Zavedos 10mg powder for solution for injection vials

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Idarubicin hydrochloride

Доступна с:

Pfizer Ltd

код АТС:

L01DB06

ИНН (Международная Имя):

Idarubicin hydrochloride

дозировка:

10mg

Фармацевтическая форма:

Powder for solution for injection

Администрация маршрут:

Intravenous

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 08010200; GTIN: 5012882008512

тонкая брошюра

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, 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 you have had a previous or current history of heart disease.
-
If y

Характеристики продукта

OBJECT 1
ZAVEDOS 10 MG POWDER FOR SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 11-Dec-2014 | Pfizer
Limited
1. Name of the medicinal product
Zavedos 10 mg Powder for Solution for Injection
2. Qualitative and quantitative composition
Each vial contains 10mg idarubicin hydrochloride
The reconstituted solution contains 1mg/ml.
Excipients with known effect:
Each vial contains 100mg of lactose monohydrate.
For the full list of excipients, see section 6.1:
3. Pharmaceutical form
Powder for Solution for Injection
Sterile, pyrogen-free, orange-red, freeze-dried powder in vial
containing 10 mg of idarubicin
hydrochloride, with 100 mg of lactose monohydrate.
4. Clinical particulars
4.1 Therapeutic indications
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).
Zavedos may be used in combination chemotherapy regimens involving
other cytotoxic agents (see
section 4.2).
4.2 Posology and method of administration
For intravenous use only.
Not for intrathecal use.
Dosage is calculated on the basis of body surface area.
Acute myeloid leukaemia (AML)
_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.
_Children_
10-12 mg/m
2
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
i.v. daily for 3 days.
_Children_
10 mg/m
2
i.v. daily for 3 days, as a single agent.
NOTE: These are general guidelines. Refer to individual protocols for
exact dosage.
All of these dosage schedules should, however, take into account the
haematological