CARDIOLITE

Main information

  • Trade name:
  • CARDIOLITE Kit for radiopharmaceutical preparation
  • Pharmaceutical form:
  • Kit for radiopharmaceutical preparation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CARDIOLITE Kit for radiopharmaceutical preparation
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1052/001/001
  • Authorization date:
  • 26-08-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1052/001/001

CaseNo:2041882

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

Bristol-MyersSquibbPharma

ChausseedelaHulpe185,B-1170Brussels,Belgium

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Cardiolitekitforradiopharmaceuticalpreparation

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom22/10/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cardiolitekitforradiopharmaceuticalpreparation

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

KitforradiopharmaceuticalpreparationofTechnetiumTc-99mSestamibi.

Powderforsolutionforinjection.

Sterilenon-pyrogeniclyophilizedwhitepowderforreconstitutionwithoxidant-freeSodiumPertechnetateTc-99m

InjectionPh.Eur.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ForintravenousinjectionafterreconstitutionwithSodiumpertechnetate[ 99m

Tc]solutionandmaybeusedfor:

Adjunctfordiagnosisofischaemicheartdisease.

Adjunctfordiagnosisandlocalisationofmyocardialinfarction.

Assessmentofglobalventricularfunction(firstpasstechniquefordeterminationofejectionfractionand/orregional

wallmotion).

Aidinthediagnosisofmalignancyinpatientswhoaresuspectedofcancerinthebreastcombinedwithinconclusive

mammography,orpalpabletumourandnegativeorinconclusivemammography.

Eachvialcontains:

Activeingredients

Tetrakis(2-methoxyisobutylisonitrile)copper(I)tetrafluoroborate1 mg

StannousChlorideDihydrate 75micrograms

CysteineHydrochlorideMonohydrate 1 mg

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4.2Posologyandmethodofadministration

Thevialisreconstitutedwithamaximumof11.1GBq(300mCi)ofoxidant-freeSodiumPertechnetateTc-99m

InjectionPh.Eur.in1-3ml.

Notlessthan3mlwillbeusedforthehighestactivityof11.1GBq.

Radiochemicalpurityshouldbecheckedpriortopatientadministration(seesection12).

Thesuggesteddoserangeforintravenousadministrationtoapatientofaverageweight(70kg)is:

Diagnosisofreducedcoronaryperfusionandmyocardialinfarction:

185-740MBq

Assessmentofglobalventricularfunction:

740-925MBq

Injectedasabolus

Fordiagnosisofischaemicheartdiseasetwoinjections(stressandrest)arerequiredinordertodifferentiatetransiently

frompersistentlyreducedmyocardialuptake.Notmorethanatotalof925MBqshouldbeadministeredbythesetwo

injectionswhichshouldbedoneatleastsixhoursapartbutmaybeperformedineitherorder.Afterthestressinjection,

exerciseshouldbeencouragedforanadditionaloneminute(ifpossible).

Fordiagnosisofmyocardialinfarctiononeinjectionatrestmaybesufficient.

Forbreastimaging: 740-925MBq

Injectedasabolus.

Forparathyroidimaging: 185-740MBq

Injectedasabolus

(Thedoseusedshouldineverycasebeaslowasreasonablypractical).

CardiacImaging:Ifpossible,patientsshouldfastforatleastfourhourspriortothestudy.Itisrecommendedthat

patientseatalightfattymealordrinkaglassortwoofmilkaftereachinjection,priortoimaging.Thiswillpromote

rapidhepatobiliaryclearanceofTechnetiumTc-99mSestamibiresultinginlessliveractivityintheimage.

Thehearttobackgroundratiowillincreasewithtimebuttheidealimagingtime,reflectingthebestcompromise

betweenheartcountrateandcontrast,isapproximately1-2hoursafterrestinjectionandstressinjection.Thereisno

evidenceforsignificantchangesinmyocardialtracerconcentrationorredistribution,thereforeimagingforupto6

hourspostinjectionispossible.

Eitherplanarortomographicimagingcanbeperformedfordiagnosisofischaemicheartdiseaseandmyocardial

infarction.BothmaybeperformedECGgated.

Forplanarimaging:thestandardthreeview(anterior,LAO45º,LAO70ºorLL)planarprojectionsshouldbeused

(e.g.5-10minuteseach).

