Imatinib STADA 600 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

IMATINIBMESILAAT SAMENSTELLING overeenkomend met ; IMATINIB

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

L01XE01

INN (Algemene Internationale Benaming):

IMATINIBMESILAAT COMPOSITION corresponding to ; IMATINIB

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

Product samenvatting:

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

Autorisatie datum:

2017-10-13

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB STADA 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 [Product name] is and what it is used for
2. What you need to know before you take [Product name]
3. How to take [Product name]
4. Possible side effects
5. How to store [Product name]
6. Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] 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.
[PRODUCT NAME] 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. [Product name]
inhibits the growth of these cells.
[PRODUCT NAME] IS ALSO A TREATMENT FOR ADULTS FOR:
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD). These are a
group of blood
diseases

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Imatinib STADA 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
[Product name] 600 mg 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
[Product name] 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 [Product name] on the outcome of bone marrow
transplantation has not been
determined.
[Product name] 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
recurrence shou