البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
PANTOPRAZOLE SODIUM HYDRATE
Takeda UK Limited
A02BC02
PANTOPRAZOLE SODIUM HYDRATE
40 Milligram
Pdr for Soln for Injection
Product subject to prescription which may not be renewed (A)
Proton pump inhibitors
Transfer Pending
2016-09-02
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PROTIUM ® I.V. 40 MG POWDER FOR SOLUTION FOR INJECTION Pantoprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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 Protium is and what it is used for 2. What you need to know before you use Protium 3. How to use Protium 4. Possible side effects 5. How to store Protium 6. Contents of the pack and other information 1. WHAT PROTIUM IS AND WHAT IT IS USED FOR Protium contains the active substance pantoprazole. Protium 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 diseases 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. PROTIUM IS USED FOR TREATING: Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid. Stomach and duodenal ulcers. Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROTIUM DO NOT USE PROTIUM - If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6). - If you are allergic to medicines containing other proton pump inhibitors. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Protium - If you have severe liver problems. Please tell your doctor if you ever had problems اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Protium i.v. 40 mg Powder for Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 40 mg pantoprazole (as sodium sesquihydrate) Excipients with known effect: Each vial contains 1 mg disodium edetate and 0.24 mg sodium hydroxide. This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. is essentially 'sodium-free'. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection 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 Protium is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, treatment with Protium i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead. Posology Gastric and duodenal ulcer, reflux oesophagitis The recommended intravenous dose is one vial of Protium (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 Protium. Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control. In case a rapid acid control is required, a starting dose of 2 x 80 mg Protium is suffici اقرأ الوثيقة كاملة