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HepaSphere™ Microspheres (With Doxorubicin) IFU- Canada (English/French)

HepaSphere™ Microspheres (With Doxorubicin) IFU- Canada (English/French)

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Published by: Merit Medical Systems on Nov 29, 2012
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HEPASPHERE MICROSPHERES CANBE USED WITH ORWITHOUTLOADINGOF DOXORUBICINHCL.
OPTION 1: PREPARATION FOR EMBOLIZATION WITHOUT DOXORUBICIN HCL (BLAND)
 The approximate reconstitution time when used without loading of doxorubicin HCl is 10 min.
•Filla10mlsyringewith100%NaCl0.9%aqueoussolutionornon-ioniccontrastmedium(or50%NaCl0.9%aqueoussolutionand50%contrast).Connectthesyringetoaneedleof
20 gauge diameter or larger.
•ToensureproperreconstitutionoftheHepaSphereMicrospheres,graspthevialhorizontallyinyourngertipsandrollthevialseveraltimes.Thiswilltransferthedrycontentsofthevial
to the sidewall.
Note:
Pullbackonlytheip-topcap;donotremovethecrimpringorthestopperfromthevial.•Carefullyinserttheneedlefromthesyringethroughthestopperofthevial.Continuerollingthevialinyourngertipsandinjectthefullamount
(10ml)
of reconstitution medium into the
vial,thenplacethevialverticallyandcarefullyremovethesyringewiththeneedleattached.
Note
:Thevialishermeticallyclosed.Properaspirationand/orventingtechniques,asapprovedbythehealthcarefacility,maybeusedforeasierinjectionofreconstitutionmediumintovial.Ifaspirationofairfromthevialisperformedpriortoreconstitution,exercisecautionnottoremovethespheresfromthevial.•ToensureahomogeneousreconstitutionoftheHepaSphereMicrospheres,gentlyinvertthevialbackandforthsothattheliquidcontactsthestopper5-10times.
Note:
Vigorousshakingmayintroducemicrobubbles,whichcancausethemicrospheres
to aggregate.
•Waitaminimumof
10 minutes
toallowtheHepaSphereMicrospherestoreconstituteandexpandfully.•Usea30mlsyringeand20gaugeorlargerneedletoaspiratethecontentsofthevial.Rotatethevialtoaverticalpositionwiththebottomofthevialfacingupward.Pulltheneedlebacksothatitissubmergedintheliquidbutnotoccludedbythestopper.Gentlyaspiratetheentirecontentsofthevialintothesyringe.
Note:
Iftheairwaspreviouslyaspiratedfromthevial,gentleinjectionofairusingthesyringepriortoaspiratingthecontentsofthevialwillensureaneasieraspirationofvialcontentsintothesyringe.Ifallcontentsarenotwithdrawn,introduceanadditionalvolumeofairandrepeattheaspirationprocess.Itispossibletoaddanadditionalamountofnon-ioniccontrastorNaCl0.9%aqueoussolutionintothesyringeinordertogetahigherdispersionofmicrospheres.
Note:
HepaSphereMicrospheresreconstitutedasdescribedabovecanbeusedinthepresenceofchemotherapeuticagentssuchascisplatin,epirubicin,doxorubicinHCl,uorouracil,irinotecanandmitomycinafterhydration.Howeverfordrugdelivery,HepaSphereMicrospheresareonlyindicatedforusewithdoxorubicinHCl(seebelowOption2).•Ifmicrosphereswerereconstitutedusing100%NaCl0.9%,non-ioniccontrastmediummustbeaddedtothesyringecontainingtheHepaSphereMicrospheresforvisualizationunderuoroscopy.Ifnon-ioniccontrastmediumwasusedtoreconstitutethemicrospheres,additionalnon-ioniccontrastmediummaybeadded.