Fortomographicimaging:eachprojectionshouldbeacquiredforapproximately20-40secondsdependingon

injecteddose.

Forassessmentofglobalventricularfunctionthesamestandardtechniquesandprojectionscanbeused,as

establishedforTc-99mfirstpassejectionstudies;datashouldbeacquiredinlistorfastframemodeinacomputer

usingahighcountratescintillationcamera.GatedBloodPoolImagingprotocolsmaybeusedforassessmentof

regionalwallmotion;however,theymustonlybeevaluatedvisually.

Breastimaging:isoptimallyinitiated5to10minutespostinjectionwiththepatientinthepronepositionwithbreast

freelypendant.A10minutelateralimageofthebreastsuspectedofcontainingcancershouldbeobtainedwiththe

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Thepatientshouldthenberepositionedsothatthecontralateralbreastispendantandalateralimageofitshouldbe

obtained.Ananteriorsupineimagemaythenbeobtainedwiththepatient’sarmsbehindherhead.

Parathyroidimaging:dependsonwhethersubtractiontechniqueorwash-outtechniqueisused.

Forthesubtractiontechnique,eithersodiumiodide(I-123)orTc-99mpertechnetatecanbeused.WhenI-123isused,

11to22MBqoforalsodiumiodide(I-123)areadministered.FourhoursaftertheadministrationofI-123,I-123neck

andthoraximagesareobtained.AfterI-123acquisition185to370MBqofTc-99mSestamibiareinjectedandimages

acquired10minutespostinjection.Whenpertechnetateisused,37to148MBqofsodiumpertechnetateareinjected

andneckandthoraximagesareacquired30minuteslater.Afterimageacquisition,185-370MBqofTc-99m

Sestamibiareinjectedandimagesacquired10minutespostinjection.

Ifdouble-phasetechniqueisused,370to740MBqofTc-99mSestamibiareinjectedandthefirstneckandthorax

imageobtained10minuteslater.Afterawash-outperiodof1to2hours,neckandthoraximagingisagainperformed.

Safetyandefficacyinchildrenbelowtheageof18havenotbeenestablished.

4.3Contraindications

Therearenoknowncontraindications.

4.4Specialwarningsandprecautionsforuse

Foreachpatient,exposuretoionisingradiationmustbejustifiedonthebasisoflikelybenefit.Theactivity

administeredmustbesuchthattheresultingradiationdoseisaslowasreasonablyachievablebearinginmindtheneed

toobtaintheintendeddiagnosticortherapeuticresult.

Exposuretoionisingradiationislinkedwithcancerinductionandapotentialfordevelopmentofhereditarydefects.

Fordiagnosticnuclearmedicineinvestigationsthecurrentevidencesuggeststhattheseadverseeffectswilloccurwith

lowfrequencybecauseofthelowradiationdosesincurred.

Formostdiagnosticinvestigationsusinganuclearmedicineproceduretheradiationdosedelivered(effectivedose/

EDE)islessthan20mSv.Higherdosesmaybejustifiedinsomeclinicalcircumstances.

ContentsofthevialareintendedonlyforuseinthepreparationofTechnetiumTc-99mSestamibiandarenottobe

administereddirectlytothepatientwithoutfirstundergoingthepreparativeprocedure.

Thisradiopharmaceuticalmaybereceived,usedandadministeredonlybyauthorisedpersonsindesignatedclinical

settings.Itsreceipt,storage,use,transferanddisposalaresubjecttotheregulationsand/orappropriatelicencesofthe

localcompetentofficialorganisation.

Radiopharmaceuticalsshouldbepreparedbytheuserinamannerwhichsatisfiesbothradiationsafetyand

pharmaceuticalqualityrequirements.Appropriateasepticprecautionsshouldbetaken,complyingwiththe

requirementsofGoodManufacturingPracticeforpharmaceuticals.

Radiopharmaceuticalagentsshouldbeusedonlybyqualifiedpersonnelwiththeappropriategovernmentauthorisation

foruseandmanipulationofradionuclides.

Nodataconcerningthediagnosticefficacyinsuspectedrecurrenceormetastaticdiseaseareavailable.

