FEIBA

Main information

  • Trade name:
  • FEIBA Pdr+Solv for soln for Inf 1000
  • Dosage:
  • 1000
  • Pharmaceutical form:
  • Pdr+Solv for soln for Inf
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FEIBA Pdr+Solv for soln for Inf 1000
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/138/002
  • Authorization date:
  • 28-05-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FEIBA1000Upowderandsolventforsolutionforinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:FactorVIIIInhibitorBypassingActivity

Astheactiveingredient,FEIBA1000U*contains1000UfactorVIIIinhibitorbypassingactivityin400–1200mg

humanplasmaprotein.

FEIBAalsocontainsthefactorsII,IXandX,mainlyinnon-activatedform,aswellasactivatedfactorVII.FactorVIII

coagulationantigen(FVIIIC:Ag)ispresentataconcentrationofupto0.1U./1U.FEIBA.Thefactorsofthe

kallikrein-kininsystemarepresentintraceamountsonly,ifatall.

*1unitofFEIBAshortenstheactivatedpartialthromboplastintime(aPTT)ofafactorVIIIinhibitorplasmaby50%of

thebuffervalue(emptyvalue).

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Powderandsolventforsolutionforinfusion.

White,off-whiteorpalegreenpowder.ThepHvalueoftheready-to-usesolutionisbetween6.8and7.6.

4CLINICALPARTICULARS

4.1TherapeuticIndications

TreatmentofbleedingepisodesinpatientswithhemophiliaAandfactorVIIIinhibitors

Treatmentofbleedinginnon-hemophiliacswithacquiredinhibitorstofactorVIII.

ProphylaxisofbleedingininhibitorhemophiliaApatientswhohaveexperiencedasignificantmusculoskeletal

bleedrequiringtheuseofabypassingagentorwithsignificantimpairmentofqualityoflifeduetobleeding

and/orwhohaveexperiencedasinglelife-threateningbleed(e.g.intracranial,intra-abdominal,intrathoracic

bleed).

4.2Posologyandmethodofadministration

Thetreatmentistobeinitiatedandmonitoredbyaphysicianexperiencedinthetreatmentofcoagulationdisorders.

Posology

Dosageanddurationoftreatmentdependontheseverityofthehaemostaticdisorder,thelocalizationandtheextentof

thebleeding,aswellastheclinicalconditionofthepatient.

Dosageandfrequencyofadministrationshouldalwaysbeguidedbytheclinicalefficacyineachindividualcase.

Asageneralguideline,adoseof50–100UFEIBAperkgbodyweightisrecommended;asingledoseof100U/kg

bodyweightandamaximumdailydoseof200U/kgbodyweightmustnotbeexceededunlesstheseverityofbleeding

warrantsandjustifiestheuseofhigherdoses.

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Paediatricuse(children)

Theexperienceinchildrenunder6yearsofageislimited;thesamedoseregimenasinadultsshouldbeadaptedtothe

child’sclinicalcondition.

1)Spontaneousbleeding

Joint,muscleandsofttissuehemorrhage

Adoseof50–75U/kgbodyweightat12-hourintervalsisrecommendedforminortomoderatelyseverebleeding.The

treatmentistobecontinueduntilaclearimprovementoftheclinicalsymptoms,e.g.reductionofpain,decreaseof

swellingorincreaseofjointmobility,occurs.

Forseveremuscleandsofttissuebleeding,e.g.retroperitonealhemorrhages,adoseof100U/kgbodyweightat12-

hourintervalsisrecommended.

Mucousmembranehemorrhage

Adoseof50U/kgbodyweightevery6hoursundercarefulmonitoringofthepatient(visualcontrolofbleeding,

repeateddeterminationofhematocrit)isrecommended.Ifthebleedingdoesnotstop,thedosemaybeincreasedto100

U/kgbodyweight,howeveradailydoseof

200U/kgbodyweightmustnotbeexceeded.

