Torbuphanol 10mg/ml solution for injection for horses, dogs and cats

Main information

  • Trade name:
  • Torbuphanol 10mg/ml solution for injection for horses, dogs and cats
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Torbuphanol 10mg/ml solution for injection for horses, dogs and cats
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • butorphanol
  • Therapeutic area:
  • Cats Non Food, Dogs Non Food, Horses Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • IE/V/0289/001
  • Authorization date:
  • 24-10-2012
  • EU code:
  • IE/V/0289/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1NAMEOFTHEVETERINARYMEDICINALPRODUCT

TorbuphanolVet10mg/mlSolutionforinjectionforhorses,dogsandcats.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Butorphanol 10mg

(asbutorphanoltartrate14.58mg/ml)

Excipients:

Benzethoniumchloride 0.1mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection.

Clear,colourlesssolution.

4CLINICALPARTICULARS

4.1TargetSpecies

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4.2Indicationsforuse,specifyingthetargetspecies

HORSE

Asananalgesic

Forreliefofpainassociatedwithcolicofgastrointestinaltractorigin.

Asasedative

Forsedationwhengivenaftertheadministrationofcertainalpha2-adrenoreceptoragonists(detomidine,

romifidine).

Fortherapeuticanddiagnosticproceduressuchasminorstandingsurgery.

DOG

Asananalgesic

Forreliefofmildtomoderatevisceralpainandpainassociatedwithpost-surgicalprocedures.

Asasedative

Incombinationwithmedetomidinehydrochloride.

Asapre-anaesthetic

Pre-anaestheticuseoftheproducthasresultedinadoserelatedreductioninthedoseofinductionanaestheticagents,

suchasthiopentonesodium.

Aspartofananaestheticregimenincombinationwithmedetomidineandketamine.

CAT

Asananalgesic

Forreliefofmildtomoderatevisceralpain.Forpre-operativeusetoprovideanalgesiaduringsurgery.Forpost-

operativeanalgesiaafteravarietyofsurgicalprocedures.

Asasedative

Incombinationwithmedetomidinehydrochloride.

Aspartofanaestheticregimenincombinationwithmedetomidineandketamine.

4.3Contraindications

Donotuseincaseofknownhypersensitivitytotheactivesubstanceortoanyoftheexcipients.Donotusefor

treatmentofanimalswithseveredysfunctionoftheliverorkidneys.

Useofbutorphanoliscontraindicatedincaseofcerebralinjuryororganicbrainlesionsandinanimalswith

obstructiverespiratorydiseases,heartdysfunctionorspasticconditions.

HORSE

Butorphanol/detomidinecombination

Thecombinationshouldnotbeusedinhorseswithapre-existingcardiacdysrhythmiaorbradycardia.

Thecombinationwillcauseareductioningastrointestinalmotilityandconsequentlyshouldnotbeusedincasesof

colicassociatedwithimpaction.

Duetoapossibledepressiveeffectontherespiratorysystem,theproductiscontraindicatedforuseinhorseswith

emphysema.

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4.4Specialwarningsforeachtargetspecies

Butorphanolisintendedforusewhereshortdurationanalgesiaisrequired.Forinformationonthedurationofanalgesia

thatcanbeexpectedfollowingtreatmentseesection5.1.However,repeattreatmentsofbutorphanolmaybe

administered.Forcaseswherelongerdurationanalgesiaislikelytoberequired,analternativetherapeuticagentshould

beused.

Inthecat,butorphanolisintendedforusewhereshorttomediumdurationanalgesiaisrequired.Forinformationonthe

durationofanalgesiathatcanbeexpectedfollowingtreatmentseesection5.1.Dependingontheclinicalresponse,

productadministrationmayberepeatedwithinsixhours.Intheabsenceofanadequateanalgesicresponse,useofan

alternativeanalgesicagent,suchasanothersuitableopioidanalgesicand/oranon-steroidalanti-inflammatorydrug,

shouldbeconsidered.Increasingofthedosemaynotincreasetheintensityordurationofanalgesia.Anyalternative

analgesiashouldtakeaccountoftheactionofbutorphanolonopioidreceptors,asdescribedinSection4.8.

