Anesketin 100 mg/ ml Solution for Injection

Main information

  • Trade name:
  • Anesketin 100 mg/ ml Solution for Injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Anesketin 100 mg/ml Solution for Injection
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ketamine
  • Therapeutic area:
  • Cats, Dogs, Horses, Other

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0459/001
  • Authorization date:
  • 20-03-2013
  • EU code:
  • UK/V/0459/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:July2013

AN.02141/2011

Page1of13

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ANESKETIN100mg/mlsolutionforinjectionfordogs,catsandhorses

Belgium:

NIMATEK100mg/mlsolutionforinjectionfordogs,catsandhorses

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Ketamine 100mg/ml

(correspondingtoketaminehydrochloride115.4mg/ml)

Excipient(s):

Chlorocresol 1mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,colourlessliquidfreefromvisibleevidenceofcontamination

4. CLINICALPARTICULARS

4.1Targetspecies

Dog,catandhorse.

4.2Indicationsforuse,specifyingthetargetspecies

Theproductmaybeusedasasoleagentforrestraintandminorsurgicalprocedures

wheremusclerelaxationisnotrequiredinthedomesticcat.

Theproductmayalsobeusedtoinduceanaesthesia:

a)inconjunctionwithbutorphanolandmedetomidineinthedogandcat,

b)inconjunctionwithxylazineinthedog,catandhorse,

c)inconjunctionwithdetomidineinthehorse,

d)inconjunctionwithromifidineinthehorse.

4.3Contraindications

Donotuseinanimalswithhepaticorrenalfailure.

Donotuseketamineasasoleagentinthehorseorthedog.

Donotuseinanimalswithseverecardiacde-compensation,apparenthighblood

pressureorglaucoma.

Donotuseinanimalswitheclampsiaorpre-eclampsia.

Donotuseincasesofhypersensitivitytotheactivesubstanceoranyoftheexcipients.

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4.4Specialwarningsforeachtargetspecies

Forverypainfulandmajorsurgicalinterventions,aswellasformaintenanceof

anaesthesia,acombinationwithinjectableorinhalationanaestheticsisnecessary.As

musclerelaxationrequiredforsurgicalprocedurescannotbeachievedwithketamine

alone,additionalmuscle-relaxantsshouldbeusedconcomitantly.Forimprovementof

anaesthesiaorprolongationofeffectketaminecanbecombinedwith α

-receptor-

agonists,anaesthetics,neuroleptanalgesics,tranquilizersandinhalationalanaesthetic

agents.Itshouldbenotedthattime-to-full-effectmaybeprolongedwhenusingthe

subcutaneousadministrationrouteincat.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals:

Asmallproportionofanimalshavebeenreportedtobeunresponsivetoketamineasan

anaestheticagentatnormaldosages.Useofpremedicantsshouldbefollowedbya

suitablereductionindosage.

Inductionandrecoveryshouldbeallowedtooccurinquietandcalmsurroundings.

Asforallanaestheticsanimalsshouldbefastedfor12hoursbeforeketamine

anaesthesia.

Atropinepremedicationmayreducesalivationincats.

Musculartwitchingandmildtonicconvulsionshavebeenreportedinthecatat

recommendeddoserates.Thesesubsidespontaneouslybutmaybepreventedbyuse

ofacepromazineorxylazinepremedication,orcontrolledbyuseofacepromazineor

ultra-shortactingbarbituratesinlowdoses.

Inthecatanddog,theeyesremainopenandthepupilsdilated.Theeyesmaybe

protectedbycoveringwithadampgauzeswaborusingappropriateointments.

Ketaminemayexhibitpro-convulsantandanti-convulsantproperties,andtherefore

shouldbeusedwithcareinpatientswithseizuredisorders.

Ketaminemayincreaseintracranialpressureandtherefore,maynotbesuitablefor

patientswithcerebrovascularinsults.