Otherseverehemorrhages

Inseverehemorrhage,suchasCNSbleeding,adoseof100U/kgbodyweightat12-hourintervalsisrecommended.In

individualcases,FEIBAmaybeadministeredat6-hourintervals,untilclearimprovementoftheclinicalconditionis

achieved.(Themaximumdailydoseof200U/kgbodyweightmustnotbeexceeded!)

2)Surgery

Insurgicalinterventions,aninitialdoseof100U/kgbodyweightmaybeadministeredpreoperatively,andafurther

doseof50–100U/kgbodyweightmaybeadministeredafter6–12hours.Asapostoperativemaintenancedose,50–

100U/kgbodyweightmaybeadministeredat6–12-hourintervals;dosage,dosageintervalsanddurationoftheperi-

andpostoperativetherapyareguidedbythesurgicalintervention,thepatient’sgeneralconditionandtheclinical

efficacyineachindividualcase.(Themaximumdailydoseof200U/kgbodyweightmustnotbeexceeded!)

3)Prophylaxis

Prophylaxisofbleedinginpatientswithahighinhibitortiterandfrequenthemorrhagesafterfailed

immunetoleranceinduction(ITI)orwhenanITIisnotconsidered:

adoseof70–100U/kgbodyweighteveryotherdayisrecommended.Ifnecessary,thedosemaybe

increasedto100U/kgbodyweightperdayoritmaybedecreasedgradually.

Prophylaxisofbleedinginpatientswithahighinhibitortiterduringanimmunetoleranceinduction

(ITI):

FEIBAmaybeadministeredconcomitantlywithfactorVIIIadministration,inadosagerangeof50–100

U/kgbodyweight,twiceperday,untilthefactorVIIIinhibitortiterhasdecreasedto<2B.U.*

*1BethesdaUnitisdefinedastheamountofantibodieswhichinhibits50%factorVIIIactivityinincubatedplasma(2hat37°C).

4)UseofFEIBAinspecialpatientgroups

Seesection5.1forinformationinrelationtohemophiliaBpatientswithfactorIXinhibitor.

IncombinationwithfactorVIIIconcentrate,FEIBAwasalsousedforlongtermtherapytoachievecompleteand

permanenteliminationofthefactorVIIIinhibitor.

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Duetothecomplexmechanismofaction,nodirectmonitoringofactiveingredientsisavailable.Coagulationtestssuch

asthewholebloodcoagulationtime(WBCT),thethromboelastogram(TEG,r-value)andtheaPTTusuallyshowonly

littlereductionanddonotnecessarilycorrelatewiththeclinicalefficacy.Thereforethesetestshavelittlesignificance

inthemonitoringofthetherapywithFEIBA.SeeSection4.4.

Methodofadministration

Reconstitutetheproductasdescribedinsection6.6andslowinfusionviatheintravenousroute.Aninfusionrateof2

U/kgbodyweightperminutemustnotbeexceeded.

4.3Contraindications

FEIBAmustnotbeusedinthefollowingsituationsiftherapeuticalternativestoFEIBAareavailable:

Hypersensitivitytotheproductoranyofthecomponents.

DisseminatedIntravascularCoagulation(DIC)

InthefollowingsituationsFEIBAshouldonlybeusedif-forexampleduetoaveryhighinhibitortitre-noresponse

totreatmentwiththeappropriatecoagulationfactorconcentratecanbeexpected.

1.Laboratoryand/orclinicalsymptomsthatareclearlyindicativeofliverdamage:duetothedelayedclearanceof

activatedcoagulationfactorssuchpatientsareatanincreasedriskofdevelopingDIC.

2.Myocardialinfarction,acutethrombosisand/orembolism:FEIBAshouldonlybeusedinlifethreatening

bleedingepisodes.

Seesection4.4.

4.4Specialwarningsandprecautionsforuse

WARNINGS

RiskofThromboticandThromboembolicEvents

Thromboticandthromboembolicevents,includingdisseminatedintravascularcoagulation(DIC),venousthrombosis,

pulmonaryembolism,myocardialinfarction,andstroke,haveoccurredinthecourseoftreatmentwithFEIBA.

