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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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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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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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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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