Buprecare Multidose 0.3 mg/ml Solution for Injection for Dogs and Cats

Main information

  • Trade name:
  • Buprecare Multidose 0.3 mg/ml Solution for Injection for Dogs and Cats
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Buprecare Multidose 0.3 mg/ml Solution for Injection for Dogs and Cats
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0245/002
  • Authorization date:
  • 28-09-2011
  • EU code:
  • UK/V/0245/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

New–AN02194/200628/05/08

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Buprecare0.3mg/mlSolutionforInjectionforDogsandCats(UK,BE,FR,IE,LU,NL,ES)

Buprenovet0.3mg/mlSolutionforInjectionforDogsandCats(AT,DE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Eachampoulecontains:

Buprenorphine0.3mg/mlasbuprenorphinehydrochloride.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,colourlesssolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsandcats

4.2 Indicationsforuse,specifyingthetargetspecies

Post-operativeanalgesiainthecatanddog.

Potentiationofthesedativeeffectsofcentrallyactingagentsinthedog.

4.3 Contraindications

Theproductshouldnotbeusedpre-operativelyforcaesareansection(seeSection4.7).

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Buprenorphinemayoccasionallycausesignificantrespiratorydepressionand,aswithotheropioid

drugs,careshouldbetakenwhentreatinganimalswithimpairedrespiratoryfunctionoranimalsthat

arereceivingdrugsthatcancauserespiratorydepression.

Asbuprenorphineismetabolisedbytheliver,itsintensityanddurationofactionmaybeaffectedin

animalswithimpairedliverfunction.

Incaseofrenal,cardiacorhepaticdysfunction,orshock,theremaybegreaterriskassociatedwiththe

useoftheproduct.Thebenefit:riskratioforusingtheproductshouldbemadebytheattendingvet.

Safetyhasnotbeenfullyevaluatedinclinicallycompromisedcats.

Thesafetyofbuprenorphinehasnotbeendemonstratedinanimalslessthan7weeksofage,therefore

useinsuchanimalsshouldbebasedonthebenefit:riskassessmentbytheveterinarian.

RepeatedadministrationearlierthantherecommendedrepeatintervalsuggestedinSection4.9isnot

recommended.

Theeffectofanopioidonheadinjuryisdependentonthetypeandseverityoftheinjuryandthe

respiratorysupportsupplied.Theproductshouldbeusedinaccordancewiththebenefit:risk

assessmentoftheattendingveterinarian.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Asbuprenorphinehasopioid-likeactivitycareshouldbetakentoavoidaccidentalself-injection.

Incaseofaccidentalself-injectionoringestion,seekmedicaladviceimmediatelyandshowthepackage

leafletorthelabeltothephysician.

Followingeyecontaminationorskincontact,washthoroughlywithcoldrunningwater,seekmedical

adviceifirritationpersists.

4.6 Adversereactions(frequencyandseriousness)

Salivation,bradycardia,hypothermia,agitation,dehydrationandmiosiscanoccurinthedog,andrarely

hypertensionandtachycardia.

Mydriasisandsignsofeuphoria(excessivepurring,pacing,rubbing)commonlyoccurincats,andwill

usuallyresolvewithin24hours.

Buprenorphinemayoccasionallycausesignificantrespiratorydepression;refertosection4.5.

Whenusedtoprovideanalgesia,sedationmayappearasanadversereaction.

4.7 Useduringpregnancy,lactationorlay

Pregnancy:

Laboratorystudiesinratshavenotproducedanyevidenceofateratogeniceffect.However,these

studieshaveshownpost-implantationlossesandearlyfoetaldeaths.Asreproductivetoxicitystudies

havenotbeenconductedinthetargetspecies,useonlyaccordingtothebenefit:riskassessmentbythe

responsibleveterinarian.

Theproductshouldnotbeusedpre-operativelyincasesofcaesareansection,duetotheriskof

respiratorydepressionintheoffspringperiparturiently,andshouldonlybeusedpost-operativelywith

specialcare(seesectiononlactationbelow).

