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

pharmacor pty ltd - omeprazole, quantity: 20 mg - capsule - excipient ingredients: purified water; gelatin; titanium dioxide; quinoline yellow; sodium lauryl sulfate; dibasic sodium phosphate; mannitol; hypromellose; macrogol 6000; purified talc; polysorbate 80; methacrylic acid copolymer; maize starch; sucrose - the relief of heartburn and other symptoms associated with gord. the treatment and prevention of relapse in erosive oesophagitis. the treatment of duodenal and gastric ulcer. combination therapy for the treatment of peptic ulcer disease associated with h. pylori infection. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs.the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be h. pylori negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. the treatment of zollinger-ellison syndrome.

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

takeda pharmaceuticals australia pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.1 mg (equivalent: pantoprazole, qty 40 mg) - granules, enteric-coated - excipient ingredients: crospovidone; povidone; triethyl citrate; titanium dioxide; polysorbate 80; purified talc; iron oxide yellow; hypromellose; sodium carbonate; microcrystalline cellulose; purified water; methacrylic acid copolymer; sodium lauryl sulfate - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:- i) duodenal ulcer, ii) gastric ulcer, iii) gastro-oesophageal reflux disease (gord): symptomatic gord. the treatment of heartburn and other symptoms associated with gord; reflux oesophagitis iv) gastrointestinal lesions refractory h2 blockers v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics; i) clarithromycin and amoxicillin, or ii) clarithromycin and metronidazole, or iii) amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism (see dosage & administration). 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

sandoz pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.1 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; triethyl citrate; crospovidone; sodium carbonate; hyprolose; calcium stearate; titanium dioxide; hypromellose; iron oxide yellow; quinoline yellow aluminium lake; macrogol 400; brilliant scarlet 4r aluminium lake; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: duodenal ulcer; gastric ulcer; gastro-oesophageal reflux disease (gord) i. symptomatic gord. the treatment of heartburn and other symptoms associated with gord ii. reflux oesophagitis; gastrointestinal lesions refractory to h2 blockers ; zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: clarithromycin and amoxicillin or; clarithromycin and metronidazole or; amoxicillin and metronidazole - is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this micro-organism. 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment. 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: duodenal ulcer; gastric ulcer; gastro-oesophageal reflux disease (gord) i. symptomatic gord. the treatment of heartburn and other symptoms associated with gord ii. reflux oesophagitis; gastrointestinal lesions refractory to h2 blockers ; zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: clarithromycin and amoxicillin or; clarithromycin and metronidazole or; amoxicillin and metronidazole - is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this micro-organism. 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

sandoz pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.1 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: hyprolose; calcium stearate; triethyl citrate; crospovidone; sodium carbonate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide yellow; quinoline yellow aluminium lake; macrogol 400; brilliant scarlet 4r aluminium lake; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: duodenal ulcer; gastric ulcer; gastro-oesophageal reflux disease (gord) i. symptomatic gord. the treatment of heartburn and other symptoms associated with gord ii. reflux oesophagitis; gastrointestinal lesions refractory to h2 blockers ; zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: clarithromycin and amoxicillin or; clarithromycin and metronidazole or; amoxicillin and metronidazole - is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this micro-organism. 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

sandoz pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.55 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: hyprolose; crospovidone; triethyl citrate; sodium carbonate; microcrystalline cellulose; colloidal anhydrous silica; calcium stearate; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; hypromellose; iron oxide yellow; quinoline yellow aluminium lake; macrogol 400; brilliant scarlet 4r aluminium lake - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: duodenal ulcer; gastric ulcer; gastro-oesophageal reflux disease (gord) i. symptomatic gord. the treatment of heartburn and other symptoms associated with gord ii. reflux oesophagitis; gastrointestinal lesions refractory to h2 blockers ; zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: clarithromycin and amoxicillin or; clarithromycin and metronidazole or; amoxicillin and metronidazole - is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this micro-organism. 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

