Detogesic 10mg/ ml Solution for Injection for Horses

Main information

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

Documents

Localization

  • Available in:
  • Detogesic 10mg/ml Solution for Injection for Horses
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Detomidine
  • Therapeutic area:
  • Horses

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0226/001
  • Authorization date:
  • 16-02-2012
  • EU code:
  • UK/V/0226/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:August2013

AN:00202/2012

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DETOGESIC10mg/mlSolutionforInjectionfor

Horses BE,BG,CY,CZ,DE,

EL,ES,FR,IE,IT,LU,

NL,PL,PT,RO,SI,

SK,UK

EQUISEDANvet10mg/mlSolutionforInjectionfor

Horses FI,NO,SE

EQUISEDAN10mg/mlSolutionforInjectionfor

Horses DK,LT.LV

EQUIDOR10mg/mlSolutionforInjectionforHorses AT,HU

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Detomidinehydrochloride10mg/ml(Detomidine8.36mg/ml)

Excipient(s):

Preservative

Methylparahydroxybenzoate(E218) 1mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

SolutionforInjection.

Clear,almostcolourlesssolutionforintravenousinjection.

4. CLINICALPARTICULARS

4.1Targetspecies

Horse

4.2Indicationsforuse,specifyingthetargetspecies

Forthesedationandslightanalgesiaofhorses,tofacilitatephysical

examinationsandtreatments,suchasminorsurgicalinterventions.

Theproductcanbeusedfor:

Medicalexaminations (e.g.endoscopic,rectalandgynaecological

examinations,X-rays).

Minorsurgicalprocedures(e.g.treatmentofwounds,dentaltreatment,

tendontreatment,excisionofskintumours,teattreatment).

Beforetreatmentandmedication(e.g.stomachtube,horseshoeing).

Forpre-medicationpriortoadministrationofinjectionorinhalationanaesthetics.

Seesection4.5beforeuse.

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4.3Contraindications

Donotuseinanimalswithcardiacabnormalitiesorrespiratorydisease.

Donotuseinanimalswithliverinsufficiencyorrenalfailure.

Donotuseinanimalswithgeneralhealthproblems(e.g.dehydratedanimals).

Donotuseinthelast3monthsofpregnancy.

Donotuseincombinationwithbutorphanolinhorsessufferingfromcolic.

Donotuseincombinationwithbutorphanolinpregnantmares.

SeealsoSections4.7and4.8.

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Assedationbegins,horsesmaystarttoswayandlowertheheadrapidlywhile

theyremainstanding.Topreventinjuriesinhorseandpeoplewhiletreating

horses,thelocationfortreatmentshouldbechosencarefully.Usual

precautionarymeasuresshouldbetakentopreventself-injury.

Animalssufferingfromshockorliverorkidneydiseaseshouldonlybetreated

accordingtothebenefit/riskassessmentbytheresponsibleveterinarysurgeon.

Theproductshouldnotbeusedinanimalssufferingfromcardiacdiseases

(withpre-existingbradycardiaandriskofatrioventricularblock),respiratory,

liverorrenalinsufficienciesoranyotherextraordinarystressconditions.

Itisrecommendedthatfeedshouldbewithheldforatleast12hourspriorto

anaesthesia.

Waterorfoodshouldnotbeofferedtotreatedanimalsuntilthedrugeffecthas

passed.

Inpainfulproceduresdetomidineshouldbeusedonlyincombinationwithan

analgesicoralocalanaesthetic.

Whilewaitingfortheonsetofsedation,animalsshouldremainincalm

surroundings.

Detomidine/butorphanolcombinationsshouldnotbeusedinhorseswitha

historyofliverdiseaseorcardiacirregularities.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductshouldbeadministeredwithcaution,andcaretakentoavoid

accidentalself-injection.

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Inthecaseofaccidentaloralintakeorself-injectionseekmedicaladvice

immediatelyandshowthepackageleaflettothedoctorbutDONOT

DRIVEassedationandchangesinbloodpressuremayoccur.

