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)

arrotex pharmaceuticals pty ltd - nifedipine, quantity: 60 mg - tablet, modified release - excipient ingredients: povidone; carbomer 934p; colloidal anhydrous silica; purified talc; magnesium stearate; macrogol 4000; lactose monohydrate; iron oxide red; hypromellose; titanium dioxide; basic butylated methacrylate copolymer - treatment of hypertension. prophylaxis of chronic stable angina pectoris.

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

avallon pharmaceuticals pty ltd - clarithromycin, quantity: 250 mg - tablet, film coated - excipient ingredients: titanium dioxide; powdered cellulose; magnesium stearate; hypromellose; macrogol 4000; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate - noumed clarithromycin 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: acute streptococcal pharyngitis; community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophilia and streptococcus pneumoniae;uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes;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 anti mycobacterial agents.prevention of disseminated mycobacterium avium complex infection in hiv infected adults with cd4 lymphocyte counts <75 cells/mm 3 (see precautions). disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae;combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. noumed clarithromycin 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:acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes; community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila; skin and skin structure infections (eg impetigo); disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. 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 clarithromycin 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 - roxithromycin, quantity: 150 mg - tablet, film coated - excipient ingredients: hypromellose; colloidal anhydrous silica; glucose; magnesium stearate; purified talc; povidone; titanium dioxide; maize starch; propylene glycol; hyprolose - adults: roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible microorganisms: upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. lower respiratory tract infection: acute bronchitis and acute exacerbation of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. nongonococcal urethritis. children: roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis. acute tonsillitis. impetigo. appropriate culture and susceptibility tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

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

arrotex pharmaceuticals pty ltd - roxithromycin, quantity: 300 mg - tablet, film coated - excipient ingredients: glucose; propylene glycol; colloidal anhydrous silica; hyprolose; maize starch; povidone; hypromellose; magnesium stearate; titanium dioxide; purified talc - adults: roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible microorganisms: upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. lower respiratory tract infection: acute bronchitis and acute exacerbation of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. nongonococcal urethritis. children: roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis. acute tonsillitis. impetigo. appropriate culture and susceptibility tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 800 mg - tablet, film coated - excipient ingredients: silicified microcrystalline cellulose; macrogol 4000; sodium chloride; iron oxide red; purified talc; titanium dioxide; hyprolose; crospovidone; polacrilin potassium; magnesium stearate; colloidal anhydrous silica; polyvinyl alcohol - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 600 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; purified talc; polyvinyl alcohol; hyprolose; polacrilin potassium; macrogol 4000; sodium chloride; titanium dioxide; iron oxide red; silicified microcrystalline cellulose; colloidal anhydrous silica; iron oxide yellow - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 400 mg - tablet, film coated - excipient ingredients: sodium chloride; hyprolose; macrogol 4000; titanium dioxide; crospovidone; polacrilin potassium; iron oxide red; colloidal anhydrous silica; iron oxide yellow; purified talc; silicified microcrystalline cellulose; polyvinyl alcohol; magnesium stearate - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

arrotex pharmaceuticals pty ltd - amitriptyline hydrochloride, quantity: 50 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; croscarmellose sodium; colloidal anhydrous silica; purified talc; magnesium stearate; macrogol 6000; hypromellose; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - for the treatment of major depression. entrip 50mg tablets are indicated only for the maintenance treatment of major depression (see precautions). nocturnal enuresis where organic pathology has been excluded.