Eliminall 50 mg Spot-on Solution for Cats

Main information

  • Trade name:
  • Eliminall 50 mg Spot-on Solution for Cats
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Eliminall 50 mg Spot-on Solution for Cats
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • fipronil
  • Therapeutic area:
  • Cats

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0381/001
  • Authorization date:
  • 28-09-2011
  • EU code:
  • UK/V/0381/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:November2011

AN:00583/2010

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Eliminall50mgspot-onsolutionforcats

Exprolinevet50mgspot-onsolutionforcats

Eliminall50mgspot-onsolutionforcats(Austria,France,Germany,Greece,Italy,

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

Exprolinevet50mgspot-onsolutionforcats(Norway,Denmark,Finland,Sweden)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1pipette(0.5ml)contains:

Activesubstance:

Fipronil 50mg

Excipients:

Butylhydroxyanisole(E320) 0.10mg

Butylhydroxytoluene(E321) 0.05mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Lightyellowtoyellow,clearliquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cats

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentandpreventionofflea(Ctenocephalidesspp.)andtick(Ixodesricinus)

infestationsincats.

Theproducthasapersistentinsecticidalefficacyforupto4weeksagainstfleas

(Ctenocephalidesspp.)andacaricidalefficacyforupto4weeksagainstIxodes

ricinusandforupto1weekagainstDermacentorreticulatusandRhipicephalus

sanguineus.Ifticksofsomespecies(DermacentorreticulatusandRhipicephalus

sanguineus)arepresentwhentheproductisapplied,alltheticksmaynotbekilled

withinthefirst48hoursbuttheymaybekilledwithinaweek.

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TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFlea

AllergyDermatitis(FAD),wherethishasbeenpreviouslydiagnosedbyaveterinary

surgeon.

4.3 Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan

2monthsoldand/orweighinglessthan1kg.

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

Donotuseinrabbits,asadversereactionsandevendeathcouldoccur.

Donotuseincasesofhypersensitivitytotheactivesubstance,dimethylsulfoxideor

toanyofotherexcipients.

4.4 Specialwarningsforeachtargetspecies

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareas

suchascarpetsandsoftfurnishingswhichshouldbetreated,incaseofmassive

infestationandatthebeginningofthecontrolmeasures,withasuitableinsecticide

andvacuumedregularly.

Theproductdoesnotpreventticksfromattachingtotheanimals.Iftheanimalhas

beentreatedpriortoexposuretotheticks,thetickwillbekilledinthefirst24-48

hoursafterattachment.Thiswillusuallybepriortoengorgement,minimisingbutnot

excludingtheriskoftransmissionofdiseases.Oncedead,tickswilloftendropoffthe

animal,butanyremainingticksmayberemovedwithagentlepull.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincats

areavailable.However,basedoninformationavailablefordogs,weeklyimmersion

inwaterforoneminutereducestheperiodofpersistentinsecticidalefficacyagainst

fleasbyoneweek.

Foroptimumcontroloffleaproblemsinamulti-pethousehold,alldogsandcatsin

thehouseholdshouldbetreatedwithasuitableinsecticide.

WhenusedaspartofastrategyforthetreatmentofFleaAllergyDermatitis,monthly

applicationstotheallergicpatientandtoothercatsinthehouseholdare

recommended.

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Avoidcontactwiththeanimal'seyes.Inthecaseofaccidentaleyecontact,

immediatelyandthoroughlyflushtheeyeswithwater.

Donotapplytheproductonwoundsordamagedskin.

Animalsshouldbeweighedaccuratelypriortotreatment.

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ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contact

betweentheproductandthemouthoreyesshouldbeavoided.

Inthecaseofaccidentaleyecontactimmediatelyandthoroughlyflushtheeyeswith

water.Ifeyeirritationpersistsseekmedicaladviceandshowthepackageleafletor

thelabeltothephysician.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,washoff

immediatelywithsoapandwater.

Washhandsafteruse.

Donotsmoke,drinkoreatduringapplication.

Peoplewithaknownhypersensitivitytofipronilordimethylsulfoxideorother

excipientsshouldavoidcontactwiththeveterinarymedicinalproduct.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildren

shouldnotbeallowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itis

thereforerecommendedthatanimalsarenottreatedduringtheday,butshouldbe

treatedduringtheearlyevening,andthatrecentlytreatedanimalsshouldnotbe

allowedtosleepwithowners,especiallychildren.