Lactation:

Studiesinlactatingratshaveshownthat,afterintramuscularadministrationofbuprenorphine,

concentrationsofunchangedbuprenorphineinthemilkequalledorexceededthatintheplasma.Asitis

likelythatbuprenorphinewillbeexcretedinthemilkofotherspecies,useisnotrecommendedduring

lactation.Useonlyaccordinglytobenefit:riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thereisevidenceinhumanstoindicatethattherapeuticdosesofbuprenorphinedonotreducethe

analgesicefficacyofstandarddosesofanopioidagonist,andthatwhenbuprenorphineisemployed

withinthenormaltherapeuticrange,standarddosesofopioidagonistmaybeadministeredbeforethe

effectsoftheformerhaveendedwithoutcompromisinganalgesia.However,itisrecommendedthat

buprenorphineisnotusedinconjunctionwithmorphineorotheropioid-typeanalgesics,e.g.etorphine,

fentanyl,pethidine,methadone,papaveretumorbutorphanol.

Buprenorphinehasbeenusedwithacepromazine,alphaxalone/alphadalone,atropine,halothane,

isoflurane,ketamine,medetomidine,propofol,sevoflurane,thiopentoneandxylazinewithoutany

observedadverseeffects.

Buprenorphinemaycausesomedrowsiness,whichmaybepotentiatedbyothercentrally-actingagents,

includingtranquillisers,sedativesandhypnotics.Theproductshouldnotbeusedinconjunctionwith

morphineorotheropioid-typeanalgesics(e.g.etorphine,fentanyl,pethidine,methadone,papaveretum

andbutorphanol).

4.9 Amountstobeadministeredandadministrationroute

Forintramuscularuse.

SpeciesPost-OperativeAnalgesia Sedation

Dog 10 – 20microgramperkg(0.3 – 0.6mlper10kg)repeatedif

necessaryafter3 – 4hourswith10microgramor5 – 6hours

with20microgramdoses. 10 – 20microgramperkg

(0.3 – 0.6mlper10kg).

Cat 10 – 20microgramperkg(0.3 – 0.6mlper10kg),repeatedif

necessary,once,after2hours.

Toensurethatanalgesiaispresentimmediatelyonrecovery,theproductcanbeadministeredpre-

operatively(seesection5.2).Pharmacologicaleffectshaveanonsetwithin30minutesofinjection.If

additionalanalgesiaissubsequentlyrequired,thismaybeachievedbyadministrationofafurtherdose

ofBuprecareorconcomitantuseofasuitableinjectableNSAID.

Anappropriatelygraduatedsyringemustbeusedtoallowaccurateadministrationoftherequireddose

volume.Thisisparticularlyimportantwheninjectingsmallvolumes.

Whenadministeredpre-operativelyinconjunctionwithotherpremedicants,itmaybepossibletoreduce

theamountofpremedicant,suchasacepromazineormedetomidine,andalsotheamountofinhalational

anaestheticused.

Animalsadministeredopioidspossessingsedativeandanalgesicpropertiesmayshowvariable

responses.Therefore,theresponsesofindividualanimalsshouldbemonitoredandsubsequentdoses

shouldbeadjustedaccordingly.Insomecasesrepeatdosesmayfailtoprovideadditionalanalgesia.In

thesecases,considerationshouldbegiventouseofananalgesicfromanalternativeclass.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Whenadministeredatoverdosetodogs,buprenorphinemaycauselethargy.Atveryhighdoses,

bradycardiaandmiosismaybeobserved.

Intoxicologicalstudiesofbuprenorphinehydrochlorideindogs,biliaryhyperplasiawasobservedafter

oraladministrationforoneyearatdoseswellinexcessofanyclinicaldoseregimeninthedog.

Incaseofoverdosage,supportivemeasuresshouldbeinstitutedandifappropriate,naloxonor

respiratorystimulantsmaybeused.However,doselevelsmanytimeshigherthanthoseindicated

abovehavebeenusedwithoutserioussideeffects.

