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

southern xp ip pty ltd - diclofenac potassium, quantity: 50 mg - oral liquid, powder for - excipient ingredients: potassium bicarbonate; saccharin sodium; mannitol; aspartame; glyceryl behenate; flavour - as short-term treatment (up to one week) for the relief of acute pain states in which there is an inflammatory component. treatment of acute migraine attacks (with or without aura). symptomatic treatment of primary dysmenorrhoea.

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

pfizer australia pty ltd - fluconazole, quantity: 10 mg/ml - oral liquid, powder for - excipient ingredients: sucrose; citric acid; sodium citrate dihydrate; sodium benzoate; xanthan gum; colloidal anhydrous silica; titanium dioxide; flavour - indications as at 21 may 2004 : diflucan, given orally, is indicated for: 1. treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note : data suggest that the clinical efficacy of diflucan is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. 2. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. 3. treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. 4. secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. 5. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note : it remains to be shown that diflucan is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. 6. vaginal candidiasis when topical therapy has failed. 7. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks (see adverse reactions). diflucan iv is indicated for the same conditions in adults and children but should be used only when diflucan cannot be administered orally.

Australia - Kiingereza - 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

Australia - Kiingereza - 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 - Kiingereza - 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.

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - voriconazole - powder for oral suspension - 40 milligram(s)/millilitre - triazole derivatives; voriconazole