OPTION 2: PREPARATION FOR EMBOLIZATION LOADED WITH DOXORUBICIN HCLWARNING:
Liposomal formulations of doxorubicin HCl are not suitable for loading into Hepa
-SphereMicrospheres.AsageneralguidelinetheloadingoflyophilizeddoxorubicinHClsolubilizedinNaCl0.9%solu-tionintoHepaSphereMicrosphereswilltakeonehour.TheHepaSphereMicrospheresshouldnotbeusedbeforetheyarefullyhydratedandexpanded.Loadingkineticsofpre-solubilizeddoxorubicinHCImayvary,dependingontheconcentrationandpHofthesolution.•ChoosetheappropriatedoseofdoxorubicinHCltoloadintotheHepaSphereMicrospheres.
Note:
AmaximumdoseofdoxorubicinHCl75mgcanbeloadedintoeachvialofHepaSphereMicrospheres.SolubilizethedesireddoseoflyophilizeddoxorubicinHClin20mlofNaCl0.9%solutionforinjection.NEVERUSEPUREWATER
Note:
MaximumrecommendedconcentrationofdoxorubicinHClis5mg/ml.ConcentrationsofdoxorubicinHClabove5mg/mlsubstantiallyincreasethesolutionviscosityandmakeitdiculttohandlewithHepaSphereMicrospheres.•Aspiratethe20mlofdoxorubicinHClsolutionintotwoseparate30mlsyringes.Each30mlsyringeshouldcontain10mlofdoxorubicinHClsolution.•Connectoneofthe30mlsyringescontaining10mlofthedoxorubicinHClsolutiontoaneedle
of 20 gauge diameter or larger.
•ToensureproperreconstitutionoftheHepaSphereMicrospheres,grasptheHepaSphereMicrospheresvialhorizontallyinyourngertipsandrollthevialseveraltimes.Thiswilltransferthedrycontentsofthevialtothesidewall.
Note:
Pullbackonlytheip-topcap;donotremovethecrimpringorthestopperfromthevial.•Carefullyinserttheneedleofoneofthe30mlsyringescontaining10mlofdoxorubicinHClsolutionthroughthestopperofthevial.Continuerollingthevialinyourngertipsandinjectthefull10mlofdoxorubicinHClsolutionintothevial.•PlacetheHepaSphereMicrospheresvialvertically.Carefullyremovethesyringewiththeneedleattached,andallowthevialtostandfor10minutesinordertocompletelyhydrate
the spheres.
•Duringthe10minuteshydrationperiod,shaketheHepaSphereMicrospheresvialseveraltimesbackandforthsothattheliquidcontactsthegreystopper.Repeatthisprocessevery2-3minutestoensureahomogenousreconstitutionoftheHepaSphereMicrospheres.
Note:
 Thevialishermeticallyclosed.Properaspirationand/orventingtechniques,asapprovedbythehealthcarefacility,maybeusedforeasierinjectionofreconstitutionmediaintothevial.Ifaspirationofairfromthevialisperformedpriortoreconstitution,exercisecautionnottoremovethespheresfromthevial.•Afterthe10minuteshydrationperiod,attacha20gaugeorlargerneedletothesecond30mlsyringecontainingtheremaining10mlofdoxorubicinHClsolutionandinsertintotheHepaSphereMicrospheresvial.AspiratethecontentsoftheHepaSphereMicrospheresvialintothe30mlsyringecontainingtheremaining10mlofdoxorubicinHClsolution.Rotatethevialtoaverticalpositionwiththebottomofthevialfacingupward.Pulltheneedlebacksothatitissubmergedintheliquidbutnotoccludedbythestopper.Gentlyaspiratetheentirecontentsofthevialintothesyringe.•PriortoremovingtheneedlefromtheHepaSphereMicrospheresvial,whileholdingthesyringevertically,gentlypulltheplungerofthesyringedown,removinganysolutionthatmaybeinthehuboftheneedle.•Replacetheneedlewithasyringecapandinvertthesyringebackandforthtodispersethecontentswithinthesyringe.Waitaminimumof60minutestoallowtheHepaSphereMicrospherestoexpandfullyandloadthedoxorubicinHCl.Duringthe60minutes,thesyringeshouldbeinvertedevery10–15minutesinordertooptimizethedrugdistribution
into the spheres.
