Israel - English - Ministry of Health

novartis israel ltd - methotrexate - tablets - methotrexate 2.5 mg - methotrexate - methotrexate - the treatment of acute lymphoblastic leukaemia and burkitt's lymphoma. the treatment of severe cases of uncontrolled psoriasis, unresponsive to conventional therapy. the treatment of adults with severe, active, classical or definite rheumatoid arthritis who are unresponsive or intolerant to conventional therapy.

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 25 mg in 1 ml - methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. in acute lymphocytic leukemia, methotrexate is indicated for use in maintenance therapy in combination with other chemotherapeutic agents.   methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types. methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin’s lymphomas. methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor. methotrexate is indicated in the symptomatic control of se

United States - English - NLM (National Library of Medicine)

sandoz inc - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 25 mg in 1 ml - methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. in acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. methotrexate is also indicated in the treatment of meningeal leukemia. methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types. methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin's lymphomas. methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - methotrexate (unii: yl5fz2y5u1) (methotrexate - unii:yl5fz2y5u1) - methotrexate 25 mg in 1 ml - methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. in acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. methotrexate is also indicated in the treatment of meningeal leukemia. methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types. methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin’s lymphomas. methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection

United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - methotrexate (unii: yl5fz2y5u1) (methotrexate - unii:yl5fz2y5u1) - methotrexate 1 g - methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. in acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. methotrexate is also indicated in the treatment of meningeal leukemia. methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types. methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin’s lymphomas. methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 1 g - methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. in acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents.  methotrexate is also indicated in the treatment of meningeal leukemia. methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types.  methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin’s lymphomas. methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resectio

Israel - English - Ministry of Health

novartis israel ltd - methotrexate - concentrate for solution for infusion - methotrexate 100 mg/ml - 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.

Israel - English - Ministry of Health

novartis israel ltd - methotrexate - solution for injection - methotrexate 20 mg/ml - methotrexate - methotrexate - psoriasis: methotrexate 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: methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well established 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.juvenile idiopathic arthritis:treatment of polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (nsaids) has been inadequatecrohn’s disease: mild to moderate crohn's disease either alone or in combination with corticosteroids in adult patients ref

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - methotrexate (unii: yl5fz2y5u1) (methotrexate - unii:yl5fz2y5u1) - methotrexate 2.5 mg - methotrexate tablets are indicated for the: -   treatment of adults and pediatric patients with acute lymphoblastic leukemia (all) as part of a combination chemotherapy maintenance regimen -   treatment of adults with mycosis fungoides (cutaneous t-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen. -   treatment of adults with relapsed or refractory non-hodgkin lymphomas as part of a metronomic combination chemotherapy regimen methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis. methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pjia). methotrexate tablets are indicated for the treatment of adults with severe psoriasis. methotrexate tablets are contraindicated in: - pregnant women receiving methotrexate tablets for treatment of non-neoplastic diseases [see warnings and precautions (5.1), and use in specific populations (8.1, 8.3)] . - patients with a

United States - English - NLM (National Library of Medicine)

