Prectival 268 mg Spot-on Solution for Dogs

Main information

  • Trade name:
  • Prectival 268 mg Spot-on Solution for Dogs
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Prectival 268 mg Spot-on Solution for Dogs
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • fipronil
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0381/004
  • Authorization date:
  • 28-09-2011
  • EU code:
  • UK/V/0381/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:November2011

AN:00586/2010

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Eliminall268mgspot-onsolutionfordogs

Exprolinevet268mgspot-onsolutionfordogs

Eliminall268mgspot-onsolutionfordogs(Austria,France,Germany,Greece,Italy,

Ireland,Luxemburg,Netherlands,UnitedKingdom,Portugal,Spain)

Exprolinevet268mgspot-onsolutionfordogs(Norway,Denmark,Finland,Sweden)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1pipette(2.68ml)contains:

Activesubstance:

Fipronil 268mg

Excipients:

Butylhydroxyanisole(E320) 0.54mg

Butylhydroxytoluene(E321) 0.27mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Lightyellowtoyellow,clearliquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofflea(Ctenocephalidesspp.)andtick(Dermacentorreticulatus)

infestations.

FortreatmentofTrichodectescanisbitingliceinfestationsondogs.Mostliceare

killedwithin2days.

Insecticidalefficacyagainstnewinfestationswithadultfleaspersistsforupto8

weeks.

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Theproducthasapersistentacaricidalefficacyforupto3weeksagainstIxodes

ricinusandupto4weeksagainstRhipicephalussanguineusandDermacentor

reticulatus.Ifticksofsomespecies(Ixodesricinus,Rhipicephalussanguineus)are

presentwhentheproductisapplied,alltheticksmaynotbekilledwithinthefirst48

hours.

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergy

Dermatitis(FAD)wherethishasbeenpreviouslydiagnosedbyaveterinarysurgeon.

4.3 Contraindications

Donotuseonpuppieslessthan2monthsoldand/orweighinglessthan2kginthe

absenceofavailabledata.

Donotuseonsick (e.g.systemicdiseases,fever)orconvalescentanimals.

Donotuseinrabbits,asadversereactionsandevendeathcouldoccur.

Thisproductisspecificallydevelopedfordogs.Donotuseincats,asthiscouldlead

tooverdosing.

Donotuseincasesofhypersensitivitytotheactivesubstance,dimethylsulphoxide

ortoanyofotherexcipients.

4.4 Specialwarningsforeachtargetspecies

Bathing/immersioninwaterwithintwodaysafterapplicationoftheproductshouldbe

avoided.Afterweeklyimmersionsinwaterforoneminutetheperiodofpersistent

insecticidalefficacyagainstfleaswas7weeks.

Theproductdoesnotpreventticksfromattachingtotheanimals.Iftheanimalhas

beentreatedpriortoexposuretotheticks,thetickswillbekilledinthefirst24-48

hoursafterattachment.Thiswillusuallybepriortoengorgement,minimisingbutnot

excludingtheriskoftransmissionofdiseases.Oncedead,tickswilloftendropoffthe

animal,butanyremainingticksmayberemovedwithagentlepull.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareas

suchascarpetsandsoftfurnishingswhichshouldbetreated,incaseofmassive

infestationandatthebeginningofthecontrolmeasures,withasuitableinsecticide

andvacuumedregularly.

WhenusedaspartofastrategyforthetreatmentoffleaAllergyDermatitis,monthly

applicationstotheallergicpatientandtootherdogsinthehouseholdare

recommended.

Foroptimalcontroloffleainfestationinmulti-pethousehold,alldogsandcatsinthe

householdshouldbetreatedwithasuitableinsecticide.

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4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Animalsshouldbeweighedaccuratelypriortotreatment.

Avoidcontactwiththeanimal'seyes.Inthecaseofaccidentaleyecontact,

immediatelyandthoroughlyflushtheeyeswithwater.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoffandtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Donotapplytheproductonwoundsordamagedskin.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contact

betweentheproductandthemouthoreyesshouldbeavoided.

Inthecaseofaccidentaleyecontactimmediatelyandthoroughlyflushtheeyeswith

water.Ifeyeirritationpersistsseekmedicaladviceandshowthepackageleafletor

thelabeltothephysician.

Donotsmoke,drinkoreatduringapplication.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,washoff

immediatelywithsoapandwater.

Washhandsafteruse.