TheriskofthromboticandthromboemboliceventsmaybeincreasedwithhighdosesofFEIBA.Manyoftheseevents

occurredwithdosesabove200U/kg/dayorinpatientswithotherriskfactorsforthromboembolicevents.Thepossible

presenceofsuchriskfactorsshouldalwaysbeconsideredinpatientswithcongenitalandacquiredhemophilia.

Inthefollowingsituations,FEIBAistobeappliedonlyifnoreactiontotreatmentwithsuitablebloodcoagulation

factorconcentratescanbeexpected–e.g.incaseofahighinhibitortiterandalife-threateninghemorrhageorriskof

bleeding(e.g.post-traumaticallyorpostoperatively):

-Disseminatedintravascularcoagulation(DIC):laboratoryfindingsand/orclinicalsymptoms

-Liverdamage:Duetothedelayedclearanceofactivatedcoagulationfactors,patientswithimpairedliverfunction

areatincreasedriskofdevelopingDIC.

-Coronaryheartdisease,acutethrombosisand/orembolism.

Allergic-TypeHypersensitivityReactions

Aswithanyintravenouslyadministeredproteinpreparation,allergictypehypersensitivityreactionsmayoccur.Patients

shouldbeinformedoftheearlysignsofhypersensitivityreactions,forexampleerythema,skinrash,generalized

urticaria,pruritus,breathingdifficulties/dyspnoea,tightnessofthechest,generalindisposition,dizzinessanddropin

bloodpressureuptoallergicshock.Ifthesesymptomsoccur,patientsshouldbeadvisedtodiscontinuethetreatment

andtocontacttheirphysicianimmediately.Shockistreatedaccordingtotherulesofmodernshocktherapy.

Whenconsideringre-exposuretoFEIBAinpatientswithsuspectedhypersensitivitytotheproductoranyofits

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orsuspectedtypeofthepatient’shypersensitivity(allergicornon-allergic),includingpotentialremedialand/or

preventativetherapyoralternativetherapeuticagents.

Therapymonitoring

Individualdosesof100U/kgbodyweightanddailydosesof200U/kgbodyweightmustnotbeexceeded.Patients

whoreceiveanindividualdoseof100U/kgbodyweightaretobemonitoredcarefully,particularlywithregardtothe

developmentofaDICortheoccurrenceofsymptomsofacutecoronaryischemia.HighdosesofFEIBAshouldbe

administeredonlyaslongasstrictlynecessary–inordertostopahemorrhage.

Ifclinicallysignificantchangesinbloodpressureorpulserate,respiratorydistress,coughingorchestpainoccur,the

infusionistobediscontinuedimmediatelyandappropriatediagnosticandtherapeuticmeasuresaretobeinitiated.

SignificantlaboratoryparametersforDICareadropinfibrinogen,adropofthethrombocytecountand/orthepresence

offibrin/fibrinogendegradationproducts(FDP).OtherparametersforDICareaclearlyprolongedthrombintime,

prothrombintimeoraPTT.InpatientswithinhibitorhemophiliaorwithacquiredinhibitorstofactorsVIII,IXand/or

XI,theaPTTisprolongedbytheunderlyingdisease.

Patientswithinhibitorhemophiliaorwithacquiredinhibitorstocoagulationfactors,whoaretreatedwithFEIBA,may

haveincreasedbleedingtendencyaswellasincreasedriskofthrombosisatthesametime.

Laboratorytestsandclinicalefficacy

Invitrotests,suchasaPTT,wholebloodcoagulationtime(WBCT)andthromboelastograms(TEG)asproofof

efficacydonothavetocorrelatewiththeclinicalpicture.Therefore,attemptstonormalizethesevaluesbyincreasing

thedoseofFEIBAcannotbesuccessful,andareeventobestronglyrejectedbecauseofthepossibleriskoftriggeringa

DICthroughoverdosing.

