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)

takeda pharmaceuticals australia pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.57 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: hypromellose; methacrylic acid copolymer; sodium lauryl sulfate; propylene glycol; povidone; sodium carbonate; calcium stearate; polysorbate 80; crospovidone; titanium dioxide; iron oxide yellow; triethyl citrate; purified water; mannitol; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - adults: 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 to 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: - 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 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. children aged from 5 to 17 years: gastro-oesophageal reflux disease (gord) - symptomatic gord. the treatment of heartburn and other symptoms associated with gord. - reflux oesophagitis. the treatment duration should not exceed 8 weeks.

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

takeda pharmaceuticals australia pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.57 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: triethyl citrate; povidone; sodium lauryl sulfate; purified water; crospovidone; methacrylic acid copolymer; mannitol; polysorbate 80; propylene glycol; calcium stearate; iron oxide yellow; sodium carbonate; titanium dioxide; hypromellose; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - adults: 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 to 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: - 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 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. children aged from 5 to 17 years: gastro-oesophageal reflux disease (gord) - symptomatic gord. the treatment of heartburn and other symptoms associated with gord. - reflux oesophagitis. the treatment duration should not exceed 8 weeks.

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) - tablet, enteric coated - excipient ingredients: sodium carbonate; iron oxide yellow; titanium dioxide; polysorbate 80; sodium lauryl sulfate; mannitol; methacrylic acid copolymer; povidone; hypromellose; triethyl citrate; propylene glycol; calcium stearate; crospovidone; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - adults: 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 to 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: - 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 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. children aged from 5 to 17 years: gastro-oesophageal reflux disease (gord) - symptomatic gord. the treatment of heartburn and other symptoms associated with gord. - reflux oesophagitis. the treatment duration should not exceed 8 weeks.

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) - tablet, enteric coated - excipient ingredients: methacrylic acid copolymer; hypromellose; sodium lauryl sulfate; povidone; mannitol; iron oxide yellow; crospovidone; propylene glycol; titanium dioxide; sodium carbonate; triethyl citrate; polysorbate 80; calcium stearate; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - adults: 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 to 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: - 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 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. children aged from 5 to 17 years: gastro-oesophageal reflux disease (gord) - symptomatic gord. the treatment of heartburn and other symptoms associated with gord. - reflux oesophagitis. the treatment duration should not exceed 8 weeks.

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

takeda pharmaceuticals australia pty ltd - vedolizumab, quantity: 331.2 mg - injection, powder for - excipient ingredients: polysorbate 80; arginine hydrochloride; histidine; sucrose; histidine hydrochloride monohydrate - ulcerative colitis,treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,crohn?s disease,treatment of adult patients with moderate to severe crohn?s disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,pouchitis,entyvio is indicated for the treatment of adult patients with moderate to severe chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

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

takeda pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 1000 mg; alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg) - tablet, film coated - excipient ingredients: povidone; microcrystalline cellulose; hypromellose; crospovidone; mannitol; purified talc; titanium dioxide; iron oxide yellow; magnesium stearate - nesina met is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,nesina met can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.

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

takeda pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 500 mg; alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; titanium dioxide; magnesium stearate; iron oxide yellow; purified talc; crospovidone; povidone; hypromellose - nesina met is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,nesina met can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.

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

takeda pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 850 mg; alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg) - tablet, film coated - excipient ingredients: titanium dioxide; purified talc; microcrystalline cellulose; povidone; mannitol; crospovidone; hypromellose; iron oxide yellow; magnesium stearate - nesina met is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,nesina met can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.

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

takeda pharmaceuticals australia pty ltd - vedolizumab, quantity: 119 mg - injection, solution - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; histidine; histidine hydrochloride monohydrate; arginine hydrochloride; polysorbate 80; water for injections - treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist. treatment of adult patients with moderate to severe crohn?s disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.