Whenusedincombinationwithotherproducts,consultthecontraindicationsand

warningsthatappearontherelevantdatasheets.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals:

Thisisapotentdrug.Particularcareshouldbetakentoavoidaccidentalself-

administration.

Peoplewithknownhypersensitivitytoketamineoranyoftheexcipientsshouldavoid

contactwiththeveterinarymedicinalproduct.

Avoidcontactwiththeskinandeyes.Washanysplashesfromskinandeyes

immediatelywithlargeamountsofwater.

Adverseeffectsonthefoetuscannotbeexcluded.Pregnantwomenshouldavoid

handlingtheproduct.

Incaseofaccidentalself-injectionorifsymptomsoccurafterocular/oralcontact,seek

medicaladviceimmediatelyandshowthepackageleafletorthelabeltothephysician,

butDONOTDRIVE.

Advicetodoctors:

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AN.02141/2011

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Donotleavepatientunattended.Maintainairwaysandgivesymptomaticandsupportive

treatment.

4.6Adversereactions(frequencyandseriousness)

Ketaminemaycausesalivationincats.

Ketaminecausesanincreasedtonusofskeletalmuscles.Musculartwitchingandmild

tonicconvulsionshavebeenreportedinthecatatrecommendeddoserates.

Ketaminecausesadose-relatedrespiratorydepression,whichmayleadtorespiratory

arrestparticularlyincats.Combinationwithrespiratorydepressantproductsmay

increasethisrespiratoryeffect.

Ketamineincreasestheheartrateandincreasesarterialbloodpressurewithconcurrent

increasedbleedingtendency.

Incatsanddogseyesremainopenedwithmydriasisandnystagmus.

Emergencereactions-ataxia,hypersensitivitytostimuli,excitation –mayoccurduring

recovery

Theremaybesomepainonintramuscularinjection.

4.7 Useduringpregnancy,lactationorlay

Ketaminepassesthebloodplacentabarrierverywell,enteringthefoetalblood

circulationbywhich75to100%ofthematernalbloodlevelscanbereached;this

anesthetizespartiallythepupsatbirthdeliveredbycaesareansection.

Theuseoftheproducthasnotbeenassessedduringpregnancyandlactation.Useonly

accordinglytothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Careshouldbetakenwhenusingketamine-halothanecombinationssincehalf-lifeof

ketamineisprolonged.Neuroleptanalgesics,tranquilizersandchloramphenicol

potentiateketamineanaesthesia.Barbituratesandopiatescanprolongtherecovery

period.Ketaminehasbeenreportedtoenhancetheoccurrenceoftachycardiaand

hypertensionwhenusedinhumanpatientsreceivingthyroidhormones.

4.9Amountstobeadministeredandadministrationroute

Forusebyintramuscular,subcutaneousorintravenousinjection.

Itshouldbenotedthatdosagesandroutesofadministrationvarywidelybetween

species.Furthermore,theeffectofketaminemayshowlargeinter-individualdifferences

andtherefore,individualdosageaccommodationisrecommended.

DOG:

Xylazine/ketamine:

Administerxylazineatadoserateof1mg/kgbyintramuscularinjection(corresponding

to0.5ml/10kgbodyweightofxylazine2%solution).Immediatelyadministerketamine

atadoserateof15mg/kgbyintramuscularinjection(correspondingto1.5ml/10kg

bodyweight).

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Dogsbecomerecumbentinapproximately3minutesandlosetheirpedalreflexin

approximately7minutes.Durationofanaesthesiaisapproximately24minutes,the

pedalreflexreturningabout30minutesfollowingadministrationoftheketamine

injection.

Table1:XylazineandKetamine100mg/mlcanineanaesthesia(IM)

Weightofdogs(kg) 1 3 5 10 15 20 25 30 40

Xylazine2%dose

(ml)* 0.050.150.250.500.751.001.251.502.00

Ketamine100mg/ml

dose

(ml)** 0.150.450.751.502.253.003.754.506.00

*basedonadoserateof1mgxylazine/kgbodyweight

**basedonadoserateof15mgketamine/kgbodyweight

Medetomidine/ketamine:

Administermedetomidineatadoserateof40µg/kg(correspondingto0.40ml/10kg

bodyweightofmedetomidine1mg/mlsolution)andketamineat5.0-7.5mg/kg

(correspondingto0.5-0.75ml/10kgbodyweight),dependingondurationofanaesthesia

required,byintramuscularinjection.

