Австралия - английски - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - methotrexate, quantity: 7.5 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.

Нова Зеландия - английски - 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.

Нова Зеландия - английски - 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.

Австралия - английски - 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

Австралия - английски - Department of Health (Therapeutic Goods Administration)

samsung bioepis au pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: water for injections; sucrose; monobasic sodium phosphate monohydrate; polysorbate 80; dibasic sodium phosphate heptahydrate - renflexis is indicated for the treatment of:,rheumatoid arthritis in adults renflexis, in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: - patients with active disease despite treatment with methotrexate; - patients with active disease who have not previously received methotrexate.,renflexis should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate,ankylosing spondylitis renflexis is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis renflexis is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy.,renflexis may be administered in combination with methotrexate.,psoriasis renflexis is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults and in children and adolescents (6 to 17 years) renflexis is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies,refractory fistulising crohn?s disease renflexis is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults and in children and adolescents (6 to 17 years) renflexis is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - esomeprazole sodium, quantity: 42.5 mg (equivalent: esomeprazole, qty 40 mg) - injection, powder for - excipient ingredients: sodium hydroxide; water for injections; disodium edetate - the short-term management of gastro-oesophageal reflux disease (gord) in patients with oesophagitis and/or severe symptoms of reflux as an alternative when oral therapy is inappropriate.,prevention of rebleeding in patients following therapeutic endoscopy for acute, bleeding gastric or duodenal ulcers.,short-term management in patients requiring continued non-steroidal anti-inflammatory drug (nsaid) therapy when oral therapy is inappropriate:,? healing of gastric ulcers associated with nsaid therapy,? prevention of gastric and duodenal ulcers associated with nsaid therapy, in patients at risk,note: esomeprazole iv should be replaced with oral therapy as soon as practicable.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methylprednisolone sodium succinate, quantity: 165.78 mg (equivalent: methylprednisolone, qty 125 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; sodium hydroxide; dibasic sodium phosphate - 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.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methylprednisolone sodium succinate, quantity: 53.05 mg (equivalent: methylprednisolone, qty 40 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; lactose monohydrate; 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.,? 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.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methylprednisolone sodium succinate, quantity: 1.326 g (equivalent: methylprednisolone, qty 1 g) - injection, powder for - excipient ingredients: sodium hydroxide; monobasic sodium phosphate monohydrate; dibasic sodium phosphate - 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.

Австралия - английски - 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.