Israel - engleză - Ministry of Health

astrazeneca (israel) ltd - esomeprazole - tablets - esomeprazole 20 mg - esomeprazole - esomeprazole - nexium tablets are indicated in adults for:gastroesophageal reflux disease (gerd)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagitis to prevent relapse- symptomatic treatment of gastroesophageal reflux disease (gerd)in combination with an appropriate antibacterial therapeutic regimen for the eradication of helicobacter pylori and:- healing of helicobacter pylori associated duodenal ulcer and- prevention of relapse of peptic ulcers in patients with helicobacter pylori associated ulcers.patients requiring nsaid therapy- healing of gastric ulcers associated with nsaid therapy. - prevention of gastric and duodenal ulcers associated with nsaid therapy in patients at risk.prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.nexium 20 mg tablets are indicated in adolescents from the age of 12 years forgastroesophageal reflux disease (gerd)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagi

Israel - engleză - Ministry of Health

taro international ltd, israel - esomeprazole - tablets - esomeprazole 40 mg - esomeprazole - esomeprazole - nexium tablets are indicated in adults for:gastroesophageal reflux disease (gerd)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagitis to prevent relapse- symptomatic treatment of gastroesophageal reflux disease (gerd)in combination with an appropriate antibacterial therapeutic regimen for the eradication of helicobacter pylori and:- healing of helicobacter pylori associated duodenal ulcer and- prevention of relapse of peptic ulcers in patients with helicobacter pylori associated ulcers.patients requiring nsaid therapy- healing of gastric ulcers associated with nsaid therapy. - prevention of gastric and duodenal ulcers associated with nsaid therapy in patients at risk.prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.nexium 40 mg tablets are indicated in adolescents from the age of 12 years for;gastroesophageal reflux disease (gerd)- treatment of erosive reflux esophagitis

Israel - engleză - Ministry of Health

astrazeneca (israel) ltd - esomeprazole - tablets - esomeprazole 40 mg - esomeprazole - esomeprazole - nexium tablets are indicated in adults for:gastroesophageal reflux disease (gerd)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagitis to prevent relapse- symptomatic treatment of gastroesophageal reflux disease (gerd)in combination with an appropriate antibacterial therapeutic regimen for the eradication of helicobacter pylori and:- healing of helicobacter pylori associated duodenal ulcer and- prevention of relapse of peptic ulcers in patients with helicobacter pylori associated ulcers.patients requiring nsaid therapy- healing of gastric ulcers associated with nsaid therapy. - prevention of gastric and duodenal ulcers associated with nsaid therapy in patients at risk.prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.nexium 40 mg tablets are indicated in adolescents from the age of 12 years for;gastroesophageal reflux disease (gerd)- treatment of erosive reflux esophagitis

Uniunea Europeană - engleză - EMA (European Medicines Agency)