Lossofpedalreflexoccursapproximately11minutesfollowinginjectionat5mg

ketamine/kgand7minutesfollowinginjectionat7.5mgketamine/kg.Durationof

anaesthesiaisapproximately30and50minutesrespectively.

ItisNOTadvisabletoreversethiscombinationinthedogwithatipamezole.

Table2:Medetomidineandketaminecanineanaesthesia(IM):Dosagechartfor

5mgketamine/kg(durationofanaesthesiaapproximately30min)

Weightofdogs(kg) 1 3 5 10 15 20 25 30 40

Medetomidine(1

mg/ml)dose(ml)* 0.040.120.200.400.600.801.001.201.60

Ketamine(100mg/ml)

dose

(ml)** 0.050.150.250.500.751.001.251.502.00

*basedonadoserateof40µgmedetomidine/kgbodyweight

**basedonadoserateof5mgketamine/kgbodyweight

Table3:Medetomidineandketaminecanineanaesthesia(IM):Dosagechartfor

7.5mgketamine/kg(durationofanaesthesiaapproximately50min)

Weightofdogs(kg) 1 3 5 10 15 20 25 30 40

Medetomidine(1

mg/ml)dose(ml)* 0.040.120.200.400.600.801.001.201.60

Ketamine(100mg/ml)

dose

(ml)** 0.080.230.380.751.131.501.882.253.00

*basedonadoserateof40µgmedetomidine/kgbodyweight

**basedonadoserateof7.5mgketamine/kgbodyweight

Butorphanol/medetomidine/ketamine:

Administerbutorphanolat0.1mg/kgandmedetomidineat25µg/kgbyintramuscular

injection.

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Dogsbecomerecumbentinapproximately6minutesandlosetheirpedalreflexin

approximately14minutes.

Ketamineinjectionshouldbeadministered15minutesfollowingthefirstinjectionata

doserateof5mg/kgbyintramuscularinjection(correspondingto0.5ml/10kg

bodyweight).

Thepedalreflexreturnsapproximately53minutesfollowingadministrationofthe

Ketamine100mg/mlinjection.Sternalrecumbencyisattainedapproximately35

minuteslaterfollowedbystandingafurther36minuteslater.

ItisNOTadvisabletoreversethiscombinationinthedogwithatipamezole.

Table4:Butorphanol,medetomidineandketaminecanineanaesthesia(IM)

Weightofdogs(kg) 1 3 5 10 15 20 25 30 40

Butorphanol(10mg/ml)

dose(ml)* 0.010.030.050.100.150.200.250.300.40

Medetomidine(1

mg/ml)dose(ml)** 0.030.080.130.250.380.500.630.751.00

Administerbutorphanolandmedetomidinebyintramuscularinjectionatthe

abovedoserates

Wait15minutesbeforeadministeringketaminebyintramuscularinjectionat

thedoseratesbelow

Ketamine(100mg/ml)

dose(ml)*** 0.050.150.250.500.751.001.251.502.00

* basedonadoserateof0.1mgbutorphanol/kgbodyweight

**basedonadoserateof25µgmedetomidine/kgbodyweight

***basedonadoserateof5mgketamine/kgbodyweight

CAT:

Ketamineasasoleagent:

Mono-anaestheticuseofketamineispossible,buttoavoidundesiredpsycomotoric

effectscombinedanaesthesiaisrecommended.Ketamineonitsownmaybeusedby

intravenousorsubcutaneousinjection,butintramuscularinjectionistherecommended

route.Thedoseis11-33mgketamine/kgdependingonthedegreeofrestraintor

surgicalinterferencethatisintended.Thefollowingdosagesareindicatedasaguide

butmayneedtobeadjusteddependingonthephysicalconditionofthepatientandthe

usageofsedativesandpremedicants.

