Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
IMATINIB AS MESYLATE
TARO INTERNATIONAL LTD, ISRAEL
L01XE01
FILM COATED TABLETS
IMATINIB AS MESYLATE 100 MG
PER OS
Required
SUN PHARMACEUTICAL INDUSTRIES LTD., INDIA
IMATINIB
Imatinib Taro 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.
2021-01-24
Page 1 of 10 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only IMATINIB TARO 100 MG IMATINIB TARO 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 and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. This leaflet contains concise information about this medicine. If you have any further questions, consult your 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 THIS MEDICINE INTENDED FOR? Imatinib Taro is indicated for the treatment of adults and children 3 years of age and above with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase, accelerated phase or blast crisis phase. Imatinib Taro is indicated for the treatment of adults with Kit-positive (CD117) metastatic malignant and/or unresectable gastrointestinal stromal tumors (GIST). Imatinib Taro is indicated as an adjuvant therapy in adults after complete tumor resection of Kit-positive (CD117) gastrointestinal stromal tumor (GIST). Imatinib Taro is indicated for the treatment of adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL), in combination with chemotherapy. Imatinib Taro is indicated for the treatment of adults with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) as monotherapy. Imatinib Taro is indicated for the treatment of adults with unresectable dermatofibrosarcoma protuberans (DFSP) and adults with recurrent and/or metastatic DFSP who are not eligi Прочитайте повний документ