Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Mannitol
Baxter Holding B.V.
B05BC; B05BC01
Mannitol
10 percent
Solution for infusion
Solutions producing osmotic diuresis; mannitol
Marketed
2007-09-14
HealthProductsRegulatoryAuthority 22March2019 CRN008KF6 Page1of10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mannitol10%SolutionforInfusionBP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mannitol: 100g/l Eachmlcontains100mgmannitol. Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM SolutionforInfusion. Clear,colourlesssolution,freefromvisibleparticles. Osmolarity:549mOsm/l(approx) pH:4.5–7.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mannitol10%Solutionforinfusionisindicatedforuseasanosmoticdiureticinthefollowingsituations: 1.Promotionofdiuresisinthepreventionand/ortreatmentoftheoliguricphaseofacuterenalfailurebeforeirreversiblerenal failurebecomesestablished. 2.Reductionofintracranialpressureandcerebraloedema,whenblood-barrierisintact. 3.Reductionofelevatedintraocularpressurewhenitcannotbeloweredbyothermeans 4.Promotionofeliminationofrenallyexcretedtoxicsubstancesinpoisoning. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Thechoiceofthespecificmannitolconcentration,dosageandrateofadministrationdependsontheage,weight,clinicaland biologicalconditionofthepatientandconcomitanttherapy. ADULTS AND ADOLESCENTS: _Acute renal failure_ Thegeneraldoserangeis50to200gmannitol(500mlto2000ml/day)ina24hourperiod,withadosagelimitof50g(500ml mannitol)onanyoneoccasion.Inmostinstances,adequateresponsewillbeachievedatadosageof50to100gmannitol/day (500mlto1000ml/day). Therateofadministrationi Læs hele dokumentet