PROPERHYDRATIONANDFREQUENTURINATIONARENECESSARYTOREDUCEBLADDER

IRRADIATION

INCASEOFKIDNEYFAILURE,EXPOSURETOIONISINGRADIATIONCANBEINCREASED.THISMUST

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nodruginteractionshavebeendescribedtodate.

4.6Pregnancyandlactation

Whenitisnecessarytoadministerradioactiveproductstowomenofchildbearingpotential,informationshouldbe

soughtaboutpregnancy.

Anywomanwhohasmissedaperiodshouldbeassumedtobepregnantuntilprovenotherwise.

Whereuncertaintyexistsitisimportantthatradiationexposureshouldbetheminimumconsistentwithobtainingthe

desiredclinicalinformation.Alternativetechniqueswhichdonotinvolveionisingradiationshouldbeconsidered.

Theanticipateddosetotheuterusfroma740MBqrestinjectionwouldbe5.8mGy.

Aradiationdoseabove0.5mGy(approximatelyequivalenttothatexposurefromannualbackgroundradiation)could

potentiallyresultinrisktothefoetus.

Itisthereforecontraindicatedinwomenknowntobepregnant.

Beforeadministeringaradioactivemedicinalproducttoamotherwhoisbreastfeedingconsiderationshouldbegiven

astowhethertheinvestigationcouldbereasonablydelayeduntilafterthemotherhasceasedbreastfeedingandasto

whetherthemostappropriatechoiceofradiopharmaceuticalhasbeenmade,bearinginmindthesecretionofactivityin

breastmilk.

Iftheadministrationisconsiderednecessary,breastfeedingshouldbeinterruptedfor24hoursandtheexpressedfeeds

discarded.

Itisusualtoadvisethatbreastfeedingcanberestartedwhenthelevelinthemilkwillnotresultinaradiationdoseto

thechildgreaterthan1mSv.

4.7Effectsonabilitytodriveandusemachines

Effectsontheabilitytodriveandusemachineshavenotbeendescribed.

4.8Undesirableeffects

ImmediatelyafterinjectionofTechnetiumTc-99mSestamibi,asmallpercentageofpatientsexperiencedametallicor

bittertaste,transientheadache,flushingandanon-itchingrash.

Afewcasesofoedema,injectionsiteinflammation,dyspepsia,nausea,vomiting,pruritus,urticaria,drymouth,fever,

dizziness,fatigue,dyspnoeaandhypotensionhavebeenattributedtoadministrationoftheagent.

Therehavealsobeenveryrarereports(<0.001%)ofsignsandsymptomsconsistentwithseizureafteradministration;a

casualrelationshiptoCardiolitehasnotbeenestablished.

4.9Overdose

IntheeventofadministrationofaradiationoverdosewithTechnetiumTc-99mSestamibitheabsorbeddosetothe

patientshouldbereducedwherepossiblebyincreasingtheeliminationoftheradionuclidefromthebodybyfrequent

micturationanddefaecation.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

PharmacodynamiceffectsarenotexpectedafteradministrationofCardiolite.

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FurtherClinicalInformation

Complementaryinformationinthecaseofdiagnosisofmalignancyinpatientswhoaresuspectedofcancerinthe

breastcombinedwithinconclusivemammographyorpalpabletumourandnegativeorinconclusivemammography.

Theoverallclinicaltrialpopulationconsistedof673patientswithpalpable(286subjects)ormammographically-

detected,nonpalpable(387subjects)abnormalities.Themedianageofthesubjectswas52years.Wheninstitutional

readscintigraphyiscomparedtotruediseasestateusingcorelaboratoryhistopathology,thediagnosticstatisticsare

goodinthecombinedtrialpopulation.Inthispopulation,theprevalenceofmalignancywas40%intheimaged

subjects.Usingwholebreastanalysis,thesensitivityofscintigraphywas85.4%,thespecificitywas78.8%,andthe

positiveandnegativepredictivevalueswere72.7%and89.1%respectively.

5.2Pharmacokineticproperties

AfterreconstitutionwithSodiumPertechnetateTc-99mInjection,Ph.Eur.solution,thefollowingcomplexforms

(TechnetiumTc-99mSestamibi):

Tc-99m(MIBI) Where:MIBI=2-methoxyisobutylisonitrile

LikeThallousChlorideT1201,thiscationiccomplexaccumulatesintheviablemyocardialtissueproportionaltothe

circulation.Scintigraphicpictureswhichwereobtainedafteri.v.injectionofTechnetiumTc-99mSestamibitoanimals

andmanarecomparablewiththoseobtainedwithThallousChlorideT1201.Thiscorrelationappliestonormalaswell

asinfarctedandischaemiccardiactissue.

