Страна: Швеция
Язык: шведский
Источник: Läkemedelsverket (Medical Products Agency)
esomeprazolmagnesium
Orifarm Generics A/S
A02BC05
esomeprazole magnesium
10 mg
Enterogranulat till oral suspension i dospåse
esomeprazolmagnesium 10,353 mg Aktiv substans; glukosmonohydrat Hjälpämne; sockersfärer Hjälpämne
Receptbelagt
Förpacknings: Dospåse, 28 st; Dospåse, 30 st; Dospåse, 32 st; Dospåse, 35 st; Dospåse, 37 st; Dospåse, 50 st; Dospåse, 56 st
Godkänd
2021-03-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esomeprazole Orifarm 10 mg gastro-resistant granules for oral suspension in sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains: 10 mg esomeprazole (as esomeprazole magnesium). Excipients with known effect: Each sachet contains 4 mg sucrose and 3 g glucose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant granules for oral suspension in sachet. A mix of light yellow and off-white to cream colored fine granules. The oral suspension is a thick light yellow liquid containing suspended pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Esomeprazole Orifarm is primarily indicated for: Paediatric population _Children 1-11 years old_ Gastroesophageal Reflux Disease (GERD) _-_ treatment of endoscopically proven erosive reflux esophagitis _-_ symptomatic treatment of gastroesophageal reflux disease (GERD) _Children over 4 years of age_ In combination with antibiotics in treatment of duodenal ulcer caused by _Helicobacter pylori._ _Adults and adolescents from the age of 12 years_ For indications in patients from the age of 12 years reference is made to gastro-resistant tablets containing esomeprazole. Esomeprazole Orifarm may also be used by patients having difficulty swallowing dispersed gastro- resistant tablets containing esomeprazole. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Paediatric population _Children 1–11 years with a bodyweight of ≥ 10 kg_ _Gastroesophageal Reflux Disease (GERD)_ _-_ Treatment of endoscopically proven erosive reflux esophagitis _-_ Weight ≥10 - <20 kg: 10 mg once daily for 8 weeks. _-_ Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks. _-_ Symptomatic treatment of gastroesophageal reflux disease (GERD) _-_ 10 mg once daily for up to 8 weeks. Doses over 1 mg/kg/day have not been studied. _Children over 4 years of age_ _Treatment of duodenal ulcer caused by Helicobacter pylori_ When selecting appropriate combination therapy, consideration should Прочитать полный документ