Significanceofthethrombocytecount

IftheresponsetotreatmentwithFEIBAisinadequate,conductingathrombocytecountisrecommendedsincea

sufficientnumberoffunctionallyintactthrombocytesisnecessaryfortheefficacyofFEIBA.

Measurestopreventtransmissionofinfectiousagents

Standardmeasurestopreventinfectionsresultingfromtheuseofmedicinalproductspreparedfromhumanbloodor

plasmaincludeselectionofdonors,screeningofindividualdonationsandplasmapoolsforspecificmarkersof

infectionandtheinclusionofeffectivemanufacturingstepsfortheinactivation/removalofviruses.Despitethis,when

medicinalproductspreparedfromhumanbloodorplasmaareadministered,thepossibilityoftransmittinginfective

agentscannotbeexcludedcompletely.Thisalsoappliestounknownoremergingvirusesandotherpathogens.

ThemeasurestakenareconsideredeffectiveforenvelopedvirusessuchasHIV,HBVandHCV,andforthenon-

envelopedvirusHAV.Themeasurestakenmaybeoflimitedvalueagainstnon-envelopedvirusessuchasparvovirus

B19.ParvovirusB19infectionmaybeseriousforpregnantwomen(fetalinfection)andforindividualswith

immunodeficiencyorincreasederythropoiesis(e.g.haemolyticanaemia).

Appropriatevaccination(hepatitisAandB)shouldbeconsideredforpatientsinregular/repeatedreceiptofhuman

plasma-derivedFactorVIIIinhibitorproducts.

ItisstronglyrecommendedthateverytimethatFEIBAisadministeredtothepatient,thenameandbatchnumberof

theproductarerecordedinordertomaintainalinkbetweenthepatientandthebatchoftheproduct.

PRECAUTIONS

Duetopatient-specificfactorstheresponsetoabypassingagentcanvary,andinagivenbleedingsituationpatients

experiencinginsufficientresponsetooneagentmayrespondtoanotheragent.Incaseofinsufficientresponsetoone

bypassingagent,useofanotheragentshouldbeconsidered.

AdministrationofFEIBAtopatientswithinhibitorsmayresultinaninitialanamnesticriseininhibitorlevels.Upon

continuedadministrationofFEIBA,inhibitorsmaydecreaseovertime.Clinicalandpublisheddatasuggestthatthe

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OnlylimitedclinicaldataisavailableontheapplicationofFEIBAfortheprophylaxisofbleedinginhemophilia

patients.

FEIBA1000Ucontainsapproximately80mgsodium(calculated)pervial.Thisistobetakenintoconsiderationin

patientsonalowsodiumdiet.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Itisnotrecommendedtoadministerantifibrinolytics,suchasepsilonaminocaproicacid,togetherwithFEIBA.

Ifapplicationofboth,antifibrinolyticssuchasepsilonaminocaproicacidandFEIBA,isindicated,theintervalbetween

theadministrationofthesetwoproductsmustbeatleast6hours.

4.6Fertility,pregnancyandlactation

ThesafetyofFEIBAduringpregnancyandlactationhasnotbeenestablished.

PhysiciansshouldcarefullyconsiderthepotentialrisksandbenefitsforeachspecificpatientbeforeprescribingFEIBA.

Pregnancyandthepostpartumperiodarecharacterizedbyanincreasedriskofthrombosis,andseveralcomplicationsof

pregnancyareassociatedwithanincreasedriskofDIC.

NoanimalreproductionstudieshavebeenconductedwithFEIBA.

4.7Effectsonabilitytodriveandusemachines

FEIBAhasno,ornegligible,influenceontheabilitytodriveortousemachines.

4.8Undesirableeffects

Theadversereactionslistedinthefollowingwerereportedwithintheframeworkofeitherpost-marketingsurveillance

orclinicaltrials.

