Isoflurane 100% Inhalation Vapour, Liquid

Main information

  • Trade name:
  • Isoflurane 100% Inhalation Vapour, Liquid
  • Pharmaceutical form:
  • Inhalation vapour, liquid
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Isoflurane 100% Inhalation Vapour, Liquid
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • isoflurane
  • Therapeutic area:
  • Cats, Dogs, Horses, Other, Other Birds

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0300/001
  • Authorization date:
  • 01-12-2012
  • EU code:
  • UK/V/0300/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:January2012

AN:01444/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Iso-Vet

Isoflurane1000mg/gInhalationVapour,liquid(AllCMSexceptSpain,

PortugalSweden,Denmark,Finland&Iceland)

IsoVet

IsoVet1000mg/gInhalationVapour,liquid(Spain&Portugal)

Attanevet

Isoflurane1000mg/gInhalationVapour,liquid(Denmark,Sweden,

Finland&Iceland)

ForuseinHorses,Dogs,Cats,OrnamentalBirds,Reptiles,Rats,Mice,

Hamsters,Chinchillas,Gerbils,GuineaPigsandFerrets.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveSubstance:

Isoflurane1000mg/g

Theveterinarymedicinalproductcontainsnoexcipients.

3. PHARMACEUTICALFORM

Inhalationvapour,Liquid.

Clear,colourless,mobile,heavyliquid

4. CLINICALPARTICULARS

4.1 TargetSpecies

Horses,dogs,cats,ornamentalbirds,reptiles,rats,mice,hamsters,

chinchillas,gerbils,guineapigsandferrets.

4.2 Indicationsforuse,specifyingthetargetspecies

Inductionandmaintenanceofgeneralanaesthesia.

4.3 Contra-indications

Donotuseincaseofknownsusceptibilitytomalignanthyperthermia.Do

notuseincaseofhypersensitivitytoisofluraneortootherhalogenated

agents.

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4.4 Specialwarningsforeachtargetspecies

Themetabolismofbirds,andtoanextentsmallmammals,isaffected

moreprofoundlybydecreasesinbodytemperature,duetohighsurface

areatobodyweightratio.Drugmetabolisminreptilesisslowandhighly

dependentuponenvironmentaltemperature.

Theeaseandrapidityofalterationofthedepthofanaesthesiawith

Isofluraneanditslowmetabolism,maybeconsideredadvantageousfor

itsuseinspecialgroupsofpatientssuchastheoldoryoung,andthose

withimpairedhepatic,renalorcardiacfunction.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Isofluranehaslittleornoanalgesicproperties.Adequateanalgesiashould

alwaysbegivenbeforesurgery.Theanalgesicrequirementsofthepatient

shouldbeconsideredbeforegeneralanaesthesiaisended.

Theuseoftheproductinpatientswithcardiacdiseaseshouldbe

consideredonlyafterarisk/benefitassessmentbytheveterinarian.

Itisimportanttomonitorbreathingandpulseforthefrequencyandits

features.Respiratoryarrestshouldbetreatedbyassistedventilation.Itis

importanttomaintainairwaysfreeandproperlyoxygenatetissuesduring

themaintenanceofanaesthesia.Inthecaseofcardiacarrest,performa

completecardiopulmonaryresuscitation.

ii. Specialprecautionstobetakenbythepersonadministeringthe

medicinalproducttoanimals

Donotbreathethevapour.UsersshouldconsulttheirNationalAuthority

foradviceonOccupationalExposureStandardsforisoflurane.

Operatingroomsandrecoveryareasshouldbeprovidedwithadequate

ventilationorscavengingsystemstopreventtheaccumulationof

anaestheticvapour.

Allscavenging/extractionsystemsmustbeadequatelymaintained.

Pregnantandbreast-feedingwomenshouldavoidcontactwiththe

productandshouldavoidoperatingroomsandanimalrecoveryareas.

