ERTRACER, FLUDEOXYGLUCOSE (18F)

Main information

  • Trade name:
  • ERTRACER, FLUDEOXYGLUCOSE (18F)
  • Dosage:
  • 1-13 GBq/ ml
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ERTRACER, FLUDEOXYGLUCOSE (18F)
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1125/001/001
  • Authorization date:
  • 21-10-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ERtracERFludeoxyglucose( 18

F)Injection,SolutionforInjection.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutionforinjectioncontains110–10,000MBqFludeoxyglucose( 18

F)atthedateandtimeofcalibration.

Theactivitypervialrangesfrom110MBqto50,000MBq.

Fluorine-18decaystostableoxygen-18withahalf-lifeof109.77minutesbyemittingpositronicradiationofmaximum

energyof634keV,followedbyphotonicannihilationradiationsof500keV.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

SolutionforInjection.

Clearandcolourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thismedicalproductisfordiagnosticuseonly.

Fludeoxyglucose( 18

F)isindicatedforusewithpositronemissiontomography(PET),eitheralone,orinconjuction

withotherdiagnosticmodalities,inthediagnosisand/orinvestigationofthefollowingconditions(seeTable1,and

section4.4,Specialwarningsandspecialprecautionsforuse):

Oncology

Forimaginginpatientsundergoingoncologicdiagnosticproceduresdescribingfunctionordiseaseswhereenhanced

glucoseinfluxofspecificorgansortissuesisthediagnostictarget.

Cardiology

Forevaluationofmyocardialviabilityinpatientswithadvancedcoronaryarterydiseaseand/orsevereimpairedleft

ventricularfunctionwhoarecandidatesforrevascularisation,whenconventionalimagingmodalitiesarenot

contributive.

Neurology

Forimagingpatientswithneurologicalconditions,includingimagingoflocalisationofepileptogenicfociinthe

presurgicalevaluationofpartialtemporalepilepsy.

Fever

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Table1:DiagnostictestsappropriateforassessmentusingFludeoxyglucose( 18

F)

PurposeofScan TypeofDiseaseCondition/Physiologicalstatus

Oncology

Fludeoxyglucose( 18

F)isindicatedforimaginginpatientsundergoingoncologicdiagnostic

proceduresdescribingfunctionordiseaseswhereenhancedglucoseinfluxofspecificorgansor

tissuesisthediagnostictargetincluding:

Diagnosis:

Monitoringof

therapeuticresponses:

Detectionincaseof

reasonablesuspicion

Characterisationofsolitarypulmonarynodule

Detectionofcancerofunknownorigin,revealedforexampleby

cervicaladenopathy,liverorbonemetastases.

Characterisationofthepancreaticmass

Headandneckcancersincludingassistanceinguidingbiopsy

Primarylungcancer

Locallyadvancedbreastcancer

Oesophagealcancer

Carcinomaofthepancreas

Colorectalcancerparticularlyinrestagingrecurrences.

Malignantlymphoma

Malignantmelanoma,Breslow>1.5mmorlymphnode

metastasisatfirstdiagnosis.

Malignantlymphoma

Headandneckcancers

Oesophageal

Gliomawithhighgradeofmalignancy(IIIorIV)

Headandneckcancers

Thyroidcancer(non–medullary):patientswithincreased

thyroglobulinserumlevelsandnegativeradioactiveiodine

wholebodyscintigraphy.

Primarylungcancer(seealsosection4.4)

Breastcancer

Carcinomaofthepancreas

Colorectalcancer

Uterinecancer

Ovariancancer

Malignantlymphoma

Malignantmelanoma

Cardiology

Evaluationofmyocardialviabilityinpatientswithadvancedcoronaryarterydiseaseand/or

severeimpairedleftventricularfunctionwhoarecandidatesforrevascularisation,when

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4.2Posologyandmethodofadministration

Posology

ADULTS(includingtheelderly):

Therecommendedactivityis400to700MBq,dependingonthebodyweightofthepatientandthetypeofcamera

used,administeredbydirectintravenousinjection.

CHILDRENANDADOLESCENTS:

Fewclinicaldataareavailableonthesafetyandefficacyofthediagnosticproductforpatientagedunder18years.

Thereforeitsuseinpaediatricsmustbecarefullyconsidered.