Avoidskin,eyeormucosalcontact.

Washtheexposedskinimmediatelyafterexposurewithlargeamountsof

freshwater.

Removecontaminatedclothesthatareindirectcontactwithskin.

Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantly

withfreshwater.Ifsymptomsoccur,seektheadviceofadoctor.

Ifpregnantwomenhandletheproduct,specialcautionshouldbeobserved

nottoself-injectasuterinecontractionsanddecreasedfoetalblood

pressuremayoccurafteraccidentalsystemicexposure.

Advicetodoctors:

Detomidineisanalpha-2-adrenoreceptoragonist.Symptoms afterabsorption

mayinvolveclinicaleffectsincludingdose-dependentsedation,respiratory

depression,bradycardia,hypotension,adrymouth,andhyperglycaemia.

Ventriculararrhythmiashavealsobeenreported.Respiratoryand

haemodynamicsymptomsshouldbetreatedsymptomatically.

4.6Adversereactions(frequencyandseriousness)

Injectionofdetomidinemaycausethefollowingsideeffects:

- Bradycardia.

- Transienthypo-orhypertension.

- Respiratorydepression,rarelyhyperventilation.

- Increaseinbloodglucose.

- Aswithothersedatives,inrarecasesparadoxicalreactions(excitations)

candevelop.

- Ataxia.

-Cardiacarrhythmia,atrioventricularandsino-atrialblock.

-Uterinecontractions.

Atdosesabove40mcg/kgbodyweight,thefollowingsymptomscanalsobe

observed:sweating,pilo-erectionandtremorofmuscles,transientpenis

prolapseinstallionsandgeldings.

Inveryrarecaseshorsesmayshowmildsymptomsofcolicfollowing

administrationofalpha-2sympathomimeticsbecausesubstancesofthisclass

transientlyinhibitthemotilityoftheintestines.Theproductshouldbe

prescribedwithcautioninhorseswhichpresentwithsignsofcolicor

impaction.

Adiureticeffectisusuallyobservedwithin45to60minutesaftertreatment.

4.7Useduringpregnancy,lactationorlay

Donotusetheproductinmaresinthelast3monthsofpregnancy.During

theremainingmonthsuseonlyaccordingtoarisk/benefitanalysisbythe

responsibleveterinarysurgeon.

Useduringlactationshouldalsobethesubjectofrisk/benefitanalysisbythe

responsibleveterinarysurgeon.

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Donotuseincombinationwithbutorphanolinpregnantmares.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofothersedativesshouldproceedonlyafterconsultationof

thewarningsandprecautionsfortheproduct(s)concerned.

Detomidineshouldnotbeusedincombinationwithsympathomimeticamines

suchasadrenaline,dobutamineandephedrine,exceptasrequiredin

anaestheticemergencies.

Theconcurrentuseofcertainpotentiatedsulphonamidesmaycausecardiac

arrhythmiawithfataloutcome.Donotuseincombinationwith

sulphonamides.

Detomidineincombinationwithothersedativesandanaestheticsshouldbe

usedcarefullybecauseadditive/synergisticeffectsmaybepossible.Where

anaesthesiaisinducedwithacombinationofdetomidineandketamine,prior

tomaintenancewithhalothane,theeffectsofhalothanemaybedelayedand

caremustbetakentoavoidoverdosage.Whendetomidineisusedasapre-

medicantpriortogeneralanaesthesia,itmaydelaytheonsetofinduction.

4.9 Amountstobeadministeredandadministrationroute

Administrationroute

Forintravenous(IV)useonly.Theproductshouldbeinjectedslowly.Onset

ofeffectismorerapidfollowingintravenoususe.

Amount(s)tobeadministered

Usealoneforsedation:dosagetable

Dosage

inmcg/kg Dosage

inml/100kg Levelof

sedation Commencement

ofeffect(min) Durationof

effect

(hrs)

10-20 0.1-0.2 Light 3-5 0.5-1

20-40 0.2-0.4 Moderate 3-5 0.5-1

Whenprolongedsedationandanalgesiaisrequired,dosesof40to80mcg/kg

canbeused.Thedurationofeffectisupto3hours.Itisrecommendedto

wait15minutesafterdetomidineadministrationbeforestartingtheplanned

procedure.

