Imatinib Intrapharm 400 mg filmomhulde tabletten

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

IMATINIBMESILAAT SAMENSTELLING overeenkomend met ; IMATINIB

Tilgængelig fra:

Intrapharm Laboratories Ltd.

ATC-kode:

L01XE01

INN (International Name):

IMATINIBMESILAAT COMPOSITION corresponding to ; IMATINIB

Lægemiddelform:

Filmomhulde tablet

Sammensætning:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Imatinib

Produkt oversigt:

Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisation dato:

2015-09-24

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB INTRAPHARM 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 FILMOMHULDE TABLETTEN
is and what it is used for
2.
What you need to know before you take
IMATINIB FILMOMHULDE TABLETTEN
3.
How to take
IMATINIB FILMOMHULDE TABLETTEN
4.
Possible side effects
5.
How to store
IMATINIB FILMOMHULDE TABLETTEN
6.
Contents of the pack and other information
1.
WHAT IMATINIB FILMOMHULDE TABLETTEN IS AND WHAT IT IS USED FOR
IMATINIB FILMOMHULDE TABLETTEN
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 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 FILMOMHULDE TABLETTEN IS ALSO A TREATMENT FOR ADULTS FOR

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Intrapharm 400 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
White to off-white, capsule shaped, bevel edged scored, film coated
tablets with a dimension of approx. 15.0
mm in length and 6.5 mm in width, debossed with H on one side and 20
on the other side, 2 and 0 separated
by a score line.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib Intrapharm 400 mg filmomhulde tabletten 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 patients with Ph+CML in 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-PDGFR

rearrangement.
The effect of Imatinib Intrapharm 400 mg filmomhulde tabletten on the
outcome of bone marrow
transplantation has not been determined.
Imatinib Intrapharm 400 mg filmomhulde tabletten is indicated for

the treatment of adult patients with Kit (CD 117) positive
unresectable and/or metastatic malignant
gastrointestinal stromal tumours (GIST)*.

the ad