Therequiredactivityadministeredtochildrenandadolescentscanbedeterminatedasafractionofthe

activityadministeredtoadultsonthebasisofbodymass,usingthefollowingmultiplyingcoefficients:

Table2:Multiplyingcoefficientsforcalculatingappropriatedosesforchildrenandadolescents(PaediatricTask

Force,EANM,1990 1)

_______________________

PiepszA,etal.Aradiopharmaceuticalsscheduleforimaginginpaediatrics.PaediatricTaskGroup,EANM.

EuropeanJournalofNuclearMedicine,1990,17,127-129.

Methodofadministration

PurposeofScan TypeofDiseaseCondition/Physiologicalstatus

Neurology

Imaginginpatientswiththefollowingneurologicalconditions:

Epilepsy,including:

Temporallobeepilepsy

Localisationofepileptogenicfociinthepresurgicalevaluationofpartialtemporalepilepsy

Dementia,including:

Alzheimer’sdementia

Picksdisease

Multi-infarct(vascular)dementia

Parkinsonsdisease

Recurrentbraintumours,andarangeofotherneurologicalconditionsinwhichfocalabnormalitiesofcarbohydrate

metabolismofbraintissueisknowntooccur.

Fever

Investigationofpyrexiaofunknownorigin(orothercaseswithoccultinflammationorinfectionwhereother

modalitiesarenon-contributary).

Weight(kg) Coefficient Weight Coefficient Weight Coefficient Weight Coefficient

0.46 38 0.73 60-62 0.96

0.14 22 0.50 40 0.76 64-66 0.98

0.19 24 0.53 42 0.78 68 0.99

0.23 26 0.56 44 0.80

0.27 28 0.58 46 0.82

0.32 30 0.62 48 0.85

0.36 32 0.65 50 0.88

0.40 34 0.68 52-54 0.90

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AdministrationofFludeoxyglucose( 18

F)[FDG]andPETexamination

TheactivityofFDGmustbemeasuredwithacalibratorimmediatelypriortoinjection.

Itisrecommendedtoinjectthisradiopharmaceuticalproductintravenouslyoveraperiodofbetween30secondsand2

minutesinordertominimisetheriskofextravasationandmigrationintothelymphvessels.

Theemissionscansareusuallystartedbetween45and120minutesafterinjectionofFludeoxyglucose( 18

F).Provided

thatasufficientactivityremainsforadequatecountingstatistics,Fludeoxyglucose( 18

F)PETcanalsobeperformedup

totwotothreehoursafteradministration,thusreducingbackgroundactivity.

Ifrequired,repeatexaminationscanbecarriedoutatshortnotice.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Rationalefortheexamination

Forallpatients(includingchildrenandadolescents),theneedforascanmustbejustifiedbytheexpecteddiagnostic

result.Inallcases,thelowestpossibleradiationdosemustbeused.NotethattheeffectivedoseperMBqisgenerally

higherinchildrenthaninadults(SeeSection5.4).

Inpatientswithreducedkidneyfunctiontherisk:benefitmustbecarefullyassessedsinceanincreasedradiation

exposureispossibleinthesepatients.

Preparationofthepatient

Patientshouldbefastedforatleastfourhourspriortothetreatment,toobtainamaximumenrichmentofactivitysince

glucoseuptakeincellsissubjecttosaturationkinetics.

Inordertoobtainimagesofthebestqualityandtoreduceradiationexposuretothebladder,patientsshouldbe

encouragedtodrinkfluidsandtoemptypriortoandafterthePETexamination.Beveragescontainingglucosemustbe

avoided.

OncologyandNeurology

Inordertoavoidhyperfixationofthetracerinmuscle,patientsshouldbeadvisedtoavoidallstrenuousphysicial

activitypriortotheexaminationandtoremainatrestbetweentheinjectionandexaminationandduringacquisitionof

images.Patientshouldbecomfortablylyingdownwithoutreadingorspeaking.

Cerebralglucosemetabolismdependsonbrainactivity.Thusneurologicalexaminationsshouldbeperformedafter

relaxationperiodinadarkenedroomandwithlessbackgroundnoise.

Abloodglucosetestshouldbeperformedpriortoadministrationsincehyperglycaemiamayresultinareduced

sensitivityofFludeoxyglucose( 18

F),especiallywhenglycaemiaisgreaterthan8mmol/l.Similarly,Fludeoxyglucose

F)PETshouldbeavoidedinsubjectspresentingwithuncontrolleddiabetes.

