אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

medtas pty ltd - methylprednisolone sodium succinate, quantity: 166 mg (equivalent: methylprednisolone, qty 125 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate dihydrate; dibasic sodium phosphate; 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

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

medtas pty ltd - methylprednisolone sodium succinate, quantity: 53 mg (equivalent: methylprednisolone, qty 40 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate dihydrate; lactose monohydrate; dibasic sodium phosphate; 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

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

panpharma australia pty ltd - hydrocortisone sodium succinate, quantity: 133.7 mg - injection, powder for - excipient ingredients: dibasic sodium phosphate; monobasic sodium phosphate - 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, hydrocortisone panpharma 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 ? congenital adrenal hyperplasia ? nonsuppurative thyroiditis ? hypercalcaemia associated with cancer. 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ? post-traumatic osteoarthritis ? synovitis of osteoarthritis ? rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ? acute and subacute bursitis ? epicondylitis ? acute nonspecific tenosynovitis ? acute gouty arthritis ? psoriatic arthritis ? ankylosing spondylitis.,3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: ? systemic lupus erythematosus ? systemic dermatomyositis (polymyositis) ? acute rheumatic carditis.,4. dermatological diseases ? pemphigus ? severe erythema multiforme (stevens-johnson syndrome) ? exfoliative dermatitis ? bullous dermatitis herpetiformis ? severe seborrhoeic dermatitis ? severe psoriasis ? mycosis fungoides.,5. 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 ? seasonal or perennial allergic rhinitis ? acute noninfectious laryngeal oedema (adrenaline is the drug of first choice).,6. ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye, such as: ? herpes zoster ophthalmicus ? iritis, iridocyclitis ? chorioretinitis ? diffuse posterior uveitis and choroiditis ? optic neuritis ? sympathetic ophthalmia ? anterior segment inflammation ? allergic conjunctivitis ? allergic corneal marginal ulcers ? keratitis.,7. gastrointestinal diseases to tide the patient over a critical period of the disease in: ? ulcerative colitis (systemic therapy) ? regional enteritis (systemic therapy).,8. respiratory diseases ? symptomatic sarcoidosis ? loeffler's syndrome not manageable by other means ? berylliosis ? fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy ? aspiration pneumonitis.,9. haematological disorders ? acquired (autoimmune) haemolytic anaemia ? erythroblastopenia (rbc anaemia) ? idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated) ? secondary thrombocytopenia in adults ? congenital (erythroid) hypoplastic anaemia.,10. neoplastic diseases for palliative management of: ? leukaemias and lymphomas in adults ? acute leukaemia in childhood.,11. 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.,12. miscellaneous ? tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy ? trichinosis with neurological or myocardial involvement.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - hydrocortisone sodium succinate, quantity: 133.7 mg (equivalent: hydrocortisone, qty 100 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate - 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, [invented name] 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 ? congenital adrenal hyperplasia ? nonsuppurative thyroiditis ? hypercalcaemia associated with cancer. 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ? post-traumatic osteoarthritis ? synovitis of osteoarthritis ? rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) ? acute and subacute bursitis ? epicondylitis ? acute nonspecific tenosynovitis ? acute gouty arthritis ? psoriatic arthritis ? ankylosing spondylitis. 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: ? systemic lupus erythematosus ? systemic dermatomyositis (polymyositis) ? acute rheumatic carditis. 4. dermatological diseases ? pemphigus ? severe erythema multiforme (stevens-johnson syndrome) ? exfoliative dermatitis ? bullous dermatitis herpetiformis ? severe seborrhoeic dermatitis ? severe psoriasis ? mycosis fungoides. 5. 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). 6. ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye, such as: ? herpes zoster ophthalmicus ? iritis, iridocyclitis ? chorioretinitis ? diffuse posterior uveitis and choroiditis ? optic neuritis ? sympathetic ophthalmia ? anterior segment inflammation ? allergic conjunctivitis ? allergic corneal marginal ulcers ? keratitis. 7. gastrointestinal diseases to tide the patient over a critical period of the disease in: ? ulcerative colitis (systemic therapy) ? regional enteritis (systemic therapy). 8. respiratory diseases ? symptomatic sarcoidosis ? loeffler?s syndrome not manageable by other means ? berylliosis ? fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy ? aspiration pneumonitis. 9. haematological disorders ? acquired (autoimmune) haemolytic anaemia ? erythroblastopenia (rbc anaemia) ? idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated) ? secondary thrombocytopenia in adults ? congenital (erythroid) hypoplastic anaemia. 10. neoplastic diseases for palliative management of: ? leukaemias and lymphomas in adults ? acute leukaemia in childhood. 