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/0245/001
  • Authorization date:
  • 15-02-2008
  • EU code:
  • UK/V/0245/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:June2013

AN.00507/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

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

4.1Targetspecies

Dogsandcats

4.2Indicationsforuse,specifyingthetargetspecies

Dog

Post-operativeanalgesia.

Potentiationofthesedativeeffectsofcentrally-actingagents.

Cat

Post-operativeanalgesia.

4.3Contraindications

Theproductshouldnotbeusedpre-operativelyforcaesareansection(seeSection4.7).

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

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Buprenorphinemayoccasionallycausesignificantrespiratorydepressionand,aswith

otheropioiddrugs,careshouldbetakenwhentreatinganimalswithimpaired

respiratoryfunctionoranimalsthatarereceivingdrugsthatcancauserespiratory

depression.

Buprenorphineshouldbeusedwithcautioninanimalswithimpairedliverfunction,

especiallybiliarytractdisease,asthesubstanceismetabolisedbytheliverandits

intensityanddurationofactionmaybeaffectedinsomeanimals.

Incaseofrenal,cardiacorhepaticdysfunction,orshock,theremaybegreaterrisk

associatedwiththeuseoftheproduct.Thebenefit:riskratioforusingtheproductshould

bemadebytheattendingvet.Safetyhasnotbeenfullyevaluatedinclinically

compromisedcats.

Thesafetyofbuprenorphinehasnotbeendemonstratedinanimalslessthan7weeksof

age,thereforeuseinsuchanimalsshouldbebasedonthebenefit:riskassessmentby

theveterinarian.

Repeatedadministrationearlierthantherecommendedrepeatintervalsuggestedin

Section4.9isnotrecommended.

Theeffectofanopioidonheadinjuryisdependentonthetypeandseverityoftheinjury

andtherespiratorysupportsupplied.Theproductshouldbeusedinaccordancewiththe

benefit:riskassessmentoftheattendingveterinarian.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Asbuprenorphinehasopioid-likeactivitycareshouldbetakentoavoidaccidentalself-

injection.

Incaseofaccidentalself-injectionoringestion,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.Naloxoneshouldbeavailablein

caseofaccidentalparenteralexposure.

Followingeyecontaminationorskincontact,washthoroughlywithcoldrunningwater,

seekmedicaladviceifirritationpersists.

4.6Adversereactions(frequencyandseriousness)

Salivation,bradycardia,hypothermia,agitation,dehydrationandmiosiscanoccurinthe

dog,andrarelyhypertensionandtachycardia.

Mydriasisandsignsofeuphoria(excessivepurring,pacing,rubbing)commonlyoccurin

cats,andwillusuallyresolvewithin24hours.

Buprenorphinemayoccasionallycausesignificantrespiratorydepression;referto

section4.5.

Whenusedtoprovideanalgesia,sedationisrarelyseen,butmayoccuratdoselevels

higherthanthoserecommended.

4.7Useduringpregnancy,lactationorlay

Pregnancy:

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Laboratorystudiesinratshavenotproducedanyevidenceofateratogeniceffect.

However,thesestudieshaveshownpost-implantationlossesandearlyfoetaldeaths.As

reproductivetoxicitystudieshavenotbeenconductedinthetargetspecies,useonly

accordingtothebenefit:riskassessmentbytheresponsibleveterinarian.

Theproductshouldnotbeusedpre-operativelyincasesofcaesareansection,dueto

theriskofrespiratorydepressionintheoffspringperiparturiently,andshouldonlybe

usedpost-operativelywithspecialcare(seesectiononlactationbelow).

Lactation:

Studiesinlactatingratshaveshownthat,afterintramuscularadministrationof

buprenorphine,concentrationsofunchangedbuprenorphineinthemilkequalledor

exceededthatintheplasma.Asitislikelythatbuprenorphinewillbeexcretedinthemilk

ofotherspecies,useisnotrecommendedduringlactation.Useonlyaccordinglyto

benefit:riskassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Buprenorphinemaycausesomedrowsiness,whichmaybepotentiatedbyother

centrally-actingagents,includingtranquillisers,sedativesandhypnotics.

