Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pantoprazole (pantoprazole sodium sesquihydrate)
Takeda GmbH
A02BC02
pantoprazole (pantoprazole sodium sesquihydrate)
40mg
powder for solution for injection
glass vial
Prescription
Registered
2019-10-29
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Controloc 40 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 40 mg of 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 Controloc 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 Controloc 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 {Controloc} (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 Controloc. 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. 3 In case a rapid acid control is required, a starting dose of 2 Прочитать полный документ