TechnetiumTc-99mSestamibifromthebloodisrapidlydistributedintothetissue:5minutesafterinjectiononlyabout

8%oftheinjecteddoseisstillincirculation.

Animalexperimentshaveshownthatuptakeisnotdependentonthefunctionalcapabilityofthesodium-potassium

pump.

Elimination

ThemajormetabolicpathwayforclearanceofTechnetiumTc-99mSestamibiisthehepatobiliarysystem.Activity

fromthegallbladderappearsintheintestinewithinonehourofinjection.Abouttwenty-sevenpercentoftheinjected

doseisclearedthroughrenaleliminationafter24hoursandapproximatelythirty-threepercentoftheinjecteddoseis

clearedthroughthefaecesin48hours.Atfiveminutespostinjectionabout8%oftheinjecteddoseremainsin

circulation.

Half-Life

ThebiologicalmyocardialT½isapproximatelyseven(7)hoursatrestandstress.TheeffectiveT½(whichincludes

biologicalandphysicalhalf-lives)isapproximatelythree(3)hours.

Myocardialuptake

Myocardialuptakewhichiscoronaryflowdependentis1.5%oftheinjecteddoseatstressand1.2%oftheinjected

doseatrest.

5.3Preclinicalsafetydata

Inacuteintravenoustoxicitystudiesinmice,ratsanddogs,thelowestdoseofthereconstitutedCardiolitekitthat

resultedinanydeathswas7mg/kg(expressedasCu(MIBI)

content)infemalerats.

Thiscorrespondsto500timesthemaximalhumandose(MHD)of0.014mg/kgforadults(70kg).

NeitherratsnordogsexhibitedtreatmentrelatedeffectsatreconstitutedCardiolitekitdosesof0.42mg/kg(30times

MHD)and0.07mg/kg(5timesMHD)respectivelyfor28days.

Studiesonreproductivetoxicityhavenotbeenconducted.Cu(MIBI)

showednogenotoxicactivityintheAmes,

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Atcytotoxicconcentrations,anincreaseinchromosomeaberrationwasobservedintheinvitrohumanlymphocyte

assay.

Nogenotoxicactivitywasobservedintheinvivomousemicronucleustestat9mg/kg.

StudiestoassessthecarcinogenicpotentialofCardiolitehavenotbeenconducted.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SodiumCitrate

Mannitol

6.2Incompatibilities

TheTechnetiumlabellingreactionsinvolveddependonmaintainingthestannouslevelinthereducedstate.Hence,

SodiumPertechnetateTc-99mInjectionPh.Eur.,containingoxidantsshouldnotbeemployed.

6.3ShelfLife

Finishedproduct:24months

Afterreconstitutiontheproductshouldbeusedwithin10hours

6.4Specialprecautionsforstorage

Beforeandafterpreparation,thedrugshouldnotbestoredabove25 O

Candshouldbeprotectedfromlight.The

contentsofthevialarenotradioactive.However,afterlabellingwithSodiumPertechnetateTc-99mInjectionPh.Eur.

thecontentsareradioactiveandthecurrentlyvalidprotectionandsafetyregulationsmustbecompliedwith.

6.5Natureandcontentsofcontainer

5mlglassvials,typeIborosilicateglass(Ph.Eur.)sealedwithahalobutylstopperandcrimpedwithanaluminium

seal.Theproductisavailableinpacksof2and5vials.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Seesection12

7MARKETINGAUTHORISATIONHOLDER

Bristol-MyersSquibbPharmaBelgiumSprl

ChausséedelaHulpe185

B-1170Brussels

Belgium

8MARKETINGAUTHORISATIONNUMBER

PA1052/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Firstdateofauthorisation:26August1991

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10DATEOFREVISIONOFTHETEXT

January2007

11DOSIMETRY

Theprojectedradiationdosestoorgansandtissuesofanaverage(70kg)patientafterintravenousinjectionof

TechnetiumTc-99mSestamibiaregivenbelow:

DataadoptedfromICRP-publicationnr.62(Volume22.nr.3.1993):“RadiologicalProtectioninBiomedical

Research.”