mylan institutional inc. - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 2.5 mg - methotrexate tablets are indicated for the: - treatment of adults and pediatric patients with acute lymphoblastic leukemia (all) as part of a combination chemotherapy maintenance regimen. - treatment of adults with mycosis fungoides (cutaneous t-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen. - treatment of adults with relapsed or refractory non-hodgkin lymphomas as part of a metronomic combination chemotherapy regimen. methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis. methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pjia). methotrexate tablets are indicated for the treatment of adults with severe psoriasis. methotrexate tablets are contraindicated in: - pregnant women receiving methotrexate tablets for treatment of non-neoplastic diseases [see warnings and precautions (5.1), and use in specific populations (8.1, 8.3)] . - patients with a history of a severe hypersensitivity reactions, including anaphylaxis, to methotrexate [see warnings and precautions (5.2)] . methotrexate tablets are contraindicated in pregnant women with non-neoplastic diseases [see contraindications (4)]. based on published reports and its mechanism of action [see clinical pharmacology (12.1)], methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman. there are no animal data that meet current standards for nonclinical developmental toxicity studies. advise pregnant women with neoplastic diseases of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. published data from case reports, literature reviews, and observational studies report that methotrexate exposure during pregnancy is associated with an increased risk of embryo-fetal toxicity and fetal death. methotrexate exposure during the first trimester of pregnancy is associated with an increased incidence of spontaneous abortions and multiple adverse developmental outcomes, including skull anomalies, facial dysmorphism, central nervous system abnormalities, limb abnormalities, and sometimes cardiac anomalies and intellectual impairment. adverse outcomes associated with exposure during second and third trimesters of pregnancy include intrauterine growth restriction and functional abnormalities. because methotrexate is widely distributed and persists in the body for a prolonged period, there is a potential risk to the fetus from preconception methotrexate exposure. a prospective multicenter study evaluated pregnancy outcomes in women taking methotrexate less than or equal to 30 mg/week after conception. the rate of spontaneous abortion and miscarriage in pregnant women exposed to methotrexate was 42% (95% confidence interval [95% ci] 29, 59), which was higher than in unexposed patients with autoimmune disease (22%; 95% ci: 17, 30) and unexposed patients with nonautoimmune disease (17%; 95% ci: 13, 23). of the live births, the rate of major birth defects in pregnant women exposed to methotrexate after conception was higher than in unexposed patients with autoimmune disease (adjusted odds ratio (or) 1.8 [95% ci: 0.6, 6]) and unexposed patients with non-autoimmune disease (adjusted or 3.1 [95% ci: 1, 10]) (2.9%). major birth defects associated with pregnancies exposed to methotrexate after conception were not always consistent with methotrexate-associated adverse developmental outcomes. limited published literature report the presence of methotrexate in human milk in low amounts, with the highest breast milk to plasma concentration ratio reported to be 0.08:1. there are no data on the effects of methotrexate or its metabolites on the breastfed child or their effects on milk production. because of the potential for serious adverse reactions in a breastfed child, instruct women not to breastfeed during treatment with methotrexate tablets and for 1 week after the final dose. methotrexate can cause malformations and fetal death at doses less than or equal to the recommended clinical doses [see use in specific populations (8.1)]. verify the pregnancy status of females of reproductive potential prior to initiating methotrexate tablets [see contraindications (4), use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment with methotrexate tablets and for 6 months after the final dose. methotrexate can cause chromosomal damage to sperm cells. advise males with female partners of reproductive potential to use effective contraception during treatment with methotrexate tablets and for 3 months after the final dose. based on published reports of female infertility after methotrexate, advise females of reproductive potential that methotrexate can cause impairment of fertility and menstrual dysfunction during treatment with methotrexate tablets and after the final dose. it is not known if the infertility may be reversed in all affected females. based on published reports of male infertility after methotrexate, advise males that methotrexate can cause oligospermia or infertility during treatment with methotrexate tablets and after the final dose. it is not known if the infertility may be reversed in all affected males. the safety and effectiveness of methotrexate tablets in pediatric patients have been established for the treatment of all as part of the combination chemotherapy maintenance regimen and the treatment of pjia [see indications and usage (1), dosage and administration (2)]. no new safety signals have been observed in pediatric patients in clinical studies [see adverse reactions (6.1)]. the safety and effectiveness of methotrexate tablets have not been established in pediatric patients for the other indications [see indications and usage (1)]. clinical studies of methotrexate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. methotrexate elimination is reduced in patients with renal impairment [see clinical pharmacology (12.3)]. patients with renal impairment are at increased risk for methotrexate adverse reactions. closely monitor patients with renal impairment [creatinine clearance (clcr) less than 90 ml/min, cockcroft-gault] for adverse reactions. reduce the dosage or discontinue methotrexate tablets as appropriate [see warnings and precautions (5.8)]. the pharmacokinetics and safety of methotrexate in patients with hepatic impairment is unknown. patients with hepatic impairment may be at increased risk for methotrexate adverse reactions based on the elimination characteristics of methotrexate [see clinical pharmacology (12.3)]. closely monitor patients with hepatic impairment for adverse reactions. reduce the dosage or discontinue methotrexate tablets as appropriate [see warnings and precautions (5.5)] .