Ectoline 10% w/ v Spot-On Solution for Medium Dogs

Main information

  • Trade name:
  • Ectoline 10% w/ v Spot-On Solution for Medium Dogs
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ectoline 10% w/v Spot-On Solution for Medium Dogs
    France
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0307/002
  • Authorization date:
  • 08-11-2011
  • EU code:
  • UK/V/0307/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:August2011

AN:00316/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FIPROLINE134mgspot-onsolutionformediumdogs

(NL:EXILFIPROLINE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

One1.34mlpipettecontains:

Activesubstance:

Fipronil 134mg

Excipients:

ButyhydroxyanisoleE320 0.268mg/pipette

ButylhydroxytolueneE321 0.134mg/pipette

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clear,colourlesstoyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs.

4.2Indicationsforuse

Treatmentofflea(Ctenocephalidesspp.)andtick(Dermacentorreticulatus)

infestations.

Insecticidalefficacyagainstnewinfestationswithadultfleaspersistsforupto8

weeks.

Theproducthasapersistentacaricidalefficacyforupto4weeksagainstticks

(Rhipicephalussanguineus,Ixodesricinus,Dermacentorreticulatus).Ifticksof

somespecies(RhipicephalussanguineusandIxodesricinus)arepresentwhen

theproductisapplied,alltheticksmaynotbekilledwithinthefirst48hoursbut

theymaybekilledwithinaweek.

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFlea

AllergyDermatitis(FAD)wherethishasbeenpreviouslydiagnosedbyaveterinary

surgeon.

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4.3Contraindications

Donotuseonpuppieslessthan2monthsoldand/orweighinglessthan2kginthe

absenceofavailabledata.

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

Donotuseinrabbits,asadversereactionsandevendeathcouldoccur.

Thisproductisspecificallydevelopedfordogs.Donotuseincats,asthiscould

leadtooverdosing.

Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyof

excipients.

4.4Specialwarningsforeachtargetspecies

Shampooinganhourpriortotreatmentdoesnotaffecttheefficacyoftheproduct

againstfleas.

Bathing/immersioninwaterwithintwodaysafterapplicationoftheproductshould

beavoided.Weeklyimmersioninwaterforoneminutereducestheperiodof

persistentinsecticidalefficacyagainstfleasbyoneweek.

Theproductdoesnotpreventticksfromattachingtotheanimals.Iftheanimalhas

beentreatedpriortoexposuretotheticks,thetickswillbekilledinthefirst24-48

hoursafterattachment.Thiswillusuallybepriortoengorgement,minimisingbut

notexcludingtheriskoftransmissionofdiseases.Oncedead,tickswilloftendrop

offtheanimal,butanyremainingticksmayberemovedwithagentlepull.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareas

suchascarpetsandsoftfurnishingswhichshouldbetreated,incaseofmassive

infestationandatthebeginningofthecontrolmeasures,withasuitableinsecticide

andvacuumedregularly.

WhenusedaspartofastrategyforthetreatmentofFleaAllergyDermatitis,

monthlyapplicationstotheallergicpatientandtootherdogsinthehouseholdare

recommended.

Foroptimalcontroloffleainfestationinmulti-pethousehold,alldogsandcatsin

thehouseholdshouldbetreatedwithasuitableinsecticide.

4.5Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Animalsshouldbeweighedaccuratelypriortotreatment.

Avoidcontactwiththeanimal’seyes.Inthecaseofaccidentaleyecontact,

immediatelyandthoroughlyflushtheeyeswithwater.

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Itisimportanttomakesurethattheproductisappliedtoanareawherethe

animalcannotlickitoffandtomakesurethatanimalsdonotlickeachother

followingtreatment

Donotapplytheproductonwoundsordamagedskin.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,

contactbetweentheproductandthemouthoreyesshouldbeavoided.

Inthecaseofaccidentaleyecontact,immediatelyandthoroughlyflushthe

eyeswithwater.Ifeyeirritationpersistsseekmedicaladviceandshowthe

packageleafletorthelabeltothephysician.

Donotsmoke,drinkoreatduringapplication.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,wash

handswithsoapandwater.Washhandsafteruse.

Animalsoroperatorswithaknownhypersensitivitytofipronilorexcipients

(seesection6.1.)shouldavoidcontactwiththeveterinarymedicinalproduct.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,and

childrenshouldnotbeallowedtoplaywithtreatedanimalsuntilthe

applicationsiteisdry.Itisthereforerecommendedthatanimalsarenot

treatedduringtheday,butshouldbetreatedduringtheearlyevening,and

thatrecentlytreatedanimalsshouldnotbeallowedtosleepwithowners,

especiallychildren.

iii.Otherprecautions

Fipronilmayadverselyaffectaquaticorganisms.Dogsshouldnotbeallowed

toswiminwatercoursesfor2daysafterapplication.

Theproductmayhaveadverseeffectsonpainted,varnishedorother

householdsurfacesorfurnishings.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlyto

thenatureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionsontheapplicationsite(skindiscoloration,localalopecia,pruritus,

erythema)andgeneralpruritusoralopeciahavebeenreportedafteruse.

