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

orion laboratories pty ltd t/a perrigo australia - chloral hydrate, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: sucrose; citric acid; sodium citrate dihydrate; saccharin sodium; glycerol; methyl hydroxybenzoate; ethanol; propylene glycol; purified water; flavour - indications as at 19 september 2003: chloral hydrate mixture is indicated pre-operatively to produce sedation. it is also indicated for short term (not more than 2 weeks) use as a hypnotic to assist in sleep disorders.

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

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: dl-alpha-tocopherol; ethanol; corn glycerides; propylene glycol; peg-40 hydrogenated castor oil - as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. for induction and/or maintenance of remission in the nephrotic syndrome. cyclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cystostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see warnings). for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life. additional indication from 11 june 1997: for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.

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

link medical products pty ltd t/a link pharmaceuticals - mercaptopurine monohydrate, quantity: 20 mg/ml - oral liquid, suspension - excipient ingredients: xanthan gum; aspartame; rubus idaeus; sodium methyl hydroxybenzoate; sodium ethyl hydroxybenzoate; potassium sorbate; sodium hydroxide; purified water - allmercap oral liquid suspension is indicated for: treatment of acute lymphoblastic leukaemia (all) in paediatric patients.

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis. see section 5.1 pharmacodynamic properties - clinical trials.

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

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

pharmaco australia ltd - clonazepam, quantity: 2.5 mg/ml - oral liquid, solution - excipient ingredients: saccharin sodium; propylene glycol; brilliant blue fcf; glacial acetic acid; flavour - tablets. most types of epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic-clonic fits, whether due to primary generalised epilepsy, or to secondary generalisation of partial epilepsy. in adults all varieties of generalised epilepsy, (including myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial epilepsy (including psychomotor seizures). injection. intravenous use for status epilepticus only. note. efficacy by the intramuscular route has not need demonstrated.

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

aft pharmaceuticals pty ltd - phenoxymethylpenicillin potassium, quantity: 56.568 mg/ml (equivalent: phenoxymethylpenicillin, qty 50 mg/ml) - oral liquid, powder for - excipient ingredients: sucrose; sodium benzoate; saccharin sodium; flavour; colour - when oral therapy is required in the treatment of mild to moderately severe infections due to penicillin sensitive organisms such as penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. for prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or sydenham's chorea. for the prevention of bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.

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

aft pharmaceuticals pty ltd - phenoxymethylpenicillin potassium, quantity: 28.284 mg/ml (equivalent: phenoxymethylpenicillin, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: sucrose; sodium benzoate; saccharin sodium; colour; flavour - when oral therapy is required in the treatment of mild to moderately severe infections due to penicillin sensitive organisms such as penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. for prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or sydenham's chorea. for the prevention of bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.

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

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - dextromethorphan hydrobromide monohydrate, quantity: 2 mg/ml - oral liquid - excipient ingredients: propylene glycol; purified water; maltitol solution; methyl hydroxybenzoate; saccharin sodium; flavour; fragrance (perfume) - cough suppressant