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

sandoz pty ltd - methotrexate, quantity: 500 mg - injection, concentrated - excipient ingredients: water for injections; sodium hydroxide - 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.

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

aft pharmaceuticals pty ltd - piperacillin sodium, quantity: 4170 mg (equivalent: piperacillin, qty 4000 mg); tazobactam sodium, quantity: 540 mg (equivalent: tazobactam, qty 500 mg) - injection, powder for - excipient ingredients: nitrogen - piptaz-aft 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, piptaz-aft 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 piptaz-aft 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 to determine their susceptibilities to piptaz-aft. therapy with piptaz-aft, however, may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued. in serious infections, presumptive therapy with piptaz-aft may be initiated before susceptibility test results are available. combination therapy with piptaz-aft and aminoglycosides may be used in the treatment of serious infections caused by pseudomonas aeruginosa. both drugs should be used in full therapeutic doses. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

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.

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: sodium hydroxide; dibasic sodium phosphate; monobasic sodium phosphate monohydrate - 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.,? congenital adrenal hyperplasia,? nonsuppurative thyroiditis,? hypercalcaemia associated with cancer.,rheumatic disorders,as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:,? ankylosing spondylitis,? psoriatic arthritis,? acute and subacute bursitis,? epicondylitis,? synovitis of osteoarthritis,? acute gouty arthritis,? acute nonspecific tenosynovitis,? post-traumatic osteoarthritis,? rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy).,collagen disease,during an exacerbation or as maintenance therapy in selected cases of:,? systemic lupus erythematosus,? systemic dermatomyositis (polymyositis),? acute rheumatic carditis.,dermatological diseases,? bullous dermatitis herpetiformis,? pemphigus,? severe psoriasis,? severe seborrhoeic dermatitis,? exfoliative dermatitis,? mycosis fungoides,? severe erythema multiforme (stevens-johnson syndrome).,allergic states,control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:,? bronchial asthma,? drug hypersensitivity reactions,? contact dermatitis,? urticarial transfusion reactions,? atopic dermatitis,? serum sickness,? acute noninfectious laryngeal oedema (adrenaline is the drug of first choice).,ophthalmic diseases,severe acute and chronic allergic and inflammatory processes involving the eye, such as:,? allergic corneal marginal ulcers,? allergic conjunctivitis,? chorioretinitis,? anterior segment inflammation,? herpes zoster ophthalmicus,? iritis, iridocyclitis,? diffuse posterior uveitis and choroiditis,? keratitis,? optic neuritis,? sympathetic ophthalmia.,gastrointestinal diseases,to tide the patient over a critical period of the disease in:,? ulcerative colitis (systemic therapy),? regional enteritis (systemic therapy).,respiratory diseases,? symptomatic sarcoidosis,? berylliosis,? aspiration pneumonitis,? loeffler?s syndrome not manageable by other means,? fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.,haematologic disorders,? idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated),? secondary thrombocytopenia in adults,? acquired (autoimmune) haemolytic anaemia,? erythroblastopenia (rbc anaemia),? congenital (erythroid) hypoplastic anaemia.,neoplastic diseases,for palliative management of:,? leukaemias and lymphomas in adults,? acute leukaemia of childhood.,oedematous states,? to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus.,nervous system,? acute exacerbations of multiple sclerosis.,miscellaneous,? tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.,? trichinosis with neurologic or myocardial involvement.,? solu-medrol is beneficial as adjunctive therapy in the treatment of acquired immunodeficiency syndrome (aids) patients with moderate to severe pneumocystis jiroveci pneumonia (pcp) when given within the first 72 hours of initial anti-pneumocystis treatment.

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

link medical products pty ltd t/a link pharmaceuticals - methotrexate, quantity: 25 mg - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; water for injections - psoriasis therapy (see warning box): trexject may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis in adults 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.,rheumatoid arthritis therapy (see warning box): 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. steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold or penicillamine, 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)

link medical products pty ltd t/a link pharmaceuticals - methotrexate, quantity: 22.5 mg - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; water for injections - psoriasis therapy (see warning box): trexject may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis in adults 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.,rheumatoid arthritis therapy (see warning box): 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. steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold or penicillamine, 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)

link medical products pty ltd t/a link pharmaceuticals - methotrexate, quantity: 20 mg - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; water for injections - psoriasis therapy (see warning box): trexject may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis in adults 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.,rheumatoid arthritis therapy (see warning box): 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. steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold or penicillamine, 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)

link medical products pty ltd t/a link pharmaceuticals - methotrexate, quantity: 17.5 mg - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; water for injections - psoriasis therapy (see warning box): trexject may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis in adults 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.,rheumatoid arthritis therapy (see warning box): 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. steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold or penicillamine, 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)

link medical products pty ltd t/a link pharmaceuticals - methotrexate, quantity: 15 mg - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; water for injections - psoriasis therapy (see warning box): trexject may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis in adults 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.,rheumatoid arthritis therapy (see warning box): 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. steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold or penicillamine, 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)

link medical products pty ltd t/a link pharmaceuticals - methotrexate, quantity: 12.5 mg - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; water for injections - psoriasis therapy (see warning box): trexject may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis in adults 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.,rheumatoid arthritis therapy (see warning box): 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. steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold or penicillamine, has not been studied and may increase the incidence of adverse effects. rest and physiotherapy as indicated should be continued.