CELSIOR

Main information

  • Trade name:
  • CELSIOR Unknown
  • Pharmaceutical form:
  • Unknown
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CELSIOR Unknown
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0611/002/001
  • Authorization date:
  • 01-04-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Celsiorsolutionfororganpreservation

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachbagwith1litresolutioncontains

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionfororganpreservation.

Clear,colourless(orslightlyyellow)solution.

pH=7.3

Osmolality:320mosmol/kg

4CLINICALPARTICULARS

4.1TherapeuticIndications

Solutionforthepreservationofthoracicorgans(heartandlung)andabdominalorgans(kidney,liver,pancreas)during

transplantation:Fromremovalfromthedonoraswellasduringstorage,transportationanduntiltransplantationintothe

recipient.

4.2Posologyandmethodofadministration

Theexactflushingmethoddependsonthecentreandonwhetherornotseveralorgansaretoberemovedatthesame

time.Flushingisoftencarriedoutintwostages:the1 st

flushwhiletheorganisstillinsituandthe2 nd

flushoncethe

organhasbeenremoved.

Theorganisflushedviaacannulainsertedintoanartery,whilemaintainingsufficientpressuretoobtainasteady

streamofsolutioninordertoproduceadequateflushing.Inthecaseoflivertransplantationthebiliarytreeisusually

flushedoutafterexplantation,beforeplacinginthestorageandtransportcontainer.

Thevolumeofflushingsolutiondependsontheorgan(s).

Glutathione 0.921g (3mmol)

Mannitol 10.930g (60mmol)

Lactobionicacid 28.664g (80mmol)

Glutamicacid 2.942g (20mmol)

Sodiumhydroxide 4.000g (100mmol)

Calciumchloridedihydrate 0.037g (0.25mmol)

Potassiumchloride 1.118g (15mmol)

Magnesiumchloridehexahydrate 2.642g (13mmol)

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Heart: Adult:1-2litres

Infants:30ml/kg

Liver: 6-8litres

Lung: 4-6litres

Kidney: 4-5litres

Pancreas: 4litres.

Multi-organ: inaccordancewiththeappropriateorgans.

Flushingshouldbecontinueduntiltheorganisuniformlypaleandtheeffluentisrelativelyclear.

Instructionsonuseandhandlingoftheproduct:

Thebaginthealuminium-protectedoutercontainercontainsoxygen-absorbersubstances.Thecontentsofthisbag

shouldnotbemixedwiththesolution.

Onlyintactcontainers(bagandaluminiumpackaging)shouldbeused.

Thereisnoneedtofilterthesolutionbeforeuse.

Forsingleuseonly.Donotreuse.

Acarefulvisualinspectionofthesolutionforturbidityshouldbecarriedout.Onlyclearandcolourlessorslightly

yellowsolutionsshouldbeused.Ifanyturbidity,precipitatesorcontaminationisevident,thesolutionmustbe

discarded.

Notsuitableforcontinuousmachineperfusion.

Thesolutionmayturnyellowduringstorage.ThisdoesnotimpairthequalityandeffectivenessofCelsior.

Afterremovalfromcoldstorage(2-8°C),thecooledsolutionshouldbeusedimmediately.

TherehavebeennoadequateclinicalstudiesoftheuseofCelsiorfororgantransplantationinchildren.

Storageundercoldconditions:

Theorganisstoredat5±3°Cinasterilecontainerappropriatelysizedfortheorgan.Theorganmustbecompletely

coveredbythecooledsolution.Theorganstoragecontainermustbeasepticallysealed.

Thecontainershouldthenbeplacedinatleastasecondcontainer.Thisshouldbefilledwithice,butnoicemustenter

theorganstoragecontainer,wheretheicecouldcomeintodirectcontactwiththeorgan.Caremustbetakentoensure

thattheorganisasepticallystoredinitscontainer,i.e.theinsideoftheorganstoragecontaineranditscontentsmust

remainsterile.

Theadditionalcontainer(s)mustbesecurelysealed.

Theorganstoragecontainersmustthenbemaintainedwithinawell-insulatedtransportcontainer.Theorganstorage

containersshouldbesurroundedbyice.

Transporttimesmustbeasshortaspossible.

4.3Contraindications

Hypersensitivitytotheactivesubstancesortoanyoftheexipients.

4.4Specialwarningsandprecautionsforuse

Notsuitablefordirectinjectionorforintravenoususeintherecipient.

Exclusivelyforuseintheflushingandcoldstorageofsolidorgans.

TheoreticalpossibilityofresidualCelsiorbeingreleasedintothegeneralcirculationoftherecipienton

declamping,whichcouldprovokecardiacarrythmiasorhypotension.Impairedcardiacfunctionintheeventof

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Therearenoknowninteractionswhenusedasdirected.

