Imakrebin 100 mg filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

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

Available from:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

ATC code:

L01XE01

INN (International Name):

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

Pharmaceutical form:

Filmomhulde tablet

Composition:

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),

Administration route:

Oraal gebruik

Therapeutic area:

Imatinib

Product summary:

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);

Authorization date:

2012-11-22

Patient Information leaflet

04/2022 PSUSA+EPAR+QRD
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMAKREBIN 100 MG FILMOMHULDE TABLETTEN
IMAKREBIN 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 Imakrebin is and what it is used for
2.
What you need to know before you take Imakrebin
3.
How to take Imakrebin
4.
Possible side effects
5.
How to store Imakrebin
6.
Contents of the pack and other information
1.
WHAT IMAKREBIN IS AND WHAT IT IS USED FOR
Imakrebin 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.
IMAKREBIN 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.
IMAKREBINIS ALSO A TREATMENT FOR ADULTS FOR:
-
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD).
These are a group of blood
diseases

Summary of Product characteristics

04/2022 PSUSA+EPAR+QRD
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Imakrebin 100 mg filmomhulde tabletten
Imakrebin 400 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imakrebin 100 mg film-coated tablets
Each film-coated tablet contains 100 mg imatinib (as imatinib
mesilate).
Imakrebin 400 mg film-coated tablets
Each film-coated tablet contains 400 mg imatinib (as imatinib
mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Imakrebin 100 mg film-coated tablets
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.
Imakrebin 400 mg film-coated tablets
Dark yellow to brownish-orange, ovaloid shaped, film-coated tablets,
21.6 mm long and 10.6 mm
wide (± 5%) with a break-line on one side and ‘400’ on the other
side. The tablet can be divided into
equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imakrebin 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

rearrangement.
The effect of imatinib on the o