PropoFlo

Main information

  • Trade name:
  • PropoFlo Plus 10mg/ml Emulsion for Injection
  • Pharmaceutical form:
  • Emulsion for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PropoFlo Plus 10mg/ml Emulsion for Injection
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0179/003
  • Authorization date:
  • 21-03-2012
  • EU code:
  • UK/V/0179/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:March2013

AN:01360/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PropoFloPlus,10mg/ml,emulsionforinjectionfordogsandcats(UK&IE)

PropoVetMultidose10mg/mlemulsionforinjectionforcatsanddogs(AT,BE,DK,

ES,FI,FR,IS,LU,NL,NO,PT&SE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Propofol,10mg/ml

Excipient(s):

Benzylalcohol(E1519),20mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Emulsionforinjection.

Awhiteemulsionwithnoevidenceofphaseseparation

4. CLINICALPARTICULARS

4.1Targetspecies

Dogsandcats.

4.2Indicationsforuse,specifyingthetargetspecies

Theveterinarymedicinalproductisindicatedfortherapeuticuseindogsandcatsas

ashort-acting,intravenousgeneralanaestheticwithashortrecoveryperiod:

Forproceduresofshortduration,lastinguptoapproximately5minutes.

Forinductionofgeneralanaesthesiawheremaintenanceisprovidedbyinhalation

anaestheticagents.

Forinductionandshort-termmaintenanceofgeneralanaesthesiabyadministration

ofincrementaldosesoftheproducttoeffectforapproximatelyhalfanhour(30

minutes),nottoexceedthetotaldosestatedinsection4.3.

Revised:March2013

AN:01360/2012

4.3Contraindications

Donotuseforprolongedinfusion(seesection4.5).

Donotexceedatotaldoseinoneanaestheticepisodeof24mg/kg(2.4ml/kg)of

propofolincatsordogs.

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceortoanyof

theexcipients.

4.4Specialwarningsforeachtargetspecies

Thisproductisastableemulsion;discardthevialifphaseseparationisobserved.

Shakethevialgentlybutthoroughlybeforewithdrawingadose.

Ifthisproductisinjectedveryslowly,aninadequateplaneofanaesthesiacanoccur.

4.5Specialprecautionsforuse

i Specialprecautionsforuseinanimals

Duringinductionofanaesthesiainanyspecies,mildhypotensionand

transientapnoea,similartoeffectswithotherintravenousanaesthetic

agents,mayoccur.Apnoeaismostlikelytooccurwithinthefirst5minutes

ofadministrationoftheproductandmustbetreatedwithoxygenand

artificialventilation.Whenevertheproductisused,facilitiesforthe

maintenanceofapatentairway,artificialventilationandoxygen

supplementationmustbeimmediatelyavailable.

Aswithotherintravenousanaestheticagents,cautionshouldbeexercised

indogsandcatswithcardiac,respiratory,renalorhepaticimpairment,or

inhypovolaemicordebilitatedanimals.

Thesafetyofthisproducthasnotbeenestablishedindogsorcats

youngerthan5monthsandshouldbeusedintheseanimalsonly

accordingtotherisk/benefitassessmentbytheresponsibleveterinarian

Thisproductshouldnotbeusedforinductionandmaintenanceofgeneral

anaesthesiabyincrementaldosesthatwouldexceedtotaldoselimits

specifiedinsection4.3(Contraindications),duetothepotentialfortoxic

effectscausedbythepreservative,benzylalcohol(seesection4.10).

ii Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Useaseptictechniqueswhenadministeringtheproduct.

Peoplewithknownhypersensitivitytoanyoftheingredientsshouldavoid

contactwiththeveterinarymedicinalproduct.

Revised:March2013

AN:01360/2012

Thisveterinarymedicinalproductisapotentdrug,exercisecautionto

avoidaccidentalself-injection.Preferablyuseaguardedneedleuntilthe

momentofinjection.

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.

Advicetothedoctor:donotleavethepatientunattended.Maintain

airwaysandgivesymptomaticandsupportivetreatment.

Incaseofsplashesontheskinorintheeyes,washoffimmediately.

4.6Adversereactions(frequencyandseriousness)

Side-effectsduringinduction,maintenanceandrecoveryareuncommon.Aswith

otheranaestheticagents,thepossibilityofrespiratoryorcardiovasculardepression

shouldbeconsidered.Duringinductionofanaesthesia,mildhypotensionand

transientapnoeamayoccur.Seesection4.5.Inductionisgenerallysmooth,with

occasionalevidenceofexcitation(paddlingoflimbs,nystagmus,focalmuscle

twitching,opistotonus). Duringtherecoveryphase,vomitionandexcitationhave

beenobservedinasmallproportionofanimals.

