País: Sudáfrica
Idioma: inglés
Fuente: South African Health Products Regulatory Authority (SAHPRA)
Teva Pharmaceuticals (Pty) Ltd
See ingredients
INJECTION
EACH 2 ml INJECTION CONTAINS METHOTREXATE 50 mg
Registered
1986-07-07
Version: mp003 _Page 1 of 17_ SCHEDULING STATUS: S4 PROPRIETARY NAMES (AND DOSAGE FORMS): ABITREXATE 50 Injection ABITREXATE 500 Injection ABITREXATE 1 g Injection ABITREXATE 5 g Injection COMPOSITION: Abitrexate 50 and Abitrexate 500: Each 1 ml contains methotrexate 25 mg Abitrexate 1 g: Each 10 ml contains methotrexate 1 g Abitrexate 5 g: Each 50 ml contains methotrexate 5 g PHARMACOLOGICAL CLASSIFICATION: A26 Cytostatic agents PHARMACOLOGICAL ACTION: Methotrexate is an antineoplastic agent, which acts as an antimetabolite of folic acid. It also has immunosuppressant qualities. When given in low doses, methotrexate is well absorbed from the gastro-intestinal tract. Higher doses are less well absorbed. It is distributed mainly in the extracellular spaces but a proportion penetrates cell membranes and is strongly bound to dihydrofolate reductase. Only small amounts of methotrexate diffuse into the cerebrospinal fluid but higher concentrations are achieved with high doses. About 50 % is bound to plasma proteins. Biphasic and triphasic clearance from plasma has been reported. The majority of a dose is excreted unchanged in the urine within 24 hours and up to 15 % may appear in the bile although because of re-absorption less may be excreted in the Version: mp003 _Page 2 of 17_ faeces. Bound methotrexate may be retained in the body for many months. INDICATIONS: Lymphoblastic leukaemia in children and meningeal leukemia. Choriocarcinoma and related trophoblastic tumours of women. Women with non-metastatic trophoblastic disease, hydatidiform mole and chorioadenoma destruens. Carcinomas of the breast, tongue, pharynx and testes (in conjunction with chlorambucil and dactinomycin). Carcinoma of the lung and osteogenic sarcomas (high dose ABITREXATE with folinic acid rescue). Treatment of severe psoriasis (see Warnings). Prevention of graft-versus-host reactions that result from marrow transplantation. Dermatomyositis, rheumatoid arthritis (not adequately responding to other therapy), Wegene Leer el documento completo