Effipro 10% w/ v Spot-On Solution for Cats

Main information

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

Documents

Localization

  • Available in:
  • Effipro 10% w/v 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/0303/001
  • Authorization date:
  • 09-02-2011
  • EU code:
  • UK/V/0303/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:September2011

AN:00356/2011

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

EFFIPRO50mgspot-onsolutionforcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

One0.5mlpipettecontains:

Activesubstance:

Fipronil 50mg

Excipients:

ButylhydroxyanisoleE3200.1mg/pipette

ButylhydroxytolueneE3210.05mg/pipette

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clear,colourlesstoyellowsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cats.

4.2 Indicationsforuse

Treatmentofflea(Ctenocephalidesspp.)andtick(Dermacentorreticulatus)

infestations.

Theproducthasapersistentinsecticidalefficacyforupto5weeksagainstfleas

(Ctenocephalidesfelis).

Theproducthasapersistentacaricidalefficacyforupto2weeksagainstticks

(Rhipicephalussanguineus,Ixodesricinus,Dermacentorreticulatus).Ifticksof

somespecies(RhipicephalussanguineusandIxodesricinus)arepresentwhen

theproductisapplied,alltheticksmaynotbekilledwithinthefirst48hoursbutthey

maybekilledwithinaweek.

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFlea

AllergyDermatitis(FAD)wherethishasbeenpreviouslydiagnosedbyaveterinary

surgeon.

4.3 Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan

2monthsoldand/orweighinglessthan1kg.

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Donotuseonsick(systemicdiseases,fever)orconvalescentanimals.

Donotuseinrabbits,asadversedrugreactionsandevendeathcouldoccur.

Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyof

excipients.

4.4 Specialwarningsforeachtargetspecies

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareas

suchascarpetsandsoftfurnishingswhichshouldbetreated,incaseofmassive

infestationandatthebeginningofthecontrolmeasures,withasuitableinsecticide

andvacuumedregularly.

Theproductdoesnotpreventticksfromattachingtotheanimals.Iftheanimalhas

beentreatedpriortoexposuretotheticks,thetickswillbekilledinthefirst24-48

hoursafterattachment.Thiswillusuallybepriortoengorgement,minimisingbutnot

excludingtheriskoftransmissionofdiseases.Oncedead,tickswilloftendropoff

theanimal,butanyremainingticksmayberemovedwithagentlepull.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincats

areavailable.However,basedoninformationavailablefordogs,shampooingan

hourpriortotreatmentdoesnotaffecttheefficacyoftheproductagainstfleas.

WhenusedaspartofastrategyforthetreatmentofFleaAllergyDermatitis,monthly

applicationstotheallergicpatientandtoothercatsinthehouseholdare

recommended.

Foroptimumcontroloffleaproblemsinamulti-pethousehold,alldogsandcatsin

thehouseholdshouldbetreatedwithasuitableinsecticide.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Avoidcontactwiththeanimal’seyes.Inthecaseofaccidentaleyecontact,

immediatelyandthoroughlyflushtheeyeswithwater.

Donotapplytheproductonwoundsordamagedskin.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,

contactbetweentheproductandthemouthoreyesshouldbeavoided.

Inthecaseofaccidentaleyecontact,immediatelyandthoroughlyflushtheeyes

withwater.Ifeyeirritationpersistsseekmedicaladviceandshowthepackage

leafletorthelabeltothephysician.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,washhands

withsoapandwater.Washhandsafteruse.

Donotsmoke,drinkoreatduringapplication.

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Animalsoroperatorswithaknownhypersensitivitytofipronilorexcipients(see

section6.1.)shouldavoidcontactwiththeveterinarymedicinalproduct.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,and

childrenshouldnotbeallowedtoplaywithtreatedanimalsuntiltheapplication

siteisdry.Itisthereforerecommendedthatanimalsarenottreatedduringthe

day,butshouldbetreatedduringtheearlyevening,andthatrecentlytreated

animalsshouldnotbeallowedtosleepwithowners,especiallychildren.

iii.Otherprecautions

Thealcoholcarriermayhaveadverseeffectsonpainted,varnishedorother

householdsurfacesorfurnishings.

4.6 Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlytothe

natureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionsattheapplicationsite(squamosis,localalopecia,pruritus,erythema)and

generalpruritusoralopeciahavebeenreportedafteruse.Exceptionally,

hypersalivation,reversibleneurologicsymptoms(hyperesthesia,depression,

nervoussymptoms)orvomitinghavebeenobservedafteruse.

4.7 Useduringpregnancyandlactation

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicor

embryotoxiceffects.Studieshavenotbeencarriedoutwiththisproductinpregnant

andlactatingqueens.Useinpregnancyandlactationonlyinaccordancewith

professionalveterinaryadviceandabenefit/riskassessment.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Routeofadministrationanddosage:

Externaluseonly.

