Idarubicin Solution for Injection 10mg/10ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IDARUBICIN HYDROCHLORIDE

Available from:

Accord Healthcare Limited

ATC code:

L01DB06

INN (International Name):

IDARUBICIN HYDROCHLORIDE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

IDARUBICIN HYDROCHLORIDE 5 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Patient Information leaflet

PATIENT INFORMATION LEAFLET
IDARUBICIN 5 MG/5 ML SOLUTION FOR INJECTION
IDARUBICIN 10 MG/10 ML SOLUTION FOR INJECTION
IDARUBICIN 20 MG/20 ML SOLUTION FOR INJECTION
IDARUBICIN (HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 Idarubicin Injection is and what it is used for
2. What you need to know before you are given Idarubicin Injection
3. How to use Idarubicin Injection
4. Possible side effects
5. How to store Idarubicin Injection
6. Contents of the pack and other information
1. WHAT IDARUBICIN INJECTION IS AND WHAT IT IS USED FOR
Idarubicin Injection belongs to a group of medicines called as
citotoxics and antimitotics agents,
which intercalate with DNA and interact with topoisomerase II, having
an inhibitory effect on the
synthesis of nucleic acid.
Idarubicin Injection is a medicine used for the treatment :
Adults
-Acute non-lymphocytic leukaemia, for remission induction in untreated
patients or for remission
induction in relapsed or refractory patients.
-Acute lymphocytic leukaemia as second line treatment.
Children
-Acute non-lymphocytic leukaemia, in combination with cytarabine, for
remission induction in
untreated patients.
-Acute lymphocytic leukaemia as second line treatment.
Idarubicin Injection may also be used in combination with other
anticancer agents.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IDARUBICIN INJECTION
DO NOT TAKE IDARUBICIN INJECTION:
-
if you are allergic to idarubicin or to any of the other ingredients
in this medicine (listed in section
6);
-
if you

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Idarubicin 5 mg/5 ml solution for injection
Idarubicin 10 mg/10 ml solution for injection
Idarubicin 20 mg/20 ml solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 5 ml contains 5 mg of idarubicin hydrochloride.
Each vial of 10 ml contains 10 mg of idarubicin hydrochloride.
Each vial of 20 ml contains 20 mg of idarubicin hydrochloride.
Each ml of solution contains 1 mg idarubicin hydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, orange red solution, free of visible suspended particles.
pH: 3 - 4.5
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cytotoxic and antimitotic agent.
Adults
- For the treatment of acute myeloid leukaemia (AML), for remission
induction in untreated patients or
for remission induction in relapsed or refractory patients.
- For second line treatment of relapsed acute lymphoblastic leukaemia
(ALL).
Children
- For first line treatment of acute myeloid leukaemia (AML), in
combination with cytarabine, for
remission induction.
- For second line treatment of relapsed acute lymphoblastic leukaemia
(ALL).
Idarubicin Accord may be used in combination chemotherapy regimens
involving other cytotoxic
agents (see section 4.2).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Dosage is usually calculated on the basis of body surface area (mg/m
2
). For intravenous use.
ACUTE NON-LYMPHOCYTIC LEUKAEMIA (AML)
Adults: In acute non-lymphocytic leukaemia the recommended dose is 12
mg/m
2
IV daily for 3 days in
combination with cytarabine. Other dose schedule which could be used
in acute non-lymphocytic
leukaemia, as a single agent or in combination, is 8 mg/m
2
IV daily for 5 days.
Children: the recommended dose range is 10-12 mg/m
2
i.v. daily for 3 days in combination with
cytarabine._ _
ACUTE LYMPHOCYTIC LEUKAEMIA (ALL)
Adults: As single agent the suggested dose is 12 mg/m
2
i.v. daily for 3 days.
Children: As single agent the suggested dose is 10 mg/m
2
i.v. daily for 3 da