Avoidusingmaskingproceduresforprolongedinductionandmaintenance

ofgeneralanaesthesia.Usecuffedendotrachealintubationwhenpossible

fortheadministrationofisofluraneduringmaintenanceofgeneral

anaesthesia.

Toprotecttheenvironment,itisconsideredgoodpracticetousecharcoal

filterswithscavengingequipment.

Careshouldbetakenwhendispensingisoflurane,withanyspillage

removedimmediatelyusinganinertandabsorbentmateriale.g.sawdust.

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Washanysplashesfromskinandeyes,andavoidcontactwiththemouth.

Ifsevereaccidentalexposureoccursremovetheoperatorfromthesource

ofexposure,seekurgentmedicalassistanceandshowthislabel.

Halogenatedanaestheticagentsmayinduceliverdamage.Incaseof

isofluranethisisanidiosyncraticresponseveryrarelyseenafterrepeated

exposure.

AdvicetoDoctors:Ensureapatentairwayandgivesymptomaticand

supportivetreatment.Notethatadrenalineandcatecholaminesmaycause

cardiacdysrhythmias.

4.6 Adversereactions(frequencyandseriousness)

Isofluraneproduceshypotensionandrespiratorydepressioninadose-

relatedmanner.Cardiacarrhythmiasandtransientbradycardiahavebeen

reportedonlyrarely.Malignanthyperthermiahasbeenreportedveryrarely

insusceptibleanimals.

WhenusingIsofluranetoanaesthetiseananimalwithaheadinjury,

considerationshouldbegivenastowhetherartificialventilationis

appropriatetomaintainnormalCO

levels,sothatcerebralbloodflow

doesnotincrease.

4.7 Useduringpregnancyandlactationorlay

Pregnancy:

Useonlyaccordinglytothebenefit/riskassessmentbytheresponsible

veterinarian.Isofluranehasbeensafelyusedforanaesthesiaduring

caesareansectioninthedogandcat.

Lactation:

Useonlyaccordinglytothebenefit/riskassessmentbytheresponsible

veterinarian.

4.8 Interactionwithothermedicamentsandotherformsofinteraction

Theactionofmusclerelaxantsinman,especiallythoseofthe

nondepolarising(competitive)typesuchasatracurium,pancuroniumor

vecuronium,isenhancedbyisoflurane.Similarpotentiationmightbe

expectedtooccurinthetargetspecies,althoughthereislittledirect

evidencetothiseffect.Concurrentinhalationofnitrousoxideenhances

theeffectofisofluraneinmanandsimilarpotentiationmightbeexpected

inanimals.

Theconcurrentuseofsedativeoranalgesicdrugsislikelytoreducethe

levelofisofluranerequiredtoproduceandmaintainanaesthesia.

Someexamplesaregivenin4.9.

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Isofluranehasaweakersensitisingactiononthemyocardium,tothe

effectsofcirculatingdysrhythmogeniccatecholamines,thanhalothane.

Isofluranemaybedegradedtocarbonmonoxidebydriedcarbondioxide

absorbents.

Forreptilesandsmallmammals,therearenodataavailable.

4.9Amount(s)tobeadministeredandadministrationroute

Isofluraneshouldbeadministeredusinganaccuratelycalibratedvaporiser

inanappropriateanaestheticcircuit,sincelevelsofanaesthesiamaybe

alteredrapidlyandeasily.

Isofluranemaybeadministeredinoxygenoroxygen/nitrousoxide

mixtures.

TheMAC(minimalalveolarconcentrationinoxygen)oreffectivedose

valuesandsuggestedconcentrationsgivenbelowforthetarget

speciesshouldbeusedasaguideorstartingpointonly.Theactual

concentrationsrequiredinpracticewilldependonmanyvariables,

includingtheconcomitantuseofotherdrugsduringtheanaesthetic

procedureandtheclinicalstatusofthepatient.

