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 - 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)

janssen-cilag pty ltd - itraconazole, quantity: 10 mg/ml - oral liquid, solution - excipient ingredients: propylene glycol; hydroxypropylbetadex; saccharin sodium; purified water; caramel; sorbitol solution (70 per cent) (non-crystallising); sodium hydroxide; hydrochloric acid; flavour - sporanox oral solution is indicated for: * the treatment of oral and/or oesophageal candidiasis in hiv-positive or other immunocompromised patients. * prophylaxis of fungal infections in neutropenic patients.

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)

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)

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)

seqirus pty ltd - vibrio cholerae, quantity: 31.25 billion organisms; vibrio cholerae, quantity: 1 mg - oral liquid, suspension - excipient ingredients: sodium chloride; dibasic sodium phosphate dihydrate; water for injections; monobasic sodium phosphate dihydrate - cholera caused by serogroup 01 vibrio cholerae: active immunisation of adults and children from two years of age, who will be visiting areas epidemic or endemic for cholera and who are at high risk of infection.

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)

aspen pharmacare australia pty ltd - amoxicillin trihydrate, quantity: 57.4 mg/ml - oral liquid, powder for - excipient ingredients: silicon dioxide; sorbitol; saccharin sodium; colloidal anhydrous silica; sodium benzoate; xanthan gum; disodium edetate; flavour - it is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: note therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. skin and skin structure: staphylococcus, non-penicillinase producing; streptococcus; e.coli (see microbiology). respiratory (acute and chronic): h.influenzae, streptococcus; s.pneumoniae; staphylococcus, non-penicillinase-producing; e.coli (see microbiology). genitourinary tract (complicated and uncomplicated, acute and chronic): e.coli (see microbiology), p.mirabilis and s.faecalis. gonorrhoea: n.gonorrhoeae (non-penicillinase producing). prophylaxis of endocarditis: amoxil may be used for the prophylaxis

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

aspen pharmacare australia pty ltd - amoxicillin trihydrate, quantity: 28.7 mg/ml - oral liquid, powder for - excipient ingredients: colloidal anhydrous silica; disodium edetate; xanthan gum; saccharin sodium; sodium benzoate; sorbitol; silicon dioxide; flavour - it is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: note therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. skin and skin structure: staphylococcus, non-penicillinase producing; streptococcus; e.coli (see microbiology). respiratory (acute and chronic): h.influenzae, streptococcus; s.pneumoniae; staphylococcus, non-penicillinase-producing; e.coli (see microbiology). genitourinary tract (complicated and uncomplicated, acute and chronic): e.coli (see microbiology), p.mirabilis and s.faecalis. gonorrhoea: n.gonorrhoeae (non-penicillinase producing). prophylaxis of endocarditis: amoxil may be used for the prophylaxis