Zavedos 1mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Idarubicin hydrochloride

Available from:

Pfizer Healthcare Ireland

ATC code:

L01DB; L01DB06

INN (International Name):

Idarubicin hydrochloride

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Anthracyclines and related substances; idarubicin

Authorization status:

Marketed

Authorization date:

2019-09-06

Patient Information leaflet

Page 1 of 7
2020-0061479, 2021-0071456, 2021-0071680
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZAVEDOS® 5 MG AND 10 MG POWDER FOR SOLUTION FOR INJECTION
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, pharmacist or nurse.
-
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, pharmacist or nurse.
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 Zavedos will be given to you
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 in adults and children for the treatment of acute non
lymphoblastic leukaemia
(ANLL), also referred to as acute myeloid leukaemia (AML).
Zavedos is also used in adults and children as a second line treatment
of relapsed acute
lymphoblastic leukaemia (ALL).
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).
-
other anthracyclines or anthracenediones.
-
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

Summary of Product characteristics

Health Products Regulatory Authority
23 February 2024
CRN00F0J5
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zavedos 1mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 1 mg of idarubicin hydrochloride.
Each vial of 5 mL of solution contains 5 mg of idarubicin
hydrochloride.
Each vial of 10 mL of solution contains 10 mg of idarubicin
hydrochloride.
Each vial of 20 mL of solution contains 20 mg of idarubicin
hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
Orange-red, clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
For the treatment of acute non-lymphoblastic leukaemia (ANLL), 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).
Paediatric population
For first line treatment of acute non-lymphoblastic leukaemia (ANLL),
in combination with cytarabine, for remission induction.
For second line treatment of relapsed acute lymphoblastic leukaemia
(ALL).
Zavedos 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 calculated on the basis of body surface area.
Acute non-lymphoblastic leukaemia (ANLL)
_Adults_
12 mg/m
2
/day i.v. daily for 3 days in combination with cytarabine.
or
8 mg/m
2
/day i.v. daily for 5 days with/without combination.
_ _
_Paediatric population_
10-12 mg/m
2
/day i.v. daily for 3 days in combination with cytarabine.
Acute lymphoblastic leukaemia (ALL)
_Adults_
As single agent in ALL the suggested dose in adults is 12 mg/m
2
/day i.v. daily for 3 days.
_ _
Health Products Regulatory Authority
23 February 2024
CRN00F0J5
Page 2 of 11
_Paediatric population_
10 mg/m
2
/day i.v. daily for 3 days, as a single agent.
NOTE: These are general guidelines. Refer to individual protocols for
exact dosage.
A