Thereisevidenceinhumanstoindicatethattherapeuticdosesofbuprenorphinedonot

reducetheanalgesicefficacyofstandarddosesofanopioidagonist,andthatwhen

buprenorphineisemployedwithinthenormaltherapeuticrange,standarddosesof

opioidagonistmaybeadministeredbeforetheeffectsoftheformerhaveendedwithout

compromisinganalgesia.However,itisrecommendedthatbuprenorphineisnotusedin

conjunctionwithmorphineorotheropioid-typeanalgesics,e.g.etorphine,fentanyl,

pethidine,methadone,papaveretumorbutorphanol.

Buprenorphinehasbeenusedwithacepromazine,alphaxalone/alphadalone,atropine,

dexmedetomidine, halothane, isoflurane, ketamine, medetomidine, propofol,

sevoflurane,thiopentoneandxylazine.Whenusedincombinationwithsedatives,

depressiveeffectsonheartrateandrespirationmaybeaugmented.

4.9Amountstobeadministeredandadministrationroute

Forintramuscularuse.

SpeciesPost-OperativeAnalgesia Sedation

Dog 10 –20microgramperkg(0.3–0.6mlper10kg)

repeatedifnecessaryafter3 –4hourswith10

microgramor5 –6hourswith20microgramdoses. 10 –20microgramper

kg(0.3 –0.6mlper10

kg).

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

repeatedifnecessary,once,after2hours.

Whilesedativeeffectsarepresentby15minutesafteradministration,analgesicactivity

becomesapparentafterapproximately30minutes.Toensurethatanalgesiaispresent

duringsurgeryandimmediatelyonrecovery,theproductshouldbeadministered

preoperativelyaspartofpremedication.

Whenadministeredforpotentiationofsedationoraspartofpremedication,thedoseof

othercentrally-actingagents,suchasacepromazineormedetomidine,shouldbe

reduced.Thereductionwilldependonthedegreeofsedationrequired,theindividual

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animal,thetypeofotheragentsincludedinpremedicationandhowanaesthesiaistobe

inducedandmaintained.Itmayalsobepossibletoreducetheamountofinhalational

anaestheticused.Animalsadministeredopioidspossessingsedativeandanalgesic

propertiesmayshowvariableresponses.Therefore,theresponsesofindividualanimals

shouldbemonitoredandsubsequentdosesshouldbeadjustedaccordingly.Insome

casesrepeatdosesmayfailtoprovideadditionalanalgesia.Inthesecases,

considerationshouldbegiventousingasuitableinjectableNSAID.

Anappropriatelygraduatedsyringemustbeusedtoallowaccuratedosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Whenadministeredatoverdosetodogs,buprenorphinemaycauselethargy.Atvery

highdoses,bradycardiaandmiosismaybeobserved.

Intoxicologicalstudiesofbuprenorphinehydrochlorideindogs,biliaryhyperplasiawas

observedafteroraladministrationforoneyearatdoselevelsof3.5mg/kg/dayand

above.Biliaryhyperplasiawasnotobservedfollowingdailyintramuscularinjectionof

doselevelsupto2.5mg/kg/dayfor3months.Thisiswellinexcessofanyclinicaldose

regimeninthedog.

Incaseofoverdosage,supportivemeasuresshouldbeinstitutedandifappropriate,

naloxoneorrespiratorystimulantsmaybeused.However,doselevelsmanytimes

higherthanthoseindicatedabovehavebeenusedwithoutserioussideeffects.

Naloxonemaybeofbenefitinreversingreducedrespiratoryrateandrespiratory

stimulantssuchasDoxapramarealsoeffectiveinman.Becauseoftheprolonged

durationofeffectofbuprenorphineincomparisontosuchdrugs,theymayneedtobe

administeredrepeatedlyorbycontinuousinfusion.

