Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pantoprazole (pantoprazole sodium)
KRKA d.d.
A02BC02
pantoprazole (pantoprazole sodium)
40mg
powder for solution for injection
(1) glass vial, (5) glass vial, (10) glass vial
Prescription
Registered
2020-07-04
1.3.1 Pantoprazole sodium sesquihydrate SPC, Labeling and Package Leaflet AM SmPCPIL155470_1 28.08.2020 – Updated: 28.08.2020 Page 1 of 11 1. NAME OF THE MEDICINAL PRODUCT Nolpaza ® 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 lzophiliyed, 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 Posology 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. CONFIDENTIAL Nolpaza powder for solution for injection 40 mg MODULE 1 VOL: 1; P: 13 / 36 1.3.1 Pantoprazole sodium sesquihydrate SPC, Labeling and Package Leaflet AM SmPCPIL155470_1 28.08.2020 – Updated: 28.08.2020 Page 2 of 11 _Recommended dose_: Gastric and duodenal ulcer, reflux oesophagitis The recommended intravenous dose is one vial of pantoprazole (40 mg) per day. Zollinger-Ell Прочитать полный документ