Australia - English - 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

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)

arrotex pharmaceuticals pty ltd - posaconazole, quantity: 40 mg/ml - oral liquid, suspension - excipient ingredients: sodium benzoate; sodium citrate dihydrate; citric acid monohydrate; titanium dioxide; glycerol; xanthan gum; liquid glucose; peg-40 hydrogenated castor oil; purified water; peg-40 stearate; benzoic acid; glyceryl monostearate; methylcellulose; polysorbate 65; simethicone; sorbic acid; sulfuric acid; flavour - posaconazole is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,posaconazole is also indicated for the: ? treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole. ? prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

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

novartis pharmaceuticals australia pty ltd - oxcarbazepine, quantity: 60 mg/ml - oral liquid, suspension - excipient ingredients: saccharin sodium; propylene glycol; purified water; methyl hydroxybenzoate; sorbitol solution (70 per cent) (non-crystallising); peg-8 stearate; sorbic acid; propyl hydroxybenzoate; ascorbic acid; dispersible cellulose; fragrance (perfume) - for use as monotherapy or adjunctive therapy for the treatment of partial seizures and generalised tonic-clonic seizures, in adults and children.

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

arrotex pharmaceuticals pty ltd - codeine phosphate hemihydrate, quantity: 5 mg/ml - oral liquid, solution - excipient ingredients: glycerol; propylene glycol; sucrose; purified water; potassium sorbate; hydrochloric acid; sodium hydroxide; propyl hydroxybenzoate; methyl hydroxybenzoate; ethyl hydroxybenzoate; butyl hydroxybenzoate; isobutyl hydroxybenzoate - relief of unproductive, dry and intractable coughs associated with colds and flu.

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

aspen pharmacare australia pty ltd - haloperidol, quantity: 2 mg/ml - oral liquid, solution - excipient ingredients: methyl hydroxybenzoate; purified water; propyl hydroxybenzoate; lactic acid - chronic therapy: the management of manifestations of psychotic disorders such as schizophrenia, psychosis due to organic brain damage or mental deficiency, the manic phase of manic depressive illness, gilles de la tourette syndrome. short term therapy: the treatment of acute alcoholism for the relief of delusions, hallucinations and confused states, and for the control of accompanying tremulousness and aggressive behaviour. in the treatment of intractable nausea and vomiting associated with radiation or malignancy and not responding to other therapy. neuroleptanalgesia

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

viatris pty ltd - cefaclor monohydrate, quantity: 26.86 mg/ml (equivalent: cefaclor, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: methylcellulose; sodium lauryl sulfate; dimeticone 350; xanthan gum; tapioca starch; erythrosine; sucrose; flavour - aclor is indicated for the treatment of the following types of infections caused by or likely to be caused by susceptible organisms: lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. upper respiratory tract 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. aclor appears to be as effective as phenoxymethyl penicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of aclor 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 organism to cefaclor.

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

alphapharm pty ltd - erythromycin ethyl succinate, quantity: 468 mg (equivalent: erythromycin, qty 400 mg) - oral liquid, powder for - excipient ingredients: sorbitol; propylene glycol alginate; sodium citrate dihydrate; erythrosine; aspartame; sodium benzoate; colloidal anhydrous silica; flavour - streptococcus pyogenes (group a beta-haemolytic streptococcus). upper and lower respiratory tract, skin and skin structure infections of mild to moderate severity. when oral medication is given, patient must comply with the prescribed regimen. therapeutic dose should be administered for at least 10 days. alpha haemolytic streptococci (viridans group). no controlled clinical efficacy trials have been conducted, however oral erythromycin has been suggested by the american heart association and the american dental association for use in bacterial endocarditis prophylaxis prior to dental/surgical procedures of the upper respiratory tract in penicillin-hypersensitive patients with a history of rheumatic, congenital or other acquired valvular heart disease. erythromycin is unsuitable prior to genitourinary or gastrointestinal tract surgery. staphylococcus aureus. acute infections of skin and skin structure of mild to moderate severity. bacterial resistance may emerge during treatment, hence cultures and sensitivity

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

alphapharm pty ltd - erythromycin ethyl succinate, quantity: 234 mg (equivalent: erythromycin, qty 200 mg) - oral liquid, powder for - excipient ingredients: sorbitol; propylene glycol alginate; sodium citrate dihydrate; erythrosine; aspartame; sodium benzoate; colloidal anhydrous silica; flavour - streptococcus pyogenes (group a beta-haemolytic streptococcus). upper and lower respiratory tract, skin and skin structure infections of mild to moderate severity. when oral medication is given, patient must comply with the prescribed regimen. therapeutic dose should be administered for at least 10 days. alpha haemolytic streptococci (viridans group). no controlled clinical efficacy trials have been conducted, however oral erythromycin has been suggested by the american heart association and the american dental association for use in bacterial endocarditis prophylaxis prior to dental/surgical procedures of the upper respiratory tract in penicillin-hypersensitive patients with a history of rheumatic, congenital or other acquired valvular heart disease. erythromycin is unsuitable prior to genitourinary or gastrointestinal tract surgery. staphylococcus aureus. acute infections of skin and skin structure of mild to moderate severity. bacterial resistance may emerge during treatment, hence cultures and sensitivity

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - trifluoperazine hydrochloride - oral tablet - 1mg