Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
METHOTREXATE
ABIC MARKETING LTD, ISRAEL
L01BA01
SOLUTION FOR INJECTION
METHOTREXATE 25 MG/ML
I.M, I.V, INTRATHECAL, INTRA-ARTERIAL, INTRA VENTRICULAR
Required
PHARMACHEMIE B.V., (TEVA GROUP) ,THE NETHERLANDS
METHOTREXATE
METHOTREXATE
Antineoplastic chemotherapy: treatment of gestational choriocarcinoma, chorioadenoma destruents and hydatidiform mole. Palliation of acute lymphocytic leukemia. Abitrexate is also indicated in the treatment and prophylaxis of meningeal leukemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukemias in children. In combination with other anticancer agents, Abitrexate may be used for the induction of remission, but is most commonly used in maintenance of induced remissions. Abitrexate may be used alone or in combination with other antineoplastics in the management of breast cancer, epidermoid cancers of the head and neck, lung cancer (particularly squamous cell and small cell types), bladder cancer and osteogenic cancer. Abitrexate is effective in the treatment of the advanced stages (III and IV Peter's Staging System) of lymphosarcoma, particularly in children, and in advanced cases of mycosis fungoides. Psoriasis: because of the high risk attending its use, Abitrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. Rheumatoid Arthritis: Abitrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose NSAIDs and usually a trial of at least one or more disease-modifying antirheumatic drugs.
2015-02-28
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת _______ FEBRUARY 1, 2015 __ םש רישכת תילגנאב רפסמו םושירה ABITREXATE 25 MG/ML SOLUTION FOR INJECTION ABITREXATE 1G/10 ML (100 MG/ML) SOLUTION FOR INJECTION ירפסמ םושיר 25MG/ML: 048 96 23819 05 1G/10ML: 100 38 24914 05 םש לעב םושירה _ SALOMON, LEVIN & ELSTEIN LTD, POBOX 3696, PETACH TIKVA 49133 ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח INDICATION CONTRAINDICATIONS Methotrexate should not be used in pregnancy, and in patients in a poor state of nutrition. Methotrexate is furthermore contraindicated in patients with serious renal liver disorders, bone marrow hypoplasia, leucopenia, thrombocytopenia, anaemia, alcohol abuse, methotrexate hypersensitivity and lung toxicity due to methotrexate. During methotrexate therapy no breastfeeding should be given. Methotrexate should not be used in pregnancy, and in patients in a poor state of nutrition. Methotrexate is furthermore contraindicated in patients with serious renal (Creatinine clearance less than 20 ml/ min) severe liver disorders, bone marrow hypoplasia, leucopenia, thrombocytopenia, anaemia, alcohol abuse, methotrexate hypersensitivity and lung toxicity due to methotrexate. During methotrexate therapy no breastfeeding should be given. Serious, acute or chronic infections such as tuberculosis and HIV. Ulcers of the oral cavity and known active gastrointestinal ulcer disease. Concurrent vaccination with live vaccines POSOLOGY, DOSAGE & ADMINISTRATION _Hepatic Function Impairment_ If the bilirubin is between 3-5, or AST more than 180, dosage should be reduced by 25%. If bilirubin is more than 5, omit the dose. WARNINGS The dose must be adjusted carefully depending on the body surface area if methotrexate is used Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS ABITREXATE TEVA Solution for Injection For I.V., Intrathecal, I.M., Intra-Arterial and Intra-Ventricular Use NAME OF THE MEDICINAL PRODUCT Abitrexate Teva QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 25 mg methotrexate. Each vial of 2 ml of solution contains 50 mg methotrexate. Each vial of 4 ml of solution contains 100 mg methotrexate. Each vial of 8 ml of solution contains 200 mg methotrexate. Each vial of 20 ml of solution contains 500 mg methotrexate. Each vial of 40 ml of solution contains 1000 mg methotrexate. PHARMACEUTICAL FORM Solution for Injection. Clear yellow-brown solution. METHOD OF ADMINISTRATION For I.V., intrathecal, I.M., intra-arterial and intra-ventricular use. THERAPEUTIC INDICATIONS ANTINEOPLASTIC CHEMOTHERAPY: Treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. Palliation of acute lymphocytic leukemia. Abitrexate Teva is also indicated in the treatment and prophylaxis of meningeal leukemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem-cell) leukemias in children. In combination with other anticancer agents, Abitrexate Teva may be used for the induction of remission, but is most commonly used in the maintenance of induced remissions. Abitrexate Teva may be used alone, or in combination with other antineoplastic drugs, in the management of breast cancer, epidermoid cancers of the head and neck, lung cancer (particularly squamous cell and small cell types), bladder cancer and osteogenic cancer. Abitrexate Teva is effective in the treatment of the advanced stages (III and IV, Peter’s Staging system) of lymphosarcoma, particularly in children, and in advanced cases of mycosis fungoides. PSORIASIS: Because of the high risk attending its use, Abitrexate Teva is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy Přečtěte si celý dokument