Euthasol 40% Solution for Injection

Main information

  • Trade name:
  • Euthasol 40% Solution for Injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Euthasol 40% Solution for Injection
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Pentobarbital
  • Therapeutic area:
  • Cats, Cattle, Dogs, Horses, Other, Pigs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0370/001
  • Authorization date:
  • 28-09-2011
  • EU code:
  • UK/V/0370/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:December2011

AN:00665/2010

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Euthasolvet.400mg/ml,solutionforinjection(AT,BE,EE,EL,FI,IE,IS,LT,LU,LV,

NO,PL,SE,UK)

Euthasol400mg/ml,solutionforinjection(ES,PT)

Euthasolvet.solutionforinjection(FR)

Euthasolvet.400mg/mlsolutionforinjectionfordogs,cats,rodents,rabbits,cattle,

sheep,goats,horsesandmink(IT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perml:

Activesubstance:

Pentobarbital(assodiumsalt) 362.9mg

(equivalentto400mgpentobarbitalsodium)

Excipient(s):

Benzylalcohol(E1519) 20mg

PatentBlueV(E131) 0.01mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearblueliquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs,cats,rodents,rabbits,cattle,sheep,goats,horsesandmink.

4.2 Indicationsforuse,specifyingthetargetspecies

Euthanasia

4.3 Contraindications

Donotuseforanaesthesia.

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4.4Specialwarningsforeachtargetspecies

-Intravenousinjectionofpentobarbitalhastheabilitytocauseinductionexcitement

inseveralspeciesofanimalandadequatesedationshouldbeappliedifdeemed

necessarybytheveterinarysurgeon.Measuresshouldbetakentoavoid

perivascularadministration(e.g.byusingintravenouscatheter).

-Theintraperitonealrouteofadministrationmaycauseaprolongedonsetofaction

withanincreasedriskofinductionexcitement.Intraperitonealadministrationmust

onlybeusedfollowingappropriatesedation.Measuresshouldbetakentoavoid

administrationintothespleenororgans/tissuewithlowcapacityforabsorption.This

routeofadministrationisonlysuitableforsmallanimals.

-Intracardiacinjectionmustonlybeusediftheanimalisheavilysedated,

unconscious,oranesthetized.

Toreducetheriskofinductionexcitement,euthanasiashouldbeperformedinaquiet

area.

Inhorsesandcattle,premedicationwithanappropriatesedativemustbeusedto

produceprofoundsedationbeforeeuthanasiaandanalternativemethodof

euthanasiashouldbeavailable.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

-Theintravenousrouteofadministrationshouldbetherouteofchoiceandadequate

sedationshouldbeappliedifdeemednecessarybytheveterinarysurgeon.For

horsesandcattlepremedicationismandatory.

Whereintravenousadministrationisimpossible,andonlyfollowingdeepsedation,

theproductmaybeadministeredviatheintracardiacrouteinallnamedspecies.

Alternatively,forsmallanimalsonly,administrationviatheintraperitonealroutecould

beused,followingappropriatesedation.

-Intheeventofaccidentaladministrationtoananimalnotpresentedforeuthanasia,

measuressuchasartificialrespiration,administrationofoxygenandtheuseof

analepticsareappropriate.

-Ingestionofeuthanasedanimalsbyotheranimalsmayleadtointoxication,

anaesthesiaandevendeath.Barbituratesarealsohighlystabletocooking

temperature.Duetotheriskofsecondaryintoxicationanimalseuthanasedwiththe

veterinarymedicinalproductshouldnotbefedtootheranimalsbutshouldbe

disposedofinaccordancewithnationallegislationandinamannerthatother

animalscannothaveaccesstothecarcasses.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Pentobarbitalisapotenthypnoticandasedative,andthuspotentiallytoxicinman.It

canbeabsorbedsystemicallythroughtheskinandifswallowed.Particularcare

shouldbetakentoavoidaccidentalingestionandself-injection.

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AN:00665/2010

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Incaseofaccidentalself-injection,ingestionorspillageontoskinorintoeyes,seek

medicaladviceimmediatelyandshowthepackageleafletorthelabeltothe

physician.DONOTdriveassedationmayoccur.

Incaseofaccidentalself-injection,obtainURGENTmedicalattention,advising

medicalservicesofbarbituratepoisoning.

Incaseofspillageontoskin,washtheexposedskinimmediatelyafterexposurewith

largeamountofwater.

Incaseofcontactwitheyes,rinseimmediatelywithplentyoffreshwaterandobtain

medicaladvice.

Incaseofingestion,washoutmouthandobtainmedicalattentionimmediately.

Impermeableprotectiveglovesshouldbewornwhenhandlingthisproduct.

Peoplewithknownhypersensitivitytopentobarbitalshouldavoidcontactwiththe

veterinarymedicinalproductoradministertheproductwithcaution.

AdvicetoDoctor:Theconcentrationofpentobarbitalintheproductissuchthatthe

accidentalinjectionoringestionofquantitiesassmallas1mlinhumanadultscan

haveseriousCNSeffects.Adoseofpentobarbitalsodiumof1g(equivalentto2.5ml

ofproduct)hasbeenreportedtobefatalinhumans.Treatmentshouldbesupportive

withappropriateintensivetherapyandmaintainingtherespiration.

