Norofol 10mg/ ml Emulsion for Injection for Cats and Dogs

Main information

  • Trade name:
  • Norofol 10mg/ ml Emulsion for Injection for Cats and Dogs
  • Pharmaceutical form:
  • Emulsion for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Norofol 10mg/ml Emulsion for Injection for Cats and Dogs
    Austria
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0371/001
  • Authorization date:
  • 29-09-2010
  • EU code:
  • UK/V/0371/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:February2011

AN:01771/2009

SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinaryMedicinalProduct

Norofol10mg/mlEmulsionforInjectionforcatsanddogs(UK,BG,CZ,LT,RO,SI,SK)

Vetofol10mg/mlEmulsionforInjectionforcatsanddogs(AT,CY,EE,FI,DE,EL,LV,

PT,ES)

2. QualitativeandQuantitativeComposition

Eachmlcontains:

ActiveSubstance

Propofol 10.0mg

Excipients

Forafulllistofexcipients,seesection6.1

3. PharmaceuticalForm

Emulsionforinjection.

Awhitehomogeneousemulsionwithnoappearanceofvisibledropletsorextraneous

foreignparticles.

4. ClinicalParticulars

4.1 TargetSpecies:

Dogsandcats.

4.2 IndicationsforUse,SpecifyingtheTargetSpecies:

NorofolInjectionisindicatedforuseindogsandcatsasashort-acting,intravenous

generalanaestheticforproceduresofshortduration,lastingupto5minutes;forthe

inductionandmaintenanceofgeneralanaesthesiausingincrementaldosestoeffect;

fortheinductionofgeneralanaesthesiawheremaintenanceisprovidedbyinhalation

anaesthetics.

4.3 Contraindications:

Donotuseinanimalsthatarehypersensitivetotheactivesubstanceoranyofthe

excipients.

Revised:February2011

AN:01771/2009

4.4 SpecialWarningsforEachTargetSpecies:

IfNorofolInjectionisinjectedveryslowly,aninadequateplaneofanaesthesiacan

occur.

Shakethevialgentlybutthoroughlybeforeopening.Donotuseifevidenceofphase

separationremainsaftergentleshaking.

4.5 SpecialPrecautionsforUse:

(i)SpecialPrecautionsforUseinAnimals

Duringinductionofanaesthesia,mildhypotensionandtransientapnoea,similarto

effectswithotherintravenousanaestheticagentsmayoccur.

Iftheproductisinjectedtoorapidly,cardiopulmonarydepressionmayoccur(apnoea,

bradycardia,hypotension).

WhenusingNorofolInjection,facilitiesforthemaintenanceofapatentairway,artificial

ventilationandoxygenenrichmentshouldbeavailable.

Inadvertentperivascularadministrationrarelycauseslocaltissuereactions.

Aswithotherintravenousanaestheticagents,cautionshouldbeexercisedindogsand

catswithcardiac,respiratory,renalorhepaticimpairment,orinhypovolaemicor

debilitatedanimals.

Sighthoundsmayhaveaslightlylongerdurationofrecoveryfromanaethesia

comparedtootherbreedsofdog.

(ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisisapotentdrug:particularcareshouldbetakentoavoidaccidentalself-

administration.Aguardedneedleshouldpreferablybeuseduntilthemomentof

injection.

Washoffsplashesfromtheskinandeyesimmediately.

Intheeventofaccidentalself-administration,seekurgentmedicalattentionandshow

thelabeltothedoctor.AdvicetoDoctor:Donotleavethepatientunattended.

Maintainairwaysandgivesymptomaticandsupportivetreatment.

(iii)OtherPrecautions

None.

Revised:February2011

AN:01771/2009

4.6 Adversereactions(FrequencyandSeriousness):

Sideeffectsduringinduction,maintenanceandrecoveryareuncommon.Inductionis

generallysmooth,minimalevidenceofexcitationhasbeenobservedinasmall

proportionofanimals.Duringtherecoveryphase,vomitingandevidenceofexcitation

havebeenobservedinasmallproportionofanimals.

Inclinicaltrialsincats,transientapnoeaduringinductionandpaw/facelicking

characteristicsduringrecoveryhavebeenobservedinasmallproportionofanimals.

Inclinicaltrialsindogs,transientapnoeaduringinductionandmaintenancehavebeen

observed.

Ifpantingisevidentbeforeinduction,itmaycontinuethroughoutthesubsequent

periodsofanaesthesiaandrecovery.

4.7 UseDuringPregnancy,LactationorLay:

Propofolhasnotbeenusedindogsandcatswherethepregnancyistobemaintained,

buthasbeenusedsuccessfullyforinductionpriortoCaesareansectioninbitches.

4.8 InteractionwithotherMedicinalProductsandOtherFormsofInteraction:

Propofolhasbeenusedinassociationwithcommonlyusedpremedicantse.g.

