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

wockhardt bio pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: sodium chloride; hydroxypropylbetadex - voriwok is indicated for treatment of the following fungal infections:,invasive aspergillosis.,serious candida infections (including c. krusei), including systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,serious fungal infections caused by scedosporium spp and fusarium spp.,other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

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

arrotex pharmaceuticals pty ltd - voriconazole, quantity: 200 mg - solution, powder for - excipient ingredients: hydroxypropylbetadex; hydrochloric acid; sodium chloride - voriconazole is indicated for treatment of the following fungal infections:,- invasive aspergillosis.,- serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,- serious fungal infections caused by scedosporium spp. and fusarium spp.,- other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,- prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

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

takeda pharmaceuticals australia pty ltd - vedolizumab, quantity: 331.2 mg - injection, powder for - excipient ingredients: polysorbate 80; arginine hydrochloride; histidine; sucrose; histidine hydrochloride monohydrate - ulcerative colitis,treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,crohn?s disease,treatment of adult patients with moderate to severe crohn?s disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,pouchitis,entyvio is indicated for the treatment of adult patients with moderate to severe chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

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

omegapharm - thiopental sodium, quantity: 470 mg - injection, powder for - excipient ingredients: - ? as the sole anaesthetic agent for brief surgical procedures.,? induction of anaesthesia prior to the administration of other anaesthetic agents.,? short-term control of convulsive states.,? supplement to regional anaesthesia or low potency agents such as nitrous oxide.

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

takeda pharmaceuticals australia pty ltd - brentuximab vedotin, quantity: 50 mg - injection, powder for - excipient ingredients: citric acid monohydrate; trehalose dihydrate; sodium citrate dihydrate; polysorbate 80 - hodgkin lymphoma,treatment of patients with previously untreated cd30+ stage iii or stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine, and dacarbazine (avd).,treatment of adult patients with cd30+ hl at higher risk of relapse or progression following asct.,treatment of adult patients with relapsed or refractory cd30+ hl:,1. following autologous stem cell transplant (asct) or,2. following at least two prior therapies when asct or multi-agent chemotherapy is not a treatment option.,peripheral t-cell lymphoma,treatment of adult patients with previously untreated cd30+ peripheral t-cell lymphoma (ptcl) in combination with cyclophosphamide, doxorubicin, and prednisone (chp).,treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (salcl).,cutaneous t cell lymphoma,treatment of adult patients with cd30+ cutaneous t-cell lymphoma (ctcl) after at least 1 prior systemic therapy.

Australia - Inggris - 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.

Australia - Inggris - 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.

Australia - Inggris - 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 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.

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

pfizer australia pty ltd - hydrocortisone sodium succinate, quantity: 334.25 mg (equivalent: hydrocortisone, qty 250 mg) - injection, powder for - excipient ingredients: dibasic sodium phosphate; monobasic 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 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.

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

pfizer australia pty ltd - hydrocortisone sodium succinate, quantity: 134 mg (equivalent: hydrocortisone, qty 100 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 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.