국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Teva Pharma B.V.
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
20 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Withdrawn
2012-12-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esomeprazole Teva Pharma B.V. 20 mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium dihydrate). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet light pink, oblong, biconvex, film-coated tablet, with “20” engraved on one side and dimensions of approximately 14.9 x 7.6 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Esomeprazole Teva Pharma B.V. tablets are indicated for: GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD): -Treatment of erosive reflux oesophagitis -Long-term management of patients with healed oesophagitis to prevent relapse -Symptomatic treatment of gastro-oesophageal reflux disease (GORD) IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS FOR THE ERADICATION OF _HELICOBACTER PYLORI_: -Healing of _Helicobacter pylori _associated duodenal ulcer -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. Adolescents from the age of 12 years GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) - treatment of erosive reflux oesophagitis - long-term management of patients with healed oesophagitis to prevent relapse - symptomatic treatment of gastro-oesophageal reflux disease (GORD) IN COMBINATION WITH ANTIBIOTICS IN TREATMENT OF DUODENAL ULCER CAUSED BY _HELICOBACTER PYLORI_. IRISH MEDICINES BOARD __________________________________________________ 전체 문서 읽기