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

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - fexofenadine hydrochloride, quantity: 6 mg/ml - oral liquid, suspension - excipient ingredients: xanthan gum; butyl hydroxybenzoate; propyl hydroxybenzoate; titanium dioxide; disodium edetate; purified water; monobasic sodium phosphate monohydrate; poloxamer; xylitol; propylene glycol; dibasic sodium phosphate heptahydrate; sucrose; flavour - relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age. relief of symptoms associated with urticaria in adults and children from 6 months of age.

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)

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)

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)

aspen pharmacare australia pty ltd - prednisolone sodium phosphate, quantity: 6.72 mg/ml (equivalent: prednisolone, qty 5 mg/ml) - oral liquid, solution - excipient ingredients: disodium edetate; dibasic sodium phosphate; propyl hydroxybenzoate; sorbitol solution (70 per cent) (non-crystallising); methyl hydroxybenzoate; purified water; monobasic sodium phosphate; flavour - wherever corticosteroid therapy is indicated.

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.

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 - 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.

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

viatris pty ltd - cefaclor monohydrate, quantity: 26.22 mg/ml (equivalent: cefaclor, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: methylcellulose; sodium lauryl sulfate; dimeticone 350; xanthan gum; erythrosine; sucrose; pregelatinised starch; 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.