (ANLL).
Whenever intravenous idarubicin hydrochloride cannot be employed e.g.
for medical,
psychological or social reasons, oral idarubicin can be used for
remission induction in
patients with previously untreated, relapsed or refractory acute
non-lymphocytic
leukaemia.
Zavedos may be used in combination chemotherapy regimens involving
other
cytotoxic agents.
As a single agent in the treatment of advanced breast cancer after
failure of front line
chemotherapy not including anthracyclines.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Route of Administration_: Oral
Dosage is usually calculated on the basis of body surface area.
In
adult
acute
non-lymphocytic
leukaemia
(ANLL)
also
referred
to
as
acute
myelogenous
leukaemia
(AML),
the
recommended
dose
schedule
suggested
is
30mg/m
2
orally given daily for 3 days as a single agent, or between 15 and
30mg/m
2
orally daily for 3 days in combination with other anti-leukemic
agents.
In advanced breast cancer the recommended dose schedule as single
agent is 45mg/m
2
orally given either on a single day or divided over 3 consecutive
days, to be repeated
every 3 or 4 weeks based on the haematological recovery.
A maximum cumulative dose of 400mg/m
2
is recommended.
These dosage schedules should, however, take into account the
haematological status
of the patient and the dosages of other cytotoxic drugs when used in
combination.
In
patients
with
hepatic
impairment
a
dose
reduction
of
Zavedos
should
be
considered. (See section 4.4).
The capsules should be swallowed whole with some water and should not
be sucked,
bitten or chewed. Zavedos Capsules may also be taken with a light
me