Dose(mg/kg) Clinicalprocedures

11(0.11ml/kg)

22-33(0.22-0.33ml/kg) Minorrestraint

Minorsurgeryandrestraintoffractious

cats

Durationofketamineanaesthesiais20-40minutesandrecoverytakesplaceoveran1-

4hourperiod.

Formajorsurgery,ketamineshouldbeusedinconjunctionwithsupplementalsedatives

oranaesthetics.Dosagevariesfrom1.25-22mg/kg(0.06-1.1ml/5kg)dependingon

thecombinationandrouteofadministrationused.

Vomitingisunlikelytooccurwhenketamineisusedalone,however,catsshouldbe

starvedforseveralhourspriortoanaesthesiawherepossible.

Ketaminesupplementarycombinationsinthecat:

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Atropinepremedicationisgenerallyrecommendedat0.05mg/kgtoreducesalivation.

Inaddition,acepromazine(0.2%solution)atadoserateof0.11mg/kg(corresponding

to0.28ml/5kgbodyweight)canbeadministeredbyintramuscularinjection,as

premedicant.Endotrachealintubationcanbeachievedduringketamineanaesthesia.

Inhalationanaesthesiamaybemaintainedbysuitablecombinationsofmethoxyflurane,

halothane,nitrousoxideandoxygen.

Xylazine/ketamine:

Administerxylazineatadoserateof1.1mg/kg(correspondingto0.28ml/5kg

bodyweightofxylazine2%solution)andatropineatadoserateof0.03mg/kg

(correspondingto0.25ml/5kgbodyweightofatropine0.06%solution)byintramuscular

injection.Wait20minutesandthenadministerketamineatadoserateof22mg/kg

(correspondingto1.1ml/5kgbodyweight)byintramuscularinjection.

Xylazinemayinducevomitingupto20minutesafteradministration.Onsetof

anaesthesiaafterintramuscularinjectionofketaminetakessome3-6minutes.

Axylazine/ketaminecombinationproducesadeeperanaesthesiawithmore

pronouncedrespiratoryandcardiaceffectsandalongerrecoveryperiodthan

acepromazine/ketaminecombinations.

Table5:Xylazineandketaminefelineanaesthesia(IM)

Weightofcat(kg) 1.5 2 2.5 3 3.5 4 4.5 5

Xylazine2%dose(ml)* 0.080.110.140.170.190.220.250.28

Atropine(600µg/ml)

dose(ml)** 0.080.100.130.150.180.200.230.25

Wait20minutes

Ketamine(100mg/ml)

dose(ml)*** 0.330.440.550.660.770.880.991.10

* basedonadoserateof1.1mgxylazine/kgbodyweight

**basedonadoserateof0.03mgatropine/kgbodyweight

***basedonadoserateof22mgketamine/kgbodyweight

Medetomidine/ketamine:

Intramuscular:

Administermedetomidineatadoserateof80µg/kgbyintramuscularinjection.This

shouldbefollowedimmediatelybytheintramuscularinjectionofketamineadoserateof

2.5-7.5mg/kg(correspondingto0.12-0.38ml/5kgbodyweight).

Onsetofanaesthesiais3-4minutes.Thedurationofsurgicalanaesthesiavaries

between30-60minutesandisrelatedtothedoseofketamineused.Ifrequired,

anaesthesiamaybeprolongedwithhalothaneandoxygenwithorwithoutnitrousoxide.

Table6:Medetomidineandketaminefelineanaesthesia(IM)

Weightofcat(kg) 1.5 2 2.5 3 3.5 4 4.5 5

Medetomidine(1

mg/ml)dose(ml)* 0.120.160.200.240.280.320.360.40

Ketamine(100mg/ml)

dose

(ml)** 0.080.100.130.150.180.200.230.25

*basedonadoserateof80µgmedetomidine/kgbodyweight

**basedonadoserateof5mgketamine/kgbodyweight

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Intravenous:

Medetomidineandketaminemaybeadministeredbyintravenousinjectionatthe

followingdoserates:40µgmedetomidine/kgand1.25mgketamine/kg.

