Country: Шведска
Језик: Шведски
Извор: Läkemedelsverket (Medical Products Agency)
esomeprazolnatrium
Grünenthal GmbH
A02BC05
esomeprazole sodium
40 mg
Pulver till infusionsvätska, lösning
esomeprazolnatrium 42,5 mg Aktiv substans
Apotek
Receptbelagt
Esomeprazol
Förpacknings: Injektionsflaska, 1 st; Injektionsflaska, 10 st
Godkänd
2003-08-22
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER CATIVA 40 MG POWDER FOR SOLUTION FOR 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 Cativa is and what it is used for 2. What you need to know before Cativa is given to you 3. How Cativa is given to you 4. Possible side effects 5. How to store Cativa 6. Contents of the pack and other information 1. WHAT CATIVA IS AND WHAT IT IS USED FOR Cativa 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. Cativa 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). Cativa 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 CATIVA IS GIVEN TO YOU YOU MUST NOT BE GIVEN CATIVA: If you are allergic to esomeprazole or any of th Прочитајте комплетан документ
1 Produktinformationen för Cativa 40 mg pulver till infusionsvätska, lösning, MTnr 19346, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. 2 SUMMARY OF THE PRODUCT CHARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT CATIVA 40 mg Powder for solution for infusion 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each vial contains esomeprazole 40 mg (as sodium salt). Each vial contains <1 mmol sodium For a full list of excipients see section 6.1. 3 P HARMACEUTICAL F ORM Powder for solution for infusion. White to off-white porous cake or powder 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Cativa for infusion is indicated for _Adults_ 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. _Children and adolescents aged 1-18 years _ 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 sh Прочитајте комплетан документ