Land: Israel
Språk: engelsk
Kilde: Ministry of Health
METHOTREXATE
NOVARTIS ISRAEL LTD
L01BA01
CONCENTRATE FOR SOLUTION FOR INFUSION
METHOTREXATE 100 MG/ML
I.M, INTRA-ARTERIAL, I.V, INTRA VENTRICULAR, INTRATHECAL
Required
EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA
METHOTREXATE
METHOTREXATE
Antineoplastic Chemotherapy: Treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. Palliation of acute lymphocytic leukemia. 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, methotrexate may be used for the induction of remission, but is most commonly used in maintenance of induced remissions. Methotrexate 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. Methotrexate is effective in the treatment of the advanced stages (III and IV, Peters’ Staging System) of lymphosarcoma, particularly in children, and in advanced cases of mycosis fungoides.
2023-09-30
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Methotrexat “Ebewe” 100mg/ml - concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 mg of methotrexate in an aqueous solution. Excipients with known effect: 1 ml contains 17.62 mg of sodium hydroxide in aqueous solution. The solution has a pH value of 7.0–8.5. For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Clear, yellow concentrate for solution for infusion. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Antineoplastic chemotherapy: Treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. Palliation of acute lymphocytic leukemia. 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, m ethotrexate may be used for the induction of remission, but is most commonly used in maintenance of induced remissions. Methotrexate 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. Methotrexate is effective in the treatment of the advanced stages (III and IV, Peters’ Staging System) of lymphosarcoma, particularly in children, and in advanced cases of mycosis fungoides. 4.2 Posology and method of administration Methotrexate should only be prescribed by doctors with experience in the use of methotrexate and who are fully familiar with the risks associated with a methotrexate treatment. WARNINGS The dose must be carefully adjusted to the body surface area if methotrexate is used to treat tumour diseases. Cases of intoxication with fatal outcome have been reported after the administration of incorrectly calculated doses. The medical personnel and the patients must be comprehensively informed about the toxic effects. Les hele dokumentet