Imatinib Denk 100 mg, filmomhulde tabletten

Maa: Alankomaat

Kieli: hollanti

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

Aktiivinen ainesosa:

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

Saatavilla:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)

ATC-koodi:

L01XE01

INN (Kansainvälinen yleisnimi):

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

Lääkemuoto:

Filmomhulde tablet

Koostumus:

CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B),

Antoreitti:

Oraal gebruik

Terapeuttinen alue:

Imatinib

Tuoteyhteenveto:

Hulpstoffen: CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B);

Valtuutus päivämäärä:

2015-09-16

Pakkausseloste

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

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Denk 100 mg, filmomhulde tabletten
Imatinib Denk 400 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Imatinib Denk 100 mg film-coated tablets: _
Each film-coated tablet contains 100 mg imatinib (as mesilate).
_Imatinib Denk 400 mg film-coated tablets: _
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
Imatinib Denk 100 mg film-coated tablets are round tablets with light
brown film coating and
a diameter of 8 mm, score on one side.
Imatinib Denk 400 mg film-coated tablets are oval tablets with light
brown film coating, 17 mm
long and 8 mm wide, score on both sides.
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib Denk 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 Imatinib Denk on the outcome of bone marrow
transplantation has not been
determined.
Imatinib Denk is indicated for
▪
the treatment of adult patients with Kit (CD 117) positive
unresectable and/or me