Absorbeddoseperunitadministeredactivity(mGy/MBq)foradults

Theeffectivedoseresultingfromanadministeredamountof925MBqintheadultis7.9mSvatrestand6.9

Organ Atrest Stress

Pancreas

Uterus

Adrenals

Bladderwall

Breast

Bonesurface

Gallbladderwall

Heart

Brain

Skin

Liver

Lungs

GI-tract

Stomach

Smallintestine

Upperlargeintestine

Lowerlargeintestine

Spleen

Kidneys

Ovaries

Redmarrow

Thyroid

Oesophagus

Salivaryglands

Muscle

Testes

Thymus

Otherorgans

7.7E-03

7.8E-03

7.5E-03

1.1E-02

3.8E-03

8.2E-03

3.9E-02

6.3E-03

5.2E-03

3.1E-03

1.1E-02

4.6E-03

6.5E-03

1.5E-02

2.7E-02

1.9E-02

6.5E-02

3.6E-02

9.1E-03

5.5E-03

5.3E-03

4.1E-03

1.4E-02

2.9E-03

3.8E-03

4.1E-03

3.1E-03

6.9E-03

7.2E-03

6.6E-03

9.8E-03

3.4E-03

7.8E-03

3.3E-02

7.2E-03

4.4E-03

2.9E-03

9.2E-03

4.4E-03

5.9E-03

1.2E-02

2.2E-02

1.6E-02

5.8E-03

2.6E-02

8.1E-03

5.0E-03

4.4E-03

4.0E-03

9.2E-03

3.2E-03

3.7E-03

4.0E-03

3.3E-03

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12INSTRUCTIONSFORPREPARATIONOFRADIOPHARMACEUTICALS

Thecontentsofthekitbeforepreparationarenotradioactive.However,afterSodiumPertechnetateTc-99mInjection,

Ph.Eur.isadded,adequateshieldingofthefinalpreparationmustbemaintained.

Theadministrationofradiopharmaceuticalscreatesrisksforotherpersonsfromexternalradiationorcontamination

fromspillofurine,vomitingetc.Radiationprotectionprecautionsinaccordancewithnationalregulationsmust

thereforebetaken.

Thepreparationcontainsnobacteriostaticpreservative.

TechnetiumTc-99mSestamibiistobeusedwithinten(10)hoursofreconstitution.

Reconstitutewithoxidant-freeSodiumPertechnetateTc-99mInjection,Ph.Eur.Theresultingsolutionisclearand

colourless.

Aswithanypharmaceuticalproduct,ifatanytimeinthepreparationofthisproducttheintegrityofthisvialis

compromiseditshouldnotbeused.

InstructionsforPreparationofTechnetiumTc-99mSestamibi

A. BoilingProcedure

PreparationofTechnetiumTc-99mSestamibifromtheCardioliteKitistobedoneaccordingtothefollowingaseptic

procedure:

1. Waterproofglovesshouldbewornduringthepreparationprocedure.Removetheplasticdiscfromthe

CardioliteKitvialandswabthetopofthevialclosurewithalcoholtodisinfectthesurface.

2. Placethevialinasuitableradiationshieldappropriatelylabelledwithdate,timeofpreparation,volumeand

activity.

3. Withasterileshieldedsyringe,asepticallyobtainadditive-free,sterile,nonpyrogenicSodiumPertechnetateTc-

99msolution(max11.1GBq–300mCi)inapproximately1to3ml.Notlessthan3mlwillbeusedforthe

highestactivityof11.1GBq.

4. AsepticallyaddtheSodiumPertechnetateTc-99msolutiontothevialintheleadshield.Withoutwithdrawing

theneedle,removeanequalvolumeofheadspacetomaintainatmosphericpressurewithinthevial.

5. Shakevigorously,about5to10quickupward-downwardmotions.

6. Removethevialfromtheleadshieldandplaceuprightinaboilingwaterbath,suchthatthevialissuspended

abovethebottomofthebath,andboilfor10minutes.Thebathmustbeshielded.Timingforthe10minutes

commencesassoonasthewaterbeginstoboilagain.