Volunteerstudiesinmanhaveindicatedthatopiateantagonistsmaynotfullyreversethe

effectsofbuprenorphine.

Pleasealsorefertosections4.5and4.6ofthisSPC.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Opioidanalgesics,oripavinederivatives

ATCvetcode:QN02AE01

5.1Pharmacodynamicproperties

Insummarybuprenorphineisapotent,long-actinganalgesicactingatopiatereceptors

inthecentralnervoussystem.

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Buprenorphineexertsitsanalgesiceffectviahighaffinitybindingtovarioussubclasses

ofopiatereceptors,particularlyµ,inthecentralnervoussystem.Atclinicaldoselevels

foranalgesia,buprenorphinedemonstrateshighefficacyandbindstoopiatereceptors

withhighaffinity,suchthatitsdissociationfromthereceptorsiteisslow,as

demonstratedininvitrostudies.Thispropertyofbuprenorphinecouldaccountforits

longerdurationofactivitywhencomparedtomorphine.Incircumstanceswhere

excessiveopiateagonistisalreadyboundtoopiatereceptors,buprenorphinecanexert

anarcoticantagonisticactivityasaconsequenceofitshigh-affinityopiatereceptor

binding,suchthatanantagonisticeffectonmorphineequivalenttonaloxonehasbeen

demonstrated.

5.2Pharmacokineticparticulars

Buprenorphineisrapidlyabsorbedafterintramuscularinjectioninvariousanimal

speciesandman.Thesubstanceishighlylipophilicandthevolumeofdistributionin

bodycompartmentsislarge.Inthecat,pharmacologicaleffectsoccurwithin30minutes

afterinjectionandpeakeffectsareusuallyobservedatabout1 –1.5hours.Following

intramuscularadministrationtocats,themeanterminalhalf-lifewas6.3hoursandthe

clearancewas23ml/kg/min,however,therewasconsiderableinter-catvariabilityin

pharmacokineticparameters.

Norelevantpharmacokineticdataareavailableinthedog.

Combinedpharmacokineticandpharmacodynamicstudiesincatshavedemonstrated

amarkeddelaybetweenplasmaconcentrationsandanalgesiceffect.Plasma

concentrationsofbuprenorphineshouldnotbeusedtoformulateindividualanimal

dosageregimens,whichshouldbedeterminedbymonitoringofthepatient’sresponse.

Themajorrouteofexcretioninallspeciesexcepttherabbit(whereurinaryexcretion

predominates)isthefaeces.BuprenorphineundergoesN-dealkylationandglucuronide

conjugationbytheintestinalwallandtheliveranditsmetabolitesareexcretedviathe

bileintothegastro-intestinaltract.

Intissuedistributionstudiescarriedoutinratsandrhesusmonkeys,thehighest

concentrationsofdrug-relatedmaterialwereobservedinliver,lungandbrain.Peak

levelsoccurredrapidlyanddeclinedtolowlevelsby24hoursafterdosing.

Proteinbindingstudiesinratshaveshownthatbuprenorphineishighlyboundtoplasma

proteins,principallytoalphaandbetaglobulins.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glucose,anhydrous

Hydrochloricacid

Waterforinjection

6.2Incompatibilities

Noneknown.

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6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Theproductdoesnotcontainanantimicrobialpreservative.Useimmediatelyafteropening

theampoule.Anysolutionremaininginanampoulefollowingwithdrawaloftherequired

doseshouldbediscarded.

6.4Specialprecautionsforstorage

Donotstoreabove25

C.

Protectfromlight.

Donotrefrigerateorfreeze.

6.5Natureandcompositionofimmediatepackaging

Presentedin1mlclearTypeIglass,snapampoules,inboxesoffive.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements

7. MARKETINGAUTHORISATIONHOLDER

AnimalcareLimited,

CommonRoad,

Dunnington,

York,YO195RU

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm10347/4024

9. DATEOFFIRSTAUTHORISATION

28May2008

10.DATEOFREVISIONOFTHETEXT

June2013

Approved: 03/06/2013

28-11-2018

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