Procare 1% w/v emulsion for injection

Main information

  • Trade name:
  • Procare 1% w/v emulsion for injection
  • Pharmaceutical form:
  • Emulsion for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Procare 1% w/v emulsion for injection
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • propofol
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0440/001
  • Authorization date:
  • 27-06-2012
  • EU code:
  • UK/V/0440/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:November2012

AN:00907/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINCALPRODUCT

Procare10mg/mlEmulsionforInjectionforCatsandDogs(UK)

Vetofol10mg/mlEmulsionforInjectionforCatsandDogs(FR,IT,IE)

Vetofolvet.10mg/mlEmulsionforInjectionforCatsandDogs(SE)

Norfol(NO,DK)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Propofol 10.0mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Emulsionforinjection.

Awhitehomogeneousemulsionwithnoappearanceofvisibledropletsor

extraneousforeignparticles.

4. CLINICALPARTICULARS

4.1 TargetSpecies

Dogsandcats.

4.2 IndicationsforUse,SpecifyingtheTargetSpecies

Theveterinarymedicinalproductisashort-acting,intravenous,general

anaestheticforproceduresofshortduration,lastingupto5minutes:

Fortheinductionandmaintenanceofgeneralanaesthesiausing

incrementaldosestoeffect,

Fortheinductionofgeneralanaesthesiawheremaintenanceisprovidedby

inhalationanaesthetics.

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceor

toanyoftheexcipients.

Revised:November2012

AN:00907/2012

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4.4 SpecialWarnings

Theproductisastableemulsion;discardthevialifphaseseparationis

observed.Iftheproductisinjectedveryslowly,aninadequateplaneof

anaesthesiacanoccur.

4.5 SpecialPrecautionsforUse

i. SpecialPrecautionsforUseinAnimals

Duringinductionofanaesthesia,mildhypotensionandtransient

apnoea,similartoeffectswithotherintravenousanaestheticagents

mayoccur.

Whenusingtheproduct,facilitiesforthemaintenanceofapatent

airway,artificialventilationandoxygenenrichmentshouldbe

available.

Aswithotherintravenousanaestheticagents,cautionshouldbe

exercisedindogsandcatswithcardiac,respiratory,renalorhepatic

impairment,orinhypovolaemicordebilitatedanimals.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisisapotentdrug:particularcareshouldbetakentoavoid

accidentalself-administration.Aguardedneedleshouldpreferably

beuseduntilthemomentofinjection.

Washoffsplashesfromtheskinandeyesimmediately.

Intheeventofaccidentalself-administration,seekurgentmedical

attentionandshowthelabeltothedoctor.AdvicetoDoctor:Do

notleavethepatientunattended.Maintainairwaysandgive

symptomaticandsupportivetreatment.

iii. Otherprecautions

None.

4.6 UndesirableEffects(FrequencyandSeriousness)

Sideeffectsduringinduction,maintenanceandrecoveryareuncommon.

Minimalevidenceofexcitationhasbeenobservedinasmallproportionof

animals.Duringtherecoveryphase,vomitingandevidenceofexcitation

havebeenobservedinasmallproportionofanimals.

Revised:November2012

AN:00907/2012

Page3of6

Inclinicaltrialsincatsanddogs,transientapnoeaduringinductionhas

beenobservedfrequently.Incatspaw/facelickingcharacteristicsduring

recoveryhavebeenobservedinasmallproportionofanimals.

Ifpantingisevidentbeforeinduction,itmaycontinuethroughoutthe

subsequentperiodsofanaesthesiaandrecovery.

Inadvertentperivascularadministrationrarelycauseslocaltissuereactions.

Repeatedanaesthesiawithpropofolincatsmaycauseoxidativeinjuryand

Heinzbodyproduction.Recoverymayalsobecomeprolonged.Limiting

repeatedanaesthesiatointervalsofmorethat48hourswillreducethe

likelihood.

4.7 UseDuringPregnancy,LactationorLay

Thesafetyofthisproductinfoetuses/neonatesandduringlactationhasnot

beenestablished,buttheproducthasbeenusedsuccessfullyforinduction

priortoCaesareansectioninbitches.

Useonlyaccordingtothebenefit/riskassessmentbytheresponsible

veterinarian.

4.8 InteractionwithotherMedicinalProductsandOtherFormsofInteraction

Propofolhasbeenusedinassociationwithcommonlyusedpremedicants

e.g.atropine,acepromazine,diazepam;inhalationalagentse.g.halothane,

nitrousoxide,enfluraneandanalgesicagentse.g.buprenorphine.No

pharmacologicalincompatibilityhasbeenencountered.

Theconcurrentuseofsedativeoranalgesicdrugsislikelytoreducethe

doseofpropofolrequiredtoproduceandmaintainanaesthesia

4.9 AmountstobeAdministeredandAdministration

Theproductisindicatedforintravenousadministrationtodogsandcats.