glaxosmithkline dungarvan limited - esomeprazole - gastroesophageal reflux - proton pump inhibitors - nexium control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - esomeprazole sodium (unii: l2c9gwq43h) (esomeprazole - unii:n3pa6559ft) - esomeprazole 20 mg in 5 ml - nexium i.v. is indicated for the short-term treatment of gerd with ee in adults and pediatric patients 1 month to 17 years, inclusively as an alternative to oral therapy when oral nexium is not possible or appropriate. nexium i.v. is indicated for risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers in adults. risk summary there are no adequate and well-controlled studies with esomeprazole in pregnant women. esomeprazole is the s-isomer of omeprazole. available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg (based on a body surface area basis for a 60 kg person). changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg. when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age (see data ). the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data esomeprazole is the s-isomer of omeprazole. four epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to h2 -receptor antagonists or other controls. a population based retrospective cohort epidemiological study from the swedish medical birth registry, covering approximately 99% of pregnancies, from 1995 to 99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. the number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low apgar score, or hospitalization was similar to the number observed in this population. the number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. a population-based retrospective cohort study covering all live births in denmark from 1996 to 2009, reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any proton pump inhibitor. the overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester. a retrospective cohort study reported on 689 pregnant women exposed to either h2 -blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. the overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an h2 -blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively. a small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% with first trimester exposures). the reported rate of major congenital malformations was 4% in the omeprazole group, 2% in controls exposed to non-teratogens, and 2.8% in disease paired controls. rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups. several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia. animal data omeprazole reproductive studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) and in rabbits at doses up to 69.1 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) during organogenesis did not disclose any evidence for a teratogenic potential of omeprazole. in rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis) administered during organogenesis produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruptions. in rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis), administered prior to mating through the lactation period. esomeprazole no effects on embryo-fetal development were observed in reproduction studies with esomeprazole magnesium in rats at oral doses up to 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) or in rabbits at oral doses up to 86 mg/kg/day (about 41 times the human dose on a body surface area basis) administered during organogenesis. a pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with esomeprazole magnesium at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg on a body surface area basis). neonatal/early postnatal (birth to weaning) survival was decreased at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis). body weight and body weight gain were reduced and neurobehavioral or general developmental delays in the immediate post-weaning timeframe were evident at doses equal to or greater than 69 mg/kg/day (about 17 times an oral human dose of 40 mg on a body surface area basis). in addition, decreased femur length, width and thickness of cortical bone, decreased thickness of the tibial growth plate and minimal to mild bone marrow hypocellularity were noted at doses equal to or greater than 14 mg/kg/day (about 3.4 times an oral human dose of 40 mg on a body surface area basis). physeal dysplasia in the femur was observed in offspring of rats treated with oral doses of esomeprazole magnesium at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis). effects on maternal bone were observed in pregnant and lactating rats in a pre- and postnatal toxicity study when esomeprazole magnesium was administered at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg on a body surface area basis). when rats were dosed from gestational day 7 through weaning on postnatal day 21, a statistically significant decrease in maternal femur weight of up to 14% (as compared to placebo treatment) was observed at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis). a pre- and postnatal development study in rats with esomeprazole strontium (using equimolar doses compared to esomeprazole magnesium study) produced similar results in dams and pups as described above. a follow up developmental toxicity study in rats with further time points to evaluate pup bone development from postnatal day 2 to adulthood was performed with esomeprazole magnesium at oral doses of 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) where esomeprazole administration was from either gestational day 7 or gestational day 16 until parturition. when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age. risk summary esomeprazole is the s-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk. there are no clinical data on the effects of esomeprazole on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for nexium and any potential adverse effects on the breastfed infant from nexium or from the underlying maternal condition. the safety and effectiveness of nexium i.v. have been established in pediatric patients 1 month to 17 years of age for the short-term treatment of gerd with ee, as an alternative to oral therapy when oral nexium is not possible or appropriate. use of nexium i.v. in this age group is based on extrapolation of adult efficacy to children and the selection of dose based on exposure-matching of pediatrics to adults supported by the following evidence: a) results observed from a pharmacokinetic (pk) study on nexium i.v. for injection in pediatric patients, b) predictions from a population pk model comparing i.v. pk data between adult and pediatric patients, and c) relationship between exposure and pharmacodynamic results obtained from adult i.v. and pediatric oral data and d) pk results from adequate and well-controlled studies that supported the approval of nexium i.v. in adults [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)] . the safety and effectiveness of nexium i.v. have not been established in patients less than 1 month of age for the treatment of gerd with ee or for risk reduction of rebleeding of gastric or duodenal ulcer following therapeutic endoscopy. juvenile animal data in a juvenile rat toxicity study, esomeprazole was administered with both magnesium and strontium salts at oral doses about 34 to 68 times a daily human dose of 40 mg based on body surface area. increases in death were seen at the high dose, and at all doses of esomeprazole, there were decreases in body weight, body weight gain, femur weight and femur length, and decreases in overall growth [see nonclinical toxicology (13.2)] . in a clinical trial of patients with bleeding gastric or duodenal ulcers, 52% of 375 patients randomized to nexium i.v. were 65 years of age and over. no overall differences in safety and efficacy were observed between the elderly and younger individuals, and other reported clinical experience with nexium i.v. and oral esomeprazole has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. gerd with ee exposure to esomeprazole was increased substantially in patients with severe hepatic impairment (child-pugh class c) but not in patients with mild to moderate hepatic impairment (child-pugh classes a and b) compared to patients with normal liver function [see clinical pharmacology (12.3)] . for adult patients, no dosage adjustment is necessary for mild to moderate hepatic impairment. for patients with severe hepatic impairment the maximum recommended dosage is 20 mg once daily [see dosage and administration (2.3)] . risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy there are no pharmacokinetic data available for nexium i.v. administered as continuous intravenous administration in patients with hepatic impairment. exposure to intravenous omeprazole, of which esomeprazole is an enantiomer, increased in patients with all degrees of hepatic impairment compared to subjects with normal liver function [see clinical pharmacology (12.3)] . for adult patients, no dosage adjustment of the initial nexium i.v. 80 mg loading dose is necessary for patients with any degree of hepatic impairment. reduce the rate of the continuous infusion to 6 mg/hour for patients with mild to moderate liver impairment (child-pugh classes a and b) and to 4 mg/hour for patients with severe hepatic impairment (child-pugh class c) [see dosage and administration (2.3)] .