11. 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. 12. miscellaneous ? tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurological or myocardial involvement.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - hydrocortisone hydrogen succinate, quantity: 127.6 mg (equivalent: hydrocortisone, qty 100 mg) - injection, powder for - excipient ingredients: sodium hydroxide; monobasic sodium phosphate monohydrate; dibasic sodium phosphate - 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, hydrocortisone 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,? congenital adrenal hyperplasia,? nonsuppurative thyroiditis,? hypercalcaemia associated with cancer.,2. rheumatic disorders,as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:,? post-traumatic osteoarthritis,? synovitis of osteoarthritis,? rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may ,require low dose maintenance therapy),? acute and subacute bursitis,? epicondylitis,? acute nonspecific tenosynovitis,? acute gouty arthritis,? psoriatic arthritis,? ankylosing spondylitis.,3. collagen diseases,during an exacerbation or as maintenance therapy in selected cases of:,? systemic lupus erythematosus,? systemic dermatomyositis (polymyositis),? acute rheumatic carditis.,4. dermatological diseases,? pemphigus,? severe erythema multiforme (stevens-johnson syndrome),? exfoliative dermatitis,? bullous dermatitis herpetiformis,? severe seborrhoeic dermatitis,? severe psoriasis,? mycosis fungoides.,5. 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).,6. ophthalmic diseases,severe acute and chronic allergic and inflammatory processes involving the eye, such as:,? herpes zoster ophthalmicus,? iritis, iridocyclitis,? chorioretinitis,? diffuse posterior uveitis and choroiditis,? optic neuritis,? sympathetic ophthalmia,? anterior segment inflammation,? allergic conjunctivitis,? allergic corneal marginal ulcers,? keratitis.,7. gastrointestinal diseases,to tide the patient over a critical period of the disease in:,? ulcerative colitis (systemic therapy),? regional enteritis (systemic therapy).,8. respiratory diseases,? symptomatic sarcoidosis,? loeffler?s syndrome not manageable by other means,? berylliosis,? fulminating or disseminated pulmonary tuberculosis when used concurrently with ,appropriate antituberculous chemotherapy,? aspiration pneumonitis.,9. haematological disorders,? acquired (autoimmune) haemolytic anaemia,? erythroblastopenia (rbc anaemia),? idiopathic thrombocytopenic purpura in adults (iv only; im administration is ,contraindicated),? secondary thrombocytopenia in adults,? congenital (erythroid) hypoplastic anaemia.,10. neoplastic diseases,for palliative management of:,? leukaemias and lymphomas in adults,? acute leukaemia in childhood.,11. 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.,12. miscellaneous,? tuberculous meningitis with subarachnoid block or impending block when used ,concurrently with appropriate antituberculous chemotherapy,? trichinosis with neurological or myocardial involvement.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - ganciclovir sodium, quantity: 546 mg (equivalent: ganciclovir, qty 500 mg) - injection, powder for - excipient ingredients: - ganciclovir sxp (ganciclovir) administered as the iv infusion is indicated for the palliative treatment of confirmed sight-threatening cytomegalovirus (cmv) disease in aids and other severely immunocompromised individuals. it is indicated for the treatment of confirmed cmv pneumonitis in bone marrow transplant patients. it is also indicated for the prophylaxis of cmv infection and disease following bone marrow and solid organ transplantation in patients at risk of cmv disease.,note: ganciclovir sxp (ganciclovir) is not indicated for congenital or neonatal cmv disease; nor for the treatment of cmv infection in non-immunocompromised individuals.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - epoprostenol sodium, quantity: 531 microgram (equivalent: epoprostenol, qty 500 microgram) - powder - excipient ingredients: arginine; sodium hydroxide; sucrose - veletri is indicated for the long-term treatment, via continuous intravenous infusion, in who functional class iii or class iv patients with:,? idiopathic pulmonary arterial hypertension,? familial pulmonary arterial hypertension,? pulmonary arterial hypertension associated with the scleroderma spectrum of diseases

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - epoprostenol sodium, quantity: 1.593 mg (equivalent: epoprostenol, qty 1.5 mg) - powder - excipient ingredients: arginine; sodium hydroxide; sucrose - veletri is indicated for the long-term treatment, via continuous intravenous infusion, in who functional class iii or class iv patients with:,? idiopathic pulmonary arterial hypertension,? familial pulmonary arterial hypertension,? pulmonary arterial hypertension associated with the scleroderma spectrum of diseases

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

vicki partridge pty ltd - amnion, quantity: 10 mg i/ml - suspension, powder for - excipient ingredients: - amnion - for treatment of chronic plantar fasciitis to reduce pain and increase function

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

south eastern sydney local health district - amnion, quantity: 1 u - graft - excipient ingredients: dimethyl sulfoxide - amnion - treatment of ophthalmic disorder/disease/trauma, or as a wound dressing