Priortouse,theproductshouldbeinspectedvisuallyforabsenceofvisible

dropletsorextraneousforeignparticlesanddiscardedifpresent.Thevial

shouldbeshakengentlybutthoroughlybeforeopening.

Induction:Theinductiondoseiscalculatedaccordingtobodyweightand

maybeadministeredtoeffectoveraperiodof10to40seconds.

Alternatively,thecalculateddosemaybegiveninfullasasinglebolusover

ashortertimeinterval.Theinductiondoseisreducedbytheuseof

premedicants.

Revised:November2012

AN:00907/2012

Page4of6

Thefollowingdoseratesareforguidanceandinpracticethedoserate

shouldbebasedonresponse.

Theaverageinductiondosefordogsandcats,eitherunpremedicatedor

whenpremedicatedwithanonalpha-2-agonisttranquillisersuchas

acepromazine,isasfollows:

Doserate(mg/kg

bodyweight) Dosevolume(ml/kg

bodyweight)

Dogs

Unpremedicated 6.5 6.5ml/10kg

Premedicated 4.0 4.0ml/10kg

Cats

Unpremedicated 8.0 2.0ml/2.5kg

Premedicated 6.0 1.5ml/2.5kg

Maintenance:Whereanaesthesiaismaintainedbyincrementalinjections,

thedoseratewillvarybetweenanimals.Incrementaldosesshouldbegiven

toeffect.Dosesofaround1mlper4.0 –8.0kgbodyweightsustain

anaesthesiaforperiodsofupto5minutes.

Maintenancebyinhalationagents:Whereinhalationagentsareusedto

maintaingeneralanaesthesia,clinicalexperienceindicatesthattheremay

beaneedtouseahigherinitialconcentrationofinhalationagentthanis

normallythecasefollowinginductionwithbarbiturateagentssuchas

thiopentone.

Continuousandprolongedexposure(greaterthan30minutes)mayleadto

slowerrecovery,particularlyincats.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Accidentaloverdosageislikelytocausecardio-respiratorydepression.

Respiratorydepressionshouldbetreatedbyartificialventilationwith

oxygen.Cardiovasculardepressionrequirestheuseofplasmaexpanders

andpressoragents.

4.11WithdrawalPeriod(s)

Notapplicable.

5. PHARMACOLOGICAL

Pharmacotherapeuticgroup:Anaesthetics;Propofol

ATCVetCode:QN01AX10

Revised:November2012

AN:00907/2012

Page5of6

5.1 Pharmacodynamicproperties

Propofol(2,6di-isopropylphenol,Diprivan;ICI35868)isanonbarbiturate

substitutedisopropylphenolwhichisusedfortheinductionand

maintenanceofanaesthesia.Propofolisashort-acting,intravenousgeneral

anaestheticforproceduresofshortduration,lastingupto5minutes.

Recoveryfromanaesthesiaisusuallyrapid.

5.2 Pharmacokineticproperties

Afterasinglebolusdose,bloodlevelprofilesarecharacterisedbyarapid

distributionphaseandarapideliminationphase.Noaccumulationofblood

levelshasbeenobservedaftermultipledailydosing.Propofolis

metabolisedintheliver.Urinaryexcretionisthemajorrouteofeliminationof

metabolitesfromthebody.

Afterintravenousadministrationtodogsatadoserateof6.5mgpropofol

perkgbodyweightononeoccasion,thefollowingparameterswere

observed:Cmaxof6.20

0.602

g/ml,volumeofdistributionof0.938

0.0896L/kg,T½(alpha)1.61

0.239minutesandT½(beta)29.5

7.06

minutes.

6. PHARMACEUTICALPARTICULARS

6.1 ListofExcipient(s)

EggLecithin

Glycerol

SoybeanOil,refined

SodiumHydroxide

WaterforInjections

6.2 Incompatibilities

Theproductshouldnotbemixedwithotherproducts.

Theemulsionshouldnotbemixedwithothertherapeuticagentsorinfusion

fluidspriortoadministration.

6.3 Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Withdrawnproductshouldbeusedimmediately.Productremaininginthe

containershouldbediscarded.

Revised:November2012

AN:00907/2012

Page6of6

6.4 SpecialPrecautionsforStorage

Donotstoreabove25°C.

Donotfreeze.

Keepvialintheoutercontainerinordertoprotectfromlight.

Storevialsintheuprightposition.

6.5 NatureandCompositionofImmediatePackaging

Notallpacksizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinal

ProductsorWasteMaterialsDerivedFromtheUseofSuchProducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordance

withlocalrequirements.

7. Nameorcorporatenameandaddressorregisteredplaceofbusinessof

theMarketingAuthorisationHolder

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co.Down

BT356JP

NorthernIreland

8. MarketingAuthorisationNumber

Vm 02000/4274

9. DateofFirstAuthorisation

Date:09January2009

10. DateofRevisionofSPC

Date:November2012

Approvedby: 20/11/2012

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