•After60minutes,letthesyringestandforthespherestosettledownandpurgeallsupernatantanddiscarditfollowingfacilityapprovedstandards.•Addaminimumof20mlofnon-ioniccontrastmediumtothe30mlsyringecontainingthedoxorubicinHClloadedHepaSphereMicrospheres,howeverlargervolumeofsolutioncanprovidebettercontrolduringembolization.Gentlyinvertthesyringe2or3timesandwait5minuntilsolutionhomogeneityisreached.•Beforeanyinjection,checkthespheresareinsuspension,ifnotinvertthesyringebackandforthtodispersecontentswithinthesyringe.
PRECAUTIONS:
HepaSphereMicrospheresmustonlybeusedbyphysicianstrainedinvascularembolizationprocedures.Thesizeandquantityofmicrospheresmustbecarefullyselectedaccordingtothelesiontobetreatedandthepotentialpresenceofshunts.OnlythephysiciancandecidethemostappropriatetimetostoptheinjectionofHepaSphereMicrospheres.Donotuseifthevial,cap,orpouchappeardamaged.Forsinglepatientuseonly-Contentssuppliedsterile-Neverreuse,reprocess,orresterilizethecontentsofavialthathasbeenopened.Reusing,reprocessingorresterilizingmaycompromisethestructuralintegrityofthedeviceandorleadtodevicefailure,whichinturnmayresultinpatientinjury,illnessordeath.Reusing,reprocessingorresterilizingmayalsocreateariskofcontaminationofthedeviceandorcausepatientinfectionorcrossinfectionincluding,butnotlimitedto,thetransmissionofinfectiousdisease(s)fromonepatienttoanother.Contamina-tionofthedevicemayleadtoinjury,illnessordeathofthepatient.Allproceduresmustbeperformedaccordingtoacceptedaseptictechnique.
HepaSphere Microspheres MUST NOT be used in their original dry state.
Theymustbere-constitutedbeforeuse.HepaSphereMicrospheresswellinaqueoussolution.Themagnitudeof
swelling depends on the ionic concentration of the solution. The microspheres swell to approxi
-matelyfourtimestheirdiameterin0.9%NaClaqueoussolutionandnon-ioniccontrastmedia,ascomparedtotheirinitialdrydiameter.Themagnitudeofswellingwhenloadedwithdoxoru-bicinHClisdependentupontheamountofdrugwithwhichtheproductisloaded.LyophilizeddoxorubicinHClmustbereconstitutedinNaCl0.9%solution.HepaSphereMicrospheresun-dergoaslightsizedecreaseofabout20%whenloadedwithdoxorubicinHClcomparedtothesizeinpureNaCl0.9%aqueoussolution.HepaSphereMicrospheresarecompressibleandcanbeinjectedeasilythroughmicrocatheters.However,injectionoftheHepaSphereMicrospheresbeforetheyarefullyexpandedcouldresultinfailuretoreachtheintendedembolizationtargetandpossibleembolizationofalargertissuearea.
