Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - methotrexate, quantity: 25 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections; sodium hydroxide - antineoplastic chemotherapy - methotrexate has a broad spectrum of antineoplastic activity. it is indicated for the treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. methotrexate may be used in combination with other chemotherapeutic agents for the palliative treatment of acute leukaemias, particularly acute lymphoblastic leukaemia. it may also be used in the treatment of burkitt's lymphoma, advanced stages (iii and iv, peters' staging system) of lymphosarcoma, especially in children, and in advanced cases of mycosis fungoides. high dose therapy - in high-dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic carcinoma. calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy. psoriasis chemotherapy (see warning box) - methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of treatment. however, due to the high risk associated with its use, methotrexate should be used after the diagnosis has been definitely established, as by biopsy and/or after dermatologic consultation.

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

bryant ranch prepack - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 2.5 mg - methotrexate tablets are indicated for the: 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: risk summary 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 recogni

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - methotrexate, quantity: 5000 mg - injection, concentrated - excipient ingredients: sodium hydroxide; water for injections - antineoplastic chemotherapy:,methotrexate has a broad spectrum of antineoplastic activity. it is indicated for the treatment of breast cancer and the palliation of acute and subacute lymphocytic leukaemia (greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias). methotrexate is now most commonly used for the maintenance of drug induced remissions.,high dose therapy:,in high dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic sarcoma. calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy.,psoriasis chemotherapy (see warnings box and section 4.4 special warnings and precautions for use).:,methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of treatment. however, due to the high risk associated with its use, methotrexate should be used after diagnosis has been definitely established , as by biopsy and/or after dermatological consultation.

Ireland - English - HPRA (Health Products Regulatory Authority)

rosemont pharmaceuticals ltd - methotrexate disodium - oral solution - 2 mg/ml - methotrexate - antineoplastic and immunomodulating agents, antimetabolites, folic acid analogues - it is indicated in the following oncological indications: the maintenance treatment of acute lymphocytic leukaemia (all) in children and adults; the treatment of malignant trophoblastic tumours and for the treatment of severe active rheumatoid arthritis in adults and the treatment of severe forms of psoriasis vulgaris including chronic plaque psoriasis, erythrodermic psoriasis, psoriatic arthritis and pustular psoriasis which are not responsive to other conventional therapies such as phototherapy, puva and retinoids.

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

a-s medication solutions - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 2.5 mg - neoplastic diseases methotrexate is indicated in the treatment of gestational choriocarcinoma, chorio-adenoma destruens and hydatidiform mole. methotrexate is used 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. psoriasis methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation . it is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affec

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

morningside healthcare ltd - methotrexate - oral tablet - 10mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

morningside healthcare ltd - methotrexate - oral tablet - 2.5mg

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - methotrexate 20 mg/ml - injection with diluent - 20 mg/ml - active: methotrexate 20 mg/ml excipient: sodium chloride sodium hydroxide water for injection - - active rheumatoid arthritis in adult patients where treatment with disease modifying antirheumatic drugs (dmards) is indicated. - polyarthritic forms of severe, active juvenile idiopathic arthritis (jia) when the response to nonsteroidal anti-inflammatory drugs (nsaids) has been inadequate - severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy such as phototherapy, puva, and retinoids, and severe psoriatic arthritis.

Malta - English - Medicines Authority

accord healthcare limited - methotrexate - solution for injection - methotrexate 25 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare limited - methotrexate - concentrate for solution for infusion - methotrexate 100 mg/ml - antineoplastic agents