Cardiology

Incardiologythediagnostictargetisviablemyocardialtissuethattakesupglucosebutishypoperfused.Itmust

thereforebeassessedbeforehandusinganappropriateblood-flowimagingtechnique.

Sinceglucoseuptakeinthemyocardiumisinsulin-dependent,foramyocardialexaminationaglucoseloadingof50g

approximatelyonehourpriortotheadministrationofFludeoxyglucose( 18

F)isrecommended.Alternatively,especially

forpatientwithdiabetesmellitus,thebloodsugarlevelcanbeadjustedbyacombinedinfusionofinsulinandglucose

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InterpretationoftheFDGPETimages

Infectiousand/orinflammatorydiseasesaswellasregenerativeprocessesaftersurgerycanresultinasignificant

uptakeofFDGandthereforeleadtofalsepositiveresults.

FalsepositiveorfalsenegativeFDG-PETresultscannotbeexcludedafterradiotherapywithinthefirst2-4months.If

theclinicalindicationrequiresanearlierdiagnosisbyFDG-PET,thereasonforFDG-PETexaminationmustbe

documented.

Adelayofatleastfourtosixweeksafterthelastadministrationofchemotherapyisoptimal,inparticulartoavoidfalse

positiveresults.IftheclinicalindicationrequiresanearlierdiagnosisbyFDG-PET,thereasonfortheearlierFDG-PET

examinationmustbedocumented.Inthecaseofchemotherapyregimenwithcyclesshorterthanfourweeks,theFDG-

PETexaminationshouldbeperformedjustbeforere-startinganewcycleoftherapy.

Inlow-gradelymphomaandsuspicionofrecurrentovarianrecurrentcancer,onlypositivepredictivevaluesshouldbe

consideredbecauseoflimitedsensitivityofFDG-PET.

Fludeoxyglucose( 18

F)isnoteffectiveindetectingbrainmetastases.

Whenusingacoincidencepositronemissiontomography(PET)scannersystem,sensitivityisreducedincomparisonto

dedicatedPETsystems,resultinginreduceddetectionoflesionssmallerthan1cm.

ItisrecommendedthatFludeoxyglucose( 18

F)imagesshouldbeinterpretedinrelationwithtomographicanatomical

imagingmodalities(e.g.CTultrasonography,MRI).FusionofthefunctionalFludeoxyglucose( 18

F)–PETimages

withmorphologicimages(e.g.PET-CT)canleadtoanincreasedsensitivityandspecificityandisrecommendedin

cancersofthepancreas,headandnecktumours,lymphoma,melanoma,lungcancersandrecurrentcolorectalcancers.

ButthebenefitinrepeatPETscansandinchildrenmustbeweighedagainsttheaddedradiationdoseassociatedwith

Generalwarnings:

Closecontactbetweenthepatientandyoungchildrenshouldbeavoidedduringtheinitial12hoursfollowingthe

injection.

Radiopharmaceuticalproductsshouldbereceived,usedandadministeredonlybyauthorisedpersonsindesignated

clinicalsettings.Receipt,storage,use,transferanddisposalmustbesubjecttotheregulationsandappropriatelicences

ofthecompetentauthorities.

Radiopharmaceuticalsshouldbepreparedbytheuserinamannerthatsatisfiesbothradiationsafetyand

pharmaceuticalqualityrequirements.

Fludeoxyglucose( 18

F)shouldbestoredandhandledinadequateshielding,soastoprotectpatientsandhospitalstaffas

muchaspossible.Inparticular,itisrecommendedtoprotectoneselffromtheeffectsofbeta+radiationandannihilation

photonsbyusinganappropriateshieldingwhenperformingwithdrawalsfromthevialandinjections.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Allmedicinalproductsthatmodifybloodglucoselevelscanaffectthesensitivityofthediagnosticexamination(e.g.

corticosteroids,valproate,carbamazepine,phenytoin,phenobarbitalandcatecholamies).

Followingadministrationofcolony-stimulatingfactors(CSFs)thereisanincreaseduptakeofFludeoxyglucose( 18

F)in

thebonemarrowandthespleenforseveraldays.ThismustbetakenintoaccountfortheinterpretationofPETimaging.

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TheadministrationofglucoseandinsulininfluencestheinfluxofFludeoxyglucose( 18

F)intothecellsandmayaffect

thequalityofthescintigraphicimage.Forscintigraphicimagesoftheheart,insulinisrequiredtoachievemaximum

uptake,particularlyinthediabeticpatient.Inthecaseofhighbloodglucoselevelsaswellaslowplasmainsulinlevels,

theinfluxofFludeoxyglucose( 18

F)intoorgansandtumoursisreduced.

