Bupredale

Main information

  • Trade name:
  • Bupredale
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bupredale
    Ireland
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0270/001
  • Authorization date:
  • 10-01-2008
  • EU code:
  • UK/V/0270/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:March2011

Amendedpages

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFVETERINARYMEDICINALPRODUCT

Buprenodale0.3mg/mlsolutionforinjectionfordogsandcats.(AT,BE,BU,CZ,DE,

FR,HU,IE,LU,NL,PL,SK,UK)

BuprenodaleVet0.3mg/mlsolutionforinjectionfordogsandcats.(DK,FI,IS,SE)

Budale0.3mg/mlsolutionforinjectionfordogsandcats.(ES,IT,PT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlampoulecontains:

ActiveSubstance(s)

Buprenorphine0.3mgasbuprenorphinehydrochloride.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,colourlesssolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsandcats

4.2 Indicationsforuse,specifyingthetargetspecies

Post-operativeanalgesiainthecatanddog.

Potentiationofthesedativeeffectsofcentrallyactingagentsinthedog.

4.3 Contra-indications

Theproductshouldnotbeusedpre-operativelyforcaesariansection(seesection

4.7).

4.4 Specialwarningsforeachtargetspecies

None

4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Revised:March2011

Amendedpages

Buprenorphinemayoccasionallycauserespiratorydepressionandaswithother

opioiddrugs,careshouldbetakenwhentreatinganimalswithimpairedrespiratory

functionoranimalsthatarereceivingdrugsthatcancauserespiratorydepression.

Asbuprenorphineismetabolisedbytheliver,itsintensityanddurationofaction

maybeaffectedinanimalswithimpairedliverfunction.

Incaseofrenal,cardiacorhepaticdysfunction,orshock,theremaybegreaterrisk

associatedwiththeuseoftheproduct.Thebenefit:riskratioforusingtheproduct

shouldbemadebytheattendingvet.Safetyhasnotbeenfullyevaluatedinclinically

compromisedcats.

Thesafetyofbuprenorphinehasnotbeendemonstratedinanimalslessthan7

weeksofage,thereforeuseinsuchanimalsshouldbebasedonthebenefit:risk

assessmentoftheveterinarian.

Repeatedadministrationearlierthantherecommendedrepeatintervalsuggested

inSection4.9isnotrecommended.

Theeffectofanopioidonheadinjuryisdependentonthetypeandseverityofthe

injuryandtherespiratorysupportsupplied.Theproductshouldbeusedin

accordancewiththebenefit:riskassessmentoftheattendingveterinarian.

ii.Specialprecautionstobetakenbythepersonadministeringthemedicinalproduct

toanimals

Asbuprenorphinehasopioid-likeactivity,careshouldbetakentoavoidaccidental

self-injection.

Incaseofaccidentalself-injectionoringestion,seekmedicaladviceimmediately

andshowthepackageleafletorthelabeltothephysician.

Followingeyecontaminationorskincontact,washthoroughlywithcoldrunning

water.Seekmedicaladviceifirritationpersists.

4.6 Adversereactions(frequencyandseriousness)

Salivation,bradycardia,hypothermia,agitation,dehydrationandmiosiscanoccurin

thedog,andrarelyhypertensionandtachycardia.

Mydriasisandsignsofeuphoria(excessivepurring,pacing,rubbing)commonlyoccur

incatsandwillusuallyresolvewithin24hours.

Buprenorphinemayoccasionallycausesignificantrespiratorydepression;referto

section4.5i).

Whenusedtoprovideanalgesia,sedationmayappearasanadversereaction.

4.7 Useduringpregnancy,lactationorlay

Pregnancy:

Laboratorystudiesinratshavenotproducedanyevidenceofateratogeniceffect.

However,thesestudieshaveshownpost-implantationlossesandearlyfoetaldeaths.

Revised:March2011

Amendedpages

Asreproductivestudieshavenotbeenconductedintargetanimals,useonlyaccording

tothebenefit:riskassessmentbytheresponsibleveterinarian.

