ANATERA 100MG/ ML SOLUTION FOR INJECTION

Main information

  • Trade name:
  • ANATERA 100MG/ ML SOLUTION FOR INJECTION
  • Dosage:
  • 10 %v/ v
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANATERA 100MG/ML SOLUTION FOR INJECTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0290/078/001
  • Authorization date:
  • 05-10-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Anatera100mg/mlsolutionforinjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlsolutioncontains100mgfluorescein(as113.2mgfluoresceinsodium)

One5mlvialcontains500mgfluorescein(as566mgfluoresceinsodium)

Containssodium(fromfluoresceinsodiumandsodiumhydroxide)atamountsupto1.45%(approximately3.15mmol)

perdose.Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection

Clear,red-orangesolution

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thismedicinalproductisfordiagnosticuseonly.

Forfluoresceinangiographyoftheocularfundus.

4.2Posologyandmethodofadministration

Posology

Useinadults,includingtheelderly:

5mlofAnatera100mg/mlsolutionforinjectionrapidlyintotheantecubitalveinaftertakingprecautionstoavoid

extravasation.Incaseswhenhighlysensitiveimagingsystemse.g.,scanninglaserophthalmoscopeareused,thedose

ofthisproductshouldbereducedto2mlofAnatera100mg/mlsolutionforinjection.

Useinpaediatricpatients:

Anatera100mg/mlsolutionforinjectionhasnotbeenstudiedinchildrenanddose-adaptationdataarenotavailable.

Therefore,Anatera100mg/mlsolutionforinjectionshouldnotbeusedinpatientsbelow18yearsasefficacyand

safetyinthisgrouphavenotbeenestablished.

Useinpatientswithrenalinsufficiency(glomerularfiltrationratebelow20ml/min):

Limitedexperienceinrenallyimpairedsubjects(glomerularfiltrationratebelow20ml/min)suggeststhat,ingeneral,

nodoseadjustmentisrequiredalthoughalongerexcretionrateinpatientswithrenalimpairmentispossible(see

section5.2).

Dialysedpatients:Reducedoseto2.5ml(halfavial)

Methodofadministrationandfluorescenceangiography

Anatera100mg/mlsolutionforinjectionshouldbeusedexclusivelybyqualifiedphysicianswithtechnicalexpertisein

performingandinterpretingfluorescenceangiography.

Thisproductshouldonlybeadministeredintravenously.

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injectedtoavoidphysicalincompatibilityreactions.Theinjectionshouldbeadministeredrapidly(1mlpersecondis

normallyrecommended)intotheantecubitalvein,aftertakingprecautionstoavoidextravasationusinga23gauge

butterfly needleforinjection.Luminescenceusuallyappearsintheretinaandchoroidalvesselsin7to14seconds.

Forfurtherinstructionsonthecorrectadministration/useofthisproduct,seesections6.2and6.6.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Anatera100mg/mlsolutionforinjectionshouldnotbeinjectedintrathecallyorintra-arterial.

4.4Specialwarningsandprecautionsforuse

Fluoresceinsodiumcaninduceseriousintolerancereactions.

Detailedquestioningofeachpatientmustbecarriedoutbeforetheangiographytosearchforanyhistoryof

cardiopulmonarydiseaseorallergyorconcomitantmedications(suchasbeta-blockingagents,includingeye-drops

solutions).Iftheexaminationappearstobereallynecessaryforapatienttreatedwithbeta-blockingagents(including

eye-dropssolutions),thisexaminationshouldbeperformedunderthesupervisionofaphysicianexperiencedin

intensivecare(resuscitation).Beta-blockingagentscouldreducethevascularcompensationreactionstoanaphylactic

shockandreducetheeffectivenessofadrenalineinthecaseofcardiovascularcollapse.Beforeanyfluoresceinsodium

injection,thephysicianshouldseekinformationaboutconcomitanttreatmentwithabeta-blockingagent.

Thesereactionsofintolerancearealwaysunpredictablebuttheyaremorefrequentinpatientswhohavepreviously

experiencedanadversereactionafterfluoresceininjection(symptomsotherthannauseaandvomiting)orinpatients

withhistoryofallergysuchasfoodordruginducedurticaria,asthma,eczema,allergicrhinitis.Intradermalskintests

arenotreliableinpredictingtheseintolerancereactionsandsotheirusecanbedangerous.Aspecializedallergy

consultationshouldbeundertakentomakethisdiagnosis.

Premedicationcanbeundertaken.However,theriskofoccurrenceofsevereadversedrugreactionsstillremains.

PremedicationincludesmainlyoralantihistaminicH1drugs,followedbycorticosteroids,beforeinjectionof

fluorescein.Giventhelowincidenceoftheseadversereactions,suchpre-medicationisnotrecommendedforall

patients.