4.6Fertility,pregnancyandlactation

Pregnancy

ThereisnoclinicalexperiencewiththeuseofFludeoxyglucose( 18

F)inpregnantwomen.

Whenitisnecessarytoadministerradioactivemedicinalproductstowomenofchildbearingpotential,information

shouldalwaysbesoughtaboutpregnancy.Anywomanwhohasmissedaperiodshouldbeassumedtobepregnant

untilprovenotherwise.Whereuncertaintyexists,itisimportantthatradiationexposureshouldbetheminimum

consistentwithachievingthedesiredclinicalinformation.Alternativetechniquesthatdonotinvolveionisingradiation

shouldbeconsidered.

Radionuclideprocedurescarriedoutonpregnantwomeninvolveradiationdosestothefoetus.Administrationof

Fludeoxyglucose( 18

F)atanactivityof400MBqresultsinanabsorbeddosetotheuterusof8.4mGy.Inthisdose

range,lethaleffectsandtheinductionofmalformations,growthretardationsandfunctionaldisordersarenottobe

expected;however,theriskoftheinductionofcancerandhereditarydefectsmaybeincreased.

Fludeoxyglucose( 18

F)shouldnotbeadministeredduringpregnancyunlessclearlynecessaryorwhenthebenefittothe

motheroutweighstherisktothefoetus.

Lactation

Fludeoxyglucose( 18

F)isexcretedintobreastmilk.

BeforeadministeringFludeoxyglucose( 18

F)toamotherwhoisbreastfeeding,considerationshouldbegivenasto

whethertheinvestigationcouldbereasonablydelayeduntilthemotherhasceasedbreastfeeding.Ifadministration

duringlactationisunavoidable,breastfeedingmustbeinterruptedforatleast12hoursafterFDGadministrationand

theexpressedmilkmustbediscarded.Whenappropriate,milkmaybedrawnoffpriortoadministrationof

Fludeoxyglucose( 18

F).Moreover,forradioprotectionreasons,itisrecommendedtoavoidclosecontactbetweenthe

motherandtheinfantduringtheinitial12hoursfollowingtheFDGinjection.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandtousemachineshavebeenperformed.

4.8Undesirableeffects

UndesirableeffectsaftertheadministrationofFludeoxyglucose( 18

F)havenotbeenobservedtodate.Sincetheamount

ofthechemicalcompoundadministeredisverylow,themajorriskiscausedbyradiation.Exposuretoionising

radiationcanbeleadtocancerordevelopmentofhereditarydefects.Mostexaminationsinvolvingnuclearmedicine

resultinexposurelevelsofradiation(theeffectivedose)oflessthan20mSv.Theprobabilityofsucheffectsarisingis

low.

Afteradministrationofthemaximumrecommendedactivity(700MBq)theeffectivedoseisabout13.3mSv(Valket

al.,2003).

4.9Overdose

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IfanoverdoseofFludeoxyglucose( 18

F)hasbeenadministered,theradiationdosedeliveredtothepatientwillbe

reducedbyincreasingasmuchaspossibletheeliminationoftheradionuclide,byforceddiuresisandfrequentbladder

voidingandbyraisingbloodglucosebyoralintakeofglucose.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

PharmacotherapeuticGroup:DiagnosticradiopharmaceuticalsATCcode:V091X04

Atthechemicalconcentrationsusedfordiagnosticexaminations,Fludeoxyglucose( 18

F)doesnotappeartohaveany

pharmacodynamicactivity.

5.2Pharmacokineticproperties

Fludeoxyglucose( 18

F)isaglucoseanaloguewhichisaccumulatedinallcellsusingglucoseasaprimaryenergy

source.Itisthereforeaccumulatedintumourswithahighglucoseturnover.

Followingintravenousinjection,thepharmacokineticprofileofFludeoxyglucose( 18

F)inthevascularcomponentis

biexponential.Ithasadistributiontimeofoneminuteandaneliminationtimeofapproximately12minutes.

ThecellularuptakeofFludeoxyglucose( 18

F)isperformedbytissue-specificcarriersystems,whicharepartlyinsulin-

dependentandthuscanbeinfluencedbyeating,nutritionalconditionandtheexistenceofdiabetesmellitus.Inpatients

withdiabetesmellitusareduceduptakeofFludeoxyglucose( 18

F)intothecellsoccursduetoachangedtissue

distributionandglucosemetabolism.

