masitinib mesylate - Søgeresultater

Den Europæiske Union - dansk - EMA (European Medicines Agency)

imatinib actavis

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic 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-pdgfr rearrangement;, 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. virkning af imatinib om resultatet af bone marrow transplantation er ikke fastlagt. imatinib actavis is indicated for: , 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 dfsp. erfaringerne med imatinib i patienter med mds/mpd, der er forbundet med pdgfr gen re-arrangementer er meget begrænset. der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

imatinib teva

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva er indiceret til behandling ofadult og pædiatriske patienter med nyligt diagnosticeret philadelphia-kromosom (bcr‑abl) positiv (ph+) kronisk myeloid leukæmi (cml), for hvem bone marrow transplantation er ikke betragtes som den første linje behandling. voksne og pædiatriske patienter med ph+ cml i kronisk fase efter svigt af interferon‑alfa terapi, eller i accelereret fase eller blast krise. voksne og pædiatriske patienter med nyligt diagnosticeret philadelphia-kromosom-positiv akut lymfoblastær leukæmi (ph+ all) integreret med kemoterapi. voksne patienter med recidiverende eller refraktær ph+ alle som monoterapi. voksne patienter med myelodysplastiske/myeloproliferative sygdomme (mds/mpd), der er forbundet med platelet-derived growth factor receptor (pdgfr) gen re-arrangementer. voksne patienter med avanceret hypereosinophilic syndrom (hes) og/eller kronisk eosinofil leukæmi (cel) med fip1l1-pdgfra omlejring. virkning af imatinib om resultatet af bone marrow transplantation er ikke fastlagt. imatinib teva is indicated forthe 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. patienter, der har en lav eller meget lav risiko for tilbagefald, bør ikke modtage adjuverende behandling. 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 (see section 5. undtagen i nyligt diagnosticeret kronisk cml-fase, der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme.