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WaterforInjectionFDAprescribinginformation,sideeffectsanduses
WaterforInjection
DosageForm:injection
SterileWaterforInjectionUSP
WaterforInjectionDescription
Thispreparationisdesignedsolelyforparenteraluseonlyafteradditiontodrugsthatrequiredilutionormust
bedissolvedinanaqueousvehiclepriortoinjection.
SterileWaterforInjection,USPisasterile,nonpyrogenicpreparationofWaterforInjectionwhichcontainsno
bacteriostat,antimicrobialagentoraddedbufferandissuppliedonlyinsingledosecontainerstodiluteor
dissolvedrugsforinjection.ForIVinjection,addsufficientamounttoasolutetomakeanapproximately
isotonicsolution.pH5.0to7.0.
WaterforInjection,USPischemicallydesignatedH2O.
WaterforInjectionClinicalPharmacology
Waterisanessentialconstituentofallbodytissuesandaccountsforapproximately70%oftotalbodyweight.
Averagenormaladultdailyrequirementrangesfromtwotothreeliters(1to1.5literseachforinsensible
waterlossbyperspirationandurineproduction).
Waterbalanceismaintainedbyvariousregulatorymechanisms.Waterdistributiondependsprimarilyonthe
concentrationofelectrolytesinthebodycompartmentsandsodium(Na+ )playsamajorroleinmaintaining
physiologicequilibrium.
ThesmallvolumeoffluidprovidedbySterileWaterforInjection,USPwhenusedonlyasapharmaceuticaid
fordilutingordissolvingdrugsforparenteralinjection,isunlikelytoexertasignificanteffectonfluidbalance
exceptpossiblyinnewbornsorverysmallinfants.
IndicationsandUsageforWaterforInjection
Thisparenteralpreparationisindicatedonlyfordilutingordissolvingdrugsforintravenous,intramuscularor
subcutaneousinjection,accordingtoinstructionsofthemanufacturerofthedrugtobeadministered.
Contraindications
SterileWaterforInjectionmustbemadeapproximatelyisotonicpriortouse.
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WaterforInjectionFDAprescribinginformation,sideeffectsanduses
Warnings
IntravenousadministrationofSterileWaterforInjectionwithoutasolutemayresultinhemolysis.
WhereWaterforInjectionisrequiredforpreparingordilutingmedicationsforuseinnewborns,only
preservativefreeSterileWaterforInjectionshouldbeused.
Precautions
General
Donotuseforintravenousinjectionunlesstheosmolarconcentrationofadditivesresultsinanapproximate
isotonicadmixture.
Consultthemanufacturersinstructionsforchoiceofvehicle,appropriatedilutionorvolumefordissolvingthe
drugstobeinjected,includingtherouteandrateofinjection.
Inspectreconstituted(dilutedordissolved)drugsforclarity(ifsoluble)andfreedomfromunexpected
precipitationordiscolorationpriortoadministration.
DrugInteractions
Somedrugsforinjectionmaybeincompatibleinagivenvehicle,orwhencombinedinthesamevehicle.
Consultwithpharmacist,ifavailable.
PregnancyCategoryC
AnimalreproductionstudieshavenotbeenconductedwithSterileWaterforInjection.Itisalsonotknown
whetherSterileWaterforInjectioncancausefetalharmwhenadministeredtoapregnantwomanorcan
affectreproductioncapacity.SterileWaterforInjectionshouldbegiventoapregnantwomanonlyifclearly
needed.
PediatricUse
Thesafetyandeffectivenessinthepediatricpopulationarebasedonthesimilarityoftheclinicalconditionsof
thepediatricandadultpopulations.Inneonatesorverysmallinfantsthevolumeoffluidmayaffectfluidand
electrolytebalance.
AdverseReactions
Reactionswhichmayoccurbecauseofthissolution,addeddrugsorthetechniqueofreconstitutionor
administrationincludefebrileresponse,localtenderness,abscess,tissuenecrosisorinfectionatthesiteof
injection,venousthrombosisorphlebitisextendingfromthesiteofinjectionandextravasation.Ifanadverse
reactiondoesoccur,discontinuetheinfusion,evaluatethepatient,instituteappropriatecountermeasures,
andifpossible,retrieveandsavetheremainderoftheunusedvehicleforexamination.
Overdosage
Useonlyasadiluentorsolvent.Thisparenteralpreparationisunlikelytoposeathreatoffluidoverload
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WaterforInjectionFDAprescribinginformation,sideeffectsanduses
exceptpossiblyinnewbornorverysmallinfants.Intheeventtheseshouldoccur,reevaluatethepatientand
instituteappropriatecorrectivemeasures(seeWARNINGS,PRECAUTIONSandADVERSEREACTIONS).
WaterforInjectionDosageandAdministration
Thevolumeofthepreparationtobeusedfordilutingordissolvinganydrugforinjection,isdependentonthe
vehicleconcentration,doseandrouteofadministrationasrecommendedbythemanufacturer.
Useaseptictechniqueforsingleentryandwithdrawalfromallcontainers.Singledosevialsshouldbe
enteredjustonce.
Whendilutingordissolvingdrugs,mixthoroughlyandusepromptly.
Donotstorereconstitutedsolutionsofdrugsforinjectionunlessotherwisedirectedbythemanufacturerof
thesolute.
Parenteraldrugproductsshouldbeinspectedvisuallyforparticulatematteranddiscolorationpriorto
administration,wheneversolutionandcontainerpermit.
HowisWaterforInjectionSupplied
Product NDC
No.
No.
Volume
918501 63323185011mLina3mLvial
918510 633231851010mLina10mLvial
918520 633231852020mLina20mLvial
918550 633231855050mLina50mLvial
Packagedinaplasticvial.Vialsarepackaged25vialspertray.
Storeat20to25C(68to77F)[seeUSPControlledRoomTemperature].
Singledoseuse.Nopreservativeadded.
Unusedportionofvialshouldbediscarded.
Useonlyifsolutionisclearandsealintact.
45768F
Revised:July2008
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WaterforInjectionFDAprescribinginformation,sideeffectsanduses
PACKAGELABELPRINCIPALDISPLAYSTERILEWATER10mLSingleDoseVialLabel
NDC6332318510
918510
SterileWaterforInjection,USP
FORDRUGDILUENTUSEONLY
Rxonly
10mLSingleDoseVial
STERILEWATER
waterinjection
ProductInformation
ProductType
HUMANPRESCRIPTIONDRUGLABEL
ItemCode(Source)
NDC:63323
185
RouteofAdministration
INTRAVENOUS,INTRAMUSCULAR,
SUBCUTANEOUS
DEASchedule
InactiveIngredients
IngredientName
Strength
WATER
Packaging
#ItemCode
PackageDescription
1 NDC:6332318510
25VIALin1TRAY
10mLin1VIAL
2 NDC:6332318550
25VIALin1TRAY
50mLin1VIAL
3 NDC:6332318520
25VIALin1TRAY
20mLin1VIAL
MarketingInformation
MarketingCategory
ApplicationNumberorMonographCitation
MarketingStartDate
ANDA
ANDA088400
09/05/2000
MarketingEndDate
LabelerFreseniusKabiUSA,LLC(608775388)
Establishment
Name
FreseniusKabiUSA,LLC
Address
ID/FEI
Operations
840771732
MANUFACTURE(63323185)
Revised:10/2014
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FreseniusKabiUSA,LLC
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WaterforInjectionFDAprescribinginformation,sideeffectsanduses
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