Note:
MaximumrecommendedconcentrationofdoxorubicinHClis5mg/ml.ConcentrationsofdoxorubicinHClabove5mg/mlsubstantiallyincreasethesolutionviscosityandmakeitdiculttohandlewithHepaSphereMicrospheres.Patientswithknownallergiestonon-ioniccontrastmediamayrequirecorticosteroidspriortoembolization.Additionalevaluationsorprecautionsmaybenecessaryinmanagingperiproceduralcarefor
patients with the following conditions:
•Bleedingdiathesisorhypercoagulativestate•Immunocompromise
POTENTIAL COMPLICATIONS:
Vascularembolizationisahigh-riskprocedure.Complicationsmayoccuratanytimeduringoraftertheprocedure,andmayinclude,butarenotlimitedto,thefollowing:•Paralysisresultingfromuntargetedembolizationorischemicinjuryfromadjacent
tissue oedema
•UndesirablereuxorpassageofHepaSphereMicrospheresintonormalarteriesadjacenttothetargetedlesionorthroughthelesionintootherarteriesorarterialbeds,suchastheinternalcarotidartery,pulmonary,orcoronarycirculation•Pulmonaryembolismduetoarteriovenousshunting•Ischemiaatanundesiredlocation,includingischemicstroke,ischemicinfarction(includingmyocardialinfarction),andtissuenecrosis•Capillarybedocclusionandtissuedamage•Vasospasm•Recanalisation•Blindness,hearingloss,andlossofsmell•Foreignbodyreactionsnecessitatingmedicalintervention•Infectionnecessitatingmedicalintervention•Complicationsrelatedtocatheterization(e.g.haematomaatthesiteofentry,clotformationatthetipofthecatheterandsubsequentdislodgement,andnerveand/orcirculatoryinjurieswhichmayresultinleginjury)•Allergicreactiontomedications(e.g.analgesics)•Allergicreactiontonon-ioniccontrastmediaorembolicmaterial•Vesselorlesionruptureandhaemorrhage•Death•AdditionalinformationisfoundintheWarningssection
SWELLING BEHAVIOR:
HepaSphereMicrospheresswellduringreconstitutionwithNaCl0.9%aqueoussolutionandnon-ioniccontrastmedia.Whenhydratedin100%NaCl0.9%aqueoussolutionornon-ioniccontrastmedium,or50%non-ioniccontrastand50%NaCl0.9%aqueoussolution,HepaSphereMicrospheresswellapproximately4timestheiroriginaldrydiameterinapproximately10minutes.Forexample,HepaSphereMicrosphereswithadiameterofapproximately50-100micronsintheirdrystatewillexpandtoapproximately200-400micronsduringreconstitutionasrecommendedbelow.Becauseoftheinherentvariabilityoftheswellingprocess,someoftheHepaSphereMicrosphereswillbeslightlyoutsideofthisrangeafterreconstitution,sothephysicianshouldbesuretocarefullyselectthesizeofHepaSphereMicrospheresaccordingtothesizeofthetargetvesselsatthedesiredlevelofocclusioninthevasculatureandthenatureoftheaqueoussolution.
Note:
 ToexpandproperlyHepaSphereMicrospheresneedtobeexposedtoaminimumof10ml
solution. The magnitude of swelling when loaded with doxorubicin HCl is dependent upon the amount
ofdrugwithwhichtheproductisloaded.HepaSphereMicrospheresundergoaslightsizedecreaseofabout20%whenloadedwithdoxorubicinHClcomparedtothesizeinpureNaCl0.9%aqueoussolution.
CATHETER COMPATIBILITY:
HepaSphereMicrospherescanbeinjectedwithmicrocatheterswiththefollowingspecications:Dry(μm)ApproximateReconstitutedSizerangem)CatheterSizeID(in.)
30-60 120-240 ≥0.02150-100 200-400 ≥0.021100-150 400-600 ≥0.024150-200 600-800 ≥0.027
INSTRUCTIONS:
HepaSphereMicrospheresmustbereconstitutedwith100%NaCl0.9%aqueoussolutionornon-ioniccontrastmedium,or50%non-ioniccontrastmediumand50%NaCl0.9%aqueoussolutionifusingwithoutdeliveryofdoxorubicinHCl,orloadedwithdoxorubicinHClsolution
before positioning the catheter.
