Australija - anglų - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - cefaclor monohydrate, quantity: 26.22 mg/ml (equivalent: cefaclor, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: methylcellulose; sodium lauryl sulfate; dimeticone 350; xanthan gum; erythrosine; sucrose; pregelatinised starch; flavour - keflor is indicated for the treatment of the following types of infections caused by or likely to be caused susceptible organisms: lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. upper respiratory infections, including pharyngitis, tonsillitis and otitis media. skin and skin structure infections. urinary tract infections, including pyelonephritis and cystitis. note: 1. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. keflor appears to be effective as phenoxymethul penicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. 2. appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organisms to cefaclor.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - amoxicillin trihydrate, quantity: 50 mg/ml - oral liquid, powder for - excipient ingredients: colloidal anhydrous silica; silicon dioxide; disodium edetate; sodium benzoate; xanthan gum; saccharin sodium; sorbitol; flavour - indications as at 6 november 2003: cilamox is indicated for the treatment of infections due to susceptible strains of the sensitive organisms. gram-negative: h. influenzae, e coli, pr. mirabilis, and n. gonorrhoeae. gram-positive: streptococcus species, s. pneumoniae, non-penicllinase producing staphlococci and bacillus anthracis. note 1: cilamox may be useful in instituting therapy prior to bacteriology; however, bacteriological studies to determine the causative organisms and their sensitivity to cilamox should be performed. note 2: penicillins are now generally regarded only as adjunctive to some other established first-line antibiotic therapy in the treatment and post-exposure prophylaxis of anthrax, because of concerns of constitutive and inducible beta-lactamase in bacillus anthracis. if use of amoxycillin is contemplated, appropriate bacteriological studies must be performed by a reliable and established test method. amoxycillin may then be suitable if the specific b. anthracis strain has been shown definitively to be sensitive to penicillin/amaxycillin.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

boucher & muir pty ltd - risperidone, quantity: 1 mg/ml - oral liquid, solution - excipient ingredients: tartaric acid; benzoic acid; purified water; hydrochloric acid - rixadone is indicated for the treatment of schizophrenia and related psychoses.,rixadone is indicated for the short-term treatment of acute mania associated with bipolar 1 disorder.,rixadone is indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type.,rixadone is indicated in the treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent.,rixadone is indicated for the treatment of behavioural disorders associated with autism in children and adolescents.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - sodium valproate, quantity: 40 mg/ml - oral liquid - excipient ingredients: purified water; sorbitol solution (70 per cent) (non-crystallising); sodium methyl hydroxybenzoate; citric acid; brilliant scarlet 4r; hyetellose; sodium propyl hydroxybenzoate; saccharin sodium; flavour - epilepsy: primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic-clonic grand mal seizures). partial (focal) epilepsy either alone or as adjuvant therapy. mania: for the treatment of mania where other therapy has proved inadequate or is inappropriate

Australija - anglų - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - brivaracetam, quantity: 10 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate dihydrate; purified water; methyl hydroxybenzoate; citric acid; glycerol; carmellose sodium; sorbitol solution (70 per cent) (crystallising); sucralose; flavour - briviact oral solution is indicated as add-on therapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 4 years of age with epilepsy

