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

arrotex pharmaceuticals pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.7 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: sodium hydroxide; hypromellose; colloidal anhydrous silica; macrogol 6000; sodium carbonate; mannitol; crospovidone; sodium starch glycollate; calcium stearate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin; 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: 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.

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

janssen-cilag pty ltd - golimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: sorbitol; histidine; polysorbate 80; water for injections - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

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

janssen-cilag pty ltd - golimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: sorbitol; polysorbate 80; water for injections; histidine - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

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

bristol-myers squibb australia pty ltd - abatacept, quantity: 125.875 mg - injection - excipient ingredients: dibasic sodium phosphate; nitrogen; water for injections; sucrose; poloxamer; monobasic sodium phosphate - 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)

pharmacor pty ltd - omeprazole, quantity: 20 mg - capsule - excipient ingredients: quinoline yellow; purified water; gelatin; titanium dioxide; 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)

pharmacor pty ltd - omeprazole, quantity: 20 mg - capsule - excipient ingredients: purified water; gelatin; quinoline yellow; titanium dioxide; 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)

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)

arrotex pharmaceuticals pty ltd - omeprazole, quantity: 20 mg - tablet, enteric coated - excipient ingredients: iron oxide black; microcrystalline cellulose; povidone; iron oxide red; crospovidone; purified talc; lactose monohydrate; hypromellose phthalate; magnesium stearate; triacetin; ascorbyl palmitate - omeprazole tablets are indicated for: a. 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. b. peptic ulcers: 1. the treatment of duodenal and gastric ulcer. 2. combination therapy for the treatment of peptic ulcer disease associated with heliobacter pylori infection. 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 heliobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. c. zollinger-ellison syndrome: the treatment of zollinger-ellison syndrome.

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

alphapharm pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.12 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: crospovidone; sodium hydroxide; mannitol; macrogol 6000; hypromellose; sodium starch glycollate; colloidal anhydrous silica; sodium carbonate; calcium stearate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin; purified water; polysorbate 80; methacrylic acid copolymer; sodium lauryl sulfate - 1. 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

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

alphapharm pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.56 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: mannitol; crospovidone; hypromellose; macrogol 6000; sodium carbonate; sodium starch glycollate; colloidal anhydrous silica; sodium hydroxide; calcium stearate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin; purified water; polysorbate 80; methacrylic acid copolymer; sodium lauryl sulfate - 1. 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