Imatinib Fresenius Kabi 400 mg filmomhulde tabletten

Страна: Нидерланды

Язык: голландский

Источник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активный ингредиент:

IMATINIBMESILAAT 478 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 400 mg/stuk

Доступна с:

Fresenius Kabi Deutschland GmbH Else-Kroener Strasse 1 61352 BAD HOMBURG V.D.H. (DUITSLAND)

код АТС:

L01XE01

ИНН (Международная Имя):

IMATINIBMESILAAT 478 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 400 mg/stuk

Фармацевтическая форма:

Filmomhulde tablet

состав:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B),

Администрация маршрут:

Oraal gebruik

Терапевтические области:

Imatinib

Обзор продуктов:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B);

Дата Авторизация:

2012-11-22

тонкая брошюра

111236PILJ
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB FRESENIUS KABI 100 MG FILMOMHULDE TABLETTEN
IMATINIB FRESENIUS KABI 400 MG FILMOMHULDE TABLETTEN
Imatinib
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, 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 Imatinib Fresenius Kabi is and what it is used for
2.
What you need to know before you take Imatinib Fresenius Kabi
3.
How to take Imatinib Fresenius Kabi
4.
Possible side effects
5.
How to store Imatinib Fresenius Kabi
6.
Contents of the pack and other information
1.
WHAT IMATINIB FRESENIUS KABI IS AND WHAT IT IS USED FOR
Imatinib Fresenius Kabi is a medicine containing an active substance
called imatinib. This medicine works
by inhibiting the growth of abnormal cells in the diseases listed
below. These include some types of cancer.
IMATINIB FRESENIUS KABI IS A TREATMENT FOR ADULTS AND CHILDREN FOR:
•
CHRONIC MYELOID LEUKAEMIA (CML)
.
Leukaemia is a cancer of white blood cells. These white cells usually
help the body to fight infection.
Chronic myeloid leukaemia is a form of leukaemia in which certain
abnormal white cells (named
myeloid cells) start growing out of control.
•
PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA
(PH-POSITIVE ALL).
Leukaemia is a cancer of white blood cells. These white cells usually
help the body to fight infection.
Acute lymphoblastic leukaemia is a form of leukaemia in which certain
abnormal white cells (named
lymphoblasts) start growing out of control. Imatinib inhibits the
growth of these cells.
IMATINIB FRESENIUS KA

Характеристики продукта

111235SKPL
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Imatinib Fresenius Kabi 100 mg filmomhulde tabletten
Imatinib Fresenius Kabi 400 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Imatinib Fresenius Kabi100 mg filmomhulde tabletten
Each film-coated tablet contains 100 mg imatinib (as imatinib
mesilate).
Imatinib Fresenius Kabi400 mg filmomhulde tabletten
Each film-coated tablet contains 100 mg imatinib (as imatinib
mesilate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Imatinib Fresenius Kabi 100 mg filmomhulde tabletten
Dark yellow to brownish-orange, round shaped, film-coated tablets of
10.1 mm (± 5%) diameter with a
break-line on one side and ‘100’ on the other side. The tablet can
be divided into equal doses.
Imatinib Fresenius Kabi 400 mg filmomhulde tabletten
Dark yellow to brownish-orange, ovaloid shaped, film-coated tablets of
21.6 mm long & 10.6 mm wide
(± 5%) with a break-line on one side and ‘400’ on the other side.
The tablet can be divided into equal
doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib Fresenius Kabi is indicated for the treatment of
•
adult and paediatric patients with newly diagnosed Philadelphia
chromosome (bcr-abl) positive
(Ph+) chronic myeloid leukaemia (CML) for whom bone marrow
transplantation is not considered
as the first line of treatment.
•
adult and paediatric patients with Ph+ CML in chronic phase after
failure of interferon-alpha
therapy, or in accelerated phase or blast crisis.
•
adult and paediatric patients with newly diagnosed Philadelphia
chromosome positive acute
lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
•
adult patients with relapsed or refractory Ph+ ALL as monotherapy.
•
adult patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD) associated with
platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
111235SKPL
•
adult patients with advanced hypereosinophilic syndrome (HES) and/o