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

astrazeneca pty ltd - esomeprazole sodium, quantity: 42.5 mg (equivalent: esomeprazole, qty 40 mg) - injection, powder for - excipient ingredients: sodium hydroxide; disodium edetate - nexium iv: the short-term management of gastro-oesophageal reflux disease (gord) in patients with oesophagitis and/or severe symptoms of reflux as an alternative when oral therapy is inappropriate. prevention of rebleeding in patients following therapeutic endoscopy for acute, bleeding gastric or duodenal ulcers. short-term management in patients requiring continued non-steroidal anti-inflammatory drug (nsaid) therapy when oral therapy is inappropriate: - healing of gastric ulcers associated with nsaid therapy; - prevention of gastric and duodenal ulcers associated with nsaid therapy, in patients at risk. nexium iv should be replaced with oral therapy as soon as practicable.

Israel - engleză - Ministry of Health

astrazeneca (israel) ltd - esomeprazole - tablets - esomeprazole 20 mg - esomeprazole - nexium tablets are indicated in adults for:gastroesophageal reflux disease (gerd)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagitis to prevent relapse- symptomatic treatment of gastroesophageal reflux disease (gerd)in combination with an appropriate antibacterial therapeutic regimen for the eradication of helicobacter pylori and:- healing of helicobacter pylori associated duodenal ulcer and- prevention of relapse of peptic ulcers in patients with helicobacter pylori associated ulcers.patients requiring nsaid therapy- healing of gastric ulcers associated with nsaid therapy. - prevention of gastric and duodenal ulcers associated with nsaid therapy in patients at risk.prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.nexium 20 mg tablets are indicated in adolescents from the age of 12 years forgastroesophageal reflux disease (gerd)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagi

Israel - engleză - Ministry of Health

astrazeneca (israel) ltd - esomeprazole - tablets - esomeprazole 40 mg - esomeprazole - nexium tablets are indicated in adults for:gastroesophageal reflux disease (gerd)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagitis to prevent relapse- symptomatic treatment of gastroesophageal reflux disease (gerd)in combination with an appropriate antibacterial therapeutic regimen for the eradication of helicobacter pylori and:- healing of helicobacter pylori associated duodenal ulcer and- prevention of relapse of peptic ulcers in patients with helicobacter pylori associated ulcers.patients requiring nsaid therapy- healing of gastric ulcers associated with nsaid therapy. - prevention of gastric and duodenal ulcers associated with nsaid therapy in patients at risk.prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.nexium 40 mg tablets are indicated in adolescents from the age of 12 years for;gastroesophageal reflux disease (gerd)- treatment of erosive reflux esophagitis

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

bryant ranch prepack - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - healing of erosive esophagitis nexium is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of nexium may be considered. in infants 1 month to less than 1 year, nexium is indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated gerd. maintenance of healing of erosive esophagitis nexium is indicated to maintain symptom resolution and healing of erosive esophagitis. controlled studies do not extend beyond 6 months. symptomatic gastroesophageal reflux disease nexium is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with gerd in adults and children 1 year or older. nexium is indicated for the reduction in the occurrence of gastric ulcers associated with continuous nsaid therapy in patients at risk for developing gastric ulcers. patient

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

a-s medication solutions - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - esomeprazole 40 mg - healing of erosive esophagitis nexium is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of nexium may be considered. in infants 1 month to less than 1 year, nexium is indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated gerd. maintenance of healing of erosive esophagitis nexium is indicated to maintain symptom resolution and healing of erosive esophagitis. controlled studies do not extend beyond 6 months. symptomatic gastroesophageal reflux disease nexium is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with gerd in adults and children 1 year or older. nexium is indicated for the reduction in the occurrence of gastric ulcers associated with continuous nsaid therapy in patients at risk for developing gastric ulcers. patient