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)

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)

viatris pty ltd - clarithromycin, quantity: 50 mg/ml - oral liquid, powder for - excipient ingredients: potassium sorbate; castor oil; titanium dioxide; hypromellose phthalate; maltodextrin; carbomer 934; citric acid; silicon dioxide; xanthan gum; sucrose; povidone; flavour - klacid (clarithromycin) is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. acute streptococcal pharyngitis; 2. community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophila and streptococcus pneumoniae; 3. uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes; 4. disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare and skin and skin structure infections due to mycobacterium chelonae. clarithromycin should be used in combination with other antimycobacterial agents. 5. prevention of disseminated mycobacterium avium complex infection in hiv-infected adults with cd4 lymphocyte counts of < 75 cells/cubic mm. (see precautions) disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis. 6. acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae; 7. combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. klacid (clarithromycin) is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes; 2. community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila; 3. skin and skin structure infections (eg impetigo); 4. disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. 5. acute otitis media. note: 1. penicillins are the drug of first choice in the treatment of acute otitis media. 2. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. there is insufficient evidence of efficacy to support the use of klacid in acute bronchitis in young children. 4. the data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

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; methyl hydroxybenzoate; propyl 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)

inova pharmaceuticals (australia) pty ltd - codeine phosphate hemihydrate, quantity: 5 mg/ml - oral liquid - excipient ingredients: glycerol; propylene glycol; purified water; sucrose; methyl hydroxybenzoate - relief of unproductive, dry and intractable coughs associated with colds and flu relief of unproductive, dry and intractable coughs associated with colds and flu.

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

viatris pty ltd - phenoxymethylpenicillin benzathine, quantity: 40.27 mg/ml (equivalent: phenoxymethylpenicillin, qty 30 mg/ml) - oral liquid, suspension - excipient ingredients: sodium propyl hydroxybenzoate; sodium methyl hydroxybenzoate; butylated hydroxyanisole; polysorbate 80; xanthan gum; sucrose; purified water; sodium citrate dihydrate; potassium sorbate; citric acid; flavour - treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. for prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or sydenham's chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. note: oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.

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

boehringer ingelheim pty ltd - nevirapine hemihydrate, quantity: 10.35 mg/ml (equivalent: nevirapine, qty 10 mg/ml) - oral liquid, suspension - excipient ingredients: purified water; sorbitol solution (70 per cent) (non-crystallising); propyl hydroxybenzoate; sodium hydroxide; carbomer 934p; polysorbate 80; sucrose; methyl hydroxybenzoate - viramune (nevirapine) oral suspension in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of 2 months. viramune xr (nevirapine) extended-release tablets in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of three years. extended-release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used. resistant virus emerges rapidly when viramune is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, viramune should always be administered in combination with at least two additional antiretroviral agents.

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

sanofi-aventis australia pty ltd - metronidazole benzoate, quantity: 64 mg/ml - oral liquid, suspension - excipient ingredients: ethanol; monobasic sodium phosphate; aluminium magnesium silicate; methyl hydroxybenzoate; sucrose; propyl hydroxybenzoate; orange oil terpeneless; flavour - anaerobic infections treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly bacteroides fragilis and other species of bacteroides, and other species such as fusobacteria, eubacteria, clostridia and anaerobic streptococci. flagyl has been used successfully in septicaemia; bacteraemia; brain abscess; necrotising pneumonia; osteomyelitis; puerperal sepsis; pelvic abscess; pelvic cellulitis; postoperative wound infections. notes. 1. because of the slow absorption and delayed peak plasma level, flagyl suspension is not recommended for use in the acute situation. 2. metronidazole is inactive against aerobic and facultative anaerobic bacteria. other indications oral treatment of urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male, and for the treatment of bacterial vaginosis. the male consort of females suffering from urogenital trichomoniasis should be treated concurrently; all forms of amoebiasis( intestinal and extraintestin

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

viatris pty ltd - cefaclor monohydrate, quantity: 53.72 mg/ml (equivalent: cefaclor, qty 50 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)

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 - ceclor 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. ceclor appears to be as effective as phenoxymethyl penicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of ceclor 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.