Note:Thevialmustremainuprightduringtheboilingstep.Useawaterbathwherethestopperwillbeabovethe

levelofthewater.

7. Removetheshieldedvialfromthewaterbathandallowtocoolforfifteenminutes.

8. Inspectvisuallyfortheabsenceofparticulatematteranddiscolorationpriortoadministration.

9. Asepticallywithdrawmaterialusingasterileshieldedsyringe.Usewithinten(10)hoursofpreparation.

10. RadiochemicalpurityshouldbecheckedpriortopatientadministrationaccordingtotheRadioTLCMethodas

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Note:Thepotentialforcrackingandsignificantcontaminationexistswhenevervialscontainingradioactivematerial

areheated.

B. ThermalCyclerProcedure

PreparationofTechnetiumTc-99mSestamibifromtheCardioliteKitistobedoneaccordingtothefollowingaseptic

procedure:

1. Waterproofglovesshouldbewornduringthepreparationprocedure.Removetheplasticdiscfromthe

CardioliteKitvialandswabthetopofthevialclosurewithalcoholtodisinfectthesurface.

2. Placethevialinasuitableradiationshieldappropriatelylabelledwithdate,timeofpreparation,volumeand

activity.

3. Withasterileshieldedsyringe,asepticallyobtainadditive-free,sterile,non-pyrogenicSodiumPertechnetateTc-

99msolution(max11.1GBq–300mCi)inapproximately1to3ml.Notlessthan3mlwillbeusedforthe

highestactivityof11.1GBq.

4. AsepticallyaddtheSodiumPertechnetateTc-99msolutiontothevialintheleadshield.Withoutwithdrawing

theneedle,removeanequalvolumeofheadspacetomaintainatmosphericpressurewithinthevial.

5. Shakevigorously,about5to10quickupward-downwardmotions.

6. Placeshieldinthesampleblock.Whileslightlypressingdownwards,givetheshieldaquarterturntomake

certainthereisafirmfitbetweentheshieldandthesampleblock.

7. Presstheproceedbuttontoinitiatetheprogram(thethermalcycleautomaticallyheatsandcoolsthevialand

contents).PleaseseetheRecon-o-statInstructionManualforfurtherdetails.

8. Inspectvisuallyfortheabsenceofparticulatematteranddiscolorationpriortoadministration.

9. Asepticallywithdrawmaterialusingasterileshieldedsyringe.Usewithinten(10)hoursofpreparation.

10. RadiochemicalpurityshouldbecheckedpriortopatientadministrationaccordingtotheRadioTLCMethodas

detailedbelow.

Radio-TLCMethodfortheQuantificationofTechnetiumTc-99mSestamibi

1. Materials

1.1 Baker-Flex-AluminiumOxideplate,#1B-F,pre-cutto2.5cmx7.5cm.

1.2 Ethanol>95%.

1.3 Capintec,orequivalentinstrumentformeasuringradioactivityinthe0.74-11.12GBq(20-300mCi)range.

1.4 1mlsyringewitha22-26gaugeneedle.

1.5 Smalldevelopingtankwithcover,(100mlbeakercoveredwithParafilm ®

issufficient).

2. Procedure

2.1 Pourenoughethanolintothedevelopingtank(beaker)tohaveadepthof3-4mmofsolvent.Coverthetank

(beaker)withParafilm ®

andallowittoequilibrateforapproximately10minutes.

2.2 Apply1dropofethanol,usinga1mlsyringewitha22-26gaugeneedleontotheAluminiumOxideTLCplate,

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2.3 Apply1dropofthekitsolutionontopoftheethanolspot.Drythespot.Donotheat!

2.4 Developtheplateadistanceof5.0cmfromthespot.

2.5 Cutthestrip4.0cmfromthebottom,themeasureeachpieceinyourdosecalibrator.

2.6 Calculatethe%Radiochemicalpurityas:

%Tc-99mSestamibi=(Activitytopportion)/(Activitybothpieces)x100.

2.7 %Tc-99mSestamibishouldbe ≥94%,otherwisethepreparationshouldbediscarded.

Note:Donotusematerialiftheradiochemicalpurityislessthan

94%.

Afterreconstitutionthecontainerandanyunusedcontentsshouldbedisposedofinaccordancewithlocalrequirements

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