•CarefullyselectthesizeofHepaSphereMicrospheresaccordingtothesizeofthetargetvesselsatthedesiredlevelofocclusioninthevasculatureandthenatureoftheaqueoussolution.Seethedescriptionof“SWELLINGBEHAVIOR”.•HepaSphereMicrospheresmaybepresentoutsidethevial.Therefore,thevialmustbeasepticallyhandledawayfromthemainsterileeld.•EnsurethecompatibilityoftheHepaSphereMicrosphereswiththeintendedsizeofcathetertobeused.Seethetableabove.•Inspectthepackagingtoconrmthatitisintact.Removethevialfromthepouch.Theexternalsurfaceofthevialissterile.ENGLISH
INTENDED USE:
HepaSphere™MicrosphereswithoutdoxorubicinHClloaded(bland)areindicatedforuseinembolizationofbloodvesselsfortherapeuticorpreoperativepurposesinthefollowing
procedures:
•Embolizationofhepatocellularcarcinoma•Embolizationofmetastasestotheliver.HepaSphereMicrospheresloadedwithdoxorubicinHClareindicatedforuseinembolizationofbloodvesselsfortherapeuticorpreoperativepurposesin:Embolizationofunresectablehepatocellularcarcinoma.
DESCRIPTION:
HepaSphereMicrospheresarepartofafamilyofembolicagentsbasedonproprietarytechnolo-gies.Theyaredesignedforcontrolled,targetedembolization.TheHepaSphereMicrospherescanbeloadedwithdoxorubicinHClandareabletoreleasethedruglocallyattheembolizationsite.HepaSphereMicrospheresarebiocompatible,hydrophilic,non-resorbable,expandable,andconformablemicrospheres.HepaSphereMicrospheresswelluponexposuretoaqueoussolutions.Theyareavailableinarangeofsizes.
Dry(μm)
30-6050-100100-150150-200
DEVICE PACKAGING:
HepaSphereMicrospheresarecontainedinasterile,10mlCyclicOlenCopolymers(COC)vial,withacrimpedcap,packagedinasealedpouch.Contents:25mgor50mgofdryHepaSphereMicrospherespervialtobereconstitutedbefore
use.
CONTRAINDICATIONS:
•Patientsintoleranttovascularocclusionprocedures•Vascularanatomyorbloodowprecludingcorrectcatheterplacementorembolicinjection•Presenceorsuspicionofvasospasm•Presenceorlikelyonsetofhaemorrhage•Presenceofsevereatheromatousdisease•FeedingarteriestoosmalltoaccepttheselectedHepaSphereMicrospheres•Presenceofcollateralvesselpathwayspotentiallyendangeringnormalterritoriesduringembolization•HighowarteriovenousshuntsorstulaewithluminaldiametergreaterthantheselectedsizeofHepaSphereMicrospheres•VascularresistanceperipheraltothefeedingarteriesprecludingpassageofHepaSphereMicrospheresintothelesion•PresenceofarteriessupplyingthelesionnotlargeenoughtoacceptHepaSphereMicrospheres•Donotuseinpulmonaryvasculature,coronaryandcentralnervoussystemvasculature•Knownsensitivitytopolyvinylalcohol-co-sodiumacrylate
WARNINGS:
•HepaSphereMicrospheressizemustbechosenafterconsiderationofthearteriovenousangiographicappearance.HepaSphereMicrospheressizeshouldbeselectedtopreventpassagefromanyarterytovein.•SomeoftheHepaSphereMicrospheresmaybeslightlyoutsideoftherange,sothephysicianshouldbesuretocarefullyselectthesizeofHepaSphereMicrospheresaccordingtothesizeofthetargetvesselsatthedesiredlevelofocclusioninthevasculatureandafterconsiderationofthearteriovenousangiographicappearance.•Becauseofthesignicantcomplicationsofmisembolization,extremecautionshouldbeusedforanyproceduresinvolvingtheextracranialcirculationencompassingtheheadandneck,andthephysicianshouldcarefullyweighthepotentialbenetsofusingembolizationagainst
the risks and potential complications of the procedure. These complications can include
