Zavedos 5 mg Hard Capsules

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Idarubicin hydrochloride

থেকে পাওয়া:

Pfizer Healthcare Ireland

এটিসি কোড:

L01DB; L01DB06

INN (International Name):

Idarubicin hydrochloride

ডোজ:

5 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Capsule, hard

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Anthracyclines and related substances; idarubicin

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

1995-02-16

তথ্য লিফলেট

Page 1 of 6
2020-0061479, 2021-0071456,
2021-0071680
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZAVEDOS® 5MG AND 10MG HARD 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 further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on 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 Hard capsules 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 a type of leukaemia called acute
non-lymphocytic
leukaemia (ANLL) also referred to as acute myelogenous leukaemia
(AML).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ZAVEDOS
DO NOT USE ZAVEDOS CAPSULES:
-
If you are allergic to Idarubicin hydrochloride or other similar
anthracycline medicines or any
of the other ingredients of this medicine (listed in Section 6).
-
If you have an infection which is not under control.
-
If your liver or kidneys are not working properly.
-
If you have had previous or current history of bone marrow depression
caused by previous
therapy.
-
If you have had a previous or current history of heart disease.
-
If you have had a previous or current history of abnormal heart
rhythms.
-
If you have had a

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
28 January 2022
CRN009WXM
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zavedos 5 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Idarubicin hydrochloride 5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard Capsules
Opaque, red cap and body, self-locking, hard gelatin capsule, size No.
4, containing an orange powder. Imprinted ‘IDARUBICIN
5’on the cap in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of acute myelogenous leukaemia (AML) intravenous
chemotherapy is the first choice of remission induction.
Zavedos capsules are indicated for remission induction as part of
attenuated combination regimes in elderly, previously
untreated AML patients only when intravenous administration cannot be
employed (e.g. for medical reasons, such as difficult
venous access or psychological reasons such as refusal of i.v.
treatment).
Zavedos capsules should not be used for palliative treatment of AML.
Zavedos capsules are intended for use under the direction of
physicians experienced in leukaemia chemo-therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage is usually calculated on the basis of body surface area.
In adult AML the recommended dose schedule is 30 mg/m
2
orally given daily for 3 days as a single agent, or between 15 and
30 mg/m
2
orally daily for 3 days in combination with other antileukemic agents.
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 meal.
4.3 CONTRAINDICATIONS

hypersensitivity to idarubicin or to any of the excipients listed in
section 6.1, other anthracyclines or
an