Fiproline 50 mg Spot-on Solution for Cats

Main information

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

Documents

Localization

  • Available in:
  • Fiproline 50 mg Spot-on Solution for Cats
    Italy
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0306/001
  • Authorization date:
  • 08-11-2011
  • EU code:
  • UK/V/0306/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:August2011

AN:00313/2011

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FIPROLINE50mgspot-onsolutionforcats

(NL:EXILFIPROLINE)

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

4.1Targetspecies

Cats.

4.2Indicationsforuse

Treatmentofflea(Ctenocephalidesspp.)andtick(Dermacentorreticulatus)

infestations.

Theproducthasapersistentinsecticidalefficacyforupto5weeksagainstfleas

(Ctenocephalidesfelis).

Theproducthasapersistentacaricidalefficacyforupto2weeksagainstticks

(Rhipicephalussanguineus,Ixodesricinus,Dermacentorreticulatus).Ifticksof

somespecies(RhipicephalussanguineusandIxodesricinus)arepresentwhen

theproductisapplied,alltheticksmaynotbekilledwithinthefirst48hoursbut

theymaybekilledwithinaweek.

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFlea

AllergyDermatitis(FAD)wherethishasbeenpreviouslydiagnosedbyaveterinary

surgeon.

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4.3Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittensless

than2monthsoldand/orweighinglessthan1kg.

Donotuseonsick(systemicdiseases,fever)orconvalescentanimals.

Donotuseinrabbits,asadversedrugreactionsandevendeathcouldoccur.

Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyof

excipients.

4.4Specialwarningsforeachtargetspecies

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareas

suchascarpetsandsoftfurnishingswhichshouldbetreated,incaseofmassive

infestationandatthebeginningofthecontrolmeasures,withasuitableinsecticide

andvacuumedregularly.

Theproductdoesnotpreventticksfromattachingtotheanimals.Iftheanimalhas

beentreatedpriortoexposuretotheticks,thetickswillbekilledinthefirst24-48

hoursafterattachment.Thiswillusuallybepriortoengorgement,minimisingbut

notexcludingtheriskoftransmissionofdiseases.Oncedead,tickswilloftendrop

offtheanimal,butanyremainingticksmayberemovedwithagentlepull.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincats

areavailable.However,basedoninformationavailablefordogs,shampooingan

hourpriortotreatmentdoesnotaffecttheefficacyoftheproductagainstfleas.

WhenusedaspartofastrategyforthetreatmentofFleaAllergyDermatitis,

monthlyapplicationstotheallergicpatientandtoothercatsinthehouseholdare

recommended.

Foroptimumcontroloffleaproblemsinamulti-pethousehold,alldogsandcatsin

thehouseholdshouldbetreatedwithasuitableinsecticide.

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

oidcontactwiththeanimal’seyes.Inthecaseofaccidentaleyecontact,

immediatelyandthoroughlyflushtheeyeswithwater.

Donotapplytheproductonwoundsordamagedskin.

ii. Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,

contactbetweentheproductandthemouthoreyesshouldbeavoided.

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Inthecaseofaccidentaleyecontact,immediatelyandthoroughlyflushthe

eyeswithwater.Ifeyeirritationpersistsseekmedicaladviceandshowthe

packageleafletorthelabeltothephysician.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,wash

handswithsoapandwater.Washhandsafteruse.

Donotsmoke,drinkoreatduringapplication.

Animalsoroperatorswithaknownhypersensitivitytofipronilorexcipients

(seesection6.1.)shouldavoidcontactwiththeveterinarymedicinalproduct.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,and

childrenshouldnotbeallowedtoplaywithtreatedanimalsuntilthe

applicationsiteisdry.Itisthereforerecommendedthatanimalsarenot

treatedduringtheday,butshouldbetreatedduringtheearlyevening,and

thatrecentlytreatedanimalsshouldnotbeallowedtosleepwithowners,

especiallychildren.

iii. Otherprecautions

Thealcoholcarriermayhaveadverseeffectsonpainted,varnishedorother

householdsurfacesorfurnishings.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlyto

thenatureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionsattheapplicationsite(squamosis,localalopecia,pruritus,erythema)

andgeneralpruritusoralopeciahavebeenreportedafteruse.Exceptionally,

hypersalivation,reversibleneurologicsymptoms(hyperesthesia,depression,

nervoussymptoms)orvomitinghavebeenobservedafteruse.

