Land: Sverige
Sprog: svensk
Kilde: Läkemedelsverket (Medical Products Agency)
esomeprazolmagnesiumtrihydrat
Orifarm AB
A02BC05
magnesium trihydrate
20 mg
Enterotablett
natriumlaurilsulfat Hjälpämne; esomeprazolmagnesiumtrihydrat 22,3 mg Aktiv substans; sockersfärer Hjälpämne
Receptbelagt
Esomeprazol
Avregistrerad
2006-04-19
1 SUMMARY OF THE PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Axiago 20 mg gastro-resistant tablets Axiago 40 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 20 mg: Each gastro-resistant tablet contains: 22.3 esomeprazole magnesium trihydrate equivalent to 20 mg esomeprazole. 40 mg: Each gastro-resistant tablet contains esomeprazole 44.5 magnesium trihydrate equivalent to 40 mg esomeprazole. Excipient (s) with known effect 20 mg: Each gastro-resistant tablet contains 28 mg sucrose 40 mg: Each gastro-resistant tablet contains 30 mg sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet 20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and A/EH on the other side. 40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and A/EI on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Axiago 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 appropriate antibacterial therapeutic regimens 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 continued 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. Treatment of Zollinger Ellison Syndrome 2 Axiago tablets are indicated in adolescents from the age of 12 years for: Gastroesophageal Reflux Disease (GERD) - treatment of erosive reflux esophagitis - long-term management of patients with healed esophagitis to prevent rela Læs hele dokumentet