Peoplewithaknownhypersensitivitytofipronilordimethylsulphoxideorother

excipientsshouldavoidcontactwiththeveterinarymedicinalproduct.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildren

shouldnotbeallowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itis

thereforerecommendedthatanimalsarenottreatedduringtheday,butshouldbe

treatedduringtheearlyevening,andthatrecentlytreatedanimalsshouldnotbe

allowedtosleepwithowners,especiallychildren.

iii)Otherprecautions

Fipronilmayadverselyaffectaquaticorganisms.Dogsshouldnotbeallowedtoswim

inwatercoursesfor2daysafterapplication.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobserved.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionsontheapplicationsite(skindiscoloration,localalopecia,pruritus,

erythema)andgeneralpruritusoralopeciahavebeenreportedafteruse.

Exceptionally,hypersalivation,reversibleneurologicsymptoms(hyperesthesia,

depression,nervoussymptoms),vomitingorrespiratorysymptomshavebeen

observedafteruse.

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4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicor

embryotoxiceffect.Studieshavenotbeencarriedoutwiththisproductinpregnant

andlactatingbitches.Useinpregnancyandlactationonlyinaccordancewith

professionalveterinaryadviceandabenefit/riskassessment.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Routeofadministrationanddosage:

Externaluseonly.

Administerbytopicalapplicationtotheskinaccordingtothebodyweightasfollows:

1pipetteof2.68mlperdogweighingover20kgandupto40kgbodyweight.

Methodofadministration:

Removethepipettefromthetriplexbag.Holdthepipetteinanuprightposition,twist

andpullthecapoff.Turnthecaparoundandplacetheotherendofthecapbackon

thepipette.Pushandtwistthecaptobreaktheseal,thenremovethecapfromthe

pipette.Spreadtheanimalhairsintheareabetweentheshoulderbladestomakethe

skinvisible.Putthetipofthepipetteontotheskinandpresstheunit-dosepipette

severaltimestoemptyitscontentsdirectlyontotheskinatoneortwospots.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoff,andtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Thehairshouldbepartedandtheproductappliedtotheskin.Temporarychangesto

thecoat(clumped/greasyhairand/ordepositsonthehair)maybenotedatthe

applicationsite.

Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestationthetreatmentschedulecanbebased

onthelocalepidemiologicalsituation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesin8week-old

puppies,growingdogsanddogsweighingabout2kgtreatedonceatfivetimesthe

recommendeddose.Theriskofexperiencingadverseeffects(seesection4.6)may

howeverincreasewhenoverdosing,soanimalsshouldalwaysbetreatedwiththe

correctpipettesizeaccordingtobodyweight.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

5.1 Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.Itacts

byinhibitingtheGABAcomplex,bindingtothechloridechannelandtherebyblocking

pre-andpost-synaptictransferofchlorideionsacrosscellmembranes.Thisresultsin

uncontrolledactivityofthecentralnervoussystemanddeathofinsectsoracarids.

Fipronilexhibitsaninsecticidalandacaricidalactivityagainstfleas(Ctenocephalides

spp),ticks(Rhipicephalusspp,Dermacentorspp,IxodessppincludingIxodes

ricinus,andlice(Trichodectescanis)inthedog.Tickswillusuallybekilledwithin48h

aftercontactwithFipronil,howeverifticksofsomespecies(Ixodesricinus,

Rhipicephalussanguineus)arealreadypresentwhentheproductisapplied,allofthe

ticksmaynotbekilledwithinthefirst48hours.Fleaswillbekilledwithin24hours.

5.2 Pharmacokineticproperties

Fipronilismainlymetabolisedtoitssulfonederivative(RM1602),whichalso

possessesinsecticidalandacaricidalproperties.Theconcentrationsoffipronilonthe

hairdecreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Butylhydroxyanisole(E320)

Butylhydroxytoluene(E321)

Polysorbate80

PovidoneK25

Dimethylsulfoxide

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6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:36months.

6.4.Specialprecautionsforstorage

Storeintheoriginalcontainerinordertoprotectfromlightandmoisture.

6.5Natureandcompositionofimmediatepackaging

Whitepolypropylenepipetteclosedwitheitherapolyethyleneorpolyoxymethylene

cap.Eachpipetteispackedinapolyethyleneterephthalate/aluminium/lowdensity

polyethylenetriplexbag.

Boxcontaining1,3,6,10,20or30pipettes.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,waterways

orditcheswiththeproductoremptycontainer.

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7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4032

9. DATEOFFIRSTAUTHORISATION

15November2011

10. DATEOFREVISIONOFTHETEXT

November2011