Država: Armenija
Jezik: engleski
Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cytarabine
EBEWE Pharma Ges. m.b.H. Nfg. KG
cytarabine
20mg/ml
solution for injection
Prescription
m12 - en-spc-pl-w - 3 1 PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Alexan ® Solution for injection and infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Alexan ® 100 mg: One vial with 5 ml solution contains 100 mg cytarabine (20 mg/ml). Alexan ® 500 mg: One vial with 10 ml solution contains 500 mg cytarabine (50 mg/ml). Alexan ® 1000 mg: One vial with 20 ml solution contains 1000 mg cytarabine (50 mg/ml). For the list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection and infusion Clear and colourless solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alexan is used in adults. 1. Standard treatment: Cytarabine is a cytostatic drug for the induction therapy of a clinical remission and/or maintenance therapy in patients with: acute non-lymphoblast leukaemia, acute lymphoblast leukaemia, acute myeloid leukaemia, diffuse hystiocytic lymphoma (non-Hodgkin’s lymphoma with high level of malignancy). 2. High dose cytarabine therapy is indicated in patients with: refractory acute non-lymphoblast leukaemia, refractory acute lymphoblast leukaemia, blast crisis in chronic myeloid leukaemia, leukaemias with particular risk, e.g. acute leukaemias with secondary carcinoma after previous chemotherapy and/or irradiation, refractory non-Hodgkin’s lymphomas. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The treatment with Alexan should be initiated under the monitoring or consultation of a physician with experience in treatment with cytostatics. m12 - en-spc-pl-w - 3 2 It must be assumed that effective cytarabine plasma levels are between 0.01 and 0.15 g/ml. The dose must be determined exactly and individually, preferably according to body surface area (BSA). Cytarabine is used in combination with other cytostatic substances within complex therapy protocols. Only general dosing recommendations can be given. For exact dosing, see treatment protocols in the specialised literature. Patients with hepatic or renal impairment In pat Pročitajte cijeli dokument