• اسم المستحضر : CARCEMIA 400MG TABLET
  • اسم المصنع : The Arab Pharmaceutical Manufacturing Co. Ltd./Sahab Site/Jordan
  • التصنيف : Import Product
  • الوكيل / الموزع : Pharmacare Drug Store
  • الشكل الصيدلاني : film coated tablet
  • المكونات الفعالة : Each tablet contains: Imatinib (as mesylate) 400 mg
  • يستخدم لـ : Carcemia is indicated for the treatment of -Adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. -Adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. -Adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymhoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. -Adult patients with relapsed or refractory Ph+ ALL as monotherapy. -Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. -Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement. The effect of imatinib on the outcome of bone marrow transplantation has not been determined. Carcemia is indicated for -The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). -The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. -The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
  • رقم التسجيل : 320/6924/30
  • تاريخ التسجيل : 17-09-2020
  • تاريخ انتهاء التسجيل : 17-09-2025

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