Mannitol 10% Solution for Infusion BP

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Mannitol

Beschikbaar vanaf:

Baxter Holding B.V.

ATC-code:

B05BC; B05BC01

INN (Algemene Internationale Benaming):

Mannitol

Dosering:

10 percent

farmaceutische vorm:

Solution for infusion

Therapeutisch gebied:

Solutions producing osmotic diuresis; mannitol

Autorisatie-status:

Marketed

Autorisatie datum:

2007-09-14

Productkenmerken

HealthProductsRegulatoryAuthority
22March2019
CRN008KF6
Page1of10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mannitol10%SolutionforInfusionBP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mannitol: 100g/l
Eachmlcontains100mgmannitol.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
SolutionforInfusion.
Clear,colourlesssolution,freefromvisibleparticles.
Osmolarity:549mOsm/l(approx)
pH:4.5–7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mannitol10%Solutionforinfusionisindicatedforuseasanosmoticdiureticinthefollowingsituations:
1.Promotionofdiuresisinthepreventionand/ortreatmentoftheoliguricphaseofacuterenalfailurebeforeirreversiblerenal
failurebecomesestablished.
2.Reductionofintracranialpressureandcerebraloedema,whenblood-barrierisintact.
3.Reductionofelevatedintraocularpressurewhenitcannotbeloweredbyothermeans
4.Promotionofeliminationofrenallyexcretedtoxicsubstancesinpoisoning.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Thechoiceofthespecificmannitolconcentration,dosageandrateofadministrationdependsontheage,weight,clinicaland
biologicalconditionofthepatientandconcomitanttherapy.
ADULTS AND ADOLESCENTS:
_Acute renal failure_
Thegeneraldoserangeis50to200gmannitol(500mlto2000ml/day)ina24hourperiod,withadosagelimitof50g(500ml
mannitol)onanyoneoccasion.Inmostinstances,adequateresponsewillbeachievedatadosageof50to100gmannitol/day
(500mlto1000ml/day).
Therateofadministrationi