Markedsedationdoesnotoccurwhentheproductisusedasasoleagentincats.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

FORALLTARGETSPECIES

Butorphanolisamorphinanderivativeandthereforepossessesopioidactivity.

Thesafetyoftheproductinpuppies,kittenandfoalshasnotbeenestablished.Useoftheproductinthesegroupsshouldbe

onthebasisofarisk-benefitanalysisbytheresponsibleveterinarian.

Duetoitsantitussiveproperties,butorphanolmayleadtoanaccumulationofmucousintherespiratorytract.Therefore,

inanimalswithrespiratorydiseasesassociatedwithincreasedmucousproduction,butorphanolshouldonlybeused

afterarisk-benefitevaluationbytheresponsibleveterinarian.

Routinecardiacauscultationshouldbeperformedpriortouseincombinationwith 2-adrenoceptoragonists.The

combinationofbutorphanoland2-adrenoceptoragonistsshouldbeusedwithcautioninanimalswithcardiovascular

disease.Theconcurrentuseofanticholinergicdrugs,e.g.atropineshouldbeconsidered.

HORSE

Theuseoftheproductattherecommendeddosemayleadtotransientataxiaand/orexcitement.Therefore,toprevent

injuries,inthepatientandpeoplewhentreatinghorses,thelocationforthetreatmentshouldbechosencarefully.

CAT

Catsshouldbeweighedtoensurethatthecorrectdoseiscalculated.Useofeitherinsulinsyringesor1mlgraduated

syringesisrecommended.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Careshouldbetakentoavoidaccidentalinjection/self-injection.Ifaccidentalself-injectionoccurs,seekmedicaladvice

immediatelyandshowthepackageleafletorthelabeltothephysician.DONOTDRIVE.Effectscanbereversedwith

anopioidantagonistsuchasnaloxone.

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4.6Adversereactions(frequencyandseriousness)

Theremaybesomepainonintramuscularinjection.

HORSE

Themostcommonlyobservedsideeffectismildataxiawhichmaypersistfor3to10minutes.

Mildtosevereataxiamaybeencounteredincombinationwithdetomidine,butclinicalstudieshaveshownthat

horsesareunlikelytocollapse.Normalprecautionsshouldbeobservedtopreventself-injury.

Mildsedationmayoccurinapproximately15%ofhorsesfollowingtheadministrationoftheveterinarymedicinal

productasasoleagent.

Butorphanolmayalsohaveadverseeffectsongastrointestinaltractmotilityinhorses,althoughthereisno

decreaseingastrointestinaltransittime.Theseeffectsaredose-relatedandgenerallyminorandtransient.

Butorphanolmaycauseexcitatorylocomotoreffects(pacing).

Whenusedincombinationwith2-adrenoceptoragonists,cardiopulmonarysystemdepressionmayoccur,that

maybefatalinrarecases.

DOG

Respiratoryandcardiacdepression(asevidencedbyadecreaseinrespiratoryrate,developmentofbradycardia

andadecreaseindiastolicpressure)mayoccur.Thedegreeofdepressionisdosedependent.

Mildsedationmayoccur.

Transientataxia,anorexia,anddiarrhoeahavebeenreportedasoccurringrarely.

Reductioningastrointestinalmotilitymayoccur.

CAT

Respiratorydepressionmayoccur.

Butorphanolmaycauseexcitation,anxiety,disorientation,dysphoriaandmydriasis.

4.7Useduringpregnancy,lactationorlay

Thesafetyofthisveterinarymedicinalproducthasnotbeenestablishedinthetargetspeciesduringpregnancyand

lactation.Theuseofbutorphanolduringpregnancyandlactationisnotrecommended.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Butorphanolmaybeusedincombinationwithothersedativessuchas2-adrenoceptoragonists(e.g.romifidineor

detomidineinhorses,medetomidineindogsandcats)wheresynergisticeffectscanbeexpected.Therefore,an

appropriatereductionindoseisnecessarywhenusedconcomitantlywithsuchagents(seesection4.9).

