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

pfizer australia pty ltd - bortezomib, quantity: 2.5 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - dbl bortezomib powder for injection, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. dbl bortezomib powder for injection, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. dbl bortezomib powder for injection is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. dbl bortezomib powder for injection in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

pfizer australia pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - dbl bortezomib powder for injection, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. dbl bortezomib powder for injection, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. dbl bortezomib powder for injection is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. dbl bortezomib powder for injection in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

pfizer australia pty ltd - bortezomib, quantity: 3 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - dbl bortezomib powder for injection, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. dbl bortezomib powder for injection, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. dbl bortezomib powder for injection is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. dbl bortezomib powder for injection in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

pfizer australia pty ltd - bortezomib - injection, powder for - excipient ingredients: mannitol; nitrogen - bortezomib powder for injection, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib powder for injection, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib powder for injection is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib powder for injection in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

juno pharmaceuticals pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: nitrogen; mannitol - bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection), in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection), as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection) is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

juno pharmaceuticals pty ltd - bortezomib, quantity: 1 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection), in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection), as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection) is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Australia - English - 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.

Australia - English - 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.

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

glaxosmithkline australia pty ltd - mepolizumab, quantity: 100 mg - injection, powder for - excipient ingredients: polysorbate 80; water for injections; dibasic sodium phosphate heptahydrate; sucrose - severe eosinophilic asthma,nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over (see section 5.1 pharmacodynamic properties, clinical trials).,chronic rhinosinusitis with nasal polyps (crswnp),nucala is indicated as add-on treatment in adult patients (18 years and above) with severe chronic rhinosinusitis with nasal polyps (crswnp) with an inadequate response to intranasal corticosteroids (see section 5.1 pharmacodynamic properties, clinical 2 trials).,relapsed or refractory egpa,nucala is indicated as an add-on treatment for relapsing or refractory eosinophilic granulomatosis with polyangiitis (egpa) in adult patients aged 18 years and over (see section 5.1 pharmacodynamic properties, clinical trials).

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.