Theproductshouldnotbeusedpre-operativelyincasesofCaesareansection,dueto

theriskofrespiratorydepressionintheoffspringperiparturiently,andshouldonlybe

usedpost-operativelywithspecialcare(seesectiononlactationbelow).

Lactation:

Studiesinlactatingratshaveshownthat,afterintramuscularadministrationof

buprenorphine,concentrationsofunchangedbuprenorphineinthemilkequalledor

exceededthatintheplasma.Asitislikelythatbuprenorphinewillbeexcretedinthe

milkofotherspecies,useisnotrecommendedduringlactation.Useonlyaccordingly

tobenefit:riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thereisevidenceinhumanstoindicatethattherapeuticdosesofbuprenorphinedo

notreducetheanalgesicefficacyofstandarddosesofanopioidagonist,andthat

whenbuprenorphineisemployedwithinthenormaltherapeuticrange,standarddoses

ofopioidagonistmaybeadministeredbeforetheeffectsoftheformerhaveended

withoutcompromisinganalgesia.However,itisrecommendedthatbuprenorphineis

notusedinconjunctionwithmorphineorotheropioid-typeanalgesics,e.g.etorphine,

fentanyl,pethidine,methadone,papaveretumorbutorphanol.

Buprenorphinehasbeenusedwithacepromazine,alphaxalone/alphadalone,atropine,

halothane,isoflurane,ketamine,medetomidine,propofol,sevoflurane,thiopentoneand

xylazinewithoutanyobservedadverseeffects.

Buprenorphinemaycausesomedrowsiness,whichmaybepotentiatedbyother

centrally-actingagents,includingtranquillisers,sedativesandhypnotics.

4.9 Amountstobeadministeredandadministrationroute

Forintramuscularuse.

Species Post-OperativeAnalgesia Potentiationofsedative

effects

Dog 10 –20microgramperkg(0.3–0.6mlper10kg)

repeatedifnecessaryafter3 –4hourswith10

microgramor5 –6hourswith20microgram

doses. 10 –20microgramperkg(0.3–

0.6mlper10kg).

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

repeatedifnecessary,once,after2hours.

Toensurethatanalgesiaispresentimmediatelyonrecovery,theproductcanbe

administeredpreoperatively(seesection5.2).Pharmacologicaleffectsoccurwithin30

minutesafterinjection.Ifadditionalanalgesiaissubsequentlyrequired,thismaybe

achievedbyadministrationofafurtherdoseofBuprenorphineorconcomitantuseofa

suitableinjectableNSAID.

Revised:March2011

Amendedpages

Anappropriatelygraduatedsyringemustbeusedtoallowaccuratedosing.Thisis

particularlyimportantwheninjectingsmallvolumes.

Whenadministeredpre-operativelyinconjunctionwithotherpremedicants,itmaybe

possibletoreducetheamountofpremedicant,suchasacepromazineor

medetomidine,andalsotheamountofinhalationalanaestheticused.

Animalsadministeredopioidspossessingsedativeandanalgesicpropertiesmay

showvariableresponses.Therefore,theresponsesofindividualanimalsshouldbe

monitoredandsubsequentdosesadjustedaccordingly.Insomecasesrepeatdoses

mayfailtoprovideadditionalanalgesia.Inthesecases,considerationshouldbegiven

tousingasuitableinjectableNSAID.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary.

Whenadministeredatoverdosetodogs,buprenorphinemaycauselethargy.Atvery

highdoses,bradycardiaandmiosismaybeobserved.

Incasesofoverdosage,supportivemeasuresshouldbeinstituted,and,ifappropriate,

naloxoneorrespiratorystimulantsmaybeused. However,doselevelsmanytimes

higherthanthoseindicatedabovehavebeenusedwithoutserioussideeffects.

Naloxonemaybeofbenefitinreversingreducedrespiratoryrateandrespiratory

stimulantssuchasDoxapramarealsoeffectiveinman.Becauseoftheprolonged

durationofeffectofbuprenorphineincomparisontosuchdrugs,theymayneedtobe

administeredrepeatedlyorbycontinuousinfusion.

Volunteerstudiesinmanhaveindicatedthatopiateantagonistsmaynotfullyreverse

theeffectsofbuprenorphine.