Isofluranemaybeusedinconjunctionwithotherdrugscommonlyusedin

veterinaryanaestheticregimesforpremedication,inductionandanalgesia.

Somespecificexamplesaregivenintheindividualspeciesinformation.

Theuseofanalgesiaforpainfulproceduresisconsistentwithgood

veterinarypractice.

RecoveryfromIsofluraneanaesthesiaisusuallysmoothandrapid.The

analgesicrequirementsofthepatientshouldbeconsideredbeforethe

terminationofgeneralanaesthesia.

Althoughanaestheticshavealowpotentialfordamagetotheatmosphere,

itisgoodpracticetousecharcoalfilterswithscavengingequipment,

ratherthantodischargethemintotheair.

HORSE

TheMACforisofluraneinthehorseisapproximately1.31%

Premedication

Isofluranemaybeusedwithotherdrugscommonlyusedinveterinary

anaestheticregimes.Thefollowingdrugshavebeenfoundtobe

compatible with isoflurane: acepromazine, alfentanil, atracurium,

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butorphanol, detomidine, diazepam, dobutamine, dopamine,

guaiphenesin,ketamine,morphine,pentazocine,pethidine,thiamylal,

thiopentoneandxylazine.Drugsusedforpremedicationshouldbe

selectedfortheindividualpatient.However,thepotentialinteractions

belowshouldbenoted.

Interactions:

DetomidineandxylazinehavebeenreportedtoreducetheMACfor

Isofluraneinhorses.

Induction

Asitisnotnormallypracticabletoinduceanaesthesiainadulthorses

usingisoflurane,inductionshouldbebytheuseofashortacting

barbituratesuchasthiopentonesodium,ketamineorguaiphenesin.

Concentrationsof3to5%isofluranemaythenbeusedtoachievethe

desireddepthofanaesthesiain5to10minutes

Isofluraneataconcentrationof3to5%inahighflowoxygenmaybe

usedforinductioninfoals.

Maintenance

Anaesthesiamaybemaintainedusing1.5%to2.5%isoflurane.

Recovery

Recoveryisusuallysmoothandrapid.

DOG

TheMACforisofluraneinthedogisapproximately1.28%.

Premedication

Isofluranemaybeusedwithotherdrugscommonlyusedinveterinary

anaestheticregimes.Thefollowingdrugshavebeenfoundtobe

compatible with isoflurane: acepromazine, atropine, butorphanol,

buprenorphine, bupivacaine, diazepam, dobutamine, ephedrine,

epinephrine, etomidate, glycopyrrolate, ketamine, medetomidine,

midazolam,methoxamine,oxymorphone,propofol,thiamylal,thiopentone

andxylazine.Drugsusedforpremedicationshouldbeselectedforthe

individualpatient.However,thepotentialinteractionsbelowshouldbe

noted.

Revised:January2012

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Interactions:

Morphine,oxymorphone,acepromazine,medetomidine,medetomidine

plusmidazolamhavebeenreportedtoreducetheMACforisofluranein

dogs.

Theconcomitantadministrationofmidazolam/ketamineduringisoflurane

anaesthesiamayresultinmarkedcardiovasculareffects,particularly

arterialhypotension.

Thedepressanteffectsofpropanololonmyocardialcontractilityare

reducedduringisofluraneanaesthesia,indicatingamoderatedegreeofβ-

receptoractivity.

Induction

Inductionispossiblebyfacemaskusingupto5%isoflurane,withor

withoutpremedication.

Maintenance

Anaesthesiamaybemaintainedusing1.5%to2.5%isoflurane.

Recovery

Recoveryisusuallysmoothandrapid.

CAT

TheMACforisofluraneinthecatisapproximately1.63%.

Premedication

Isofluranemaybeusedwithotherdrugscommonlyusedinveterinary

anaestheticregimes.Thefollowingdrugshavebeenfoundtobe

compatiblewithisoflurane:acepromazine,atracurium,atropine,diazepam,

ketamine,andoxymorphone.Drugsusedforpremedicationshouldbe

selectedfortheindividualpatient.However,thepotentialinteractions

belowshouldbenoted.