Becauseoftheantitussivepropertiesofbutorphanol,itshouldnotbeusedincombinationwithanexpectorant,as

thismayleadtoanaccumulationofmucousintheairways.

Becauseofitsantagonistpropertiesattheopiatemu(µ)receptor,butorphanolmayremovetheanalgesiceffectin

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4.9Amountstobeadministeredandadministrationroute

Horse:Intravenoususe(IV).

DogandCat:Intravenous(IV),subcutaneous(SC)andintramuscular(IM)use.

Whenadministeringasanintravenousinjection,donoinjectasabolus.

IfrepeatSCorIMadministrationsarerequired,usedifferentinjectionsites.

Rapidintravenousinjectionshouldbeavoided.

Numberofbroachingsshouldbelimitedto 40.

Forinformationonthedurationofanalgesiathatcanbeexpectedfollowingtreatment,seesection5.1.

HORSE

Asananalgesic

Monotherapy:

0.1mg/kg(1ml/100kgbw)IV.Thedosemayberepeatedasrequired.Analgesiceffectsareseenwithin15

minutesofinjection.

Asasedative

Withdetomidine:

Detomidinehydrochloride:0.012mg/kgIV,followedwithin5minutesby

Butorphanol:0.025mg/kgIV.

Withromifidine:

Romifidine:0.04-0.12mg/kgIV,followedwithin5minutesby

Butorphanol:0.02mg/kgIV.

DOG

Asananalgesic

Monotherapy:

0.2-0.3mg/kg(0.02-0.03ml/kgbw)IV,IMorSCinjection.

Administer15minutesbeforeterminatinganaesthesiatoprovideanalgesiaintherecoveryphase.Repeatdoseas

required.

Asasedative

Withmedetomidine:

Butorphanol:0.1mg/kg(0.01ml/kgbw)IVorIM

Medetomidine:0.01-0.025mg/kgIVorIM.

Allow20minutesforsedationtodevelopbeforecommencingtheprocedure.

Asapremedicant/pre-anaesthetic

Forsedationandasapremedicanttobarbiturateanaesthesia.

Butorphanol:0.1mg/kg(0.01ml/kgbw)IVorIM

Medetomidine:0.01mg/kgIVorIM

Asapre-anaesthetic

Monotherapyforcanineanalgesia.

Butorphanol:0.1-0.2mg/kg(0.01-0.02ml/kgbw)IV,IMorSCgiven15minutespriortoinduction.

Partofanaestheticregimenincombinationwithmedetomidineandketamine:

Butorphanol:0.1mg/kg(0.01ml/kgbw)IM

Medetomidine:0.025mg/kgIM,followedafter15minutesby

Ketamine:5mg/kgIM.

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CAT

Asananalgesic

Pre-operative:

Butorphanol:0.4mg/kg(0.04ml/kgbw)IMorSC

Administer15-30minutespriortotheadministrationofIVinductionanaestheticagents

Administer5minutesbeforeinductionwithIMinductionanaestheticagentssuchascombinationsofIM

acepromazine/ketamineorxylazine/ketamine.Seealsosection5.1.fordurationofanalgesia.

Post-operative:

Administer15minutesbeforerecovery:

eitherButorphanol: 0.4mg/kg(0.04ml/kgbw)SCorIM

0.1mg/kg(0.01ml/kgbw)IV

Asasedative

Withmedetomidine:

Butorphanol:0.4mg/kg(0.04ml/kgbw)IMorSC.

Medetomidine:0.05mg/kgSC.

Additionallocalanaesthesiashouldbeusedforwoundsuturing.

Aspartoftheanaestheticregimen

Incombinationwithmedetomidineandketamine:

IMadministration:

Butorphanol:0.4mg/kg(0.04ml/kgbw)IM

Medetomidine:0.08mg/kgIM

Ketamine:5mg/kgIM.

