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

alphapharm pty ltd - hydrochlorothiazide, quantity: 12.5 mg; candesartan cilexetil, quantity: 32 mg - tablet - excipient ingredients: carmellose calcium; hyprolose; maize starch; glyceryl monostearate; lactose monohydrate; magnesium stearate; iron oxide yellow - the treatment of hypertension. treatment should not be initiated with these fixed dose combinations.

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

alphapharm pty ltd - mycophenolate mofetil, quantity: 250 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; microcrystalline cellulose; croscarmellose sodium; sodium lauryl sulfate; silicon dioxide; magnesium stearate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; indigo carmine; iron oxide yellow; sorbitan monolaurate; iron oxide red; potable water; gelatin - ceptolate (mycophenolate mofetil) is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. ceptolate (mycophenolate mofetil) is indicated for the prophylaxis of organ rejection in paediatric patients with a body surface area of greater than or equal to 1.25 square metres, receiving allogeneic renal transplants.

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

southern cross pharma pty ltd - leflunomide, quantity: 20 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; maize starch; povidone; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000 - treatment of active rheumatoid arthritis.,treatment of active psoriatic arthritis. leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. the combined use of leflunomide with other disease modifying antirheumatic drugs (dmards) has not been adequately studied (see precautions).

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

southern cross pharma pty ltd - leflunomide, quantity: 10 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; maize starch; povidone; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 4000 - treatment of active rheumatoid arthritis.,treatment of active psoriatic arthritis. leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. the combined use of leflunomide with other disease modifying antirheumatic drugs (dmards) has not been adequately studied (see precautions).

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

alphapharm pty ltd - hydrochlorothiazide, quantity: 12.5 mg; candesartan cilexetil, quantity: 16 mg - tablet, uncoated - excipient ingredients: hyprolose; iron oxide yellow; maize starch; iron oxide red; glyceryl monostearate; carmellose calcium; lactose monohydrate; magnesium stearate - the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

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

alphapharm pty ltd - mycophenolate mofetil, quantity: 500 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; povidone; sodium lauryl sulfate; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - ceptolate (mycophenolate mofetil) is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. ceptolate (mycophenolate mofetil) is indicated for the prophylaxis of organ rejection in paediatric patients with a body surface area of greater than or equal to 1.25 square metres, receiving allogeneic renal transplants.

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

aspen pharmacare australia pty ltd - codeine phosphate hemihydrate, quantity: 10 mg; doxylamine succinate, quantity: 5.1 mg; paracetamol, quantity: 499.95 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; crospovidone; povidone; stearic acid; self-emulsifying glyceryl monostearate; pregelatinised maize starch - for the temporary relief of acute moderate pain and fever

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

alphapharm pty ltd - vancomycin hydrochloride, quantity: 1.026 g (equivalent: vancomycin, qty 1 g) - injection, powder for - excipient ingredients: nitrogen; hydrochloric acid; water for injections - vancomycin hydrochloride for intravenous infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial medicine, including the penicillins and cephalosporins. vancomycin is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg enterococcus faecalis), vancomycin is effective only in combination with an aminoglycoside. vancomycin is effective for the treatment of diphtheroid endocarditis. vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral administration the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

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

alphapharm pty ltd - vancomycin hydrochloride, quantity: 513 mg (equivalent: vancomycin, qty 500 mg) - injection, powder for - excipient ingredients: hydrochloric acid; water for injections; nitrogen - vancomycin hydrochloride for intravenous infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial medicine, including the penicillins and cephalosporins. vancomycin is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg enterococcus faecalis), vancomycin is effective only in combination with an aminoglycoside. vancomycin is effective for the treatment of diphtheroid endocarditis. vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral administration the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

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

sanofi-aventis australia pty ltd - sodium valproate, quantity: 500 mg - tablet, enteric coated - excipient ingredients: hyprolose; calcium silicate; amaranth aluminium lake; titanium dioxide; polyvinyl acetate phthalate; diethyl phthalate; stearic acid; purified talc; povidone; hypromellose; magnesium stearate; macrogol 6000; indigo carmine aluminium lake; citric acid monohydrate - 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.