Theriskofhypersensitivityreactionswithfluoresceinsodiumrequires:

-Closemonitoringofthepatientbytheophthalmologistperformingtheexamination,throughouttheexaminationand

foratleast30minutesafter;

-Maintainingtheinfusionlineforatleast5minutes,totreatapossiblesevereadversereactionwithoutdelay;

-Tohaveatone’sdisposalappropriatematerialforemergencyresuscitationwhichisbasedatfirstontheinstallationof

a2ndintravenousline,allowingtherestorationoftheplasmavolume(aqueoussolutionpolyionicorcolloidal

substituteofplasma)andtheintravenousinjectionofadrenalineattherecommendeddosage(seesection4.5).

Note:

ExtravasationshouldbeavoidedduetothehighpHoffluoresceinsolutionwhichcanresultinseverelocaltissue

damage(severepaininthearmforseveralhours,sloughingoftheskin;superficialphlebitis).Whenextravasation

occurs,theinjectionshouldbeimmediatelydiscontinued.

IfanX-rayprocedureisconductedwithin36hoursofinjection(maximumdurationoffluoresceineliminationfromthe

body),theresultanthighvisibilityoftheexcretoryorgansintheX-rayimagemayleadtomisinterpretation.

Intheeventofseriousintolerancereactionsduringafirstangiography,thebenefitofan

additionalfluoresceinangiographyshouldbebalancedwiththeriskofseverehypersensitivity

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bypatientsonacontrolledsodiumdiet.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoresceinisarelativelyinertdyeandspecificdruginteractionstudieshavenotbeenreported.Therearefewcase

reportsonpotentialinteractionswithorganicaniontransportersandinterferencewithcertainlaboratorytests.

Compoundsthatinhibitorcompetewiththeactivetransportoforganicanions(e.g.,probenicid)mayaffectthe

systemicprofileoffluorescein.

TheconcomitantuseofAnatera100mg/mlsolutionforinjectionwithbeta-blockingagents(includingeye-drops

solutions)mayrarelyprovokesevereanaphylacticreactions(seesection4.4).

ConcomitantintravenousinjectionofothersolutionsorthemixingofAnatera100mg/mlsolutionforinjectionwith

othersolutionsshouldbeavoidedasthepossibilityofinteractionscannotbeexcluded.

Itispossiblethatfluoresceinmayinfluencecertainbloodandurinevaluesfor3to4daysafterapplication.

4.6Fertility,pregnancyandlactation

Pregnancy

ThereareinsufficientdataavailableconcerningtheuseofAnatera100mg/mlsolutionforinjectioninpregnancy.

Animalstudiesdonotindicateteratogeniceffects(seesection5.3).However,duetolimitedexperience,cautionshould

beexercisedwhenconsideringtheuseofAnatera100mg/mlsolutionforinjectionduringpregnancy.

Lactation

Fluoresceinsodiumisexcretedinhumanmilkforupto4days.Followingfluoresceinangiography,breast-feeding

shouldthereforebediscontinuedfor4daysandthemilkshouldbepumpedoffanddiscardedduringthisperiod.

4.7Effectsonabilitytodriveandusemachines

Ifmydriasisisnecessaryfortheexaminationwithfluorescenceangiographyvisualacuityisinfluencedandthusaffects

theabilitytoreactintrafficorusemachinery.Thepatientmustbemadeawarethatafterapplicationanduntilvisual

acuityreturnstonormal,drivingavehicleoroperatingdangerousmachineryisprohibited.

4.8Undesirableeffects

Themostfrequentlyreportedtreatmentrelatedundesirableeffectswerenausea,vomiting,syncopeandpruritis.More

severeadversereactionshavebeenreportedshortlyafterfluoresceininjectionsuchasangioedema,respiratory

disorders(bronchospasm,laryngealoedema,respiratoryfailure),anaphylacticshock,hypotension,respiratoryarrest

andcardiacarrest.

Additionally,ayellowishdiscolourationoftheskincouldappearbutusuallydisappearswithin6to12hours.Urine,

whichmayalsoexhibitabrightyellowcolouration,returnstoitsnormalcolourafter24to36hours.

Thefollowingundesirableeffectswereassessedtobetreatment-relatedandareclassifiedaccordingtothefollowing

convention:verycommon( ≥1/10),common(>1/100to<1/10),uncommon(>1/1000to≤1/100),rare(>1/10,000to≤

1/1000),orveryrare( ≤1/10,000).Withineachfrequencygrouping,undesirableeffectsarepresentedindecreasing

orderofseriousness.

