IMATINIB - TRIMA 100 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

IMATINIB AS MESYLATE

Tilgjengelig fra:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

ATC-kode:

L01XE01

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

IMATINIB AS MESYLATE 100 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Terapeutisk område:

IMATINIB

Indikasjoner:

Imatinib - Trima is indicated for the• Treatment of adult patients and children 3 years of age and above with Ph+ chronic myeloid leukaemia (Ph+ -CML) in chronic phase, accelerated phase or blast crisis.• Treatment of adult patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). • Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.• Treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy. • Treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy. • Treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.• Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements. • Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1- PDGFRα fusion kinase negative. • Treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-kit mutation.

Autorisasjon dato:

2021-11-30

Informasjon til brukeren

P00001146
0723B
PIL-0723-05
P00001146
0723B
402 000
PIL-0723-05
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
Imatinib-Trima
100 mg
Imatinib-Trima
400 mg
Film-coated Tablets
Film-coated Tablets
Composition:
Each film-coated tablet
contains:
Each film-coated tablet
contains:
Imatinib (as mesylate) 100 mg
Imatinib (as mesylate) 400 mg
Inactive ingredients: see section 6 “Further Information”.
Read this leaflet carefully in its entirety before using the
medicine. Keep this leaflet. You may need to read it again.
This leaflet contains concise information about the medicine.
If you have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them even if it seems to you that their
medical condition is similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
Imatinib-Trima is a medicine containing an active substance
called imatinib. The medicine works by inhibiting the production
of the abnormal cells in the diseases listed below, some of
which are certain types of cancer.
Imatinib-Trima is indicated for the treatment of adults and
children
3
years
of
age
and
above,
with
Philadelphia
chromosome-positive
chronic
myeloid
leukemia
in
the
chronic phase, accelerated phase or blast crisis phase.
Imatinib-Trima is indicated for the treatment of adults with
Kit-positive )CD117( metastatic malignant and/or unresectable
gastrointestinal stromal tumors )GIST(.
Imatinib-Trima is indicated as an adjunct therapy in adults after
complete tumor resection of the Kit-positive )CD117( GIST.
Imatinib-Trima is indicated for the treatment of adults with
newly diagnosed Philadelphia chromosome-positive acute
lymphoblastic
leukemia
)ALL(,
in
combination
with
chemotherapy.
Imatinib-Trima is indicated for the treatment of adults with
relapsed or refractory Philadelphia chromosome-positive
acute lymphoblastic leukemia )ALL( as monotherapy.
Imatinib-Tri