国: スウェーデン
言語: スウェーデン語
ソース: Läkemedelsverket (Medical Products Agency)
esomeprazolnatrium
Orifarm AB
A02BC05
esomeprazole sodium
40 mg
Pulver till injektions-/infusionsvätska, lösning
esomeprazolnatrium 42,5 mg Aktiv substans
Receptbelagt
Esomeprazol
Avregistrerad
2010-07-15
Page 1 of 7 Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER NEXIUM 40 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION esomeprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, nurse or pharmacist. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Nexium is and what it is used for 2. What you need to know before Nexium is given to you 3. How Nexium is given to you 4. Possible side effects 5. How to store Nexium 6. Contents of the pack and other information 1. WHAT NEXIUM IS AND WHAT IT IS USED FOR Nexium contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. Nexium is used for the short-term treatment of certain conditions, when you are unable to have treatment by mouth. It is used to treat the following conditions: Adults • ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. • Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Nexium can also be used to stop stomach ulcers from forming if you are taking NSAIDs. • Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. Children and adolescents aged 1-18 years • ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. 2. WHAT YOU NEED TO KNOW BEFORE NEXIUM IS GIVEN TO YOU YOU MUST NOT BE GIVEN NEXIUM: • If you are allergic to eso 完全なドキュメントを読む
Page 1 of 15 1 1 NAME OF THE MEDICINAL PRODUCT Nexium 40 mg Powder for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains esomeprazole 40 mg (as sodium salt). Excipient(s) with known effect This medicinal product contains <1 mmol sodium (23mg) per 40 mg, i.e. essentially sodium free. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion White to off-white porous cake or powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nexium for injection and infusion is indicated in adults for: • Gastric antisecretory treatment when the oral route is not possible, such as: gastroesophageal reflux disease (GERD) in patients with esophagitis and/or severe symptoms of reflux. healing of gastric ulcers associate with NSAID therapy. prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk. • prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. Nexium for injection and infusion is indicated in children and adolescents aged 1-18 years for: • Gastric antisecretory treatment when the oral route is not possible, such as: gastroesophageal reflux disease (GERD) in patients with erosive reflux esophagitis and/or severe symptoms of reflux. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults _Gastric antisecretory treatment when the oral route is not possible_ Patients who cannot take oral medication may be treated parenterally with 20-40 mg once daily. Patients with reflux oesophagitis should be treated with 40 mg once daily. Patients treated symptomatically for reflux disease should be treated with 20 mg once daily. _ _ For healing of gastric ulcers associated with NSAID therapy the usual dose is 20 mg once daily. For prevention of gastric and duodenal ulcers associated with NSAID therapy, patients at risk should be treated with 20 mg once daily. _ _ Page 2 of 15 2 Usually the intravenous treatment duration is short an 完全なドキュメントを読む