אוסטרליה - אנגלית - 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.

אוסטרליה - אנגלית - 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.

אוסטרליה - אנגלית - 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.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - cannabidiol, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: sesame oil; sucralose; ethanol absolute; flavour - epidyolex is indicated for use as adjunctive therapy of seizures associated with lennox-gastaut syndrome (lgs) or dravet syndrome (ds) for patients 2 years of age and older.

אוסטרליה - אנגלית - 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

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - atenolol, quantity: 5 mg/ml - oral liquid, solution - excipient ingredients: propylene glycol; propyl hydroxybenzoate; saccharin sodium; purified water; citric acid monohydrate; sorbitol solution (70 per cent) (non-crystallising); sodium citrate dihydrate; methyl hydroxybenzoate; flavour - all grades of hypertension including hypertension of renal origin.,frequent disabling angina without evidence of cardiac failure,cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those with acute myocardial infarction),myocardial infarction - late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain)

אוסטרליה - אנגלית - 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

אוסטרליה - אנגלית - 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.

אוסטרליה - אנגלית - 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.

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

elanco gmbh - triclabendazole - oral suspension - 5 percent weight/volume - benzimidazoles and related substances - sheep - endoparasiticide