Forcombinationwithotherproductstointensifysedationorforpremedication

priortogeneralanaesthesia,dosesof10to30mcg/kgcanbeused.Priorto

useincombinationwithotherproductssuchasbutorphanolorketamine,

consulttheappropriateproductdetailsfordoseratesAllow5minutesafterthe

administrationofdetomidineforthehorsetobecomedeeplysedatedbefore

anysubsequenttreatment.

Thebodyweightoftheanimaltobetreatedshouldbedeterminedas

accuratelyaspossibletoavoidoverdosing.

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Intheeventofanaccidentaloverdose,cardiacarrhythmias,hypotension,

delayedrecoveryandprofoundCNSandrespiratorydepressionmayoccur.

Shouldtheeffectsofdetomidinebecomelife-threatening,administrationofan

alpha-2-adrenergicantagonistisrecommended

4.11Withdrawalperiod(s)

Meatandoffal:2days

Milk:12hours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Sedativeandanalgesic

ATCvetcode: QN05CM90

5.1 Pharmacodynamicproperties

Theactiveingredientoftheproductis4-(2,3-dimethylbenzyl)-imidazole-

hydrochloride(INN:detomidine).Detomidineleadstosedationoftreated

animalsandrelievespain,withdurationandintensityofeffectbeingdose

related.Detomidineactsasanagonistatalpha-2adrenoceptors,and

observedanalgesiceffectsareduetoinhibitionoftransmissionofthepain

impulsewithintheCNS.

Detomidineactsonperipheralalpha-adrenoceptors,thereforeanincreasein

bloodglucoselevelandathigherdosagespiloerection,sweatinganddiuresis

mayoccur.Aninitialincreaseinmeanbloodpressureisobserved,which

returnstonormalorslightlybelowandheartratedecreases.TheECGshows

anenlargedPR-interval,andmildatrio-ventricularblocksmaybeobserved.

Thesechangesaretransient.Respiratoryresponseincludesaninitial

decreaseinrespirationrate,increasingtonormalorslightlyhighervalues

withinafewminutes.

5.2 Pharmacokineticparticulars

Detomidineisabsorbedrapidlyafterintramuscularinjection,withaT

of15-

30minutes.Bioavailabilityafterintramuscularadministrationis66-85%.

Afterrapiddistributionofdetomidineintothetissues,withahalf-lifeof0.15

hourspostintravenousinjection,detomidineisalmostcompletely

metabolized,mainlyintheliver-t

is1to2hours.Thevolumeofdistribution

rangesfrom0.75to1.89l/kg,andproteinbindingis75-85%.Theelimination

half-lifeinthehorsewas1.19hours,withlessthan1%parentcompound

presentinurine.Metabolitesaremainlyexcretedviaurineandfaeces.

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6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylparahydroxybenzoate(E218)

Sodiumchloride

Sodiumhydroxide(forpHadjustment)

WaterforInjections

6.2Incompatibilities

Thisveterinarymedicinalproductmustnotbemixedwithotherveterinary

medicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinal

productaspackagedforsale:

3years

Shelf-lifeafterfirstopeningimmediatepackaging: 28days.

6.4. Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalcartoninordertoprotectfromlight.

Storeinadryplace.

6.5Natureandcompositionofimmediatepackaging

Multi-dose,clear,Type1glassvial,withpierceablebromobutylrubberstopper

andanaluminiumcollar,containing10ml.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

VetcareLimited

Peltotuentie5

25130Muurla

Finland

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8. MARKETINGAUTHORISATIONNUMBER

Vm03379/4000

9. DATEOFFIRSTAUTHORISATION

Date:07April2008

10. DATEOFREVISIONOFTHETEXT

Date:August2013

Approved:21/08/2013