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

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - bromhexine hydrochloride, quantity: 0.8 mg/ml - oral liquid - excipient ingredients: benzoic acid; maltitol solution; menthol; purified water; sucralose; flavour - for use as a mucolytic to break down mucus and help clear the chest in conditions accompanied by excessive mucus secretions, such as in the common cold, influenza, infections of the respiratory tract or in other conditions where excess mucus is produced.

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

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - bromhexine hydrochloride, quantity: 1.6 mg/ml - oral liquid - excipient ingredients: menthol; purified water; benzoic acid; sucralose; maltitol solution; flavour - for use as a mucolytic to break down mucus and help clear the chest in conditions accompanied by excessive mucus secretions, such as in the common cold, influenza, infections of the respiratory tract or in other conditions where excess mucus is produced.

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

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

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - bromhexine hydrochloride, quantity: 0.8 mg/ml - oral liquid - excipient ingredients: maltitol solution; hyetellose; benzoic acid; sucralose; purified water; flavour - for use as a mucolytic to break down mucus and help clear the chest in conditions accompanied by excessive mucus secretions, such as in the common cold, influenza, infections of the respiratory tract or in other conditions where excess mucus is produced.

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

orion laboratories pty ltd t/a perrigo australia - diazepam, quantity: 1 mg/ml - oral liquid, solution - excipient ingredients: ethanol; propylene glycol; glycerol; citric acid; sodium citrate dihydrate; purified water; flavour - indications as at 30 september 2003: diazepam is indicated in the management of anxiety disorders and for the short term relief of the symptoms of anxiety. diazepam is a useful adjunct for the relief of reflux muscle spasm due to local trauma (injury, inflammation) to muscles, bones and joints. it is also indicated in the management of cerebral spasiticity due to upper motor neuron lesions such as cerebral palsy and paraplegia, and spasticity in athetosis and stiff man syndrome. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.

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

orion laboratories pty ltd t/a perrigo australia - phenobarbital, quantity: 3 mg/ml - oral liquid, solution - excipient ingredients: purified water; ethanol; glycerol; sorbitol; flavour - indications as at 16 january 2002: treatment of epilepsy.

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

seqirus pty ltd - tramadol hydrochloride, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: sucrose; propylene glycol; sodium cyclamate; saccharin sodium; purified water; glycerol; ethoxylated hydrogenated castor oil; mint oil dementholised; potassium sorbate; flavour - tramal oral drops are indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

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

pfizer australia pty ltd - sirolimus, quantity: 1 mg/ml - oral liquid, solution - excipient ingredients: polysorbate 80; propylene glycol; ethanol; ascorbyl palmitate; phosphatidyl choline; mono- and di- glycerides; soy fatty acids - indications as at 9 february 2004: rapamune is indicated for the prophylaxis of organ rejection in patients at mild to moderate immunological risk receiving renal transplants. therapeutic drug monitoring of sirolimus is required.