blindness,hearingloss,lossofsmell,paralysis,anddeath.SafetyandeectivenessofthisdeviceforuseinvolvingtheextracranialcirculationencompassingtheheadandneckoranyotherpartofthebodyotherthantheliverhasnotbeenestablishedandhasthereforenotbeenapprovedbyHealthCanada.•Seriousradiationinducedskininjurymayoccurtothepatientduetolongperiodsofuoroscopicexposure,largepatient,angledx-rayprojectionsandmultipleimagerecordingrunsorradiographs.Refertoyourfacility’sclinicalprotocoltoensuretheproperradiationdoseisappliedforeachspecictypeofprocedureperformed.•Onsetofradiationinjurytothepatientmaybedelayed.Patientsshouldbecounselledonpotentialradiationeects,whattolookforandwhotocontactifsymptomsoccur.•HepaSphereMicrospheresMUSTNOTbereconstitutedinsterilewaterforinjection.ReconstitutioninsterilewaterresultsinextensiveswellingthatrenderstheinjectionofHepaSphereMicrospheresverydicultormaypreventinjection.•DonotreconstituteHepaSphereMicrosphereswithLipiodol/Ethiodol.•Paycarefulattentionforsignsofmistargetedembolization.DuringinjectioncarefullymonitorpatientvitalsignstoincludeSAO2(e.g.hypoxia,CNSchanges).Considerterminatingtheprocedure,investigatingforpossibleshunting,orincreasingMicrospheressizeifanysignsofmistargetingoccurorpatientsymptomsdevelop.•ConsiderupsizingtheMicrospheresifangiographicevidenceofembolizationdoesnotquicklyappearevidentduringinjectionoftheMicrospheres.•SeeproductmonographforHealthCanadaauthorizedindicationsforusefordoxorubicinHCl.InformationhereinisspecicallyfortheuseofHepaSphereMicrosphereswithorwithout
doxorubicin HCl.
Warnings about use of small microspheres:
•Carefulconsiderationshouldbegivenwheneveruseiscontemplatedofembolicagentsthataresmallerindiameterthantheresolutioncapabilityofyourimagingequipment.Thepresenceofarteriovenousanastomoses,branchvesselsleadingawayfromthetargetareaoremergentvesselsnotevidentpriortoembolizationcanleadtomistargetedembolizationandseverecomplications.•Microspheressmallerthan100micronswillgenerallymigratedistaltoanastomoticfeedersandthereforearemorelikelytoterminatecirculationtodistaltissue.Greaterpotentialofischemicinjuryresultsfromuseofsmallersizedmicrospheresandconsiderationmustbegiventotheconsequenceofthisinjurypriortoembolization.Thepotentialconsequencesincludeswelling,necrosis,paralysis,abscessand/orstrongerpost-embolizationsyndrome.•Postembolizationswellingmayresultinischemiatotissueadjacenttotargetarea.Caremustbegiventoavoidischemiaofintolerant,nontargetedtissuesuchasnervoustissue.730133002/AID103112
0459-2004
DELIVERY INSTRUCTIONS:
•Carefullyevaluatethevascularnetworkassociatedwiththetargetlesionutilizinghigh
resolution imaging.
Note:
Itisimportanttodetermineifanyarteriovenousshuntsarepresentbeforebeginningembolization.•Usingstandardtechniques,positionthedeliverycatheterwithinthetargetvesselandthecathetertipascloseaspossibletotheembolizationtarget.•Useaninjectionsyringenolargerthan3mlforthedeliveryofdoxorubicinloadedHepaSphereMicrospheres.Useofa1mlinjectionsyringeisrecommended.•Aspirate1mloftheHepaSphereMicrospheresmixtureintotheinjectionsyringe.•Twomethodsforembolicaliquotsequesteringforinjectionmaybeused:
 
Option 1:
Connecta3way-stopcocktothe30mlsyringecontainingthedoxorubicinloadedHepaSphereMicrospherestotheinfusionmicrocatheterandusea1mlsyringeforinjectionthroughtheopenportofthe3way-stopcock.