4.6Adversereactions(frequencyandseriousness)

Minormuscletwitchingmayoccurafterinjection.

Deathmaybedelayediftheinjectionisadministeredperivascularlyorinto

organs/tissueswithlowcapacityforabsorption.Barbituratescanbeirritatingwhen

administeredperivascularly.

Pentobarbital sodium has the ability to cause induction excitement.

Premedication/sedationsignificantlyreducestheriskofexperiencinginduction

excitement.

Veryoccasionallyoneorafewgaspingrespirationsoccuraftercardiacarrest.Atthis

stagetheanimalisalreadyclinicallydead.

4.7Useduringpregnancy,lactationorlay

Ifeuthanasiaisnecessary,theproductcanbeusedinpregnantorlactatinganimals.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Whenanaggressiveanimalistoundergoeuthanasia,premedicationwithamore

easilyadministered(oral,subcutaneousorintramuscular)sedativeisrecommended.

Althoughpremedicationwithsedativesmaydelaythedesiredeffectoftheproduct

duetodecreasedcirculatoryfunctionthismaynotbeclinicallynoticeablesinceCNS

depressantdrugs(opioids,α2adrenoreceptoragonists,phenothiazinesetc)canalso

increasetheeffectofpentobarbital.

4.9 Amountstobeadministeredandadministrationroute

Adoseof140mg/kg,equivalentto0.35ml/kg,isconsideredsufficientforallindicated

routesofadministration.

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AN:00665/2010

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Theintravenousrouteofadministrationshouldbetherouteofchoiceandadequate

sedationshouldbeappliedifdeemednecessarybytheveterinarysurgeon.For

horsesandcattlepremedicationismandatory.

Whenintravenousadministrationisdifficult,andonlyfollowingdeepsedationor

anaesthesia,theproductmaybeadministeredviatheintracardiacroute.

Alternatively,forsmallanimalsonly,administrationviatheintraperitonealroute

couldbeused,butonlyfollowingappropriatesedation.

Theintravenousinjectionincompanionanimalsshouldbecarriedoutwitha

continuousinjectionrateuntilunconsciousnessoccurs.

Inhorsesandcattle,pentobarbitalshouldbeinjectedrapidly.

Thestoppershouldnotbepuncturedmorethan20times.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Notapplicable.

4.11Withdrawalperiod(s)

Adequatemeasuresshouldbetakentoensurethatcarcassesofanimalstreatedwith

thisproductandtheby-productsoftheseanimalsdonotenterthefoodchainandare

notusedforhumanoranimalconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:barbiturates

ATCvetcode:QN51AA01

5.1 Pharmacodynamicproperties

PentobarbitalsodiumisanoxybarbituratederivativeofBarbituricAcid.Barbiturates

depresstheentirecentralnervoussystembut,quantitatively,variousareasare

affecteddifferentlymakingtheproductapotenthypnoticandsedative.The

immediateeffectistheunconsciousnessofdeepanaesthesiafollowedby,athigh

doserates,rapiddepressionoftherespiratorycentre.Breathingstopsandcessation

ofheartactionquicklyfollowsleadingtorapiddeath.

5.2Pharmacokineticparticulars

Wheninjectedintothebloodstream,abarbiturateionises,thedegreedependingon

thedissociationconstantoftheagentandthepHoftheblood.Barbituratesbindwith

plasmaproteins,forminganequilibriumofboundandunbounddrugincirculating

blood.Cellpenetrationcanonlyoccurwiththeundissociatedform.

Aftercellpenetration,dissociationagainoccursandbindingofthedrugto

intracellularorganellestakesplace.

Tissuechangesduetocellularpenetrationandintracellularbindinghavenotbeen

described.Ingeneral,theeffectsontissuescanbecategorisedasdirectand

indirect.Ingeneral,theseeffectsaresubtleandlittleisknownconcerningthem.

Followingintracardiacuseunconsciousnessisalmostimmediateandcardiacarrest

followswithin10seconds.

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AN:00665/2010

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Followingintravenoususeunconsciousnessfollowsin5-10secondsafter

completionofadministration.

Deathfollows5-30secondslater.Intraperitoneally,euthanasiaisachievedin3-10

minutes(duetodepressionoftherespiratorycentre,theanimalmaybeclinically

deadpriorcardiacarrest).

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol(E1519)

PatentBlueV(E131)

Ethanol(96percent)

Propyleneglycol

Waterforinjections

6.2Incompatibilities

Donotmixwithothermedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Donotfreeze.

Storeintheoriginalpackagingtoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

100mlcolourlesstypeIIglassvialwithalightgreybromobutylrubberstopperandan

aluminiumcap.

250mlcolourlesstypeIIglassvialwithadarkgreybromobutylrubberstopperand

analuminiumcap.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

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7. MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Wilgenweg7

3421TVOudewater

TheNetherlands

8.MARKETINGAUTHORISATIONNUMBER

Vm19994/4016

9.DATEOFFIRSTAUTHORISATION

12December2011

10.DATEOFREVISIONOFTHETEXT

December2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Administrationonlybyaveterinarysurgeon.

Tobesuppliedonlyonveterinaryprescription.