Clinicalexperiencehasshownthatwhenketamineandmedetomidinehavebeenused

intravenouslyincatsandtheneedforanaesthesiahaspassed,administrationof100µg

atipamezole/kgbyintramuscularinjectionresultsinrecoverytosternalrecumbencyin

approximately10minutesandtostandinginapproximately14minutes.

Table7:Medetomidineandketaminefelineanaesthesia(IV)

Weightofcat(kg) 1.5 2 2.5 3 3.5 4 4.5 5

Medetomidine(1

mg/ml)dose(ml)* 0.060.080.100.120.140.160.180.20

Ketamine(100mg/ml)

dose

(ml)** 0.020.030.030.040.050.050.060.06

*basedonadoserateof40µgmedetomidine/kgbodyweight

**basedonadoserateof1.25mgketamine/kgbodyweight

Atropineisnotnormallynecessarywhenusingamedetomidine/ketaminecombination.

Useofeitherinsulinsyringesor1mlgraduatedsyringesisrecommendedtoensure

accuratedosing.

Butorphanol/medetomidine/ketamine:

Intramuscular:

Administerbutorphanolatadoserateof0.4mg/kg,medetomidineatadoserateof80

µg/kgandketamineatadoserateof5mg/kg(correspondingto0.25ml/5kg

bodyweight)byintramuscularinjection.

Catsbecomerecumbentin2-3minutesfollowinginjection.Lossofpedalreflexoccurs3

minutespostinjection.At45minutespostinduction,reversalwith200µg

atipamezole/kgresultsinreturnofpedalreflex2minuteslater,sternalrecumbency6

minuteslaterandstanding31minuteslater.

Table8:Butorphanol,medetomidineandketaminefelineanaesthesia(IM)

Weightofcat(kg) 1.5 2 2.5 3 3.5 4 4.5 5

Butorphanol(10mg/ml)

dose(ml)* 0.060.080.100.120.140.160.180.20

Medetomidine(1

mg/ml)dose(ml)** 0.120.160.200.240.280.320.360.40

Ketamine(100mg/ml)

dose

(ml)*** 0.080.100.130.150.180.200.230.25

* basedonadoserateof0.4mgbutorphanol/kgbodyweight

**basedonadoserateof80µgmedetomidine/kgbodyweight

***basedonadoserateof5mgketamine/kgbodyweight

Intravenous:

Administerbutorphanolatadoserateof0.1mg/kg,medetomidineatadoserateof40

µg/kgandketamine,dependingondepthofanaesthesiarequired,atadoserateof

1.25-2.5mg/kg(correspondingto0.06-0.13ml/5kgbodyweight)byintravenous

injection.

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Approximatetimescaleswhenusingthetriplecombinationintravenously:

Ketamine

dose

(mg/kg)* Timeto

recumbency Timetoloss

ofpedal

reflex Timeto

returnof

pedalreflex Timeto

sternal

recumbency Timeto

standing

1.25 32sec 62sec 26min 54min 74min

2.50 22sec 39sec 28min 62min 83min

*inconjunctionwithbutorphanolat0.1mg/kgandmedetomidineat40µg/kg

Clinicalexperiencehasshownthatreversal,atanystage,with100µgatipamezole/kg

resultsinreturnofthepedalreflex4minuteslater,sternalrecumbency7minuteslater

andstanding18minuteslater.