PleasealsorefertoSections4.5.i)and4.6ofthisSPC.

4.11Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPARTICULARS

Pharmacotherapeuticgroup:Opioidanalgesics,oripavinederivatives

ATCvetcode:QN02AE01.

5.1 Pharmacodynamicproperties

Insummarybuprenorphineisapotent,long-actinganalgesicactingatopiatereceptors

inthecentralnervoussystem.

Buprenorphineexertsitsanalgesiceffectviahighaffinitybindingtovarioussubclasses

ofopiatereceptors,particularlyµ,inthecentralnervoussystem.Atclinicaldoselevels

foranalgesia,buprenorphinedemonstrateshighefficacyandbindstoopiatereceptors

withhighaffinityandhighreceptoravidity,suchthatitsdissociationfromthereceptor

siteisslow,asdemonstratedininvitrostudies.Thisuniquepropertyofbuprenorphine

Revised:March2011

Amendedpages

couldaccountforitslongerdurationofactivitywhencomparedtomorphine.In

circumstanceswhereexcessiveopiateagonistisalreadyboundtoopiatereceptors,

buprenorphinecanexertanarcoticantagonisticactivityasaconsequenceofitshigh-

affinityopiatereceptorbinding,suchthatanantagonisticeffectonmorphineequivalent

tonaloxonehasbeendemonstrated.

5.2 Pharmacokineticparticulars

Buprenorphineisrapidlyabsorbedafterintramuscularinjectioninvariousanimal

speciesandman.Thesubstanceishighlylipophilicandthevolumeofdistributionin

bodycompartmentsislarge.Inthecat,pharmacologicaleffectsoccurwithin30

minutesafterinjectionandpeakeffectsareusuallyobservedatabout1 –1.5hours.

Followingintramuscularadministrationtocats,themeanterminalhalf-lifewas6.3

hoursandtheclearancewas23ml/kg/min,however,therewasconsiderableinter-cat

variabilityinpharmacokineticparameters.

Norelevantpharmacokineticdataareavailableinthedog.

Combinedpharmacokineticandpharmacodynamicstudiesincatshavedemonstrated

amarkeddelaybetweenplasmaconcentrationsandanalgesiceffect.Plasma

concentrationsofbuprenorphineshouldnotbeusedtoformulateindividualanimal

dosageregimens,whichshouldbedeterminedbymonitoringofthepatient’s

response.

Themajorrouteofexcretioninallspeciesexcepttherabbit(whereurinaryexcretion

predominates)isthefaeces.BuprenorphineundergoesN-dealkylationand

glucuronideconjugationbytheintestinalwallandtheliveranditsmetabolitesare

excretedviathebileintothegastro-intestinaltract.

Intissuedistributionstudiescarriedoutinratsandrhesusmonkeysthehighest

concentrationsofdrug-relatedmaterialwereobservedinliver,lungandbrain.Peak

levelsoccurredrapidlyanddeclinedtolowlevelsby24hoursafterdosing.

Proteinbindingstudiesinratshaveshownthatbuprenorphineishighlyboundto

plasmaproteins,principallytoalphaandbetaglobulins.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Glucoseanhydrous

Sodiumhydroxide(pHadjustment)

Hydrochloricacid(pHadjustment)

Waterforinjection

6.2 Incompatibilities

Noneknown.

6.3 Shelf-life

Revised:March2011

Amendedpages

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years

Theproductdoesnotcontainanantimicrobialpreservative.Anysolutionremainingin

anampoulefollowingwithdrawaloftherequireddoseshouldbediscarded.

6.4 Specialprecautionsforstorage

Donotstoreabove25°C.Keeptheampouleintheoutercartoninordertoprotectfrom

light.

Donotrefrigerateorfreeze.

6.5 Natureandcompositionofimmediatepackaging

Cardboardcartoncontainingfive1ml colourlessTypeIglass‘snap’topampoules.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse,

JamageIndustrialEstate,

TalkePits,

Stoke-on-Trent

ST71XW.

UK.

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm10434/4035

9. DATEOFFIRSTAUTHORISATION

17February2009

10. DATEOFREVISIONOFTHETEXT

March2011