Australija - anglų - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - levetiracetam, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: acesulfame potassium; purified water; maltitol solution; methyl hydroxybenzoate; ammonium glycyrrhizinate; citric acid monohydrate; propyl hydroxybenzoate; sodium citrate dihydrate; glycerol; flavour - keppra (film coated tablets and 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 generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige). keppra concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - amisulpride, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: methyl hydroxybenzoate; hydrochloric acid; propyl hydroxybenzoate; purified water; potassium sorbate; saccharin sodium; gluconolactone; sodium gluconate; flavour - amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - naproxen, quantity: 25 mg/ml - oral liquid, suspension - excipient ingredients: sorbitol solution (70 per cent) (crystallising); aluminium magnesium silicate; purified water; sucrose; sodium chloride; fumaric acid; methyl hydroxybenzoate; sunset yellow fcf; sodium hydroxide; flavour - treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, for the symptomatic treatment of primary dysmenorrhoea, for the relief of acute and/or chronic pain states in which there is an inflammatory component and as an analgesic in acute migraine attack.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - amoxicillin trihydrate, quantity: 25 mg/ml - oral liquid, powder for - excipient ingredients: colloidal anhydrous silica; silicon dioxide; disodium edetate; sodium benzoate; xanthan gum; saccharin sodium; sorbitol; flavour - indications as at 6 november 2003: cilamox is indicated for the treatment of infections due to susceptible strains of the sensitive organisms. gram-negative: h. influenzae, e coli, pr. mirabilis, and n. gonorrhoeae. gram-positive: streptococcus species, s. pneumoniae, non-penicllinase producing staphlococci and bacillus anthracis. note 1: cilamox may be useful in instituting therapy prior to bacteriology; however, bacteriological studies to determine the causative organisms and their sensitivity to cilamox should be performed. note 2: penicillins are now generally regarded only as adjunctive to some other established first-line antibiotic therapy in the treatment and post-exposure prophylaxis of anthrax, because of concerns of constitutive and inducible beta-lactamase in bacillus anthracis. if use of amoxycillin is contemplated, appropriate bacteriological studies must be performed by a reliable and established test method. amoxycillin may then be suitable if the specific b. anthracis strain has been shown definitively to be sensitive to penicillin/amaxycillin.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - rotavirus g2 human-bovine reassortant, quantity: 1400000 infectious unit/ml; rotavirus g3 human-bovine reassortant, quantity: 1100000 infectious unit/ml; rotavirus g1 human-bovine reassortant, quantity: 1100000 infectious unit/ml; rotavirus g4 human-bovine reassortant, quantity: 1000000 infectious unit/ml; rotavirus p1 [8] human-bovine reassortant, quantity: 1150000 infectious unit/ml - oral liquid - excipient ingredients: polysorbate 80; sucrose; sodium citrate dihydrate; sodium hydroxide; monobasic sodium phosphate; glucose monohydrate; sodium ascorbate; sodium chloride; ammonium metavanadate; calcium chloride dihydrate; cupric sulfate pentahydrate; ferric nitrate nonahydrate; ferrous sulfate heptahydrate; magnesium chloride hexahydrate; dried magnesium sulfate; manganese sulfate tetrahydrate; ammonium molybdate; potassium chloride; sodium acetate; sodium bicarbonate; dibasic sodium phosphate; zinc sulfate heptahydrate; alanine; arginine hydrochloride; asparagine; aspartic acid; cysteine hydrochloride; cystine dihydrochloride; glutamic acid; glycine; histidine hydrochloride monohydrate; hydroxyproline; isoleucine; leucine; lysine hydrochloride; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine disodium; valine; biotin; ergocalciferol; choline chloride; folic acid; inositol; menadione; nicotinamide; nicotinic acid; aminobenzoic acid; calcium pantothenate; pyridoxal hydrochloride; pyridoxine hydrochloride; retinol acetate; riboflavine; dl-alpha-tocopheryl phosphate disodium; thiamine hydrochloride; cyanocobalamin; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine monophosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride; sodium hypoxanthine; linoleic acid; alpha lipoic acid; phenolsulfonphthalein; putrescine dihydrochloride; sodium pyruvate; ribose; thymidine; thymine; uracil; sodium xanthine; monoethanolamine; 2-mercaptoethanol; adenosine; uridine; cytidine; guanosine; dexamethasone; epidermal growth factor; hydrocortisone; insulin; alprostadil; liothyronine; ascorbic acid; magnesium sulfate heptahydrate; monobasic sodium phosphate monohydrate; zinc sulfate; arginine; cysteine; cystine; histidine; lysine; tyrosine; adenosine triphosphate; guanine; putrescine - rotateq is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).