Table9:Butorphanol,medetomidineandketaminefelineanaesthesia(IV):

Dosagechartfor2.5mg/kgketamine(durationofanaesthesiaapproximately28

minutes)

Weightofcat(kg) 1.5 2 2.5 3 3.5 4 4.5 5

Butorphanol(10mg/ml)

dose(ml)* 0.020.020.030.030.040.040.050.05

Medetomidine(1

mg/ml)dose(ml)** 0.060.080.100.120.140.160.180.20

Ketamine(100mg/ml)

dose

(ml)*** 0.040.050.060.080.090.100.110.13

* basedonadoserateof0.1mgbutorphanol/kgbodyweight

**basedonadoserateof40µgmedetomidine/kgbodyweight

***basedonadoserateof2.5mgketamine/kgbodyweight

HORSE:

Fortheproductionofshort-termanaesthesiasuitableforminorsurgicalinterferencesor

forinductionpriortoinhalationanaesthesia.Whenromifidineordetomidineareusedas

thepremedicant,anaesthesiamayalsobemaintainedwitha‘top-up’combinationof

eitherromifidineandKetamine100mg/mlordetomidineandketamineatregular8-10

minuteintervals.Ketamineshouldneverbeusedasasoleanaestheticagent.

Itisgenerallyacceptedasgoodanaestheticpracticetostarveanimalsforaperiodprior

toanaesthesiawherepossible.

Toachievethebestresults,itisimportantthehorsesarenotstressedbeforethe

anaesthetic.Itisequallyimportantthatthewholeprocedure,frominductiontorecovery,

shouldtakeplaceinquietandcalmsurroundings.

Forhorsesthatarestressedbeforetheprocedure,theuseof0.03mg/kgacepromazine

45minutespriortoadministrationofeitherdetomidineorromifidinefacilitateshandling

andplacementofanintravenouscatheter.

Ifthehorsefailstobecomesedatedfollowingtheinjectionofeitherxylazine,detomidine

orromifidine,thenketamineshouldnotbeinjectedandtheanaestheticprocedure

shouldbeabandoned.Thesituationshouldbeassessedtoestablishwhythehorse

failedtorespond,andthentheenvironmentand/orthedrugsshouldbeadjustedas

necessary,beforetryingagainthefollowingday.

Whenusingatotalintravenoustechniqueandforsafeandeffectiveuseofatop-up

regime,theuseofanintravenouscatheterisstronglyadvised.

Duringcastrationithasbeennotedthattheuseof10mllidocainedividedbetweenthe

testicleseliminatesthepossibleresponsetoligationofthetesticularcordand

minimisesthenumberoftop-upsrequired.

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Xylazine/ketamine:

Xylazineshouldbeadministeredbyslowintravenousinjectionatadoserateof1.1

mg/kg(correspondingto1.1ml/100kgbodyweightofxylazine10%solution).Thehorse

shouldappearsedatedby2minutespostinjection.Injectionofketamineshouldbe

administeredatthisstage.Itisrecommendednottodelaytheketamineinjectionlonger

than5minutesafterxylazineadministration.Ketamineshouldbeadministeredasan

intravenousbolusatadoserateof2.2mg/kg(correspondingto2.2ml/100kg

bodyweight).

Inductionandrecumbencytakesome1-2minutes.Musclejerkingmayoccurinthefirst

minutes,butthisusuallysubsides.

Anaesthesiaisvariableinduration,lastingbetween10-30minutes,butusuallylessthan

20minutes.Horsesinvariablystand25-45minutesafterinduction.Recoveryisgenerally

quiet,butmayoccursuddenly.Itisimportantthereforethatshortdurationinterferences

onlyareattempted,orarrangementstoprolonganaesthesiaaremade.Forlonger

periodsofanaesthesia,intubationandmaintenancebyinhalationanaesthesiacanbe

used.

Table10:Xylazineandketamineequineanaesthesia(IV)

Weightofhorse(kg) 50 100 150 200 250 300 400 500 600

Xylazine10%dose

(ml)* 0.601.101.702.202.803.304.40 5.50 6.60

Wait2minutes

Ketamine(100mg/ml)

dose(ml)** 1.102.203.304.405.506.608.8011.0013.20

*basedonadoserateof1.1mgxylazine/kgbodyweight

**basedonadoserateof2.2mgketamine/kgbodyweight

Detomidine/ketamine:

Detomidineshouldbeadministeredbyintravenousinjectionatadoserateof20µg/kg.