Inclinicaltrialsincatsanddogs,transientapnoeahasbeenobservedduring

induction.Incatssneezing,occasionalretchingandapaw/facelickingcharacteristic

duringrecoveryhavebeenobservedinasmallproportionofcases.

Ifpantingisevidentbeforeinduction,itmaycontinuethroughoutthesubsequent

periodsofanaesthesiaandrecovery.

Inadvertentperivascularadministrationrarelycauseslocaltissuereactions.

RepeatedanaesthesiawithpropofolincatsmaycauseoxidativeinjuryandHeinz

bodyproduction.Recoverymayalsobecomeprolonged.Limitingrepeated

anaesthesiatointervalsofmorethan48hourswillreducethelikelihood.

4.7Useduringpregnancy,lactationorlay

Thesafetyofthisproductinfoetuses/neonatesandduringlactationhasnotbeen

established.Inhumansparenterallyadministeredbenzylalcoholhasbeen

associatedwithafataltoxicsyndromeinpretermneonates.

Pregnancy

Useonlyaccordingtotherisk/benefitassessmentbytheresponsibleveterinarian.

Lactation

Useonlyaccordingtotherisk/benefitassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Propofolhasbeenusedafterpremedicationwithcommonlyusedpremedicants,e.g.

atropine,acepromazine,diazepam, 

-2adrenoceptoragents,priortomaintenance

withinhalationalagents,e.g.halothane,nitrousoxide,sevoflurane,isofluraneand

Revised:March2013

AN:01360/2012

priortoadministrationofanalgesicagents,e.g.pethidine,buprenorphine.No

pharmacologicalincompatibilityhasbeenencountered.

Theconcurrentuseofsedativeoranalgesicdrugsislikelytoreducethedoseof

PropoFloPlusrequiredtoproduceandmaintainanaesthesia.Seesection4.9.

4.9Amountstobeadministeredandadministrationroute

Theveterinarymedicinalproductisasterileproductforintravenousadministration.

Generalhandlingprocedures

Priortouse,theproductshouldbeinspectedvisuallyforabsenceofparticulate

matteranddiscolourationanddiscardedifpresent.

Shakethevialgentlybutthoroughlybeforeopening.Seesections4.4and6.3.

DosageforInductionbyPropoFloPlus

Theinductiondoseiscalculatedaccordingtobodyweightandmaybeadministered

toeffectoveraperiodof10-40seconds.Seesection4.4.Theuseofpreanaesthetic

drugsmaymarkedlyreducepropofolrequirements.Aswithothersedativehypnotic

agents,theamountofopioid, 

-2agonistand/orbenzodiazepinepremedicationwill

influencetheresponseofthepatienttoaninductiondoseoftheproduct.

Whereanimalshavebeenpremedicatedwithan 

-2agonistsuchasmedetomidine,

thedoseofpropofol(aswithanyotherintravenousanaestheticagent)shouldbe

reducedbyupto85%(e.g.from6.5mg/kgforunpremedicateddogsto1.0mg/kgfor

dogspremedicatedwithan 

-2agonist).

Theaverageinductiondosefordogsandcats,eitherunpremedicatedorwhen

premedicatedwithanon- 

-2agonisttranquillisersuchasacepromazine,isgivenin

thefollowingtable.

Thesedosesareforguidanceonly;theactualdoseshouldbebasedontheresponse

oftheparticularanimal.Seesection4.3.

Dosemg/kg

bodyweight Dosevolumeml/kg

bodyweight

DOGS

Unpremedicated

Premedicated

-withnon- 

-2agonist

-withan 

-2agonist

6.5mg/kg

4.0mg/kg

1.0mg/kg

0.65ml/kg

0.40ml/kg

0.10ml/kg

CATS

Unpremedicated

Premedicated

-withnon- 

-2agonist

-withan 

-2agonist

8.0mg/kg

6.0mg/kg

1.2mg/kg

0.80ml/kg

0.60ml/kg

0.12ml/kg

Revised:March2013

AN:01360/2012

DosageforMaintenancebyPropoFloPlus

Whenanaesthesiaismaintainedbyincrementalinjections,thedoseratewillvary

betweenanimals.Administerincrementaldosesoftheproducttoeffectbygiving

smalldosesofaround0.1ml/kgbodyweight(1.0mg/kgbodyweight)oftheinduction

dosewhenanaesthesiabecomestoolight.Thesedosesmayberepeatedasoften

asrequired,allowing20-30secondstoassesstheeffectbeforefurtherincrements

aregiven.Experiencehasshownthatdosesofapproximately1.25-2.5mg

(0.125-0.25ml)perkgbodyweightsustainanaesthesiaforperiodsofupto

5minutes.