4.7Useduringpregnancyandlactation

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicor

embryotoxiceffects.Studieshavenotbeencarriedoutwiththisproductin

pregnantandlactatingqueens.Useinpregnancyandlactationonlyinaccordance

withprofessionalveterinaryadviceandabenefit/riskassessment.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Routeofadministrationanddosage:

Externaluseonly.

Administerbytopicalapplicationtotheskin1pipetteof0.5mlperanimal.

Methodofadministration:

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Thermoformedpipettes:

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethatthe

contentsarewithinthemainbodyofthepipette.Breakthesnap-offtopofthespot-

onpipettealongthescoredline.

Partthepet’scoatuntilitsskinisvisible.Placethetipofthepipettedirectly

againstthebaredskinandsqueezegentlyseveraltimestoemptyitscontents

Repeatthisproce dureatoneortwodifferentpointsalongthecat’sback,

preferablyatthebaseoftheheadandbetweentheshoulders.

Polypropylenepipettes:

Removethepipettefromtheblisterpackaging.Holdthepipetteinanupright

position,twistandpullthecapoff.Turnthecaparoundandplacetheotherendof

thecapbackonthepipette.Twistthecaptobreaktheseal,thenremovethecap

fromthepipette.

Partthepet’scoatuntilitsskinisvisible.Placethetipofthepipettedirectly

againstthebaredskinandsqueezegentlyseveraltimestoemptyitscontents.

Repeatthisprocedureatoneortwopointsalongthecat’sback,preferablyatthe

baseoftheheadandbetweentheshoulders.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoff,andtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsince

thiswillcauseastickyappearanceofhairsatthetreatmentspot.However,should

thisoccur,itwilldisappearwithin24hourspostapplication.

Whitedepositsmayalsobeseenatthesiteforupto48hoursafterapplication.

Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestationthetreatmentschedulecanbe

basedonthelocalepidemiologicalsituation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesincatsand

kittensaged2monthsandolderandweighingabout1kgtreatedatfivetimesthe

recommendeddose(dailytherapeuticdoseappliedonfiveconsecutivedays)for

threeconsecutivemonthsexceptforitchingandvomitingthatoccurredonce.The

riskofadverseeffectsmayincreaseincasesofover-dose.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

5.1Pharmacodynamicproperties

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.

5.2Pharmacokineticparticulars

Invitro,fipronilismainlymetabolisedwithsubcellularliverfractionstoitssulfone

derivative.However,thismaybeoflimitedrelev ance‘invivo’asfipronilispoorly

absorbedinthecat.Theconcentrationsoffipronilonthehairdecreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ButylhydroxyanisoleE320

ButylhydroxytolueneE321

Benzylalcohol

Diethyleneglycolmonoethylether

6.2Incompatibilities

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Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Storebelow30

C.Storeinadryplace.Storeintheoriginalpackage.

6.5Natureandcompositionofimmediatepackaging

Thermoformedpipettes:Whiteortransparentmulti-layerplasticsingle-dose

pipettecontaininganextractiblevolumeof0.5ml.

Theinternallayersincontactwiththeproductaremadeofpolyacrylonitrile-

methacrylate.Thewhiteexternalcomplexiscomposedofpolypropylene/cyclic

olefinecopolymer/polypropylene.

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

Polypropylenepipettes:Whitepolypropylenesingle-dosepipettecontainingan

extractiblevolumeof0.5mlpackagedinuncolouredplasticblistercomposedof

polypropylene/cyclicolefinecopolymer/polypropyleneclosedbyheatsealing

withathermosealablelacqueredaluminiumfoilandplacedinacartonboxor

blistercard.

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

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainer.

7. MARKETINGAUTHORISATIONHOLDER

FRANCODEX

ère

avenue –2065m–L.I.D.

06516Carros

FRANCE

+33(0)492087304

+33(0)492087348

8. MARKETINGAUTHORISATIONNUMBER

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Vm 32991/4001

9. DATEOFFIRSTAUTHORISATION

Date:17April2009

10.DATEOFREVISIONOFTHETEXT

Date:August2011