Alfaxan 10mg/ml Soution for Injection

Main information

  • Trade name:
  • Alfaxan 10mg/ml Soution for Injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Alfaxan 10mg/ml Soution for Injection
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0278/001
  • Authorization date:
  • 13-05-2011
  • EU code:
  • UK/V/0278/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:September2013

AN:00543/2013

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Alfaxan10mg/mlsolutionforInjectionforDogsandCats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:Alfaxalone10mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Clearcolourlesssolution

4.CLINICALPARTICULARS

4.1Targetspecies

Dogsandcats

4.2Indicationsforuse,specifyingthetargetspecies

Asaninductionagentpriortoinhalationanaesthesia.Asasoleanaestheticagentfor

theinductionandmaintenanceofanaesthesiafortheperformanceofexaminationor

surgicalprocedures.

4.3Contraindications

Donotuseincombinationwithotherintravenousanaestheticagents.

4.4Specialwarnings

Duringrecovery,itispreferablethatanimalsarenothandledordisturbed.Thismay

leadtopaddling,minormuscletwitchingormovementsthataremoreviolent.While

betteravoided,suchreactionsareclinicallyinsignificant.

4.5Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Appropriateanalgesiashouldbeprovidedincaseswhereprocedures

areanticipatedtobepainful.

Thesafetyoftheveterinarymedicinalproductinanimalslessthan12

weeksofagehasnotbeendemonstrated.

Transientpostinductionapnoeafrequentlyoccurs,particularlyoxygen

supplementationshouldbeemployed.Facilitiesforintermittentpositive

pressureventilationshouldbeavailable.

Revised:September2013

AN:00543/2013

Page2of7

Inordertominimisethepossibilityofapnoea,administertheveterinary

medicinalproductbyslowintravenousinjectionandnotasarapiddose.

Especiallywhenusinghigherdosesoftheveterinarymedicinalproduct,

adose-dependentrespiratorydepressionmayoccur.Oxygenand/or

intermittentpositivepressureventilationshouldbeadministeredto

counteractthethreateninghypoxaemia/hypercapnea.Thisshouldbe

particularlyimportantinriskyanaestheticcasesandwheneverthe

anaesthesiaistobecarriedoutforalongerperiodoftime.

Inbothdogsandcats,thedoseintervalformaintenanceofanaesthesia

byintermittentbolusadministrationmayrequirelengtheningbymore

than20%,orthemaintenancedosebyintravenousinfusionmayrequire

reductionbymorethan20%,whenhepaticbloodflowisseverely

diminishedorhepatocellularinjuryissevere.

Aswithallgeneralanaestheticagents:

Itisadvisabletoensurethatthepatienthasbeenfastedbefore

receivingtheanaesthetic.

Additionalmonitoringisadvisedandparticularattentionshouldbe

paidtorespiratoryparametersinagedanimals,orincaseswhere

theremaybeadditionalphysiologicalstressimposedbypre-existing

pathology,shockorcaesareansection.

Followinginductionofanaesthesia,theuseofanendotrachealtube

isrecommendedtomaintainairwaypatency.

Itisadvisabletoadministersupplementaloxygenduring

maintenanceofanaesthesia.

Respiratoryembarrassmentmayoccur –ventilationofthelungswith

oxygenshouldbeconsideredifhaemoglobinsaturationwithoxygen

(SpO

%)fallsbelow90%orifapnoeapersistsforlongerthan60

seconds.

Ifcardiacarrhythmiasaredetected,attentiontorespiratoryventilation

withoxygenisthefirstpriorityfollowedbyappropriatecardiac

therapyorintervention.

Psychomotorexcitementmaybeencounteredinaminorityofdogs

andcatsrecoveringfromanaesthesiawiththeveterinarymedicinal

product.Post-anaestheticrecoveryshouldthustakeplacein

appropriatefacilitiesandundersufficientsupervision.Useofa

benzodiazepineasthesolepremedicantmayincreasetheprobability

ofpsychomotorexcitement.

(ii)Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Iftheproductcomesintocontactwiththeeyesorskin,washoff

immediatelywithwater.Incaseofaccidentalselfinjectionseek

immediatemedicalattentionandshowtheproductliteraturetothe

Revised:September2013

AN:00543/2013

Page3of7

doctor.

4.6Adversereactions(frequencyandseriousness)

Inclinicalstudiesusingtheveterinarymedicinalproduct,44%ofdogsand19%ofcats

experiencedpostinductionapnoea,whichwasdefinedasthecessationofbreathingfor

30secondsormore.Themeandurationofapnoeaintheseanimalswas100seconds

indogsand60secondsincats.Endotrachealintubationandoxygensupplementation

shouldthereforebeemployed.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedincaseswhere

pregnancyistobecontinuedorduringlactation.Itseffectsuponfertilityhavenotbeen

evaluated.However,studiesusingalfaxaloneinpregnantmice,ratsandrabbitshave

demonstratednodeleteriouseffectsongestationofthetreatedanimals,oronthe

reproductiveperformanceoftheiroffspring.Theproductshouldbeusedinpregnant

animalsaccordingtotherisk-benefitassessmentperformedbytheveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Theveterinarymedicinalproducthasbeendemonstratedtobesafewhenusedin

combinationwiththefollowingpremedicantclasses:

TheconcomitantuseofotherCNSdepressantsshouldbeexpectedtopotentiatethe

depressanteffectsoftheveterinarymedicinalproduct,necessitatingcessationoffurther

administrationoftheveterinarymedicinalproductwhentherequireddepthof

anaesthesiahasbeenreached.