Thehorseshouldappearsedatedbyfiveminutespostinjection.Atthisstageketamine

shouldbeadministeredatadoserateof2.2mg/kg(correspondingto2.2ml/100kg

bodyweight)asanintravenousbolus.

Onsetofanaesthesiaisgradual;mosthorsestakeapproximately1minutetobecome

recumbent.Large,fithorsesmaytakeupto3minutesforrecumbency.Anaesthesia

continuestodeepenforafurther1-2minutesandduringthistimethehorseshouldbe

leftquietly.Horsesregainsternalrecumbencyapproximately20minutespostketamine

injectiongivingasurgicalanaesthesiadurationof10-15minutes.

Maintenanceofsurgicalanaesthesia:

Shoulditbecomenecessarytoprolonganaesthesia,eitherofthefollowingregimesmay

beused:

a)Thiopentalsodium

Thiopentalsodiummaybeadministeredintravenouslyinbolusesof1mg/kgas

required.Totaldosesof5mg/kg(five1mg/kgincrements)havebeengiven.Total

dosesgreaterthanthismayreducethequalityofrecovery.Thiopentalsodiumcanalso

beadministeredinincrementsifsufficientdepthofanaesthesiaisnotachieved.The

horsemaybeataxicifencouragedtostandprematurelyandsoshouldbelefttostandin

itsowntime.

b)Detomidine/ketamine

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Administer10µgdetomidine/kg,i.e.½theinitialpremedicationdosebyintravenous

injection,followedimmediatelyby1.1mgketamine/kg,i.e.½theinitialinductiondose

byintravenousinjection.Thiswillprovideapproximately10minutesadditionalsurgical

anaesthesia,whichcanberepeatedatregular10minuteintervals(upto5times)

withoutcompromisingrecovery.

Table11:Detomidineandketamineequineanaesthesia(IV):Premedicationand

inductionofanaesthesia

Weightofhorse(kg) 50 100 150 200 250 300 400 500 600

Detomidine(10mg/ml)

dose(ml)* 0.100.200.300.400.500.600.80 1.00 1.20

Wait5minutes

Ketamine(100mg/ml)

dose(ml)** 1.102.203.304.405.506.608.8011.0013.20

*basedonadoserateof20µgdetomidine/kgbodyweight

**basedonadoserateof2.2mgketamine/kgbodyweight

Table12:Detomidineandketamineequineanaesthesia(IV):Maintenance(top-

up)doseat10minuteintervals

Weightofhorse(kg) 50 100 150 200 250 300 400 500 600

Detomidine(10mg/ml)

dose(ml)* 0.050.100.150.200.250.300.400.500.60

Ketamine(100mg/ml)

dose(ml)** 0.551.101.652.202.753.304.405.506.60

*basedonadoserateof10µgdetomidine/kgbodyweight

**basedonadoserateof1.1mgketamine/kgbodyweight

Romifidine/ketamine:

Romifidineshouldbeadministeredbyintravenousinjectionatadoserateof100µg/kg.

Thehorseshouldappearsedatedbyfivetotenminutespostinjection.Atthisstage

ketamineshouldbeadministeredatadoserateof2.2mg/kg(correspondingto2.2

ml/100kg)asanintravenousbolus.Sedationshouldbeapparentbeforetheinductionof

anaesthesia.

