Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
PANTOPRAZOLE SODIUM SESQUIHYDRATE
Pliva Pharma Limited
40 Milligram
Pdr for Soln for Injection
2012-03-30
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 of pantoprazole (as sodium sesquihydrate) _Excipients_ Each vial contains 5.0 mg of sodium citrate dihydrate and sodium hydroxide q.s. This medicinal product contains less than 1 mmol sodium (23 mg) 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. White or almost white, uniform porous cake. For the solution reconstituted with 10 ml of 0.9% NaCl solution the pH is approximately 10 and the osmolality is approximately 382 mOsm/Kg For the solution reconstituted with a further 100 ml of 0.9% NaCl solution or 5% glucose solution the pH is approximately 9 and 8.5, respectively 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. The intravenous administration of pantoprazole 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 i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead. _Recommended dose_: Gastric and duodenal ulcer, reflux oesophagitis The recommended intravenous dose is one vial of pantoprazole (40 mg) per day. Zollinger-Ellison Syndrome and other pathological hypersecretory conditions For the long-term management of Zollinger-Ellison Syndrome and Prečítajte si celý dokument