Naloxonemaybeofbenefitinreversingreducedrespiratoryrateandrespiratorystimulantssuchas

Doxapramarealsoeffectiveinman.Becauseoftheprolongeddurationofeffectofbuprenorphinein

comparisontosuchdrugs,theymayneedtobeadministeredrepeatedlyorbycontinuousinfusion.

Volunteerstudiesinmanhaveindicatedthatopiateantagonistsmaynotfullyreversetheeffectsof

buprenorphine.

Pleasealsorefertosections4.5and4.6ofthisSPC.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Opioidanalgesics,oripavinederivatives

ATCvetcode:QN02AE01

5.1 Pharmacodynamicproperties

Insummarybuprenorphineisapotent,long-actinganalgesicactingatopiatereceptorsinthecentral

nervoussystem.

Buprenorphineexertsitsanalgesiceffectviahighaffinitybindingtovarioussubclassesofopiate

receptors,particularlyµ,inthecentralnervoussystem.Atclinicaldoselevelsforanalgesia,

buprenorphinedemonstrateshighefficacyandbindstoopiatereceptorswithhighaffinity,suchthatits

dissociationfromthereceptorsiteisslow,asdemonstratedininvitrostudies.Thispropertyof

buprenorphinecouldaccountforitslongerdurationofactivitywhencomparedtomorphine.In

circumstanceswhereexcessiveopiateagonistisalreadyboundtoopiatereceptors,buprenorphinecan

exertanarcoticantagonisticactivityasaconsequenceofitshigh-affinityopiatereceptorbinding,such

thatanantagonisticeffectonmorphineequivalenttonaloxonehasbeendemonstrated .

5.2 Pharmacokineticparticulars

Buprenorphineisrapidlyabsorbedafterintramuscularinjectioninvariousanimalspeciesandman.The

substanceishighlylipophilicandthevolumeofdistributioninbodycompartmentsislarge.Inthecat,

pharmacologicaleffectsoccurwithin30minutesafterinjectionandpeakeffectsareusuallyobserved

atabout1 – 1.5hours.Followingintramuscularadministrationtocats,themeanterminalhalf-lifewas6.3

hoursandtheclearancewas23ml/kg/min,however,therewasconsiderableinter-catvariabilityin

pharmacokineticparameters.

Norelevantpharmacokineticdataareavailableinthedog.

Combinedpharmacokineticandpharmacodynamicstudiesincatshavedemonstratedamarkeddelay

betweenplasmaconcentrationsandanalgesiceffect.Plasmaconcentrationsofbuprenorphineshould

notbeusedtoformulateindividualanimaldosageregimens,whichshouldbedeterminedbymonitoring

ofthepatient’sresponse.

Themajorrouteofexcretioninallspeciesexcepttherabbit(whereurinaryexcretionpredominates)is

thefaeces.BuprenorphineundergoesN-dealkylationandglucuronideconjugationbytheintestinalwall

andtheliveranditsmetabolitesareexcretedviathebileintothegastro-intestinaltract.

Intissuedistributionstudiescarriedoutinratsandrhesusmonkeys,thehighestconcentrationsofdrug-

relatedmaterialwereobservedinliver,lungandbrain.Peaklevelsoccurredrapidlyanddeclinedtolow

levelsby24hoursafterdosing.

Proteinbindingstudiesinratshaveshownthatbuprenorphineishighlyboundtoplasmaproteins,

principallytoalphaandbetaglobulins.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Glucose,anhydrous

Hydrochloricacid

Waterforinjection

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Theproductdoesnotcontainanantimicrobialpreservative.Useimmediatelyafteropeningtheampoule.

Anysolutionremaininginanampoulefollowingwithdrawaloftherequireddoseshouldbediscarded.

6.4 Specialprecautionsforstorage

Donotstoreabove25

C.

Protectfromlight.

Donotrefrigerateorfreeze.

6.5 Natureandcompositionofimmediatepackaging

Presentedin1mlclearTypeIglass,snapampoules,inboxesoffive.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

AnimalcareLimited,

CommonRoad,

Dunnington,

York,YO195RU

UK

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm10347/4024

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

28May2008

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

28-11-2018

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