Imatinib Vocate 600 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

IMATINIBMESILAAT 717 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 600 mg/stuk

Beschikbaar vanaf:

Vocate Pharmaceuticals SA 150 Gounari street 16674 GLYFADA (GRIEKENLAND)

ATC-code:

L01XE01

INN (Algemene Internationale Benaming):

IMATINIBMESILAAT 717 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 600 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Imatinib

Autorisatie datum:

2019-04-10

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB VOCATE 600 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 Vocate film-coated tablets is and what it is used for
2.
What you need to know before you take Imatinib Vocate film-coated
tablets
3.
How to take Imatinib Vocate film-coated tablets
4.
Possible side effects
5.
How to store Imatinib Vocate film-coated tablets
6.
Contents of the pack and other information
1.
WHAT IMATINIB VOCATE FILM-COATED TABLETS IS AND WHAT IT IS USED FOR
Imatinib Vocate film-coated tablets 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 VOCATE FILM-COATED TABLETS 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. In adult patients Imatinib Vocate is used to treat a late
stage of Chronic Myeloid
Leukaemia called “blast crisis”. In children and adolescents
however it may be used to treat
all stages of the illness.
-
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
infect

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Vocate 600 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 600 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Imatinib Vocate are white to off white, capsule shaped, biconvex
film-coated tablets, with a dimension of
16.5x8.0 mm, debossed with H on one side and I1 on the other side, I
and 1 separated by a score line.
The tablet can be divided into two equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib Vocate 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-PDGFR
α
rearrangement.
The effect of Imatinib Vocate on the outcome of bone marrow
transplantation has not been determined.
Imatinib Vocate is indicated for
•
the treatment of adult patients with Kit (CD 117) positive
unresectable and/or metastatic malignant
gastrointestinal stromal tumours (GIST)*.
•
the adjuvant treatment of adult patients who are at significant risk
of relapse following resection of Kit
(CD117)-positive GIST*. Patients who have a low or very low risk of
recurr