Immunesystemdisorders:

Uncommon:hypersensitivity

Rare:anaphylacticreaction

VeryRare:anaphylacticshock

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Common:syncope

Uncommon:paresthesia,dizziness,headache

VeryRare:convulsion

NotKnown:vertebrobasilarinsufficiency

Cardiacdisorders:

Rare:cardiacarrest

VeryRare:anginapectoris,bradycardia,tachycardia

Vasculardisorders:

Uncommon:thrombophlebitis

Rare:hypotension,shock

VeryRare:hypertension,vasospasm,vasodilation,pallor,hotflush

Respiratory,thoracicandmediastinaldisorders:

Uncommon:cough,throattightness

Rare:bronchospasm

VeryRare:respiratoryarrest,pulmonaryoedema,asthma,laryngealoedema,dyspnoea,nasaloedema,sneezing

Gastrointestinaldisorders:

VeryCommon:nausea

Common:abdominaldiscomfort,vomiting

Uncommon:abdominalpain

Skinandsubcutaneoustissuedisorders:

Common:pruritus

Uncommon:urticaria

Generaldisordersandadministrationsiteconditions:

Common:extravasation

Uncommon:dysphasia,pain,feelinghot

4.9Overdose

Nocaseofoverdosehasbeenreported.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:DIAGNOSTICAGENTS,Colouringagents

ATCcode:S01JA01

Fluoresceinsodiumisafluorochromeusedinmedicineasadiagnosticstain.Fluoresceinisusedtomaketheblood

vesselsoftheocularfundusvisible(angiographyoftheretinaandchoroid).

5.2Pharmacokineticproperties

Distribution:

Within7to14secondsafterintravenousadministrationintoantecubitalvein,fluoresceinusuallyappearsinthecentral

arteryoftheeye.Withinafewminutesofintravenousadministrationoffluorescein,ayellowishdiscolourationofthe

skinoccurs,whichbeginstofade6to12hoursafterdosing.Variousestimatesofvolumeofdistributionindicatethat

fluoresceindistributeswellintointerstitialspace(0.5L/kg).

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Fluoresceinundergoesrapidmetabolismtofluoresceinmonoglucuronide.Afterintravenousadministrationof

fluoresceinsodium(14mg/kg)to7healthysubjects,approximately80%offluoresceininplasmawasconvertedto

glucuronideconjugateafteraperiodof1hourpostdose,indicatingrelativelyrapidconjugation.

Excretion:

Fluoresceinanditsmetabolitesaremainlyeliminatedviarenalexcretion.Afterintravenousadministration,theurine

remainsslightlyfluorescentfor24to36hours.Arenalclearanceof1.75ml/min/kgandahepaticclearance(dueto

conjugation)of1.50ml/min/kghavebeenestimated.Thesystemicclearanceoffluoresceinisessentiallycompleteby

48to72hoursafteradministrationof500mgfluorescein.Althoughalongerexcretionrateinpatientswithrenal

impairmentispossible,limitedexperienceinrenallyimpairedsubjects(glomerularfiltrationratebelow20ml/min)

suggeststhat,ingeneral,nodoseadjustmentisrequired.

5.3Preclinicalsafetydata

Non-clinicaldataforsodiumfluoresceinrevealnospecialhazardforhumansbasedonstudiesofsingledosetoxicity.

Fluoresceindidnotshowteratogeniceffectsinratsandrabbits.Fluoresceincrossestheplacentalbarrier.Afterthe

intravenousapplicationof500mg/kgintensefluorescencewasdetectablebothinthefoetusandtheamnioticfluid.

Studiesonmutagenicitydidnotshowanymutageniceffectsoffluoresceinsodium.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumhydroxide(forpH-adjustment)

Hydrochloricacid(forpH-adjustment)

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

Toavoidphysicalincompatibilities,thisproductmustnotbeadministeredsimultaneouslywithothersolutionsfor

injectionwithacidpH(especiallyantihistamines)bythesameintravenousroute(seesection4.2forinformationabout

cannulas).

Onceopenedthevialmustbeimmediatelyused.

6.3ShelfLife

2years

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Donotfreeze.

Keepthevialintheoutercartoninordertoprotectfromlight.

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Glass(typeI)vialwithgreychlorobutylcoatedrubberstopperandaluminumsealwithpolypropyleneflip-offcap.

Packcontaining12vialsof5mlinjectionsolution.

6.6Specialprecautionsfordisposalandotherhandling

Thesolutionistobeinspectedvisuallyforparticulatematteranddiscolourationpriortoadministration.Thesolution

shouldonlybeusedifthesolutionisclearandfreefromparticles.Forsingleuseonly.Anyunusedproductorwaste

materialshouldbedisposedofinaccordancewithlocalrequirements.DonotuseAnatera100mg/mlsolutionfor

injectionifthevialiscrackedordamagedinanyway.

7MARKETINGAUTHORISATIONHOLDER

AlconLaboratories(UK)Limited

BoundaryWay

HemelHempstead

Herts.

HP27UD

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA290/78/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:5thOctober2007.

10DATEOFREVISIONOFTHETEXT

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