PropoFlo Plus, 10mg/ml, Emulsion for Injection

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
    Portugal
  • 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

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration