Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Pantoprazole sodium sesquihydrate
AS Kalceks
A02BC02
Pantoprazole sodium sesquihydrate
Powder for solution for injection
pantoprazole
Not marketed
2023-06-09
PACKAGE LEAFLET: INFORMATION FOR THE USER PANTOPRAZOLE 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 Pantoprazole is and what it is used for 2. What you need to know before you are given Pantoprazole 3. How Pantoprazole will be given 4. Possible side effects 5. How to store Pantoprazole 6. Contents of the pack and other information 1. WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR This medicine contains the active substance pantoprazole. It 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 medicine 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 thinks it is possible. PANTOPRAZOLE IS USED IN ADULTS FOR TREATING: – reflux oesophagitis. This is 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 that cause too much acid to be produced in the stomach. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PANTOPRAZOLE YOU SHOULD NOT BE GIVEN PANTOPRAZOLE – if you are allergic to pantoprazole or 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 or nurse b Lire le document complet
Health Products Regulatory Authority 13 June 2023 CRN00CPP5 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pantoprazole 40 mg powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 40 mg pantoprazole (as sodium sesquihydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection. White or almost white uniform porous cake. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pantoprazole is indicated for use in adults for: 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 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, intravenous treatment with pantoprazole should be discontinued and 40 mg of pantoprazole should be administered orally instead. Posology _Gastric and duodenal ulcer, reflux oesophagitis_ The recommended dose is 40 mg pantoprazole daily. _Zollinger-Ellison syndrome and other pathological hypersecretory conditions_ For the long-term management of Zollinger-Ellison syndrome and other pathological hypersecretory conditions the recommended initial dose is 80 mg pantoprazole daily. Thereafter, the dose can be adjusted according to measurements of gastric acid secretion. With daily doses above 80 mg, 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, an initial dose of 2 x 80 mg pantoprazole is sufficient to manage a decrease of acid output into the target range (< 10 mEq/h) within one hour in the majority of Lire le document complet