Imatinib Hetero Europe 100 mg filmomhulde tabletten

국가: 네덜란드

언어: 네덜란드어

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

유효 성분:

IMATINIBMESILAAT SAMENSTELLING overeenkomend met ; IMATINIB

제공처:

Hetero Europe S.L. Viladecans Business Park, Edificio Brasil, Catalunya 83-85 08840 VILADECANS (SPANJE)

ATC 코드:

L01XE01

INN (International Name):

IMATINIBMESILAAT COMPOSITION corresponding to ; IMATINIB

약제 형태:

Filmomhulde tablet

구성:

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

관리 경로:

Oraal gebruik

치료 영역:

Imatinib

제품 요약:

Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); TALK (E 553 B); TITAANDIOXIDE (E 171);

승인 날짜:

2017-12-23

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB HETERO EUROPE 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 [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:
-
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, [Product name] 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.
[PRODUCT NAME] IS A TREATMENT FOR ADULTS AND CHILDREN FOR:
-
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 lymp

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Hetero Europe 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
White to off-white coloured, round, bevel edged scored tablets
debossed with H on one side and 19 on the
other side, 1 and 9 separated by a score line.
Dimensions: approximately 7.15mm x 3.3mm
Tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product name] 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-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 ri