bristol-myers squibb australia pty ltd - abatacept, quantity: 262.5 mg - injection - excipient ingredients: monobasic sodium phosphate; sodium chloride; sodium hydroxide; maltose; hydrochloric acid - orencia in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying anti-rheumatic drugs (dmards), such as methotrexate or tumour necrosis factor (tnf) blocking agents. a reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with orencia and methotrexate.,orencia in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.,orencia is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). orencia may be used as monotherapy or concomitantly with methotrexate (mtx). (there is no clinical trial data for the use of orencia subcutaneous formulation in children, therefore its use in children cannot be recommended.),orencia is indicated for the treatment of active psoriatic arthritis (psa) in adults when the response to previous disease-modifying anti-rheumatic drug (dmard) therapy has been inadequate. orencia can be used with or without non-biologic dmards.,orencia should not be administered concurrently with other biological dmards (eg, tnf inhibitors, rituximab, or anakinra).

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

pharmaco australia ltd - omeprazole magnesium, quantity: 20.6 mg (equivalent: omeprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: magnesium stearate; macrogol 6000; methacrylic acid copolymer; sodium hydroxide; polysorbate 80; titanium dioxide; hyprolose; iron oxide red; sodium stearylfumarate; microcrystalline cellulose; crospovidone; hypromellose; purified talc; triethyl citrate; glyceryl monostearate; synthetic paraffin; maize starch; sucrose - gastro-oesophageal reflux disease (gord). 1. symptomatic gord. the relief of heartburn and other symptoms associated with gord. 2. erosive oesophagitis. the treatment and prevention of relapse. peptic ulcers. 1. the treatment of duodenal and gastric ulcer. 2. combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infections. 3. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be helicobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. zollinger-ellison syndrome. the treatment of zollinger-ellison syndrome.

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

medis pharma pty ltd - rabeprazole sodium, quantity: 20 mg - tablet, enteric coated - excipient ingredients: methacrylic acid - ethyl acrylate copolymer (1:1); mannitol; sodium lauryl sulfate; ethylcellulose; polysorbate 80; magnesium stearate; hyprolose; purified talc; iron oxide yellow; povidone; light magnesium oxide; propylene glycol; titanium dioxide - rabeprazole is indicated for: ,? treatment and prevention of relapse of gastro-oesophageal reflux disease ,? symptomatic treatment of gastro-oesophageal reflux disease ,? treatment of duodenal ulcers ,? treatment of gastric ulcers. ,patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,rabeprazole is also indicated, in combination with clarithromycin and amoxycillin, for: ,? eradication of helicobacter pylori in patients with peptic ulcer disease or chronic gastritis ,? healing of peptic ulcers in patients with helicobacter pylori associated ulcers.

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

strides pharma science pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.1 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: triethyl citrate; sodium carbonate; hyprolose; iron oxide yellow; calcium stearate; crospovidone; hypromellose; mannitol; methacrylic acid - ethyl acrylate copolymer (1:1) - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:- i) duodenal ulcer, ii) gastric ulcer, iii) gastro-oesophageal reflux disease (gord): symptomatic gord. the treatment of heartburn and other symptoms associated with gord; reflux oesophagitis iv) gastrointestinal lesions refractory h2 blockers v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics; i) clarithromycin and amoxicillin, or ii) clarithromycin and metronidazole, or iii) amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism. 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

arrotex pharmaceuticals pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.4 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: mannitol; sodium carbonate; sodium starch glycollate; crospovidone; colloidal anhydrous silica; calcium stearate; hypromellose; macrogol 6000; sodium hydroxide; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) duodenal ulcer; ii) gastric ulcer; iii) gastro-oesophageal reflux disease (gord): symptomatic gord. the treatment of heartburn and other symptoms associated with gord; reflux oesophagitis; iv) gastrointestinal lesions refractory h2 blockers; v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.