Frequencycategories:

verycommon ≥1/10

common ≥1/100to<1/10

uncommon ≥1/1,000to<1/100

rare ≥1/10,000to<1/1,000

Veryrare <1/10,000

Notknown cannotbeestimatedfromtheavailabledata

Systemorgan

classesaccordingto

theMedDRAdata

base AdverseReactions Frequency

Bloodandlymphatic

systemdisorders Disseminatedintravascularcoagulation(DIC)

Increaseofinhibitortiter(anamnesticresponse) a Notknown

Notknown

Immunesystem

disorders Hypersensitivityreactions

Urticaria

Anaphylacticreaction Notknown

Notknown

Notknown

Nervoussystem

disorders Paresthesia

Hypaesthesia

Thromboticstroke

Embolicstroke

Headache

Somnolence

Dizziness Notknown

Notknown

Notknown

Notknown

Notknown

Notknown

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Increaseofinhibitortiter(anamnesticresponse)[notaMedDRAPT]istheriseofpreviouslyexistinginhibitortitersoccurringafter

theadministrationofFEIBA.SeeSection4.4.

Rapidintravenousinfusionmaycausestabbingpainandafeelingofnumbnessinfaceandlimbs,aswellasadropin

bloodpressure.

Thromboemboliceventsmightoccuraftertheadministrationofdosesabovethemaximumdailydoseand/orprolonged

application,seeSection4.4

Forsafetywithrespecttotransmissibleagents,seeSection4.4.

4.9Overdose

OverdoseofFEIBAmayincreasetheriskofundesiredeventssuchasthromboembolism,DICormyocardialinfarction

(seeSection4.4).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:bloodcoagulationfactors,ATCcode:B02BD03.

AlthoughFEIBAwasdevelopedintheearlyseventiesanditsfactorVIIIinhibitorbypassingactivityhasbeenproven

invitroaswellasinvivo,itsmodeofactionisstillthesubjectofscientificdiscussion.Currentscientificworkspointto

Dysgeusia Notknown

Cardiacdisorders Cardiacinfarction

Tachycardia Notknown

Notknown

Vasculardisorders Embolism(thromboemboliccomplications)

Hypotension

Hypertension

Flushing Notknown

Notknown

Notknown

Notknown

Respiratory,

Thoracic,and

Mediastinaldisorders Pulmonaryembolism

Bronchospasm

Wheezing

Cough

Dyspnea Notknown

Notknown

Notknown

Notknown

Notknown

Gastrointestinal

disorders Vomiting

Diarrhea

Abdominaldiscomfort

Nausea Notknown

Notknown

Notknown

Notknown

Skinand

subcutaneoustissue

disorders Sensationofnumbnessintheface

Angioedema

Urticaria

Pruritus

Rash Notknown

Notknown

Notknown

Notknown

Notknown

Generaldisordersand

administrationsite

conditions Painattheinjectionsite

Malaise

Feelinghot

Chills

Pyrexia

Chestpain

Chestdiscomfort Notknown

Notknown

Notknown

Notknown

Notknown

Notknown

Notknown

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inthemodeofactionofFEIBA.

TheexperienceinhemophiliaBpatientswithfactorIXinhibitorislimited.40casereportsareavailablewhenFEIBA

wasusedfortreatmentandpreventionofbleedingepisodesinhemophiliaBpatientswithfactorIXinhibitor.3of

these40patientsexperiencedanaphylacticreactionduringtreatment.

TherearealsoisolatedreportsontheuseofFEIBAinthetreatmentofpatientswithacquiredinhibitorstofactorsX,XI

andXIII.

5.2Pharmacokineticproperties

AsthemodeofactionofFEIBAisstillbeingdiscussed,itisnotpossibletomakeaconclusivestatementaboutthe

pharmacokineticproperties.