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

enfluraneandanalgesicagentse.g.pethidine,buprenorphine.Nopharmacological

interactionshavebeenencountered.

Theemulsionshouldnotbemixedwithothertherapeuticagentsorinfusionfluidsprior

toadministration.

Revised:February2011

AN:01771/2009

4.9 AmountstobeAdministeredandAdministrationRoute:

Theproductisindicatedforintravenousadministrationtodogsandcats.Thevial

shouldbeshakenthoroughlybeforeopening.

Induction:Theinductiondoseiscalculatedaccordingtobodyweightandmaybe

administeredtoeffectoveraperiodof10to40seconds.Alternatively,thecalculated

dosemaybegiveninfullasasinglebolustoeffect,atthediscretionoftheVeterinary

Surgeon(Seesection4.5i).Theinductiondoseisreducedbytheuseof

premedicants.

Thefollowingdoseratesareforguidanceandinpracticethedoserateshouldbe

basedonresponse.

Theaverageinductiondosefordogsandcats,eitherunpremedicatedorwhen

premedicatedwithatranquillisersuchasacepromazine,isasfollows:

Dose(mg/kgbodyweight) Dosevolume(ml/kg

bodyweight)

Dogs

Unpremedicated 6.5 0.65ml/kg

Premedicated 4.0 0.4ml/kg

Cats

Unpremedicated 8.0 0.8ml/kg

Premedicated 6.0 0.6ml/kg

Maintenance:Whereanaesthesiaismaintainedbyincrementalinjections,thedose

ratewillvarybetweenanimals.Incrementaldosesshouldbegiventoeffect.Dosesof

approximately1.25 –2.5mg(0.125–0.25ml)perkgbodyweightsustainanaesthesia

forperiodsofupto5minutes.

Maintenancebyinhalationagents:Whereinhalationagentsareusedtomaintain

generalanaesthesia,clinicalexperienceindicatesthattheremaybeaneedtousea

higherinitialconcentrationofinhalationagentthanisnormallythecasefollowing

inductionwithbarbiturateagentssuchasthiopentone.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary:

Accidentaloverdosageislikelytocausecardio-respiratorydepression.Respiratory

depressionshouldbetreatedbyartificialventilationwithoxygen.Cardiovascular

depressionrequirestheuseofplasmaexpandersandpressoragents.

4.11WithdrawalPeriod(s):

Notapplicable.

5. PharmacologicalProperties

Pharmacotherapeuticgroup:Anesthetics.

ATCVetCode:QN01AX10

Revised:February2011

AN:01771/2009

5.1 Pharmacodynamicproperties:

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

isopropylphenolwhichisusedfortheinductionandmaintenanceofanesthesia.

Propofolisashort-acting,intravenousgeneralanaestheticforproceduresofshort

duration,lastingupto5minutes.Recoveryfromanaesthesiaisusuallyrapid.

5.2 Pharmacokineticproperties:

Afterasinglebolusdose,bloodlevelprofilesarecharacterisedbyarapiddistribution

phaseandarapideliminationphase.Noaccumulationofbloodlevelshasbeen

observedaftermultipledailydosing.Urinaryexcretionisthemajorrouteofelimination

ofmetabolitesfromthebody.

AfterintravenousadministrationofNorofol10mg/mlEmulsionforInjectiontodogsata

doserateof6.5mgpropofolperkgbodyweightononeoccasion,thefollowing

parameterswereobserved:Volumeofdistributionof0.938

0.0896L/kg,T½(alpha)

1.61

0.239minutesandT½(beta)29.5

7.06minutes.

6. PharmaceuticalParticulars

6.1 ListofExcipient(s):

Lecithin

Glycerol

RefinedSoybeanOil

SodiumHydroxide

WaterforInjections

6.2 Incompatibilities:

NorofolInjectionshouldnotbemixedwithotherproducts.

6.3 Shelf-Life:

2years.

Withdrawnproductshouldbeusedimmediately.Thisproductdoesnotcontainan

antimicrobialpreservative.Anysolutionremaininginthevialfollowingwithdrawalofthe

requireddoseshouldbediscarded.

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25°C.

Donotfreeze.

Protectfromlight.

Keepthecontainerintheoutercarton.

Storevialsintheuprightposition.

Revised:February2011

AN:01771/2009

6.5 NatureandCompositionofImmediatePackaging:

NorofolInjectionispresentedin20mland50mltypeIclearglassvialssealedwith

bromobutylbungsandaluminiumcaps.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProductsor

WasteMaterialsDerivedFromtheUseofSuchProducts,ifappropriate:

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co.Down,BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm02000/4275

9. DATEOFFIRSTAUTHORISATION

9January2009

10. DATEOFREVISIONOFTHETEXT

February2011