Theuseofonepremedicantoracombinationofpremedicantsoftenreducesthedose

oftheveterinarymedicinalproductrequired.

Premedicationwithalpha-2-adrenoceptoragonistssuchasxylazineandmedetomidine

canmarkedlyincreasethedurationofanaesthesiainadosedependentfashion.In

ordertoshortenrecoveryperiodsitmaybedesirabletoreversetheactionsofthese

premedicants.

Benzodiazepinesshouldnotbeusedassolepremedicantsindogsandcatsasthe

qualityofanaesthesiainsomepatientsmaybesub-optimal.Benzodiazepinesmaybe

DrugClass Examples

Phenothiazines acepromazinemaleate

Anticholinergicagents atropinesulfate

Benzodiazepines diazepam,midazolamhydrochloride,

Alpha-2-adrenoceptor

agonists xylazinehydrochloride,medetomidine

hydrochloride

Opiates methadone,morphinesulfate,butorphanol

tartrate,buprenorphinehydrochloride

NSAIDs carprofen,meloxicam

Revised:September2013

AN:00543/2013

Page4of7

medicinalproduct.

Refertosection4.3.

4.9Amountstobeadministeredandadministrationroute

Inductionofanaesthesia:

Theinductiondoseoftheveterinarymedicinalproductisbasedondatatakenfrom

controlledlaboratoryandfieldstudiesandistheamountofdrugrequiredfor9of10

dogsorcats(i.e.90thpercentile)tobesuccessfullyinducedforanaesthesia.

Dosingrecommendationsforinductionofanaesthesiaareasfollows:

DOGS CATS

Un-

premedicated Premedicated Un-

premedicated Premedicated

mg/kg 3 2 5 5

ml/kg 0.3 0.2 0.5 0.5

Thedosingsyringeshouldbepreparedtocontaintheabovedose.Therateof

intravenousinjectionshouldbesuchthatthetotaldose,ifrequired,wouldbe

administeredoverthefirst60seconds.If,60secondsaftercompletedeliveryofthisfirst

inductiondose,intubationisstillnotpossible,onefurthersimilardosemaybe

administeredtoeffect.Thenecessaryinjectionratecanbeachievedbyadministration

ofonequarter(¼)ofthecalculateddoseevery15seconds.Administrationshould

continueuntiltheclinicianissatisfiedthatthedepthofanaesthesiaissufficientfor

endotrachealintubation,oruntiltheentiredosehasbeenadministered.

Maintenanceofanaesthesia:

Followinginductionofanaesthesiawiththeveterinarymedicinalproduct,theanimal

maybeintubatedandmaintainedontheveterinarymedicinalproductoraninhalation

anaestheticagent.Maintenancedosesoftheveterinarymedicinalproductmaybegiven

assupplementalbolusesorasconstantrateinfusion.Theveterinarymedicinalproduct

hasbeenusedsafelyandeffectivelyinbothdogsandcatsforprocedureslastingforup

toonehour.Thefollowingdosessuggestedformaintenanceofanaesthesiaarebased

ondatatakenfromcontrolledlaboratoryandfieldstudiesandrepresenttheaverage

amountofdrugrequiredtoprovidemaintenanceanaesthesiaforadogorcat.However

theactualdosewillbebasedontheresponseoftheindividualpatient.

Dosingrecommendationsformaintenanceofanaesthesiaareasfollows:

DOGS CATS

Un-

premedicated Premedicated Un-

premedicated Premedicated

Doseforconstantrateinfusion

mg/kg/hour 8-9 6-7 10-11 7-8

mg/kg/minute 0.13-0.15 0.10-0.12 0.16-0.18 0.11-0.13

ml/kg/minute 0.013-0.015 0.010-0.012 0.016-0.018 0.011-0.013

Bolusdoseforeach10minutesmaintenance

mg/kg 1.3-1.5 1.0-1.2 1.6-1.8 1.1-1.3

ml/kg 0.13-0.15 0.10-0.12 0.16-0.18 0.11-0.13

Revised:September2013

AN:00543/2013

Page5of7

Wheremaintenanceofanaesthesiaiswiththeveterinarymedicinalproductfor

procedureslastingmorethan5to10minutes,abutterflyneedleorcathetercanbeleft

inthevein,andsmallamountsoftheveterinarymedicinalproductinjectedsubsequently

tomaintaintherequiredlevelanddurationofanaesthesia.Inmostcasestheaverage

durationofrecoverywhenusingtheveterinarymedicinalproductformaintenancewill

belongerthanifusinganinhalantgasasamaintenanceagent.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Acutetolerancetooverdosehasbeendemonstratedupto10timestherecommended