Continuousandprolongedexposure(greaterthan30minutes)mayleadtoslower

recovery,particularlyincats.Seesection4.3and4.10.

Maintenancebyinhalationagents

Wheninhalationagentsareusedtomaintaingeneralanaesthesia,experience

indicatesthatitmaybenecessarytouseahigherinitialconcentrationoftheinhalant

anaestheticthanisusuallyrequiredfollowinginductionwithbarbiturateagentssuch

asthiopentone.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Accidentaloverdosageislikelytocausecardio-respiratorydepression.Overdoseis

likelytocauseapnoea.Incasesofrespiratorydepression,stopdrugadministration,

establishapatentairway,andinitiateassistedorcontrolledventilationwithpure

oxygen.Cardiovasculardepressionshouldbetreatedwithplasmaexpanders,

pressoragents,anti-arrhythmicagentsorothertechniquesasappropriateforthe

observedabnormality.

Propofol

Asingledoseof19.5mg/kg(1.95ml/kg)indogsandbolusandintermittentdoses

totalling24mg/kg(2.4ml/kg)incatsdidnotcauseharm.Bolusandintermittent

dosestotalling38.6mg/kg(3.9ml/kg)producedparaesthesiainoneoffourcatsand

prolongedrecoveryinallfourcatstreated.

BenzylAlcohol(preservative)

Benzylalcoholtoxicitymayleadtoprolongedrecoveryandhyperkinesiaincats,and

neurologicalsignssuchastremorsindogsandfatalitiesinbothspecies.Thereisno

specificantidote;supportivetreatmentshouldbegiven.

Indogs,lethaldosesofbenzylalcoholcouldresultfromadministrationofthe

maximumtotaldoseofpropofolstatedinsection4.3,everyhourfor9hours,based

onpharmacokineticmodellingandliteraturereports.Incats,lethaldosesofbenzyl

alcoholcouldoccurwithin6.5hoursofadministration,basedonliteraturereports,

directestimationandmaintenancedoserates.

Revised:March2013

AN:01360/2012

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Generalanaesthetic

ATCvetCode:QN01AX10

5.1Pharmacodynamicproperties

Propofol(2,6-diisopropylphenol)isanintravenoussedativehypnoticagentforusein

theinductionandmaintenanceofgeneralanaesthesia.

Propofolisashort-actinganaestheticcharacterisedbyrapidonsetandshortduration

ofanaesthesiaandbyrapidrecovery.Propofolproducesunconsciousnessbyits

depressantactiononthecentralnervoussystem.

5.2Pharmacokineticparticulars

Intravenousinjectionisfollowedbyextensivemetabolismofpropofolintheliverto

inactiveconjugateswhichareexcretedintheurine(majorroute)andfaeces.

Eliminationfromthecentralcompartmentoccursrapidly,withaninitialhalf-lifeofless

than10minutes.Afterthisinitialphase,thedecreaseinplasmaconcentrationis

slower.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol(E1519)

Soya-beanoil,refined

Purifiedeggphosphatides(egglecithin)

Glycerol

Oleicacid

Sodiumhydroxide(forpHadjustment)

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithanyotherveterinarymedicinalproducts.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelflifeafterfirstopeningtheimmediatepackaging:28days.

Theproductisamultidosevial.

6.4.Specialprecautionsforstorage

Revised:March2013

AN:01360/2012

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.Donot

freeze.

Keepthevialintheoutercarton.

6.5Natureandcompositionofimmediatepackaging

PropoFloPlusissuppliedasawhiteaqueousisotonicemulsionforintravenous

injectioncontainedinvials(TypeIglass)withfluorinatedpolymercoatedbromobutyl

rubberstoppersandflipoffaluminium/polypropyleneseals.Therearetwopack

sizes:

20mlvialsofproductwhicheachcontain200mgpropofol(propofol10mg/ml),

5vialspercarton

50mlvialsofproductwhicheachcontain500mgpropofol(propofol10mg/ml),1vial

percarton

Notallpacksizesmaybemarketed

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

AbbottLaboratoriesLtd

AbbotHouse

VanwallBusinessPark

VanwallRoad

Maidenhead

Berkshire

SL64XE

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER

Vm 00037/4072

9. DATEOFFIRSTAUTHORISATION

Date:15December2010

10.DATEOFREVISIONOFTHETEXT

Date:March2013

APPROVED 5April2013