Interactions:

Intravenousadministrationofmidazolam-butorphanolhasbeenreported

toalterseveralcardio-respiratoryparametersinisoflurane-inducedcats

ashasepiduralfentanylandmedetomidine.Isofluranehasbeenshownto

reducethesensitivityofthehearttoadrenaline(epinephrine).

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Induction

Inductionispossiblebyfacemaskusingupto4%isoflurane,withor

withoutpremedication.

Maintenance

Anaesthesiamaybemaintainedusing1.5%to3%isoflurane.

Recovery

Recoveryisusuallysmoothandrapid.

ORNAMENTALBIRDS

FewMAC/ED

valueshavebeenrecorded.Examplesare1.34%forthe

Sandhillcrane,1.45%fortheracingpigeon,reducedto0.89%bythe

administrationofmidazolam,and1.44%forcockatoos,reducedto1.08%

bytheadministrationofbutorphanolanalgesic.

Theuseofisofluraneanaesthesiahasbeenreportedformanyspecies,

fromsmallbirdssuchaszebrafinches,tolargebirdssuchasvultures,

eaglesandswans.

Druginteractions/compatibilities

Propofolhasbeendemonstratedintheliteraturetobecompatiblewith

isofluraneanaesthesiainswans.

Interactions:

ButorphanolhasbeenreportedtoreducetheMACforisofluranein

cockatoos.MidazolamhasbeenreportedtoreducetheMACfor

isofluraneinpigeons.

Induction

Inductionwith3to5%isofluraneisnormallyrapid.Inductionof

anaesthesiawithpropofol,followedbyisofluranemaintenance,hasbeen

reportedforswans.

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Maintenance

Themaintenancedosedependsonthespeciesandindividual.Generally,

2to3%issuitableandsafe.

Only0.6to1%maybeneededforsomestorkandheronspecies.

Upto4to5%maybeneededforsomevulturesandeagles.

3.5to4%maybeneededforsomeducksandgeese.

Generally,birdsrespondveryrapidlytochangesinconcentrationof

isoflurane.

Recovery

Recoveryisusuallysmoothandrapid.

REPTILES

Isofluraneisconsideredbyseveralauthorstobetheanaestheticofchoice

formanyspecies.Theliteraturerecordsitsuseonawidevarietyof

reptiles(eg.variousspeciesoflizard,tortoise,iguanas,chameleonand

snakes).

TheED

wasdeterminedinthedesertiguanatobe3.14%at35˚Cand

2.83%at20˚C.

Druginteractions/compatibilities

Nospecificpublicationsonreptileshavereviewedcompatibilitiesor

interactionsofotherdrugswithisofluraneanaesthesia.

Induction

Inductionisusuallyrapidat2to4%isoflurane.

Maintenance

1to3%isausefulconcentration

Recovery

Recoveryisusuallysmoothandrapid

RATS,MICE,HAMSTERS,CHINCHILLAS,GERBILS,GUINEAPIGS

ANDFERRETS

Isofluranehasbeenrecommendedforanaesthesiaofawidevarietyof

‘smallmammals’(eg.rats,mouse,hamster,chinchilla,gerbil,guineapig

andferret).

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TheMACformicehasbeencitedas1.34%,andfortheratas1.38%,

1.46%and2.4%.

Druginteractions/compatibilities

Nospecificpublicationsonsmallmammalshavereviewedcompatibilities

orinteractionsofotherdrugswithisofluraneanaesthesia.

Induction

Isofluraneconcentration2to3%.

Maintenance

Isofluraneconcentration0.25to2%.

Recovery

Recoveryisusuallysmoothandrapid.

