Land: Malta
Språk: engelsk
Kilde: Medicines Authority
ESOMEPRAZOLE
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom
A02BC05
ESOMEPRAZOLE 40 mg
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
ESOMEPRAZOLE 40 mg
POM
DRUGS FOR ACID RELATED DISORDERS
Withdrawn
2014-07-15
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ESOMEPRAZOLE 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Esomeprazole is and what it is used for 2. What you need to know before you use Esomeprazole 3. How to use Esomeprazole 4. Possible side effects 5. How to store Esomeprazole 6. Contents of the pack and other information 1. WHAT IS ESOMEPRAZOLE AND WHAT IT IS USED FOR Esomeprazole 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. Esomeprazole is used for the short-term treatment of certain conditions, when you are unable to have treatment by mouth. It is used to treat: • ‘Gastro-oesophageal reflux disease’ (GORD) in adults, adolescents and children. 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 in adults caused by medicines called NSAIDs (Non-Steroidal Anti- Inflammatory Drugs). Esomeprazole can also be used to stop stomach ulcers from forming if you are taking NSAIDs. • Prevention of rebleeding in adults following therapeutic endoscopy for acute bleeding gastric or duoden Les hele dokumentet
Esomeprazole 40 mg Powder for Solution for Injection/Infusion SE/H/1304/01/DC v4 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Esomeprazole 40 mg Powder for Solution for Injection/Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 42.5 mg esomeprazole sodium equivalent to 40 mg esomeprazole. Excipients with known effect: Each vial contains less than 1 mmol sodium. For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion. White to off-white cake/powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Esomeprazole for injection and infusion is indicated for: _Adults_ • gastric antisecretory treatment when the oral route is not possible, such as: • gastro-oesophageal reflux disease (GORD) in patients with oesophagitis and/or severe symptoms of reflux • healing of gastric ulcers associated 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. _Children and adolescents aged 1-18 years _ • gastric antisecretory treatment when the oral route is not possible, such as: - gastro-oesophageal reflux disease (GORD) in patients with erosive reflux oesophagitis 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 2 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 trea Les hele dokumentet