Administerbytopicalapplicationtotheskin1pipetteof0.5mlperanimal.

Methodofadministration:

Thermoformedpipettes:

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethatthe

contentsarewithinthemainbodyofthepipette.Breakthesnap-offtopofthespot-

onpipettealongthescoredline.

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Partthepet’scoatuntilitsskinisvisible.Placethetipofthepipettedirectlyagainst

thebaredskinandsqueezegentlyseveraltimestoemptyitscontentsRepeatthis

procedureatoneortwodifferentp ointsalongthecat’sback,preferablyatthebase

oftheheadandbetweentheshoulders.

(Note:theshapeofthemarketedpipettescanbedifferentaswellasthepictures

onthemarketedboxes/packageleaflets.)

Polypropylenepipettes:

Removethepipettefromtheblisterpackaging.Holdthepipetteinanupright

position,twistandpullthecapoff.Turnthecaparoundandplacetheotherendof

thecapbackonthepipette.Twistthecaptobreaktheseal,thenremovethecap

fromthepipette.

Partthepet’scoatuntilitsskinisvisible.Placethetipofthepipettedirectlyagainst

thebaredskinandsqueezegentlyseveraltimestoemptyitscontents.Repeatthis

procedureatoneortwopointsalongthecat’sback,preferablyatthebaseofthe

headandbetweentheshoulders.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoff,andtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

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Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsince

thiswillcauseastickyappearanceofhairsatthetreatmentspot.However,should

thisoccur,itwilldisappearwithin24hourspostapplication.

Whitedepositsmayalsobeseenatthesiteforupto48hoursafterapplication.

Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestationthetreatmentschedulecanbe

basedonthelocalepidemiologicalsituation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesincatsandkittens

aged2monthsandolderandweighingabout1kgtreatedatfivetimesthe

recommendeddose(dailytherapeuticdoseappliedonfiveconsecutivedays)for

threeconsecutivemonthsexceptforitchingandvomitingthatoccurredonce.The

riskofadverseeffectsmayincreaseincasesofover-dose.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

5.1 Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.It

actsbyinhibitingtheGABAcomplex,bindingtothechloridechannelandthereby

blockingpre-andpost-synaptictransferofchlorideionsacrosscellmembranes.

Thisresultsinuncontrolledactivityofthecentralnervoussystemanddeathof

insectsoracarids.

Fipronilexhibitsaninsecticidalandacaricidalactivityagainstfleas

(Ctenocephalidesspp)andticks(Rhipicephalusspp,Dermacentorspp,Ixodes

spp.includingIxodesricinus)inthecat.

Fleaswillbekilledwithin24h.Tickswillusuallybekilledwithin48haftercontact

withFipronil,howeverifticksofsomespecies(Rhipicephalussanguineusand

Ixodesricinus)arepresentwhentheproductisapplied,alltheticksmaynotbe

killedwithinthefirst48hours.

5.2 Pharmacokineticparticulars

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Invitro,fipronilismainlymetabolisedwithsubcellularliverfractionstoitssulfone

derivative.However,thismaybeoflimitedrelevance‘invivo’asfipronilispoorly

absorbedinthecat.Theconcentrationsoffipronilonthehairdecreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

ButylhydroxyanisoleE320

ButylhydroxytolueneE321

Benzylalcohol

Diethyleneglycolmonoethylether

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:24months.

6.4. Specialprecautionsforstorage

Storebelow30

C.Storeinadryplace.Storeintheoriginalpackage.

6.5 Natureandcompositionofimmediatepackaging

Thermoformedpipettes:Whitemulti-layerplasticsingle-dosepipettecontainingan

extractiblevolumeof0.5ml.

Theinternallayersincontactwiththeproductaremadeofpolyacrylonitrile-

methacrylate.Thewhiteexternalcomplexiscomposedofpolypropylene/cyclic

olefinecopolymer/polypropylene.

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

Polypropylenepipettes:Whitepolypropylenesingle-dosepipettecontainingan

extractiblevolumeof0.5mlpackagedinuncolouredplasticblistercomposedof

polypropylene/cyclicolefinecopolymer/polypropyleneclosedbyheatsealingwith

athermosealablelacqueredaluminiumfoilandplacedinacartonboxorblister

card.

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

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

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Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainer.

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7. MARKETINGAUTHORISATIONHOLDER

VirbacS.A.

ère

avenue –2065m–L.I.D.

06516Carros

FRANCE

+33(0)492087304

+33(0)492087348

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 05653/4150

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

06May2009

10. DATEOFREVISIONOFTHETEXT

September2011