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

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

arrotex pharmaceuticals pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.2 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: crospovidone; methacrylic acid copolymer; sodium carbonate; titanium dioxide; macrogol 8000; magnesium stearate; iron oxide yellow; lactose; triethyl citrate; purified talc; hypromellose; microcrystalline cellulose - symptomatic improvement and healing of the following gastrointestinal diseases which require a reduction in acid secretion. - duodenal ulcer. - gastric ulcer. - gastroesophageal reflux disease (gord). symptomatic gord: the treatment of heartburn and other symptoms associated with gord. - reflux oesophagitis. - gastrointestinal lesions refractory to h 2-blockers. - zollinger-ellison syndrome.. patients whose gastric or duodenal ulceration is not associated with ingestion of nsaids require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.. prevention of gastroduodenal lesions and dyspeptic symptoms associated with nonselective nsaids in increased risk patients with a need for continuous nonselective nsaid treatment.

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

arrotex pharmaceuticals pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.6 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: methacrylic acid copolymer; magnesium stearate; titanium dioxide; purified talc; lactose; sodium carbonate; triethyl citrate; crospovidone; macrogol 8000; iron oxide yellow; hypromellose; microcrystalline cellulose - symptomatic improvement and healing of the following gastrointestinal diseases which require a reduction in acid secretion. - duodenal ulcer. - gastric ulcer. - gastroesophageal reflux disease (gord). symptomatic gord: the treatment of heartburn and other symptoms associated with gord. - reflux oesophagitis. - gastrointestinal lesions refractory to h 2-blockers. - zollinger-ellison syndrome.. patients whose gastric or duodenal ulceration is not associated with ingestion of nsaids require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.. prevention of gastroduodenal lesions and dyspeptic symptoms associated with nonselective nsaids in increased risk patients with a need for continuous nonselective nsaid treatment.

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

sun pharma anz pty ltd - pantoprazole sodium, quantity: 45.113 mg - tablet, enteric coated - excipient ingredients: hyprolose; triethyl citrate; crospovidone; purified talc; calcium stearate; sodium lauryl sulfate; sodium carbonate; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); mannitol; titanium dioxide; iron oxide yellow; hypromellose; propylene glycol; povidone; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion i.e for duodenal ulcer, gastric ulcer, gastro-oesophageal reflux disease (gord) including - symptomatic gord. the treatment of heartburn and other symptoms associated with gord; - reflux oesophagitis; gastrointestinal lesions refractory to h2 blockers, and zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal 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)

sun pharma anz pty ltd - pantoprazole sodium, quantity: 22.557 mg - tablet, enteric coated - excipient ingredients: purified talc; microcrystalline cellulose; sodium carbonate; sodium lauryl sulfate; iron oxide yellow; titanium dioxide; triethyl citrate; mannitol; crospovidone; hyprolose; methacrylic acid - ethyl acrylate copolymer (1:1); calcium stearate; hypromellose; propylene glycol; povidone; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion i.e for duodenal ulcer, gastric ulcer, gastro-oesophageal reflux disease (gord) including - symptomatic gord. the treatment of heartburn and other symptoms associated with gord; - reflux oesophagitis; gastrointestinal lesions refractory to h2 blockers, and zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal 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)

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.

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - diclofenac potassium 50 mg - carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ; gastrointestinal bleeding, ulceration, and perforation ). diclofenac potassium tablets are indicated: - for treatment of primary dysmenorrhea - for relief of mild to moderate pain - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis diclofenac is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see warnings ; anaphylactic reactions, serious skin reactions ). - history of asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal

United States - English - NLM (National Library of Medicine)

redpharm drug, inc. - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - diclofenac potassium 50 mg - carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation). diclofenac potassium tablets are indicated: • for treatment of primary dysmenorrhea • for relief of mild to moderate pain • for relief of the signs and symptoms of osteoarthritis • for relief of the signs and symptoms of rheumatoid arthritis diclofenac is contraindicated in the following patients: • known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see warnings; anaphylactic reactions, serious skin reactions). • history of asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylact

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)

arrotex pharmaceuticals 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 - 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.