 
Option 2:
SerialaliquotsofthedoxorubicinloadedHepaSphereMicrospherescanbedrawnfromthe30mlsyringeintoa1mlinjectionsyringethrougha3way-stopcockthatisnotattachedtotheinfusioncatheter.The1mlsyringecontainingeachaliquotcanbeattachedindependentlytotheinfusionmicrocatheterandinjected.•Invertthe30mlsyringebackandforthtomaintainthehomogenoussuspensionoftheHepaSphereMicrospheresmixture.•Undercontinuousuoroscopicguidance,injectthealiquotofdoxorubicinloadedHepaSphereMicrospheresinaslow,nonforceful,pulsatilemanneroveratimeperiodofapproximately1minutepermlofmicrospheressolution.Alwaysinjectunderfree-owconditionsandmonitorforreux.
Note:
Reuxofembolicspherescaninduceimmediateischemiaofuntargetedtissuesandvessels.•WhenstasisinthefeedingpedicleoccurswhiledeliveringthedoxorubicinHClloadedHepaSphereMicrospheres,waitaminimumof5minutesthenperformaselectiveangiogramafterthefull5minuteswaittoverifythecessationofantegradeow.•Ifcessationofantegradeowhasnotoccurred,continueinfusionunderuoroscopicguidanceuntilthedesireddevascularizationisobtained.•AftertheHepaSphereMicrosphereinfusioniscompleted,removethecatheterwhilemaintaininggentleaspirationtoavoiddislodginganyresidualHepaSphereMicrospheresthatmaystillbeinthecatheterlumen.Discardthecatheterafterremovalanddonotreuse.•DiscardanyopenvialorunusedHepaSphereMicrospheres.
CAUTION:
Intheeventthatthecatheterbecomesobstructedorsignicantinfusionresistanceisencoun-teredduringinjection,donotattempttoushthecatheterwithexcessivepressurebecausereuxofembolicmaterialmayoccurresultinginuntargetedembolization.Removethecatheterwhileapplyinggentleaspirationanddiscard.
CONSERVATION AND STORAGE:
HepaSphereMicrospheresmustbestoredinadry,darkplaceintheiroriginalvialsandpackag-ing.Usebythedateindicatedonthelabelsoftheouterboxandpouch.Whentheprocedureofreconstitutioniscompleted,storethesolutionofHepaSphereMicro-spheresin2to8°Cconditionsandusewithin24hours,IFnotusedimmediately.DonotstoreHepaSphereMicrospheresaftercontrastmediumhasbeenadded.SizeofdryColourcodeQuantityofproducts(µm)(labelborders)microspheres(mg)Reference
30-60 Orange 25 V 225 HS50 V 250 HS50-100 Yellow 25 V 325 HS50 V 350 HS100-150 Blue 25 V 525 HS50 V 550 HS150-200 Red 25 V 725 HS50 V 750 HS
INFORMATION ON PACKAGING:
SymbolDesignationManufacturer:Name&AddressUsebydate:year-monthBatchcode
Catalogue number
DonotresterilizeDonotuseifpackageisdamagedKeepawayfromsunlightKeepdryDonotre-useCaution-RefertoInstructionsForUseNon-pyrogenicSterilizedusingirradiationECmarklogo-Notiedbodyidentication:0459
/
Sizeofdrymicrospheres/SizeofhydratedmicrospheresAllseriousorlifethreateningadverseeventsordeathsassociatedwithuseofHepaSphereMicrospheresshouldbereportedtothedevicemanufacturer.
Biosphere Medical, S.A.
ParcdesNations-ParisNord2383ruedelaBelleEtoile95700RoissyenFranceFranceTel:+33(0)148172525Fax:+33(0)149380268

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