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

alphapharm pty ltd - lactulose solution, quantity: 1 ml/ml (equivalent: lactulose, qty 660 mg/ml) - oral liquid, solution - excipient ingredients: - for the treatment of acute, and the prevention and treatment of chronic portal-systemic encephalopathy, including the stages of hepatic precoma and coma. for the treatment of chronic and habitual constipation.

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)

aspen pharmacare australia pty ltd - prednisolone sodium phosphate, quantity: 6.72 mg/ml (equivalent: prednisolone, qty 5 mg/ml) - oral liquid, solution - excipient ingredients: propylene glycol; dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate; disodium edetate; methyl hydroxybenzoate; propyl hydroxybenzoate; purified water - whenever corticosteroid therapy is indicated.

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

biomed aust pty ltd - methadone hydrochloride, quantity: 5 mg/ml - oral liquid, solution - excipient ingredients: water for injections; colour - biodone forte is indicated for the detoxification and maintenance treatment of dependence on opioid drugs.

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)

aspen pharma pty ltd - methadone hydrochloride, quantity: 5 mg/ml - oral liquid, solution - excipient ingredients: glycerol; sodium benzoate; purified water; sorbitol solution (70 per cent) (non-crystallising); ethanol; sunset yellow fcf; flavour - methadone syrup is indicated for the treatment of dependence on opioid drugs.,methadone syrup is indicated for the management of severe pain where: (i) other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and (ii) the pain is opioid-responsive, and (iii) requires daily, continuous, long-term treatment.,methadone syrup is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,methadone syrup is not indicated as an as-needed (prn) analgesia.,methadone syrup is not recommended for use in ambulant patients.

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

eli lilly australia pty ltd - fluoxetine hydrochloride, quantity: 4.47 mg/ml (equivalent: fluoxetine, qty 4 mg/ml) - oral liquid - excipient ingredients: glycerol; purified water; benzoic acid; sucrose; flavour - the treatment of major depressive disorders as defined in the approved product information. the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd), as defined in the dsm-iii-r; ie. the obsessions and compulsions cause marked distress, are time consuming, or significantly interfere with social or occupational functioning. indications as at 6 june 2000: for the treatment of: major depression. obsessive compulsive disorders. premenstrual dysphoric disorder (pmdd) as defined by dsm-iv criteria. the essential features of pmdd, according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating a

Australia - English - 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.

Australia - English - 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.