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

pfizer australia pty ltd - sirolimus, quantity: 0.5 mg - tablet, sugar coated - excipient ingredients: dl-alpha-tocopherol; iron oxide yellow; macrogol 8000; carnauba wax; iron oxide red; microcrystalline cellulose; purified talc; iron oxide black; povidone; magnesium stearate; macrogol 20000; shellac; sucrose; calcium sulfate; glyceryl monooleate; titanium dioxide; poloxamer; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; sulfuric acid - rapamune is indicated for the prophylaxis of organ rejection in patients at mild to moderate immunological risk receiving renal transplants. therapeutic drug monitoring of sirolimus is required.

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

pfizer australia pty ltd - sirolimus, quantity: 2 mg - tablet, sugar coated - excipient ingredients: iron oxide red; shellac; dl-alpha-tocopherol; glyceryl monooleate; lactose monohydrate; macrogol 20000; calcium sulfate; titanium dioxide; iron oxide black; iron oxide yellow; magnesium stearate; povidone; macrogol 8000; microcrystalline cellulose; sucrose; carnauba wax; purified talc; poloxamer; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; sulfuric acid - for the prophylaxis of organ rejection in patients at mild to moderate immunological risk receiving renal transplants. therapeutic drug monitoring of sirolimus is required.

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

glaxosmithkline australia pty ltd - atovaquone, quantity: 250 mg; proguanil hydrochloride, quantity: 100 mg - tablet, film coated - excipient ingredients: poloxamer; hyprolose; hypromellose; macrogol 400; magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; macrogol 8000; iron oxide red; povidone - malarone is indicated for the treatment of plasmodium falciparum malaria in adults and children aged 3 years or older. indications as at 1 november 2001: "prophylaxis of plasmodium falciparum malaria in individuals weighing >40kg". this approval is based on the evaluation of the information and data provided with the original letter of application and with any subsequent correspondence and submissions relating to the application. indications as at 13 january 2003: prophylaxis of plasmodium falciparum malaria in adults and children 11kg and over; treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

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

fresenius kabi australia pty ltd - olive oil, quantity: 50 g; fish oil - rich in omega-3 acids, quantity: 30 g; medium chain triglycerides, quantity: 60 g; soya oil, quantity: 60 g - injection, intravenous infusion - excipient ingredients: glycerol; sodium oleate; dl-alpha-tocopherol; water for injections; egg lecithin; sodium hydroxide - supply of energy and essential fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated.

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

fresenius kabi australia pty ltd - olive oil, quantity: 50 g; fish oil - rich in omega-3 acids, quantity: 30 g; medium chain triglycerides, quantity: 60 g; soya oil, quantity: 60 g - injection, intravenous infusion - excipient ingredients: glycerol; sodium oleate; dl-alpha-tocopherol; water for injections; egg lecithin; sodium hydroxide - supply of energy and essential fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated.

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

fresenius kabi australia pty ltd - chromic chloride hexahydrate, quantity: 5.33 microgram/ml; ferric chloride hexahydrate, quantity: 540 microgram/ml; sodium selenite, quantity: 17.29 microgram/ml; sodium fluoride, quantity: 210 microgram/ml; cupric chloride dihydrate, quantity: 102.3 microgram/ml; potassium iodide, quantity: 16.6 microgram/ml; sodium molybdate dihydrate, quantity: 4.85 microgram/ml; manganese chloride tetrahydrate, quantity: 19.79 microgram/ml; zinc chloride, quantity: 1.05 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; xylitol - to meet basal to moderately increased requirements of trace elements in parenteral nutrition in adults, when either oral or enteral nutrition is inappropriate

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

fresenius kabi australia pty ltd - olive oil, quantity: 50 g; fish oil - rich in omega-3 acids, quantity: 30 g; medium chain triglycerides, quantity: 60 g; soya oil, quantity: 60 g - injection, intravenous infusion - excipient ingredients: glycerol; sodium oleate; dl-alpha-tocopherol; water for injections; egg lecithin; sodium hydroxide - supply of energy and essential fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated.

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

fresenius kabi australia pty ltd - dl-alpha-tocopherol, quantity: 0.64 mg/ml; retinol palmitate, quantity: 135.3 microgram/ml; phytomenadione, quantity: 20 microgram/ml; ergocalciferol, quantity: 1 microgram/ml - injection, concentrated - excipient ingredients: sodium hydroxide; water for injections; glycerol; egg lecithin; soya oil - vitalipid n infant is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat- soluble vitamins a, d2, e and k1 in paediatric patients up to 11 years of age.

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

fresenius kabi australia pty ltd - phytomenadione, quantity: 15 microgram/ml; ergocalciferol, quantity: 0.5 microgram/ml; retinol palmitate, quantity: 194.1 microgram/ml; dl-alpha-tocopherol, quantity: 0.91 mg/ml - injection, concentrated - excipient ingredients: soya oil; egg lecithin; glycerol; water for injections; sodium hydroxide - vitalipid n adult is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat- soluble vitamins a, d2, e and k1.

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

fresenius kabi australia pty ltd - fish oil - rich in omega-3 acids, quantity: 30 g/l; medium chain triglycerides, quantity: 60 g/l; olive oil, quantity: 50 g/l; soya oil, quantity: 60 g/l - injection, intravenous infusion - excipient ingredients: egg lecithin; glycerol; sodium oleate; water for injections; sodium hydroxide; dl-alpha-tocopherol - parenteral nutrition for adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.