Maintenanceofsurgicalanaesthesia:

Shoulditbecomenecessarytoprolonganaesthesia,eitherofthefollowingregimesmay

beused:

a)Thiopentalsodium

Thiopentalsodiummaybeadministeredintravenouslyinbolusesof2.5mg/kgwhen

signsofreturningconsciousnessappear.Thiscanberepeatedupto3timesafter

induction.Totaldosesgreaterthanthismayreducethequalityofrecovery.Thehorse

maybeataxicifencouragedtostandprematurelyandsoshouldbelefttostandinits

owntime.

b)Romifidine/ketamine

Dependingondepthanddurationofanaesthesiarequired,administerromifidine

intravenouslywithinthedoserangeof25-50µg/kgbodyweight,i.e.¼-½theinitial

premedicationdosefollowedimmediatelybyketamineintravenouslyatadoserateof

1.1mg/kgbodyweight,i.e.½theinitialinductiondose).Eachtop-uplastsapproximately

8-10minutesandcanberepeatedatregular8-10minuteintervals(upto5times)

withoutcompromisingrecovery.

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Table13:Romifidineandketamineequineanaesthesia(IV):Premedicationand

inductionofanaesthesia

Weightofhorse(kg) 50 100 150 200 250 300 400 500 600

Romifidine(10mg/ml)

dose(ml)* 0.501.001.502.002.503.004.00 5.00 6.00

Wait5-10minutes

Ketamine(100mg/ml)

dose(ml)** 1.102.203.304.405.506.608.8011.0013.20

*basedonadoserateof100µgdetomidine/kgbodyweight

**basedonadoserateof2.2mgketamine/kgbodyweight

Table14:Romifidineandketamineequineanaesthesia(IV):Maintenance(top-

up)doseat8-10minuteintervals

Weightofhorse(kg) 50 100 150 200 250 300 400 500 600

Romifidine(10mg/ml)

dose(ml)* 0.250.500.751.001.251.502.002.503.00

Ketamine(100mg/ml)

dose(ml)** 0.551.101.652.202.753.304.405.506.60

*basedonadoserateof50µgromifidine/kgbodyweight

**basedonadoserateof1.1mgketamine/kgbodyweight

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inexcessivedoses,significantrespiratorydepressionmayoccur.Ifnecessary,suitable

artificialaidstomaintainventilationandcardiacoutputshouldbeuseduntilsufficient

detoxificationhastakenplacetoenableareturntoadequatespontaneousventilation

andcardiacactivity.Pharmacologicalcardiacstimulantsarenotrecommended,unless

noothersupportivemeasuresareavailable.

4.11Withdrawalperiod(s)

Horse

Meatandoffal:1day

Milk:1day

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:dissociativeanaesthetic,ATCvetcode:QN01AX03

5.1.Pharmacodynamicproperties

Ketamineisadissociativeanaestheticagent.Ketamineinducesastateofcatalepsy

withamnesiaandanalgesia;muscletoneismaintainedincludingthepharyngealand

laryngealreflexes.Theheartrate,bloodpressureandcardiacoutputareincreased;

respiratorydepressionisnotanoticeablefeature.Allthesecharacteristicsmaybe

modifiediftheproductisusedincombinationwithotheragents.

5.2.Pharmacokineticparticulars

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Ketamineundergoesextensivehepaticbiotransformationindogs,horsesandprimates.

Somehepaticmetabolismoccursincats,butnormallythemajorityofthedrugis

excretedviathekidney.Recoveryofketamineafterintravenousbolusisbyrapid

redistributionfromtheCNStoothertissues,primarilyfat,lung,liverandkidney.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Chlorocresol

Sodiumhydroxide(forpHadjustment)

Hydrochloricacid(forpHadjustment)

Waterforinjections

6.2Incompatibilities

Theproductmustnotbemixedwithotherveterinarymedicinalproducts,withthe

exceptionoftheinfusionfluids0.9%sodiumchloride,Ringerssolutionandlactated

Ringerssolution.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

ClearcolourlesstypeIglassvialswithbromobutylrubberstoppersandaluminiumcaps

filledwith5ml,10ml,20ml,25ml,30mland50ml.

1vialinacardboardbox

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25,5531AEBladel,TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm16849/4048

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9. DATEOFFIRSTAUTHORISATION

08July2013

10 DATEOFREVISIONOFTHETEXT

July2013

Approved: 08/07/2013