Imatinib Amomed 100 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

IMATINIBMESILAAT SAMENSTELLING overeenkomend met ; IMATINIB

Beschikbaar vanaf:

Amomed Pharma GmbH

ATC-code:

L01XE01

INN (Algemene Internationale Benaming):

IMATINIBMESILAAT COMPOSITION corresponding to ; IMATINIB

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Imatinib

Product samenvatting:

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);

Autorisatie datum:

2012-11-22

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB AMOMED 100 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 Amomed is and what it is used for
2.
What you need to know before you take Imatinib Amomed
3.
How to take Imatinib Amomed
4.
Possible side effects
5.
How to store Imatinib Amomed
6.
Contents of the pack and other information
1.
WHAT IMATINIB AMOMED IS AND WHAT IT IS USED FOR
Imatinib Amomed 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 AMOMED 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.
In adult patients Imatinib Amomed is used to treat a late stage of
Chronic Myeloid Leukaemia called “blast
crisis”. In children and adolescents how

Productkenmerken

1. NAME OF THE MEDICINAL PRODUCT
Imatinib Amomed 100 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
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.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib Amomed is indicated for the treatment of

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.

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 α 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
unresectable dermatofibrosarcoma protuberans
(DFSP) and adult patients with recurrent and/or metastatic DFSP who
are not eligible for surgery.
In adult and paediatric patients, the effectiveness of imatinib is
based on overall haematological and
cytogenetic response rates and progression-free survival in CML, on
haematological and cytogenetic
response rates in Ph+ ALL,