Stany Zjednoczone - angielski - NLM (National Library of Medicine)

santarus, inc.. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9), sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - omeprazole 20 mg - zegerid for oral suspension and zegerid capsules are indicated in adults for the : zegerid for oral suspension is indicated in adults for the : zegerid is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see warnings and precautions (5.2), adverse reactions (6.2)] . proton pump inhibitors (ppis), including zegerid, are contraindicated in patients receiving rilpivirine containing products [see drug interactions (7)] . risk summary there are no adequate and well-controlled studies with zegerid in pregnant women. zegerid contains omeprazole and sodium bicarbonate. omeprazole there are no adequate and well-controlled studies with omeprazole in pregnant women. available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcom

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

physicians total care, inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9), sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - omeprazole 40 mg - zegerid (omeprazole/sodium bicarbonate) is indicated for short-term treatment of active duodenal ulcer. most patients heal within four weeks. some patients may require an additional four weeks of therapy. [see clinical studies (14.1)] zegerid is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [see clinical studies (14.2)] symptomatic gerd zegerid is indicated for the treatment of heartburn and other symptoms associated with gerd. [see clinical studies (14.3)] erosive esophagitis zegerid is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy. the efficacy of zegerid used for longer than 8 weeks in these patients has not been established. if a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. if there is recurrence of erosive esophagitis or gerd symptoms (e.g., heartburn), additional 4-8 week courses of zegerid may be considered. [see clinical studies (1

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

dr.reddy's laboratories limited - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9), sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - omeprazole 20 mg - omeprazole and sodium bicarbonate capsules are indicated in adults for the: - short-term treatment of active duodenal ulcer. most patients heal within four weeks. some patients may require an additional four weeks of therapy. - short-term treatment (4 to 8 weeks) of active benign gastric ulcer. - treatment of heartburn and other symptoms associated with gerd for up to 4 weeks. - short-term treatment (4 to 8 weeks) of ee due to acid-mediated gerd which has been diagnosed by endoscopy in adults. the efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with ee has not been established. if a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. if there is recurrence of ee or gerd symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole and sodium bicarbonate capsules may be considered. - the efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with ee has not been e

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

sterling knight pharmaceuticals llc - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37) - omeprazole 40 mg - omeprazole and sodium bicarbonate is a proton pump inhibitor indicated for: - short-term treatment of active duodenal ulcer (1.1) - short-term treatment of active benign gastric ulcer (1.2) - treatment of gastroesophageal reflux disease (gerd) (1.3) - maintenance of healing of erosive esophagitis (1.4) the safety and effectiveness of omeprazole and sodium bicarbonate capsules in pediatric patients (<18 years of age) have not been established. (8.4) omeprazole and sodium bicarbonate is indicated for short-term treatment of active duodenal ulcer. most patients heal within four weeks. some patients may require an additional four weeks of therapy. [see clinical studies (14.1)] gastric ulcer omeprazole and sodium bicarbonate is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [see clinical studies (14.2)] symptomatic gerd omeprazole and sodium bicarbonate is indicated for the treatment of heartburn and other symptoms associated with gerd for up to 4 weeks. [see clinical studies (14.3)

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

paddock laboratories, llc - sodium polystyrene sulfonate (unii: 1699g8679z) (polystyrene sulfonic acid - unii:70ko0r01ry) - sodium polystyrene sulfonate 15 g in 60 ml - sodium polystyrene sulfonate suspension, usp is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, oral or rectal administration in neonates (particularly in premature infants), and in any post-operative patient until normal bowel function resumes (see precautions ).

Malezja - angielski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

kck pharmaceutical industries sdn. bhd. - calcium carbonate; sodium bicarbonate; magnesium carbonate,light; simethicone -

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium sulfate anhydrous (unii: ml30mj2u7i) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - gastrointestinal obstruction - bowel perforation - gastric retention - ileus - toxic colitis or toxic megacolon - known allergies to components of the kit [see description (11)] teratogenic effects: pregnancy category c. animal reproduction studies have not been conducted with sodium sulfate, potassium sulfate and magnesium sulfate oral solution. it is also not known whether sodium sulfate, potassium sulfate and magnesium sulfate oral solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfate, potassium sulfate and magnesium sulfate oral solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when sodium sulfate, potassium sulfate and magnesium sulfate oral solution is administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. of the 375 patients who received sodium sulfate, potassium sulfate and magnesium sulfate oral solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. no overall differences in safety or effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. geriatric patients reported more vomiting when sodium sulfate, potassium sulfate and magnesium sulfate oral solution was given as a one-day preparation.

Malezja - angielski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

idaman pharma manufacturing sdn bhd - sodium bicarbonate; magnesium carbonate,light -

Irlandia - angielski - HPRA (Health Products Regulatory Authority)

reckitt benckiser ireland ltd - sodium alginate; sodium hydrogen carbonate; calcium carbonate - chewable tablet - 250 mg/133.5 mg/80 milligram(s) - other drugs for peptic ulcer and gastro-oesophageal reflux disease (gord); alginic acid

Irlandia - angielski - HPRA (Health Products Regulatory Authority)

casen-recordati s.l. - sodium picosulfate; light magnesium oxide; citric acid anhydrous - powder for oral solution in sachet - 10,3.5,10.97 gram(s) - contact laxatives; sodium picosulfate, combinations