IMATINIB TEVA 400 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

IMATINIB AS MESYLATE

Tilgjengelig fra:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC-kode:

L01XE01

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

IMATINIB AS MESYLATE 400 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Terapeutisk område:

IMATINIB

Indikasjoner:

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. Imatinib Teva is also indicated for the treament of : Adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy. Adult patients with relapsed or refractory Ph + ALL as monotherapy. Adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. Adult patients with myelodyspiastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR ( platelet - derived growth factor receptor ) gene re- arrangements. Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) who have the FIP1L1- PDGFRalfa fusion kinase (mutational analysis or FISH demonstration fo CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-P

Autorisasjon dato:

2015-06-24

Informasjon til brukeren

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
IMATINIB TEVA
® 100 MG
FILM-COATED TABLETS
COMPOSITION:
Each film-coated tablet contains:
Imatinib (as mesylate) 100 mg
IMATINIB TEVA
® 400 MG
FILM-COATED TABLETS
COMPOSITION:
Each film-coated tablet contains:
Imatinib (as mesylate) 400 mg
For the list of inactive ingredients in the
preparation,
see
section
6
-
“Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. 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 THE
TREATMENT OF YOUR AILMENT. DO NOT PASS IT ON
TO OTHERS. IT MAY HARM THEM EVEN IF IT SEEMS
TO YOU THAT THEIR AILMENT IS SIMILAR.
Women who may become pregnant (women
of child-bearing age) must use effective
contraceptives when taking this preparation,
as this medicine may harm the unborn
baby.
1. WHAT IS THE MEDICINE INTENDED
FOR?
For treatment of adults and children (above 3
years of age) with:
∙ Chronic Myeloid Leukemia (CML) with
Philadelphia
chromosome
positive
(Ph-positive CML).
For treatment of adults with:
∙ Philadelphia chromosome positive Acute
Lymphoblastic Leukemia (Ph+ ALL).
∙ Dermatofibrosarcoma Protuberans (DFSP).
∙ Myelodysplastic/Myeloproliferative Diseases
(MDS/MPD).
∙ Hypereosinophilic Syndrome and/or Chronic
Eosinophilic Leukemia (HES/CEL).
∙ Aggressive Systemic Mastocytosis (ASM).
Imatinib Teva
®
is used to treat leukemia, which
is a cancer of white blood cells. The white blood
cells usually help the body fight infections.
∙ CML is a cancer of the blood which makes
the body produce too many abnormal white
blood cells called myeloid cells.
∙ Ph+ ALL is a cancer of the blood which
makes the body produce too many abnormal
white blood cells called lymphoblast cells.
∙ DFSP is a cancer of the tissue beneath the
skin, in which some of the cells start growi