البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
IMATINIB AS MESYLATE
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
L01XE01
FILM COATED TABLETS
IMATINIB AS MESYLATE 400 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
IMATINIB
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
2015-06-24
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 اقرأ الوثيقة كاملة