doseof2mg/kginthedog(i.e.upto20mg/kg)andupto5timestherecommended

doseof5mg/kginthecat(i.e.upto25mg/kg).Forbothdogsandcats,these

excessivedosesdeliveredover60secondscauseapnoeaandatemporarydecreasein

meanarterialbloodpressure.Thedecreaseinbloodpressureisnotlifethreateningand

iscompensatedforbychangesinheartrate.Theseanimalscanbetreatedsolelyby

intermittentpositivepressureventilation(ifrequired)witheitherroomairor,preferably,

oxygen.Recoveryisrapidwithnoresidualeffects.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:othergeneralanaesthetics

ATCvetcode:QN01AX05.

5.1Pharmacodynamicproperties

Alfaxalone(3- α-hydroxy-5-α-pregnane-11,20-dione)isaneuroactivesteroidmolecule

withpropertiesofageneralanaesthetic.Theprimarymechanismfortheanaesthetic

actionofalfaxaloneismodulationofneuronalcellmembranechlorideiontransport,

inducedbybindingofalfaxalonetoGABA

cellsurfacereceptors.Alfaxalonehaslimited

analgesicpropertiesatclinicaldoses.

5.2Pharmacokineticparticulars

Thevolumeofdistributionafterasingleinjectionofclinicaldosesof2and5mg/kgbw

ofalfaxaloneindogsandcatsis2.4L/kgand1.8L/kg,respectively.Invitrocatanddog

hepatocytestudiesshowthatalfaxaloneexperiencesbothPhaseI(cytochromeP450

dependent)andPhaseII(conjugationdependent)metabolism.Bothcatsanddogsform

thesamefive(5)PhaseIalfaxalonemetabolites.ThePhaseIImetabolitesobservedin

catsarealfaxalonesulphateandalfaxaloneglucuronide,whilealfaxaloneglucuronideis

observedinthedog.

Incats,themeanterminalplasmaeliminationhalf-life(t1/2)foralfaxaloneis

approximately45minutesfora5mg/kgdose.Meanplasmaclearancefora5mg/kg

doseis25.1±7.6ml/kg/min.

Indogs,themeanterminalplasmaeliminationhalf-life(t1/2)foralfaxaloneis

approximately25minutesfora2mg/kgdose.Plasmaclearancefora2mg/kgdoseis

Revised:September2013

AN:00543/2013

Page6of7

59.4±12.9ml/kg/min.

Inbothdogsandcatstheeliminationofalfaxalonedemonstratesnon-linear(dose-

dependent)pharmacokinetics.

Alfaxalonemetabolitesarelikelytobeeliminatedfromthedogandcatbythe

hepatic/faecalandrenalroutes,similartootherspecies.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Hydroxypropylbetadex

SodiumChloride

DisodiumPhosphateAnhydrous

PotassiumDihydrogenPhosphate

SodiumHydroxide(forpHadjustment)

HydrochloricAcid,Concentrated(forpHadjustment)

WaterforInjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,theveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Thisproductdoesnotcontainanantimicrobialpreservative.Anysolutionremainingin

thevialfollowingwithdrawaloftherequireddoseshouldbediscarded.

6.4.Specialprecautionsforstorage

Donotfreeze.Keepthecontainerintheoutercarton.

6.5Natureandcompositionofimmediatepackaging

Cardboardboxwithoneglassvialof10mlwithabromobutylrubberstopperand

aluminiumcap.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

Revised:September2013

AN:00543/2013

Page7of7

7. MARKETINGAUTHORISATIONHOLDER

Jurox(UK)Limited

MicrobialDevelopmentsBuilding

SpringLaneNorth

MalvernLink

Worcestershire

WR141BU

UnitedKingdom

8.MARKETINGAUTHORISATIONNUMBER

Vm

:25296/4000

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Date:23November2006

10.DATEOFREVISIONOFTHETEXT

Date:September2013

Approved:04/10/2013

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Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety

22-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/mNsFqKTfFk

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/WAPabvM811

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/YRV0lVSRkh

FDA - U.S. Food and Drug Administration

21-5-2018

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/GzY50eEVp9

FDA - U.S. Food and Drug Administration

18-5-2018

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Active substance: Cysteamine bitartrate (gastroresistant)) - Transfer of orphan designation - Commission Decision (2018)3137 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/034/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3039 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/016/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Active substance: Everolimus) - Transfer of orphan designation - Commission Decision (2018)3038 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

28-3-2018

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Active substance: Chimeric monoclonal antibody against claudin-18 splice variant 2) - Transfer of orphan designation - Commission Decision (2018)2007 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/083/10/T/01

Europe -DG Health and Food Safety