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

alphapharm pty ltd - nizatidine, quantity: 300 mg - capsule - excipient ingredients: croscarmellose sodium; iron oxide yellow; magnesium stearate; colloidal anhydrous silica; gelatin; sodium lauryl sulfate; purified talc; titanium dioxide; pregelatinised maize starch; iron oxide red; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - tacidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer. in most patients, the ulcer will heal within 4 weeks. tacidine is also indicated for the maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150mg at bedtime, after healing of the active duodenal ulcer. continuous therapy with nizatidine for longer than 1 year has not been studied. tacidine is indicated for up to 8 weeks for the treatment of benign gastric ulcer. tacidine is indicated for up to 12 weeks for the treatment of oesophagitis, including erosive and ulcerative oesophagitis and associated heartburn due to reflux.

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

alphapharm pty ltd - nizatidine, quantity: 150 mg - capsule - excipient ingredients: magnesium stearate; croscarmellose sodium; gelatin; allura red ac; pregelatinised maize starch; colloidal anhydrous silica; quinoline yellow; titanium dioxide; sodium lauryl sulfate; iron oxide yellow; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - tacidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer. in most patients, the ulcer will heal within 4 weeks. tacidine is also indicated for the maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150mg at bedtime, after healing of the active duodenal ulcer. continuous therapy with nizatidine for longer than 1 year has not been studied. tacidine is indicated for up to 8 weeks for the treatment of benign gastric ulcer. tacidine is indicated for up to 12 weeks for the treatment of oesophagitis, including erosive and ulcerative oesophagitis and associated heartburn due to reflux.

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

alphapharm pty ltd - cefalexin monohydrate, quantity: 52.6 mg/ml (equivalent: cefalexin, qty 50 mg/ml) - oral liquid, powder for - excipient ingredients: sodium lauryl sulfate; allura red ac; methylcellulose; dimeticone 350; xanthan gum; pregelatinised maize starch; sucrose; flavour - indications as at 24 february 2004: ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by s. pneumoniae and group a beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. ibilex is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of ibilex in the subsequent prevention of rheumatic fever are not available at present.) bacterial sinusitis caused by streptococci, s. pneumoniae and s. aureus (methicillin-sensitive only) otitis media due to s. pneumoniae, staphylococci; skin and soft tissue infections caused by staphlococci anr/or streptococci; genitourinary tract infections, including acute prostatic caused by e. coli, p. mirabilis, and klebsiella sp. the effectiveness of ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and ibilex is not indicated in these conditions. note: appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to ibilex. renal function studies should be performed when indicated

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

alphapharm pty ltd - cefalexin monohydrate, quantity: 26.3 mg/ml (equivalent: cefalexin, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: sodium lauryl sulfate; allura red ac; methylcellulose; dimeticone 350; xanthan gum; pregelatinised maize starch; sucrose; flavour - indications as at 24 february 2004: ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by s. pneumoniae and group a beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. ibilex is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of ibilex in the subsequent prevention of rheumatic fever are not available at present.) bacterial sinusitis caused by streptococci, s. pneumoniae and s. aureus (methicillin-sensitive only) otitis media due to s. pneumoniae, staphylococci; skin and soft tissue infections caused by staphlococci anr/or streptococci; genitourinary tract infections, including acute prostatic caused by e. coli, p. mirabilis, and klebsiella sp. the effectiveness of ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and ibilex is not indicated in these conditions. note: appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to ibilex. renal function studies should be performed when indicated

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

alphapharm pty ltd - flunitrazepam, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; pregelatinised maize starch; magnesium stearate; indigo carmine; titanium dioxide; hypromellose; brilliant blue fcf; sunset yellow fcf; quinoline yellow; macrogol 4000 - severe cases of insomnia

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

alphapharm pty ltd - cefalexin monohydrate, quantity: 526 mg (equivalent: cefalexin, qty 500 mg) - capsule, hard - excipient ingredients: titanium dioxide; quinoline yellow; gelatin; magnesium stearate; patent blue v; dimeticone 350; microcrystalline cellulose; carmellose sodium - indications as at 24 february 2004: ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by s. pneumoniae and group a beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. ibilex is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of ibilex in the subsequent prevention of rheumatic fever are not available at present.) bacterial sinusitis caused by streptococci, s. pneumoniae and s. aureus (methicillin-sensitive only) otitis media due to s. pneumoniae, staphylococci; skin and soft tissue infections caused by staphlococci anr/or streptococci; genitourinary tract infections, including acute prostatic caused by e. coli, p. mirabilis, and klebsiella sp. the effectiveness of ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and ibilex is not indicated in these conditions. note: appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to ibilex. renal function studies should be performed when indicated

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

alphapharm pty ltd - cefalexin monohydrate, quantity: 263 mg (equivalent: cefalexin, qty 250 mg) - capsule, hard - excipient ingredients: gelatin; dimeticone 350; magnesium stearate; titanium dioxide; patent blue v; quinoline yellow; microcrystalline cellulose; carmellose sodium - indications as at 24 february 2004: ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by s. pneumoniae and group a beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. ibilex is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of ibilex in the subsequent prevention of rheumatic fever are not available at present.) bacterial sinusitis caused by streptococci, s. pneumoniae and s. aureus (methicillin-sensitive only) otitis media due to s. pneumoniae, staphylococci; skin and soft tissue infections caused by staphlococci anr/or streptococci; genitourinary tract infections, including acute prostatic caused by e. coli, p. mirabilis, and klebsiella sp. the effectiveness of ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and ibilex is not indicated in these conditions. note: appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to ibilex. renal function studies should be performed when indicated

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

alphapharm pty ltd - temazepam, quantity: 10 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; maize starch; magnesium stearate - adjunctive therapy for the short term management of insomnia in adults.

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

alphapharm pty ltd - trimethoprim, quantity: 300 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; povidone; sodium starch glycollate; purified talc; magnesium stearate - this product approved for registration as a variation of a product accepted for inclusion in the artg as 'currently supplied' at the commencement of the act. indications are held in artg paper records. previous product number aust r 17577 and 43120. product information not reviewed. indications as at 5 december 1984 : treatment of acute urinary tract infections caused by sensitive organisms.

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

alphapharm pty ltd - mercaptamine (cysteamine) bitartrate, quantity: 441.72 mg (equivalent: mercaptamine (cysteamine), qty 150 mg) - capsule, hard - excipient ingredients: microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; sodium lauryl sulfate; silicon dioxide; croscarmellose sodium; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - for the management of nephropathic cystinosis in children and adults.