Species MAC(%) Induction(%) Maintenance

(%) Recovery

Horse 1.31 3.0 –5.0

(foals) 1.5 –2.5 Smoothand

rapid

Dog 1.28 Upto5.0 1.5 –2.5 Smoothand

rapid

Cat 1.63 Upto4.0 1.5 –3.0 Smoothand

rapid

Ornamental

birds Seeposology 3.0 –5.0 Seeposology Smoothand

rapid

Reptiles Seeposology 2.0 –4.0

1.0 –3.0

Smoothand

rapid

Rats,mice,

hamsters,

chinchillas,

gerbils,guinea

pigsand

ferrets 1.34(mouse)

1.38/1.46/2.40

(rat)

2.0 –3.0

0.25 –2.0 Smoothand

rapid

4.10Overdose (symptoms, emergency procedures, antidotes) if

necessary

Isofluraneoverdosemayresultinprofoundrespiratorydepression.

Therefore,respirationmustbemonitoredcloselyandsupportedwhen

necessarywithsupplementaryoxygenand/orassistedventilation.

Incasesofseverecardiopulmonarydepression,administrationof

isofluraneshouldbediscontinued,thebreathingcircuitshouldbeflushed

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withoxygen,theexistenceofapatentairwayensured,andassistedor

controlled ventilation with pure oxygen initiated. Cardiovascular

depressionshouldbetreatedwithplasmaexpanders,pressoragents,

antiarrhythmicagentsorotherappropriatetechniques.

4.11Withdrawalperiod(s)

Horses:meat2days

“Notauthorisedforuseinlactatinganimalsproducingmilkforhuman

consumption”

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anaesthetic,general-halogenated

hydrocarbons

ATCvetcode:QN01AB06

5.1 Pharmacodynamicproperties

Isofluraneproducesunconsciousnessbyitsactiononthecentralnervous

system.Ithaslittleornoanalgesicproperties.

Likeotherinhalationanaestheticsofthistype,isofluranedepressesthe

respiratoryandcardiovascularsystems.

5.2 PharmacokineticParticulars

sofluraneisabsorbedoninhalationandisrapidldistributediathe

bloodstreamtoothertissues,includingthebrain.tsbloodgaspartition

coefficientat3 Cis1.4.TheabsorptionanddistributionofIsofluraneand

theeliminationofnon-metabolisedisofluranebythelungsareallrapid,

withtheclinicalconsequencesofrapidinductionandrecoveryandeasy

andrapidcontrolofthedepthofanaesthesia.

Metabolismofisofluraneisminimal(about0.2%,mainlytoinorganic

fluoride)andalmostalloftheadministeredisofluraneisexcreted

unchangedbythelungs.

6. PHARMACEUTICALPARTICULARS

6.1 ListandExcipients

None

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6.2 Incompatibilities

Isofluranehasbeenreportedtointeractwithdrycarbondioxide

absorbentstoformcarbonmonoxide.Inordertominimisetheriskof

formationofcarbonmonoxideinrebreathingcircuitsandthepossibilityof

elevatedcarboxyhaemoglobinlevels,carbondioxideabsorbentsshould

notbeallowedtodryout.

6.3 Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years

6.4 Specialprecautionsforstorage

Donotstoreabove25°C.Protectfromdirectsunlight&directheat.

Storeintightlyclosedoriginalcontainer.

6.5 Natureandcompositionofimmediatepackaging

TypeIIIamberglassbottlescontaining100mlor250mlofIsoflurane,

fittedwithablackphenolic/ureascrewcapwithalow-densitypolyethylene

coneinsert.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedproductorwastematerialshouldbedisposedofin

accordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

PiramalHealthcareUKLimited

WhaltonRoad,

Morpeth,

NorthumberlandNE613YA,

UnitedKingdom

Tel:00441670562400

Fax:00441670562543

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 29595/4001

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9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

Date:12 th August2009

10. DATEOFREVISIONOFTHETEXT

Date:January2012

Conditionofsupply:PrescriptionOnlyMedicine