Exceptionally,hypersalivation,reversibleneurologicsymptoms(hyperesthesia,

depression,nervoussymptoms),vomitingorrespiratorysymptomshavebeen

observedafteruse.

4.7Useduringpregnancyandlactation

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicor

embryotoxiceffect.Studieshavenotbeencarriedoutwiththisproductinpregnant

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andlactatingbitches.Useinpregnancyandlactationonlyinaccordancewith

professionalveterinaryadviceandabenefit/riskassessment.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Routeofadministrationanddosage:

Externaluseonly.

Administerbytopicalapplicationtotheskinaccordingtothebodyweightas

follows:

1pipetteof1.34mlperdogweighingover10kgandupto20kgbodyweight.

Methodofadministration:

Thermoformedpipettes:

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethatthe

contentsarewithinthemainbodyofthepipette.Breakthesnap-offtopofthespot-

onpipettealongthescoredline.

Partthepet’scoatuntilitsskinisvisible.Placethetipofthepipettedirectly

againstthebaredskinandsqueezegentlyseveraltimestoemptyitscontents

Repeatthisprocedureatoneortwodifferentpointsalongthepet’sback.

Polypropylenepipettes:

Removethepipettefromtheblisterpackaging.Holdthepipetteinanupright

position,twistandpullthecapoff.Turnthecaparoundandplacetheotherendof

thecapbackonthepipette.Twistthecaptobreaktheseal,thenremovethecap

fromthepipette.

Partthepet’scoatuntilitsskinisvisible.Placethetipofthepipettedirectly

againstthebaredskinandsqueezegentlyseveraltimestoemptyitscontents.

Repeatthisprocedureatoneortwopointsalongthepet’sback.

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Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoff,andtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsince

thiswillcauseastickyappearanceofhairsatthetreatmentspot.However,should

thisoccur,itwilldisappearwithin24hourspostapplication.

Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestationthetreatmentschedulecanbe

basedonthelocalepidemiologicalsituation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesin2month-old

puppies,growingdogsanddogsweighingabout2kgtreatedwiththetherapeutic

doseonfiveconsecutivedays.Theriskofadverseeffects(seesection4.6)may

increaseincasesofoverdose.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

5.1Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.It

actsbyinhibitingtheGABAcomplex,bindingtothechloridechannelandthereby

blockingpre-andpost-synaptictransferofchlorideionsacrosscellmembranes.

Thisresultsinuncontrolledactivityofthecentralnervoussystemanddeathof

insectsoracarids.

Fipronilexhibitsaninsecticidalandacaricidalactivityagainstfleas

(Ctenocephalidesspp),ticks(Rhipicephalusspp,Dermacentorspp,Ixodesspp

includingIxodesricinus)inthedog.

Fleaswillbekilledwithin24h.Tickswillusuallybekilledwithin48haftercontact

withFipronil,howeverifticksofsomespecies(Rhipicephalussanguineusand

Ixodesricinus)arealreadypresentwhentheproductisapplied,alloftheticks

maynotbekilledwithinthefirst48hours.

5.2Pharmacokineticparticulars

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Fipronilismainlymetabolisedtoitssulfonederivative(RM1602),whichalso

possessesinsecticidalandacaricidalproperties.Theconcentrationsoffipronilon

thehairdecreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ButylhydroxyanisoleE320

ButylhydroxytolueneE321

Benzylalcohol

Diethyleneglycolmonoethylether

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Storebelow30°C.Storeinadryplace.Storeintheoriginalpackage.

6.5Natureandcompositionofimmediatepackaging

Thermoformedpipettes:Whiteortransparentmulti-layerplasticsingle-dose

pipettescontaininganextractiblevolumeof1.34ml.

Theinternallayersincontactwiththeproductaremadeofpolyacrylonitrile-

methacrylate.Thewhiteexternalcomplexiscomposedofpolypropylene/cyclic

olefinecopolymer/polypropylene.

Boxesof1,2,3,4,6,8,12,24,30,60,90or150pipettes.

Polypropylenepipettes:Whitepolypropylenesingle-dosepipettescontainingan

extractiblevolumeof1.34mlpackagedinuncolouredplasticblistercomposedof

polypropylene/cyclicolefinecopolymer/polypropyleneclosedbyheatsealingwith

athermosealablelacqueredaluminiumfoilandplacedinacartonboxorblister

card.

Blistercardsorboxesof1,2,3,4,6,8,12,24,30,60,90or150pipettes.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

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Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainer.

7. MARKETINGAUTHORISATIONHOLDER

Francodex

ère

avenue –2065m–L.I.D.

06516Carros

FRANCE

+33(0)492087304

+33(0)492087348

8. MARKETINGAUTHORISATIONNUMBER

Vm 32991/4003

9. DATEOFFIRSTAUTHORISATION

Date:16April2009

10.DATEOFREVISIONOFTHETEXT

Date:August2011