Fludeoxyglucose( 18

F)istransportedviathecellmembraneinasimilarwaytoglucose,butonlyundergoesthefirst

stepofglycolysis,resultingintheformationofFludeoxyglucose( 18

F)-6-phosphate,whichremainstrappedwithinthe

tumourcellsandisnotfurthermetabolised.Sincesubsequentdephosphorylationbyintracellularphosphatasesisslow,

Fludeoxyglucose( 18

F)-6-phosphateisretainedinthetissuesoverseveralhours(knownasatrappingmechanism).

Inhealthysubjects,Fludeoxyglucose( 18

F)iswidelydistributedthroughoutthebody,particularlyinthebrainand

heartandtolesserdegreeinthelungsandliver.

TheeliminationofFludeoxyglucose( 18

F)ischieflyrenal(duetofiltrationthroughtherenalglomeruliandabsenceof

reabsorptionbyrenaltubules)with20%ofactivitybeingexcretedinurineinthetwohoursfollowinginjection.

Bindingtorenalparenchymaisweakbutbecauseofrenalelimination,theentireurinarysystems,particularlythe

bladder,exhibitsmarkedactivity.

Fludeoxyglucose( 18

F)crossesthroughtheblood-brainbarrier.Approximately7%oftheinjecteddoseaccumulatesin

thebrainwithin80-100minutesafterinjection.Epileptogenicfociexhibitareducedglucosemetabolisminseizure-free

phases.

Approximately3%oftheactivityistakenupbythemyocardiumwithin40minutes.Thedistributionof

Fludeoxyglucose( 18

F)innormalheartismainlyhomogenous,however,regionaldifferencesofupto15%are

describedfortheinterventricularseptum.Duringandafterareversiblemyocardialischaemia,anincreasedglucose

uptakeoccursintothemyocardialcell.

0.3and0.9-2.4%oftheinjectedactivityisaccumulatedinthepancreasandlungs.

Fludeoxyglucose( 18

F)isalsoboundtoalesserextenttoocularmuscle,pharynxandtheintestine.Bindingtomuscle

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Intumours,theFludeoxyglucose( 18

F)injectionaccumulatesprogressivelyforseveralhours(3-4hours).Dueto

radioactivedecay,theoptimalimagingtimeisaround90minutes.Asaresultofhighhepaticphosphataseactivitythe

Fludeoxyglucose( 18

F)concentrationintheliverdiminishesmorerapidlythaninotherpartsofthebody.

5.3Preclinicalsafetydata

Inpreclinicalstudiesofacutetoxicitythe50-foldhumandoseindogsandthe1000-foldhumandoseinmicedidnot

revealanysignsoftoxicity.

Studiesofchronictoxicity,mutagenicpotential,aswellasstudiesofreproductivetoxicityandcarcinogenicpotential

havenotbeenperformedbecauseoftheintendedclinicaluseofthesubstance(usuallyasingleintravenousdoseinthe

rangeofnanogrammesormicrogrammes).

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumchloride

Waterforinjections

Sodiumdihydrogenphosphatedihydrate

6.2Incompatibilities

Thismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthosementionedinsection12,

Instructionsforpreparationofradiopharmaceuticals.

6.3Shelflife

12hours.

Theshelf-lifeafterthefirstdosehasbeenwithdrawnisfourhours.

Theexpirytimeanddatearestatedonthelabelofeachvial.

6.4Specialprecautionsforstorage

Donotstoreabove25˚C.

Thevialdoesnotcontainapreservativeagent.Iftheproductisformultipleuse,theneachdosemustbepreparedunder

asepticconditions.

Thisproductshouldbestoredinaccordancewithnationalregulationsconcerningradioactiveproducts.

6.5Natureandcontentsofcontainer

Type1(Ph.Eur.)glassvial(maximumsize11mlor15ml)closedwitheitherabromobutylorETFE-coatedchlorobutyl

rubberstopperandsealedwithanaluminiumcrimpcap.Thevialisshieldedbyaleadcontainerwithinasealedouter

container.

