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

arrotex pharmaceuticals pty ltd - posaconazole, quantity: 40 mg/ml - oral liquid, suspension - excipient ingredients: sodium benzoate; sodium citrate dihydrate; citric acid monohydrate; titanium dioxide; glycerol; xanthan gum; liquid glucose; peg-40 hydrogenated castor oil; purified water; peg-40 stearate; benzoic acid; glyceryl monostearate; methylcellulose; polysorbate 65; simethicone; sorbic acid; sulfuric acid; flavour - posaconazole is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,posaconazole is also indicated for the: ? treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole. ? prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

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

orthomolecular medisearch laboratories pty ltd trading as biological therapies - colecalciferol, quantity: 0.125 mg/ml - oral liquid, solution - excipient ingredients: glycerol; citric acid monohydrate; purified water; peg-35 castor oil; sodium benzoate; vegetable oil; dl-alpha-tocopherol - help maintain/support bone mineralisation ; vitamin d helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency

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

strides pharma science pty ltd - levetiracetam, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: maltitol solution; purified water; citric acid monohydrate; glycerol; methyl hydroxybenzoate; propylene glycol; sodium citrate dihydrate; acesulfame potassium; propyl hydroxybenzoate; ammonium glycyrrhizinate; flavour - use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation; monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy; add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme); and add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (ige).

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

aft pharmaceuticals pty ltd - levetiracetam, quantity: 10 % w/v - oral liquid, solution - excipient ingredients: acesulfame potassium; propyl hydroxybenzoate; purified water; maltitol solution; glycerol; sodium citrate dihydrate; methyl hydroxybenzoate; ammonium glycyrrhizinate; citric acid monohydrate; flavour - levetiracetam-aft oral solution is indicated for:,use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme),and,add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (ige).,levetiracetam-aft concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

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

aspen pharmacare australia pty ltd - ranitidine hydrochloride, quantity: 16.8 mg/ml (equivalent: ranitidine, qty 15 mg/ml) - oral liquid - excipient ingredients: hypromellose; ethanol; sorbitol solution (70 per cent) (non-crystallising); butyl hydroxybenzoate; saccharin sodium; propyl hydroxybenzoate; sodium chloride; dibasic sodium phosphate; monobasic potassium phosphate; purified water; flavour - short-term treatment of proven duodenal ulcer and gastric ulcer, including intravenous use for prophylaxis against recurrent haemorrhage: maintenance treatment to reduce the risk of relapse in duodenal ulcer: maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer: treatment of gastrinoma (zollinger-ellison syndrome): short-term treatment of severe reflux oesophagitis: treatment of scleroderma oesophagitis. the intravenous injection is indicated where oral treatment is inappropriate. new indications as at 2 november 1993: 1. short-term treatment of proven duodenal ulcer and gastric ulcer, including intravenous use for prophylaxis against recurrent haemorrhage. 2. maintenance treatment to reduce the risk of relapse in duodenal ulcer. 3. maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer. 4. treatment of gastrinoma (zollinger-ellison syndrom

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

carotino (australia) pty ltd - biotin, quantity: 1.6 microgram/ml; calcium pantothenate, quantity: 440 microgram/ml; choline bitartrate, quantity: 30.64 mg/ml; cyanocobalamin, quantity: 0.2 microgram/ml; ferrous fumarate, quantity: 3.05 mg/ml (equivalent: iron, qty 1 mg/ml); folic acid, quantity: 20 microgram/ml; nicotinamide, quantity: 1 mg/ml; pyridoxine hydrochloride, quantity: 150 microgram/ml (equivalent: pyridoxine, qty 123.5 microgram/ml); riboflavin, quantity: 120 microgram/ml; thiamine hydrochloride, quantity: 140 microgram/ml; zinc sulfate monohydrate, quantity: 1.1 mg/ml (equivalent: zinc, qty 400.7 microgram/ml); colecalciferol, quantity: 1.6 microgram/ml; retinol palmitate, quantity: 36.85 microgram/ml - oral liquid - excipient ingredients: glycerol; carmoisine; potassium sorbate; purified water; sodium benzoate; sucralose; xanthan gum; maize starch; acacia; silicon dioxide; dl-alpha-tocopherol; sucrose; medium chain triglycerides; potable water; gelatin; butylated hydroxytoluene; aluminium starch octenylsuccinate; aluminium sodium silicate; flavour - maintain/support energy levels ; maintain/support nail health/strength/thickness ; aid/assist healthy red blood cell production ; aid/assist/helps oxygen transport to body tissues ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; maintain/support cognitive function/mental function ; maintain/support brain function ; maintain/support skin health

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

aspen pharmacare australia pty ltd - flucloxacillin sodium monohydrate, quantity: 27.2 mg/ml (equivalent: flucloxacillin, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: ammonium glycyrrhizinate; sodium benzoate; sucrose; saccharin sodium; disodium edetate; sodium citrate; erythrosine; flavour - for the treatment of confirmed or suspected staphylococcal and other gram-positive coccal infections. indications include pneumonia, osteomyelitis, skin and skin structure and wound infections, infected burns and cellulitis.

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

aspen pharmacare australia pty ltd - flucloxacillin sodium monohydrate, quantity: 54.4 mg/ml (equivalent: flucloxacillin, qty 50 mg/ml) - oral liquid, powder for - excipient ingredients: erythrosine; sodium citrate; sodium benzoate; sucrose; ammonium glycyrrhizinate; disodium edetate; saccharin sodium; flavour - for the treatment of confirmed or suspected staphylococcal and other gram-positive coccal infections. indications include pneumonia, osteomyelitis, skin and skin structure and wound infections, infected burns and cellulitis.

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

arrotex pharmaceuticals pty ltd - lamivudine, quantity: 5 mg/ml - oral liquid, solution - excipient ingredients: hydrochloric acid; methyl hydroxybenzoate; sodium citrate dihydrate; propyl hydroxybenzoate; sucrose; citric acid; propylene glycol; sodium hydroxide; purified water; flavour - zeffix (lamivudine) is indicated for the treatment of children (2 years and above), adolescent and adult patients with chronic hepatitis b and evidence of hepatitis b virus (hbv) replication. this indication is based on changes in serological and histological markers in clinical studies of up to 2 years duration in adult patients with compensated liver disease and serological data up to 18 months in children and adolescents. children and adolescent also require evidence of active hepatic inflammation. (see clinical trials). the safety and efficacy of zeffix (lamivudine) have not been established in patients with decompensated liver disease in placebo controlled studies. however, zeffix (lamivudine) has been shown to reduce hbv dna levels prior to and post liver transplantation.

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

gold cross products and services pty ltd - sodium chloride, quantity: 8 mg/g; potassium chloride, quantity: 24.5 mg/g; sodium citrate dihydrate, quantity: 27.75 mg/g - oral liquid, powder for - excipient ingredients: glucose monohydrate; calcium phosphate; sucrose; citric acid; colloidal anhydrous silica; flavour - perspiration causes loss of not only water but electrolytes (body salts) such as sodium and potassium. the ionic sodium and potassium in glucolyte helps restore the natural electrolyte/water balance in the body and glucose gives energy to overcome fatigue. glucolyte is indicated in all cases of fluid loss. vomiting, diarrhoea, high temperature and other times when excessive perspiration brings about dehydration,,a glucose /electrolyte powder for the treatment of dehydration due to diarrhoea, vomiting and other illnesses, vigorous exercise or heat exhaustion.