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

generic health 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 - adults 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: ? duodenal ulcer ? gastric ulcer ? gastro-oesophageal reflux disease (gord): - symptomatic gord. the treatment of heartburn and other symptoms associated with gord - 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 microorganism (see section 4.2 dose and method of 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)

pharmacor 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.

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: colloidal anhydrous silica; hypromellose; sodium carbonate; mannitol; calcium stearate; macrogol 6000; sodium hydroxide; crospovidone; sodium starch glycollate; 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)

strides pharma science pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.4 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: colloidal anhydrous silica; hypromellose; macrogol 6000; sodium starch glycollate; mannitol; calcium stearate; sodium carbonate; crospovidone; 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.

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)

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.

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

generic health pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.7 mg (equivalent: pantoprazole, qty 20 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 - adults 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: ? duodenal ulcer ? gastric ulcer ? gastro-oesophageal reflux disease (gord): - symptomatic gord. the treatment of heartburn and other symptoms associated with gord - 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 microorganism (see section 4.2 dose and method of 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)

ipca pharma (australia) 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.

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

gm pharma international 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.

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

strides pharma science pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.7 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: sodium starch glycollate; hypromellose; sodium carbonate; crospovidone; colloidal anhydrous silica; mannitol; sodium hydroxide; calcium stearate; macrogol 6000; 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.