4.6Fertility,pregnancyandlactation

NoanimalstudieswithCelsiorhavebeenperformedonreproductiontoxicity,lactation,andplacentaluptake.Alsono

adequateandwellcontrolledstudiesusingCelsiorinpregnantandlactatingwomenhavebeenconducted.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

SinceCelsiorisnotadministeredtoorganrecipientsthemselves,nosolution-specificsideeffectsaretobe

expected.

Hypersensitivityreactionstotheactivesubstancesortoanyoftheexipientscanoccur.

ThereisatheoreticalpossibilityofresidualCelsiorbeingreleasedintothegeneralcirculationoftherecipienton

declamping,whichcouldprovokecardiacarrythmiasorhypotension.Impairedcardiacfunctionintheeventof

non-optimalheartpreservationintheearlypost-transplantationphasecannotberuledout.

Ifrelativelylargevolumesenterthesystemiccirculationasaresultofimproperuse,thismayleadtovolume

overloadorelectrolyteabnormalities,particularlyinpatientswithcardiacdefectsorrenalfailure.Insuchcases,

intensivecareshouldbeinstituted.

4.9Overdose

Notapplicablewhenusedasdirected.

Ifrelativelylargevolumesenterthesystemiccirculationasaresultofimproperuse,thismayleadtovolumeoverload

orelectrolyteabnormalities,particularlyinpatientswithcardiacdefectsorrenalfailure.Insuchcases,intensivecare

shouldbeinstituted.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Solventanddilutingagents,incl.irrigatingsolutions.

ATCcode: V07AB.

Celsiorissuitableforheart,lungandabdominalorgantransplantpreservation.

Administrationofthesolutionattherecommendedtemperatureeffectivelycoolstheorgan,anditsmetabolic

requirementsandassociatedenergyconsumptionarereduced.Inparticular,Celsiorreducesischaemicreperfusion

damageduetothefollowingproperties:

Preventionofoxidativedamagecausedbyfreeradicalsduemainlytotheuseofreducedglutathioneasthe

antioxidant.

Preventionofhypothermia-inducedcellularswellingandoedemaduetotheuseofmembrane-impermeable

substancesmannitolandlactobionicacidwhichholdwaterintheextracellularcompartmentduetotheirosmotic

effect.

Reductionofcalciumloadingbyuseofasuitablesolution,e.g.lowcalciumconcentration,moderatelyhigh

potassiumconcentrationswhichisalsoslightlyhyperkalaemicandhighsodiumandmagnesiumconcentrations

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Regenerationofhigh-energysubstancesbysupplyingthemwithglutamate,ahigh-energysubstrate,,whichallows

energytobeproducedinanaerobicsituations.

Provisionofabufferingcapacityduetotheuseofhistidine,whichpreventstissueacidosiscausedbylacticacid

accumulation.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Preclinicalstudieshavedemonstratednospecifictoxicityattributabletotheproduct.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjection

Sodiumhydroxide4%(forpHadjustment).

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3ShelfLife

2years.

Afteropening:24hours.

6.4Specialprecautionsforstorage

Inordertoprotectfromlightstoreinoriginalaluminiumprotectedoverwrap.Storeandtransportrefrigerated(2°C–8°

Donotfreeze.

6.5Natureandcontentsofcontainer

Celsiorisasterileready-to-usesolutionstoredinanethylenevinylacetatecopolymerbaginanouteraluminiumbag

containingoxygen-absorber.

Thebagincontactwiththesolutionismanufacturedfromanethylenevinylacetatecopolymer(EVAM type).

Packsize:4bagseachcontaining1litreofsolution.

6.6Specialprecautionsfordisposalandotherhandling

Althoughthepackagingmaterialsareproducedunderasepticconditions,theoutsideoftheCelsiorbagisnotsterile.

TheoutsideofthebagshouldbedecontaminatedifCelsioristobepouredoutofit.

Thealuminiumouterpackagingandtheoxygen-absorberbagshouldberemovedbeforeuse.Assoonastheouter

packaginghasbeenremoved,thecontainershouldbecheckedforanyleaksbysqueezingthebag.Ifaleakisfound,the

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Thelabelledsideofthebagshouldbevisibleinfrontinpreparationforuse.The3exitportsshouldbeextendedfrom

thebag.Thetabontheleftportshouldbepulled,andtheprotectivecapremovedcompletelyfromtheopening.The

spikeonastandardcystoscopyinfusionsetshouldbeinsertedintotheleftportwithatwistingmotion.Theinfusion

lineshouldbeclampeduntilthestartoftheinfusion.

Thebagofsolutionshouldbeplacedinsideanappropriatelysizedpressurecuff.Thecuffshouldbeinflatedtoapply

sufficientpressuretoexpressthefluid.Beforeinfusion,thesolutioncontainershouldbesuspendedfromasufficient

heighttoguaranteeasteadystreamofthesolution.

7MARKETINGAUTHORISATIONHOLDER

GenzymeEuropeB.V.

Gooimeer10

1411DDNaarden

TheNetherlands

8MARKETINGAUTHORISATIONNUMBER

PA611/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1stApril2011

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