देश: आर्मेनिया
भाषा: अंग्रेज़ी
स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cytarabine
Corden Pharma Latina S.p.A
L01BC01
cytarabine
500mg
powder lyophilized for solution for injection
glass vial
Prescription
Registered
2023-03-04
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CYTOSAR ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Solution for injection, containing cytarabine 20 mg and 100 mg per mL. Concentrate for solution for infusion, containing cytarabine 100 mg per mL. Powder freeze dried, containing cytarabine 20 mg, 40 mg, 100 mg and 500 mg. Powder freeze dried for solution for injection, containing cytarabine 100 mg, 500 mg, 1 g, and 2 g. 3. PHARMACEUTICAL FORM Lyophilisate: white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • . acute lymphocytic and/or nonlymphocytic leukemia (for induction and maintenance of remission); • for prophylaxis or treatment of meningeal leukemia (as intrathecal injections, alone or in combination with other antineoplastic drugs); • treatment of non-Hodgkin’s lymphoma; • treatment of chronic myelocytic leukemia (blast phase). High dose cytarabine treatment: • refractory non-Hodgkin’s lymphoma; • refractory acute lymphocytic and/or nonlymphocytic leukemia, as well as poor-risk leukemias; • relapsed acute leukemia; • secondary leukemia following previous chemo- and/or radiotherapy; • manifest leukemia following preleukemia transformation: • acute nonlymphocytic leukemia in patients under 60 years of age (for consolidation of remission); • chronic myelocytic leukemia (blast phase). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The schedule and method of administration varies with the program of therapy to be used. In every individual case, special literature should be consulted. Cytosar ® may be given by intravenous infusion or injection, subcutaneously (usually as maintenance therapy), or intrathecally. Mean daily dose is 100-200 mg/m 2 . For elderly patients or those with low bone marrow reserves, the dose should be 50-70 mg/m 2 . Induction of remission in acute leukemia: in combination with other antineoplastic agents, 100 mg/m 2 /day as continuous intravenous infusion during 7 days or 100 mg/m 2 i.v. every 12 hours over 7 consecuti पूरा दस्तावेज़ पढ़ें