Onevialcontains1-14.9mlofsolution,correspondingto110to50,000MBqatcalibrationtime.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

M2iLtd

BlackrockClinic

Blackrock

Co.Dublin

RepublicofIreland

8MARKETINGAUTHORISATIONNUMBER

PA1125/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:21 st

October2005

DateofRenewal21stMarch2011

10DATEOFREVISIONOFTHETEXT

November2011

11DOSIMETRY

ThetablebelowshowsthedosimetryascalculatedaccordingtotheICRP80Publication.

Table3:DoseabsorbedperunitofActivityAdministered(mGy/MBq)

Organ Absorbed

Dosein

Adults Absorbeddoseinchildren(mGy/MBq)for

differentagegroups

15yrs 10yrs 5yrs 1yr

Adrenalglands 0.012 0.015 0.024 0.038 0.072

Bladderwall 0.16 0.21 0.28 0.32 0.59

Bonesurfaces 0.011 0.014 0.022 0.035 0.066

Brain 0.028 0.028 0.030 0.034 0.048

Breasts 0.0086 0.011 0.018 0.029 0.056

Bileduct 0.012 0.015 0.023 0.035 0.066

Investinalwall 0.011 0.014 0.022 0.036 0.068

Smallintestine 0.013 0.017 0.027 0.041 0.077

Colon 0.013 0.017 0.027 0.040 0.074

ULIwall 0.012 0.016 0.025 0.039 0.072

LLIwall 0.015 0.019 0.029 0.042 0.076

Heart 0.062 0.081 0.12 0.20 0.35

Kidneys 0.021 0.025 0.036 0.054 0.096

Liver 0.011 0.014 0.022 0.037 0.070

Lungs 0.010 0.014 0.021 0.034 0.065

Muscles 0.011 0.014 0.021 0.034 0.065

Oesophagus 0.011 0.015 0.022 0.035 0.068

Ovaries 0.015 0.020 0.030 0.044 0.082

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ForFludeoxyglucose( 18

F)theeffectivedoseresultingfromadministrationofanactivityof400MBqisabout7.6mSv

(foranindividualweighing70kg).Forthisactivityradiationdoesdeliveredtothecriticalorgans(bladder,heartand

brain)arerespectively64mGy,25mGyand11mGy.

Forotherstudiestheeffectivedoseinanindividualweighing70kgisapproximatelyasfollows:

Foroncologicaldiagnosticpurposesinjectedactivitiesof100to400MBqarerecommended,givingamaximal

effectivedoseof8.7mSv.

Forchildrenandadolescents,areductionintheinjectedactivitymustbeapplied(seesection4.2,posologyandmethod

ofadministration)

12INSTRUCTIONSFORPREPARATIONOFRADIOPHARMACEUTICALS

Thepackagemustbecheckedbeforeuseandtheactivitymeasuredusingacalibrator.Themedicinalproductmaybe

dilutedwithsodiumchloride9mg/ml(0.9%)solutionforinjection.

Withdrawalsshouldbeperformedunderasepticconditions.

Thevialsmustnotbeopenedafterdisinfectingthestopper,thesolutionsshouldbewithdrawnviathestopperusinga

singledosesyringefittedwithsuitableprotectiveshieldingandadisposablesterileneedle.

Thesolutionshouldbevisuallyinspectedpriortouse,usingappropriateprotectiveshielding.Onlyclearsolutions,free

fromvisibleparticles,shouldbeused.

Theadministrationofradiopharmaceuticalsposesrisksforotherpeoplefromexternalradiationduetocloseproximity

withinjectedpatients,contaminationfromspillsofurine,vomitetc.Radiationprotectionprecautions,inaccordance

withcompetentauthoritylicensingrequirements,mustthereforebetaken.

Radioactivewastemustbedisposedofinconformitywiththerelevantnationalandinternationalregulations.Since

Fludeoxyglucose( 18

F)hasaphysicalhalf-lifeofapproximately110minutes,wastefromFDGisnolongerdeemeda

Bonemarrow 0.011 0.014 0.022 0.032 0.061

Skin 0.0080 0.010 0.016 0.027 0.052

Spleen 0.011 0.014 0.022 0.036 0.069

Testes 0.012 0.016 0.026 0.038 0.073

Thymus 0.011 0.015 0.022 0.035 0.068

Thyroid 0.10 0.013 0.021 0.035 0.068

Uterus 0.021 0.026 0.039 0.055 0.10

Otherorgans 0.011 0.014 0.022 0.034 0.063

Effectivedose(mSv/MBq) 0.019 0.025 0.036 0.050 0.095

Typeofstudy Injectedactivity Effectivedose

Brainstudies 185 4

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