4.6 Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobserved.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionsontheapplicationsite(squamosis,localalopecia,pruritus,erythema)and

generalpruritusoralopeciahavebeenreportedafteruse.Exceptionally,

hypersalivation,reversibleneurologicsymptoms(hyperesthesia,depression,

nervoussymptoms)orvomitinghavebeenobservedafteruse.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicor

embryotoxiceffects.Studieshavenotbeencarriedoutwiththisproductinpregnant

andlactatingqueens.Useinpregnancyandlactationonlyinaccordancewith

professionalveterinaryadviceandabenefit/riskassessment.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Routeofadministrationanddosage:

Externaluseonly.

Administerbytopicalapplicationtotheskin1pipetteof0.5mlperanimal.

Methodofadministration:

Removethepipettefromthetriplexbag.Holdthepipetteinanuprightposition,twist

andpullthecapoff.Turnthecaparoundandplacetheotherendofthecapbackon

thepipette.Pushandtwistthecaptobreaktheseal,thenremovethecapfromthe

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pipette.Spreadthehairsoftheanimalbetweentheshoulderbladestomaketheskin

visible.Placethetipofthepipetteontheskinandsqueezegentlytoemptyits

contentsontotheskin,preferablyattwospots,oneatthebaseoftheskullanda

second2-3cmsfurtherback.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoff,andtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Thehairshouldbepartedandtheproductappliedtotheskin.Temporarychangesto

thecoat(clumped/greasyhairand/ordepositsonthehair)maybenotedatthe

applicationsitewhichnormallydisappearswithin24hours.

Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestationthetreatmentschedulecanbe

basedonthelocalepidemiologicalsituation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesincatsandkittens

aged2monthsandolderandweighingabout1kgtreatedonceamonthatfivetimes

therecommendeddoseforthreeconsecutivemonths.Theriskofexperiencing

adverseeffectsmayhoweverincreasewithoverdosing(seesection4.6).

4.11Withdrawalperiod

Notapplicable.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

5.1 Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.Itacts

byinhibitingtheGABAcomplex,bindingtothechloridechannelandthereby

blockingpre-andpost-synaptictransferofchlorideionsacrosscellmembranes.This

resultsinuncontrolledactivityofthecentralnervoussystemanddeathofinsectsor

acarids.

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Fipronilexhibitsaninsecticidalandacaricidalactivityagainstfleas(Ctenocephalides

spp.)andticks(Rhipicephalusspp.,Dermacentorspp.,Ixodesspp.includingIxodes

ricinus)inthecat.

Fleaswillbekilledwithin24hours.Tickswillusuallybekilledwithin48hafter

contactwithfipronil,howeverifticksofsomespecies(Dermacentorreticulatusand

Rhipicephalussanguineus)arepresentwhentheproductisapplied,alloftheticks

maynotbekilledwithinthefirst48hours,butmaybekilledwithinaweek.

5.2 Pharmacokineticproperties

Invitro,fipronilismainlymetabolisedwithsubcellularliverfractionstoitssulfone

derivative.However,thismaybeoflimitedrelevance“invivo”asfipronilispoorly

absorbedinthecat.Theconcentrationsoffipronilonthehairdecreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Butylhydroxyanisole(E320)

Butylhydroxytoluene(E321)

Polysorbate80

PovidoneK25

Dimethylsulfoxide

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:30months.

6.4. Specialprecautionsforstorage

Storeintheoriginalcontainerinordertoprotectfromlightandmoisture.

6.5 Natureandcompositionofimmediatepackaging

Whitepolypropylenepipetteclosedwitheitherapolyethyleneorpolyoxymethylene

cap.Each0.5mlpipetteispackedinapolyethyleneterephthalate/aluminium/low

densitypolyethylenetriplexbag.

Boxcontaining1,3,6,10,20or30pipettes.

Notallpacksizesmaybemarketed.

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6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainer.

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4029

9. DATEOFFIRSTAUTHORISATION

14November2011

10. DATEOFREVISIONOFTHETEXT

November2011