5.3Preclinicalsafetydata

BasedonacutetoxicitystudiesinfactorVIIIknockoutmiceandinnormalmice,andinrats,withdoseshigherthanthe

maximumdailydoseinhumans(>200U/kgbodyweight),itcanbeconcludedthatthesideeffectsinconnectionwith

FEIBAaremainlytheresultofhypercoagulationduetothepharmacologicalproperties.

Toxicitystudieswithrepeatedadministrationinanimalexperimentsarepracticallyunfeasibleasinterferenceoccurs

throughthedevelopmentofantibodiestoheterologousproteins.

Sincehumanbloodcoagulationfactorsarenotseenascarcinogenicormutagenic,experimentalanimalstudies,

especiallyinheterologousspecies,werenotconsiderednecessary.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Powder: Sodiumchloride

Sodiumcitrate

Solvent: SterilizedWaterforInjections

6.2Incompatibilities

ThismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthesolventmentionedinSection6.6.

Asinallbloodcoagulationpreparations,theefficacyandtoleranceofthemedicinalproductmaybeimpairedbybeing

mixedwithothermedicinalproducts.Itisadvisabletorinseacommonvenousaccesswithasuitablesolution,e.g.with

isotonicsalinesolution,beforeandaftertheadministrationofFEIBA.

Coagulationfactorsderivedfromhumanplasmamaybeadsorbedbytheinnersurfacesofcertaintypesof

injection/infusiondevices.Ifthisweretooccur,itcouldresultinfailureoftherapy.Therefore,onlyapprovedplastic

infusiondevicesmaybeusedwithFEIBA.

6.3ShelfLife

Twoyears.

Chemicalandphysicalin-usestabilityhasbeendemonstratedfor3hoursatroomtemperature.Fromamicrobiological

pointofview,unlessthemethodofreconstitutionprecludestheriskofmicrobialcontamination(controlledand

validatedasepticconditions),theproductshouldbeusedimmediately.Ifnotusedimmediately,in-usestoragetimes

andconditionsaretheresponsibilityoftheuser.

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6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Donotfreeze.

Storeintheoriginalpackageinordertoprotectfromlight.Forstorageconditionsofthereconstitutedmedicinal

product–seesection6.3.

6.5Natureandcontentsofcontainer

Thepowderissuppliedinavialmadeofsurfacetreated,colorlessglass(hydrolyticclassII).Thesolventissuppliedin

avialmadeofsurfacetreated,colorlessglass(hydrolyticclassI).Thevialsareclosedbyastoppermadeofbutyl

rubber.

Thepackagecontainseither

1vialwithFEIBA1000U

1vialwith20mlsterilizedWaterforInjections

1disposablesyringe

1disposableneedle

1butterflyneedlewithclamp

1filterneedle

1transferneedle

1aerationneedle

1vialwithFEIBA1000U

1vialwith20mlsterilizedWaterforInjections

1BAXJECTIIHi-Flow

1disposablesyringe

1disposableneedle

1butterflyneedlewithclamp

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

FEIBAistobereconstitutedimmediatelypriortoadministration.Thesolutionshouldbeusedimmediately(asthe

preparationdoesnotcontainpreservatives).

Swirlgentlyuntilallmaterialisdissolved.EnsurethatFEIBAiscompletelydissolved;otherwise,lessFEIBAUnits

willpassthroughthedevicefilter.

Afterreconstitution,thesolutionshouldbeinspectedforparticulatematteranddiscolorationpriortoadministration.

Donotusesolutionswhicharecloudyorhavedeposits.

Opencontainersmustnotbere-used.

Donotusetheproductifitssterilebarrierhasbeenbreached,itspackagedamagedorifitshowssignsofdeterioration.

UseonlytheincludedsterilizedWaterforInjectionsandtheincludeddevicesetforreconstitution.Ifdevicesotherthan

thoseenclosedareused,ensuretheuseofanadequatefilterwithaporesizeofatleast149µm.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

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Warmtheunopenedsolventvial(sterilizedWaterforInjections)toroomtemperatureormax.+37°Cif

necessary.

