Imatinib Devatis 100 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

IMATINIBMESILAAT 119,5 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 100 mg/stuk

Beschikbaar vanaf:

Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)

ATC-code:

L01XE01

INN (Algemene Internationale Benaming):

IMATINIBMESILAAT 119,5 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 100 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Imatinib

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2015-02-25

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB DEVATIS 100 MG FILMOMHULDE TABLETTEN
IMATINIB DEVATIS 400 MG FILMOMHULDE TABLETTEN
Imatinib mesilate
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 Devatis is and what it is used for
2.
What you need to know before you take Imatinib Devatis
3.
How to take Imatinib Devatis
4.
Possible side effects
5.
How to store Imatinib Devatis
6.
Contents of the pack and other information
1. WHAT IMATINIB DEVATIS IS AND WHAT IT IS USED FOR
Imatinib Devatis 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 DEVATIS 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
Devatis inhibits the growth of
these cells.
IMATINIB DEVATIS IS ALSO A TREATMENT FOR ADULTS FOR:
-
MYELODYSPLASTIC/MYELOPROLIFERA

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Imatinib Devatis 100 mg filmomhulde tabletten
Imatinib Devatis 400 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg imatinib (as mesilate).
Each film-coated tablet contains 400 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
100 mg Tablets:
Dark yellow to brownish-orange coloured, round, score on one side,
biconvex film-coated tablets and
with a diameter of 10.1 mm. approximately.
The tablet can be divided into two equal doses.
400 mg Tablets:
Dark yellow to brownish-orange coloured, capsule-shaped, biconvex
film-coated tablets with
dimensions 21.3 mm x 9.6 mm approximately.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib 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.
-
adult patients with advanced hypereosinophilic syndrome (HES) and/or
chronic eosinophilic
leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
The effect of imatinib on the outcome of bone marrow transplantation
has not been determined.
Imatinib is indicated for
-
the treatment of adult patients with Kit (CD 117) positive
unresectable and/or metastatic malignant
gastrointestinal stromal tumours (GIST).
-
the adjuva