IMATINIB TEVA 100 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IMATINIB AS MESYLATE

Available from:

TEVA ISRAEL LTD

ATC code:

L01XE01

Pharmaceutical form:

FILM COATED TABLETS

Composition:

IMATINIB AS MESYLATE 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA ISRAEL LTD, ISRAEL

Therapeutic area:

IMATINIB

Therapeutic indications:

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-PDGFR alfa fusion kinase negative .Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-kit mutation.Imatinib Teva is also indicated for the treatment of adult patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST)Imatinib Teva is also indicated for Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.

Authorization date:

2020-06-30

Patient Information leaflet

PATIENT LEAFLET 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 information regarding inactive ingredients and
allergens, see section 2 “Important information
about some of the ingredients of the medicine” and
section 6 “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. Keep this leaflet. You may have to read it
again. This leaflet contains concise information about
the medicine. If you have additional questions, refer to
the doctor or the pharmacist. This medicine has been
prescribed for treatment of your illness. Do not pass
it on to others. It may harm them even if it seems to
you that their illness is similar.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Imatinib Teva is a medicine that contains the active
ingredient imatinib. The medicine works by inhibiting
the production of abnormal cells in the diseases listed
below, some of which are certain types of cancer.
Imatinib Teva is intended for the treatment of adults
and children aged 3 and above, with Philadelphia
chromosome-positive chronic myeloid leukemia, in
the chronic phase, accelerated phase or blast crisis
phase.
Imatinib Teva is intended for the treatment of adults
with Kit (CD117)-positive malignant metastatic and/or
unresectable gastrointestinal stromal tumors (GIST).
Imatinib Teva is intended as an adjuvant treatment
in adults after complete surgical resection of the Kit
(CD117)-positive gastrointestinal stromal tumor (GIST).
Imatinib Teva is intended for the treatment of adults
with newly diagnosed Philadelphia chromosome-
positive acute lymphoblastic leukemia (ALL), in
combination with chemotherapy.
Imatinib Teva is intended for the treatment of adults
with relapsed or refractory Philade