Removetheprotectivecapsfromthepowdervialandsolventvial(Fig.A)anddisinfecttherubberstoppersof

bothvials.

Opentheprotectivecapfromoneendoftheenclosedtransferneedlebytwisting,removeitandinserttheneedle

throughtherubberstopperofthesolventvial(Fig.BandC).

Removetheprotectivecapfromtheotherendofthetransferneedletakingcarenottotouchtheexposedend!

Invertthesolventvialandinsertthefreeendofthetransferneedlethroughtherubberstopperofthepowdervial

(Fig.D).Thesolventwillbedrawnintothepowdervialbyvacuum.

Disconnectthetwovialsbyremovingthetransferneedlefromthepowdervial(Fig.E).Gentlyswirlthepowder

vialtoacceleratedissolution.

Uponcompletereconstitutionofthepowder,inserttheenclosedaerationneedle(Fig.F)andanyfoamwill

collapse.Removetheaerationneedle.

Infusion:

1.Openoneendoftheprotectivecapfromtheenclosedfilterneedlebytwisting,removeitandfittheneedleontothe

steriledisposablesyringe.Drawthesolutionintothesyringe(Fig.G).

2.Disconnectthefilterneedlefromthesyringeandslowlyadministerthesolutionintravenouslywiththeenclosed

infusionset(ortheencloseddisposableneedle).

ReconstitutionofthepowderforpreparingasolutionforinfusionwiththeBAXJECTIIHi-Flow:

Warmtheunopenedsolventvial(sterilizedWaterforInjections)toroomtemperature(15°Cto25°C),for

examplebyusingawaterbathforseveralminutes(max.37°C)ifnecessary.

Removetheprotectivecapsfromthepowdervialandsolventvialanddisinfecttherubberstoppersofboth

vials.Placethevialsonanevensurface.

OpenthepackagingoftheBAXJECTIIHi-Flowbypullingofftheprotectivefoilwithouttouchingthe

contentsofthepackage(Fig.a).Donotremovethetransfersystemfromthepackageatthispoint.

Turnthepackagearoundandpressthetransparentplasticpinthroughtherubberstopperofthesolventvial

(Fig.b).NowremovethepackagingfromtheBAXJECTIIHi-Flow(Fig.c).Donotremovetheblue

protectivecapfromtheBAXJECTIIHi-Flow.

Nowturnthesystem,consistingoftheBAXJECTIIHi-Flowandthesolventvial,insuchawaythatthe

solventvialisontop.PressthepurplepinoftheBAXJECTIIHi-FlowthroughtheFEIBAvial.The

solventisdrawnintotheFEIBAvialbyvacuum(Fig.d).

Swirl,butdonotshaketheentiresystemgentlyuntilthepowderisdissolved.MakesurethattheFEIBA

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Infusion

RemovetheblueprotectivecapfromtheBAXJECTIIHi-Flow.TightlyconnectthesyringetotheBAXJECTII

Hi-Flow.DONOTDRAWAIRINTOTHESYRINGE.(Fig.e).Inordertoensuretightconnectionbetweensyringe

andBAXJECTIIHi-Flow,theuseofaluerlocksyringeishighlyrecommended(turnsyringeinclockwisedirection

untilstoppositionwhenmounting).

Invertthesystemsothatthedissolvedproductisontop.Drawthedissolvedproductintothesyringebypulling

theplungerbackSLOWLYandensurethatthetightconnectionbetweenBAXJECTIIHi-Flowandthesyringeis

maintainedthroughoutthewholepullingprocess(Fig.f).

Disconnectthesyringe.

Iffoamingoftheproductinthesyringeoccurs,waituntilthefoamiscollapsed.Slowlyadministerthesolution

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Donotexceedaninfusionrateof2U.FEIBA/kgbodyweightperminute.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLimited

CaxtonWay

Thetford

IP243SENorfolk

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA167/138/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28thMay2010

10DATEOFREVISIONOFTHETEXT

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