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

pfizer australia pty ltd - clozapine, quantity: 50 mg/ml - oral liquid, suspension - excipient ingredients: povidone; sodium propyl hydroxybenzoate; purified water; sodium methyl hydroxybenzoate; xanthan gum; glycerol; monobasic sodium phosphate dihydrate; sodium hydroxide; hydrochloric acid; sorbitol solution (70 per cent) (crystallising) - treatment with clopine is indicated only in people with treatment-resistant schizophrenia, ie. people with schizophrenia who are non-responsive to, or intolerant of other antipsychotic drugs. non-responsiveness is defined as lack of satisfactory clinical improvement despite the use of adequate doses of at least two classes of marketed antipsychotic drugs prescribed for reasonable durations. intolerance is defined as the impossibility to achieve adequate benefit with other antipsychotic drugs because of severe and untreatable neurological adverse reactions (extrapyramidal side effects or tardive dyskinesia).

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

care pharmaceuticals pty ltd - paracetamol, quantity: 24 mg/ml; codeine phosphate hemihydrate, quantity: 1 mg/ml - oral liquid - excipient ingredients: macrogol 400; purified water; saccharin sodium; methyl hydroxybenzoate; glycerol; citric acid monohydrate; sodium citrate dihydrate; propyl hydroxybenzoate; sodium chloride; flavour - for the temporary relief of acute moderate pain when paracetamol alone is not sufficient in patients over the age of 12 years (see also contraindications and paediatric use).

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

janssen-cilag pty ltd - risperidone, quantity: 1 mg/ml - oral liquid, solution - excipient ingredients: purified water; benzoic acid; tartaric acid; sodium hydroxide - risperdal is indicated for the treatment of schizophrenia and related psychoses. risperdal is indicated for the short term treatment of acute mania associated with bipolar 1 disorder. risperdal is also indicated for the treatment of behavioural disturbances in dementia. risperdal 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 (see clinical trials for maintenance data). risperdal is indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see clinical trials).

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

viatris pty ltd - phenytoin, quantity: 6 mg/ml - oral liquid, suspension - excipient ingredients: sodium benzoate; polysorbate 40; citric acid monohydrate; glycerol; purified water; carmellose sodium; ethanol; vanillin; carmoisine; sucrose; sunset yellow fcf; aluminium magnesium silicate; flavour - dilantin is indicated for the control of grand mal and psychomotor seizures. dilantin will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, dilantin frequently improves the mental condition and outlook of epileptic patients and there is also increasing evidence that dilantin is valuable in the prevention of seizures occurring during or after neurosurgery and in the treatment of certain cardiac arrythmias. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administration).

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

novartis pharmaceuticals australia pty ltd - carbamazepine, quantity: 20 mg/ml - oral liquid, suspension - excipient ingredients: hyetellose; methyl hydroxybenzoate; purified water; dispersible cellulose; propyl hydroxybenzoate; sorbitol solution (70 per cent) (non-crystallising); peg-8 stearate; sorbic acid; propylene glycol; saccharin sodium; flavour - 1. epilepsy: complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalisation; generalised tonic-clonic seizures; mixed seizure patterns incorporating the above. tegretol is suitable for monotherapy and combination therapy. tegretol is usually not effective in absence seizures, atonic seizures and myoclonic seizures and should not be used for status epilepticus (see "precautions"). 2. trigeminal neuralgia: for relief of pain in idiopathic trigeminal neuralgia and trigeminal neuralgia due to multiple sclerosis; and in idiopathic glossopharyngeal neuralgia. (tegretol is not a simple analgesic and is not intended for trivial facial pain or headache). 3. mania and bipolar affective disorders: treatment of mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrence.

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

sun pharma anz pty ltd - cefaclor monohydrate, quantity: 52.45 mg/ml (equivalent: cefaclor, qty 50 mg/ml) - oral liquid, powder for - excipient ingredients: citric acid; colloidal anhydrous silica; xanthan gum; sucrose; sodium benzoate; allura red ac; sodium citrate dihydrate; flavour; potable water; simethicone; cetostearyl alcohol - infections due to susceptible microorganisms. lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. upper respiratory tract infections, including pharyngitis and tonsillitis and otitis media. skin and skin structure infections. urinary tract infections, including pyelonephritis and cystitis. note: penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefaclor appears to be as effective as phenoxymethylpenicillin 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. appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.

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

sun pharma anz pty ltd - cefaclor monohydrate, quantity: 26.23 mg/ml (equivalent: cefaclor, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: citric acid; xanthan gum; sucrose; sodium citrate dihydrate; colloidal anhydrous silica; sodium benzoate; allura red ac; flavour; potable water; simethicone; cetostearyl alcohol - infections due to susceptible microorganisms. lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. upper respiratory tract infections, including pharyngitis and tonsillitis and otitis media. skin and skin structure infections. urinary tract infections, including pyelonephritis and cystitis. note: penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefaclor appears to be as effective as phenoxymethylpenicillin 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. appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.

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

glaxosmithkline australia pty ltd - salbutamol sulfate, quantity: 0.48 mg/ml (equivalent: salbutamol, qty 0.4 mg/ml) - oral liquid - excipient ingredients: sodium benzoate; hypromellose; citric acid monohydrate; sodium chloride; purified water; sodium citrate dihydrate; saccharin sodium; flavour - indications as at 14 february 2005: ventolin is indicated for the prevention and relief of bronchospasm in bronchial asthma of all types and for the alleviation of any reversible airways obstruction associated with conditions such as chronic bronchitis or emphysema.

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

arrotex pharmaceuticals pty ltd - captopril, quantity: 5 mg/ml - oral liquid, solution - excipient ingredients: sodium benzoate; hydrochloric acid; sodium hydroxide; sodium citrate dihydrate; disodium edetate; purified water; citric acid - 1.hypertension: capoten (captopril) is indicated for the treatment of hypertension. in using capoten, consideration should be given to the risk of neutropenia/agranulocytosis (see precautions). capoten is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of captopril and thiazides are approximately additive. 2. myocardial infarction: capoten is indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction less than or equal to 40%, and to reduce the incidence of overt heart failure and subsequent hospitalisations for congestive heart failure in these patients. the efficacy data for the use of captopril following myocardial infarction are strongest for initiation of therapy beyond 3 days post-infarct. 3. heart failure: capoten (captopril) is indicated for the treatment of heart failure. in symptomatic patients it is recommended that capoten be administered together with a diuretic. 4. diabetic nephropathy: capoten is indicated for the treatment of diabetic nephropathy in patients with type 1 insulin- dependent diabetes mellitus.

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

alphapharm pty ltd - cefaclor monohydrate, quantity: 52.45 mg/ml (equivalent: cefaclor, qty 50 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.