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)

aspen pharmacare australia pty ltd - ondansetron hydrochloride dihydrate, quantity: 1 mg/ml (equivalent: ondansetron, qty 0.8 mg/ml) - oral liquid, solution - excipient ingredients: citric acid; sodium citrate dihydrate; sodium benzoate; sorbitol solution (70 per cent) (crystallising); purified water; flavour - ondansetron (tablets, syrup and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy. ondansetron (injection) is also indicated for the prevention and treatment of post-operative nausea and vomiting.

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)

aspen pharmacare australia pty ltd - atovaquone, quantity: 150 mg/ml - oral liquid, suspension - excipient ingredients: poloxamer; saccharin sodium; benzyl alcohol; purified water; xanthan gum; flavour - wellvone suspension is indicated for: acute treatment of mild to moderate pneumocystis carinii pneumonia (pcp) (difference of alveolar and arterial oxygen tensions [(a-a)do2]<=45mmhg(6kpa) and oxygen tension in arterial blood (pa02)>=60mmhg(8kpa) breathing room air) in adult patients with aids who are intolerant of trimethoprim/sulphamethoxazole therapy.

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

aft pharmaceuticals pty ltd - pregabalin, quantity: 20 mg/ml - oral liquid, solution - excipient ingredients: sucralose; monobasic sodium phosphate monohydrate; purified water; methyl hydroxybenzoate; dibasic sodium phosphate; flavour - pregabalin-aft is indicated for the treatment of neuropathic pain in adults.,pregabalin-aft is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

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

australian nuclear science and technology organisation t/a ansto - sodium iodide(131i), quantity: 1201 mbq - oral liquid, solution - excipient ingredients: sodium bicarbonate; sodium thiosulfate pentahydrate; water for injections - .

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

australian nuclear science and technology organisation t/a ansto - sodium iodide(131i), quantity: 50 mbq - oral liquid, solution - excipient ingredients: sodium thiosulfate pentahydrate; water for injections; sodium bicarbonate - sodium iodide (131i) solution bp (for therapy) is indicated in the treatment of hyperthyroidism's and the detection and ablation of residual functioning thyroid tissue in differentiated thyroid carcinoma

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)

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.