Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
imatinib
Actavis Group PTC ehf
L01EA01
imatinib
Protein kinase inhibitors, Antineoplastic agents
Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
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. , The effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Revision: 13
Withdrawn
2013-04-17
75 B. PACKAGE LEAFLET Medicinal product no longer authorised 76 PACKAGE LEAFLET: INFORMATION FOR THE USER IMATINIB ACTAVIS 50 MG HARD CAPSULES imatinib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Imatinib Actavis is and what it is used for 2. What you need to know before you take Imatinib Actavis 3. How to take Imatinib Actavis 4. Possible side effects 5. How to store Imatinib Actavis 6. Contents of the pack and other information 1. WHAT IMATINIB ACTAVIS IS AND WHAT IT IS USED FOR Imatinib Actavis is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer. IMATINIB ACTAVIS IS A TREATMENT FOR: - CHRONIC MYELOID LEUKAEMIA (CML). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control. In adult patients, Imatinib Actavis is intended for use in the most advanced phase of the disease (blast crisis). In children and adolescents, Imatinib Actavis can be used in different phases of the disease (chronic, accelerated phase and blast crisis). - PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA (PH-POSITIVE ALL) . Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaem Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Imatinib Actavis 50 mg hard capsules Imatinib Actavis 100 mg hard capsules Imatinib Actavis 400 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Imatinib Actavis 50 mg hard capsules Each hard capsule contains 50 mg imatinib (as mesilate). Imatinib Actavis 100 mg hard capsules Each hard capsule contains 100 mg imatinib (as mesilate). Imatinib Actavis 400 mg hard capsules Each hard capsule contains 400 mg imatinib (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Imatinib Actavis 50 mg hard capsules Hard capsule of size 3 with light yellow cap and light yellow body imprinted with “50 mg” in black ink. Imatinib Actavis 100 mg hard capsules Hard capsule of size 1 with light orange cap and light orange body imprinted with “100 mg” in black ink. Imatinib Actavis 400 mg hard capsules Hard capsule of size 00 with orange opaque colour cap and body imprinted with “400 mg” in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 and paediatric 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 Læs hele dokumentet