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

orion pharma (aus) pty limited - methotrexate sodium, quantity: 2.742 mg (equivalent: methotrexate, qty 2.5 mg) - tablet, uncoated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate - antineoplastic chemotherapy treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. chexate is also 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. psoriasis chemotherapy (see warnings box and section 4.4) because of the high risk attending to its use, chexate is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and / or after dermatologic consultations. rheumatoid arthritis chemotherapy (see warnings box and section 4.4) management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to or intolerant of an adequate trial of nsaids and one or more disease modifying drugs. aspirin, nsaids and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of nsaids including salicylate has not been fully explored (see section 4.4, and 4.5). steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. rest and physiotherapy as indicated should be continued.

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

orion pharma (aus) pty limited - methotrexate sodium, quantity: 10.97 mg (equivalent: methotrexate, qty 10 mg) - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose - antineoplastic chemotherapy treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. chexate is also 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. psoriasis chemotherapy (see warnings box and section 4.4) because of the high risk attending to its use, chexate is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and / or after dermatologic consultations. rheumatoid arthritis chemotherapy (see warnings box and section 4.4) management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to or intolerant of an adequate trial of nsaids and one or more disease modifying drugs. aspirin, nsaids and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of nsaids including salicylate has not been fully explored (see section 4.4, and 4.5). steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. rest and physiotherapy as indicated should be continued.

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

European Union - English - EMA (European Medicines Agency)

medac gesellschaft fuer klinische spezialpraeparate mbh - asparaginase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years and adults.

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

accord healthcare pty ltd - methotrexate, quantity: 100 mg/ml - injection, solution - 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, 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.

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.

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.

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - carmustine - hodgkin disease; lymphoma, non-hodgkin - antineoplastic agents - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

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

sandoz pty ltd - methotrexate, quantity: 1000 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.