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)

pfizer australia pty ltd - methylprednisolone sodium succinate, quantity: 663.13 mg (equivalent: methylprednisolone, qty 500 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate monohydrate; dibasic sodium phosphate; sodium hydroxide - when oral therapy is not feasible and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, solu-medrol powder for injection is indicated only for intravenous or intramuscular use in the following conditions:,endocrine disorders,? primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).,? acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogues are used).,? preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.,? shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.,? c

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

pfizer australia pty ltd - hydrocortisone sodium succinate, quantity: 668.5 mg (equivalent: hydrocortisone, qty 500 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; sodium hydroxide - when oral therapy is not feasible, and the strength, form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, solu-cortef powder for injection is indicated for intravenous or intramuscular use in the following conditions: 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplements may be necessary, particularly when synthetic analogues are used). preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected

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

medtas pty ltd - methylprednisolone sodium succinate, quantity: 663 mg (equivalent: methylprednisolone, qty 500 mg) - injection, powder for - excipient ingredients: dibasic sodium phosphate; monobasic sodium phosphate dihydrate; sodium carbonate - when oral therapy is not feasible & strength, dosage form & route of administration of drug reasonably lend preparation to treatment of following conditions. intravenous or intramuscular use only.,endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is drug of choice; mineralocorticoid supplementation may be necessary particularly when synthetic analogues are used). preoperatively & in event of serious trauma or illness in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. shock unresponsive to conventional therapy if adrenocortical insufficiency exists or suspected, congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcaemia associated with cancer. congenital adrenal hy

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

juno pharmaceuticals pty ltd - tazobactam sodium, quantity: 547 mg (equivalent: tazobactam, qty 500 mg); piperacillin sodium, quantity: 4.253 g (equivalent: piperacillin, qty 4 g) - injection, powder for - excipient ingredients: - piperacillin and tazobactam is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: lower respiratory tract infections; urinary tract infections (complicated and uncomplicated); intra-abdominal infections; skin and skin structure infections; bacterial septicaemia; and gynaecological infections. children under the age of 12 years: in hospitalised children aged 2 to 12 years, piperacillin and tazobactam is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of two years. while piperacillin and tazobactam is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing, piperacillin resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order t

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

pfizer australia pty ltd - tazobactam sodium, quantity: 540 mg (equivalent: tazobactam, qty 500 mg); piperacillin sodium, quantity: 4.17 g (equivalent: piperacillin, qty 4 g) - injection, powder for - excipient ingredients: disodium edetate; citric acid monohydrate - tazocin ef is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: 1. lower respiratory tract infections. 2. urinary tract infections (complicated and uncomplicated). 3. intra-abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections. children under the age of 12 years. in hospitalised children aged 2 to 12 years, tazocin ef is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years. while tazocin ef is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection t

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

alphapharm pty ltd - aciclovir sodium dihydrate, quantity: 628.8 mg (equivalent: aciclovir, qty 500 mg) - injection, powder for - excipient ingredients: - aciclovir mylan (aciclovir sodium) is indicated for:,- promoting resolution of acute clinical manifestations of mucocutaneous herpes simplex virus infections in immunocompromised patients,- treatment of severe first episode primary or non-primary genital herpes in immune competent patients,- treatment of acute manifestations of varicella zoster virus infection in immunocompromised patients,- treatment of herpes zoster (shingles) in immune competent patients who show very severe acute local or systemic manifestations of the disease. (benefits can be expected in patients with rash duration shorter than 72 hours. the use of the intravenous infusion may be warranted in only a small subgroup of immune competent patients with shingles).,- treatment of herpes simplex encephalitis.

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - methotrexate 100 mg/ml - concentrate for injection - 100 mg/ml - active: methotrexate 100 mg/ml excipient: sodium hydroxide water for injection - 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 medicine 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 carcinoma. calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy. psoriasis chemotherapy. 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 the diagnosis has been definitely established, as by biopsy and/or after dermatological 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,