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

omegapharm - mitomycin, quantity: 2 mg - injection, powder for - excipient ingredients: mannitol - mitomycin is indicated in the palliative treatment of carcinoma of the stomach, pancreas, colon, lung (non-small cell), breast, cervix, head and neck, liver and bladder.

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 2277.2 mg (equivalent: gemcitabine, qty 2000 mg) - injection, powder for - excipient ingredients: sodium hydroxide; mannitol; hydrochloric acid; sodium acetate - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 1138.6 mg (equivalent: gemcitabine, qty 1000 mg) - injection, powder for - excipient ingredients: hydrochloric acid; sodium acetate; sodium hydroxide; mannitol - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 227.72 mg (equivalent: gemcitabine, qty 200 mg) - injection, powder for - excipient ingredients: mannitol; sodium acetate; hydrochloric acid; sodium hydroxide - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

accord healthcare pty ltd - gemcitabine hydrochloride (equivalent: gemcitabine, qty 1 g) - injection, powder for - excipient ingredients: hydrochloric acid; mannitol; sodium hydroxide; sodium acetate trihydrate - treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. treatment of patients with 5-fu refractory pancreatic cancer. treatment of patients with bladder cancer, alone or in combination with cisplatin. treatment, in combination with paclitaxel, of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed > six months following platinum based therapy.

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

accord healthcare pty ltd - gemcitabine hydrochloride, quantity: 228 mg (equivalent: gemcitabine, qty 200 mg) - injection, powder for - excipient ingredients: mannitol; sodium acetate trihydrate; sodium hydroxide; hydrochloric acid - treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. treatment of patients with 5-fu refractory pancreatic cancer. treatment of patients with bladder cancer, alone or in combination with cisplatin. treatment, in combination with paclitaxel, of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed > six months following platinum based therapy.

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

abraxis bioscience australia pty ltd - paclitaxel, quantity: 100 mg - injection, powder for - excipient ingredients: albumin; sodium octanoate; sodium acetyltryptophanate - metastatic breast cancer abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. non-small cell lung cancer abraxane, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. metastatic adenocarcinoma of the pancreas abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

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

abraxis bioscience australia pty ltd - paclitaxel, quantity: 250 mg - injection, powder for - excipient ingredients: albumin; sodium octanoate; sodium acetyltryptophanate - metastatic breast cancer abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. non-small cell lung cancer abraxane, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. metastatic adenocarcinoma of the pancreas abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

Australia - Inggris - 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 - Inggris - 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.