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

novo nordisk pharmaceuticals pty ltd - catridecacog, quantity: 5.25 mg/ml - drug delivery system - excipient ingredients: - novothirteen is indicated for routine prophylaxis of bleeding in patients with congenital factor xiii a-subunit deficiency.

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

aspen pharmacare australia pty ltd - methadone hydrochloride, quantity: 10 mg/ml - injection, solution - excipient ingredients: water for injections - physeptone is indicated for the management of severe pain where: (i) other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and (ii) the pain is opioid-responsive, and (iii) requires daily, continuous, long-term treatment. ,physeptone is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,physeptone is not indicated as an as-needed (prn) analgesia.,physeptone is not recommended for use in ambulant patients.

Australia - English - 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

Australia - English - 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: 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

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

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, solution - excipient ingredients: metacresol; glycerol; water for injections; hydrochloric acid; sodium hydroxide - indications as at 05 feb 2002 : humulin is indicated for the treatment of insulin - dependant diabetic patients.

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

roche products pty ltd - enfuvirtide, quantity: 90 mg - diluent, not applicable - excipient ingredients: water for injections - fuzeon (enfuvirtide) is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in antiretroviral experienced patients with treatment failure due to intolerance to previous antiretroviral agents or with evidence of hiv-1 replication despite ongoing therapy. evidence to support this indication is based on surrogate endpoints (change in viral load and cd4 count) in controlled studies following 48 weeks of treatment (see clinical trials)

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

sanofi-aventis australia pty ltd - rabies immunoglobulin, quantity: 150 iu/ml - injection - excipient ingredients: glycine; sodium chloride; water for injections - imogam rabies pasteurized is indicated in subjects who are thought to have been exposed to rabies virus, especially cases of major exposure, in accordance with w.h.o. recommendations as specified in the international product information.

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

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: sodium hydroxide; glycerol; metacresol; zinc oxide; phenol; dibasic sodium phosphate heptahydrate; protamine sulfate; hydrochloric acid; water for injections - this product accepted for registration as 'currently supplied' at the time of commencement of the act. humulin is indicated for the treatment of insulin-dependent diabetic patients.

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

pfizer australia pty ltd - methylprednisolone sodium succinate, quantity: 2.6525 g (equivalent: methylprednisolone, qty 2 g) - injection, powder for - excipient ingredients: dibasic sodium phosphate; sodium hydroxide; 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.,? c

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

australian nuclear science and technology organisation t/a ansto - chromium(51cr) edetate, quantity: 8 mbq/ml - injection, solution - excipient ingredients: sodium chloride; water for injections; chromium edetate - indications as at 17 sep 02 : determination of glomerular filtration rate in the assessment of renal function.