Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
PANTOPRAZOLE
Takeda GmbH
PANTOPRAZOLE
40 Milligram
Pdr for Soln for Injection
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-10-21
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PANTOPRAZOLE NYCOMED I.V. 40 MG POWDER FOR SOLUTION FOR INJECTION Pantoprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Pantoprazole Nycomed is and what it is used for 2. Before you use Pantoprazole Nycomed 3. How to use Pantoprazole Nycomed 4. Possible side effects 5. How to store Pantoprazole Nycomed 6. Further information 1. WHAT PANTOPRAZOLE NYCOMED IS AND WHAT IT IS USED FOR Pantoprazole Nycomed is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related disease of the stomach and intestine. This preparation is injected into a vein and will only be given to you if your doctor thinks pantoprazole injections are more suitable for you at the moment than pantoprazole tablets. Tablets will replace your injections as soon as your doctor sees fit. PANTOPRAZOLE NYCOMED IS USED FOR TREATING: - Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitating of stomach acid. - Stomach and duodenal ulcers - Zollinger-Ellison Syndrome and other conditions producing too much acid in the stomach. 2. BEFORE YOU USE PANTOPRAZOLE NYCOMED DO NOT USE PANTOPRAZOLE NYCOMED - If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazole Nycomed (see section 6). - If you are allergic t Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pantoprazole Nycomed i.v. 40 mg powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate) _Excipients:_ Each vial contains 1mg disodium edetate and 0.24mg sodium hydroxide. This medicinal product contains less than 1 mmol sodium (23mg) per vial, i.e. is essentially 'sodium-free'. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection A white to off-white powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Reflux oesophagitis - Gastric and duodenal ulcer - Zollinger-Ellison syndrome and other pathological hypersecretory conditions 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicine should be administered by a healthcare professional and under appropriate medical supervision Intravenous administration of Pantoprazole Nycomed is recommended only if oral application is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, treatment with Pantoprazole Nycomed i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead. _Recommended dosage_ Gastric and duodenal ulcer, reflux oesophagitis The recommended intravenous dose is one vial of Pantoprazole Nycomed (40 mg pantoprazole) per day. Zollinger-Ellison syndrome and other pathological hypersecretory conditions For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg Pantoprazole Nycomed. Thereafter, the dosage can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, t Прочитайте повний документ