IVadministration:

Butorphanol:0.1mg/kg(0.01ml/kgbw)IV

Medetomidine:0.04mg/kgIV

Ketamine:1.25-2.50mg/kgIV(dependingondepthofanaesthesiarequired).

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Themostimportantresultofoverdosageisrespiratorydepression.Thiscanbereversedwithanopioidantagonist(e.g.

naloxone).

Otherpossiblesignsofoverdoseinthehorseincluderestlessness/excitability,muscletremor,ataxia,hypersalivation,

decreaseofgastrointestinalmotilityandseizure.Inthecat,themainsignsofoverdoseareincoordination,salivation,

andmildconvulsions.

4.11WithdrawalPeriod(s)

Horse:Meatandoffal:zerodays.

Milk:zerodays.

5PHARMACOLOGICALorIMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Analgesics,morphinanderivatives.

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5.1Pharmacodynamicproperties

Butorphanoltartrate(R(-)enantiomer)isacentrallyactinganalgesic.Itsactionisagonist-antagonistattheopiate

receptorsinthecentralnervoussystem;agonistatthekappa()opioidreceptorsubtypeandantagonistatthemu(µ)

receptorsubtype.Thekappa()receptorscontrolanalgesia,sedationwithoutdepressionofcardiopulmonarysystem

andbodytemperature,whereasthemu(µ)receptorscontrolsupraspinalanalgesia,sedationanddepressionof

cardiopulmonarysystemandbodytemperature.Theagonistcomponentofbutorphanolactivityistentimesmorepotent

thantheantagonistcomponent.

Onsetanddurationofanalgesia:

Analgesiagenerallyoccurswithin15minutesfollowingadministrationinhorse,dogandcat.Afterasingleintravenous

doseinthehorse,analgesiausuallylastsfor15–60minutes.Inthedog,itlastsfor15-30minutesafterasingle

intravenousadministration.Incatswithvisceralpain,analgesiceffectfor15minutesupto6hoursafterbutorphanol

administrationhasbeendemonstrated.Incatswithsomaticpain,thedurationofanalgesiahasbeenconsiderably

shorter.

5.2Pharmacokineticproperties

Inthehorse,butorphanolhasahighclearance(onaverage1.3L/h.kg)afterintravenousadministration.Ithasashort

terminalhalf-life(mean<1hour),indicatingthat97%ofadosewillbeeliminatedafterintravenousadministrationin,

onaverage,lessthan5hours.

Inthedog,butorphanoladministeredbytheintramuscularroutehasahighclearance(around3.5L/h.kg).Ithasashort

terminalhalf-life(mean<2hours),indicatingthat97%ofadosewillbeeliminatedafterintramuscularadministration

in,onaverage,lessthan10hours.Repeateddosepharmacokineticsandthepharmacokineticsfollowingintravenous

administrationhavenotbeenstudied.

Inthecat,butorphanoladministeredbythesubcutaneousroutehasalowclearance(<1320mL/kg.h).Ithasarelatively

longterminalhalflife(around6hours)indicatingthat97%ofthedosewillbeeliminatedinapproximately30hours.

Repeateddosepharmacokineticshavenotbeenstudied.

Butorphanolismetabolisedextensivelyintheliverandexcretedintheurine.Thevolumeofdistributionislarge,

suggestingwidedistributionintotissue.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzethoniumchloride

Citricacid(monohydrate)

Sodiumcitrate

Sodiumchloride

Waterforinjection

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithotherveterinary

medicinalproducts.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4Specialprecautionsforstorage

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6.5Natureandcompositionofimmediatepackaging

Cardboardboxwith1amberglasstypeIvialof10or50mlwithachlorobutylstopperandaluminiumoverseal.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwastematerials

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproductsshouldbe

disposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

PfizerHealthcareIreland

Tradingas:PfizerAnimalHealth

Ringaskiddy

Co.Cork

Ireland

8MARKETINGAUTHORISATIONNUMBER(S)

VPA:10019/194/001

9DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

November2012

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