Fiproline 2.5 mg/ml Cutaneous Spray, Solution for Cats & Dogs

Main information

  • Trade name:
  • Fiproline 2.5 mg/ml Cutaneous Spray, Solution for Cats & Dogs
  • Pharmaceutical form:
  • Cutaneous spray, solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fiproline 2.5 mg/ml Cutaneous Spray, Solution for Cats & Dogs
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • fipronil
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0305/001
  • Authorization date:
  • 08-11-2011
  • EU code:
  • UK/V/0305/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:August2011

AN:00540/2011

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FIPROLINE2.5mg/mlcutaneousspray,solutionforcatsanddogs

(NL:EXILFIPROLINE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlofsolutioncontains

Activesubstance:

Fipronil 2.5mg

Excipient:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Cutaneousspray,solution.

Clear,colourlesstoyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogsandcats.

4.2Indicationsforuse,specifyingthetargetspecies

Treatmentoffleainfestation(Ctenocephalidesspp.)indogsandcats.

Treatmentoftickinfestation(Ixodesricinus,Rhipicephalussanguineus)indogs

andcats.

Treatmentofbitingliceinfestationsindogs(Trichodectescanis)andcats

(Felicolasubrostratus).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFlea

AllergyDermatitis(FAD).

Insecticidalefficacyagainstnewinfestationswithadultfleaspersistsforupto6

weeksincatsandupto3monthsindogs,dependingonenvironmentalchallenge.

Theproducthasapersistentacaricidalefficacyforupto4weeksagainstticks,

dependingonthelevelofenvironmentalchallenge.

4.3Contraindications

Donotuseonsick(systemicdisea ses,fever…)orconvalescentanimals.

Donotuseinrabbits,asadversereactionsandevendeathcouldoccur.

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Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyof

excipients.

4.4Specialwarningsforeachtargetspecies

Donotexceedtherecommendeddosage.

Avoidcontactwiththeanimal’seyes.

Donotspraydirectlyontoareasofbrokenskin.

Allowtreatedanimalstodryinawellventilatedroom(seealsosection4.5).

Donotconfineanimalsinanenclosedspaceorpetcarrieruntilthecoatistotally

dry.

Intheabsenceofspecifictoleranceandefficacydata,theproductisnot

recommendedforthetreatmentofspeciesotherthancatsanddogs.

Whenusedaspartofastrategyforthetreatmentoffleaallergydermatitis,monthly

applicationstotheallergicpatientandtoothercatsanddogsinthehouseholdare

recommended.

Foroptimumefficacy,itisnotrecommendedtobatheorshampooanimalsinthe

twodayspriortoorfollowingtreatmentwiththeproduct.Bathingorshampooing

uptofourtimesintwomonthshasbeenshowntohavenosignificanteffectonthe

residualefficacyoftheproduct.Monthlytreatmentisrecommendedwhenmore

frequentshampooingiscarriedout.

Treatmentofbedding,carpetsandsoftfurnishingswithasuitableinsecticidewill

aidreductioninenvironmentalchallengeandmaximisethedurationofprotection

againstre-infestationprovidedbytheproduct.

Foroptimumcontroloffleaproblemsinamulti-pethousehold,alldogsandcatsin

thehouseholdshouldbetreatedwithasuitableinsecticide.

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Itisimportanttomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Theremaybeanattachmentofsingleticks.Forthisreasontransmissionof

infectiousdiseasescannotbecompletelyexcludedifconditionsare

unfavourable.

Theproductisnotsuitablefordirecttreatmentoftheenvironment.

Keeptreatedanimalsawayfromfiresorothersourcesofheat,andsurfaces

likelytobeaffectedbythealcoholspray,foratleast30minutesfollowing

sprayinganduntilthefuristotallydry.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

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Thisproductcancausemucousmembraneandeyeirritation.Therefore,

contactbetweentheproductandthemouthoreyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcohol

shouldavoidcontactwiththeproduct.Avoidcontentscomingintocontact

withthefingers.Ifthisoccurs,washhandswithsoapandwater.

Afteraccidentalocularexposuretheeyeshouldberinsedcarefullywithplain

water.

Treatedanimalsshouldnotbehandleduntilthefurisdry,andchildrenshould

notbeallowedtoplaywithtreatedanimalsuntilthefurisdry.Itistherefore

recommendedthatanimalsarenottreatedduringtheday,butshouldbe

treatedduringtheearlyevening,andthatrecentlytreatedanimalsarenot

allowedtosleepwithowners,especiallychildren.

Sprayanimalsintheopenairorawellventilatedroom.

Donotbreathespray.Donotsmoke,drinkoreatduringapplication.

WearPVCornitrileglovesduringtreatmentofanimals.Itisrecommended

towearawaterproofapronfortheprotectionofclothing.Ifclothingbecomes

heavilywettedwiththeproduct,itshouldberemovedandwashedbeforere-

use.

Disposeofglovesafteruseandthenwashhandswithsoapandwater.

Washsplashesfromskinwithsoapandwaterimmediately.Ifirritation

occurs,seekmedicaladvice.Peoplewithknownsensitivityorasthmamay

beparticularlysensitivetotheproduct.Donotuseproductifyouhave

previouslyexperiencedareactiontoit.

Treatmentofmultipleanimals:Goodventilationisparticularlyimportant

whereseveralanimalsaretobetreated.Treatmultipleanimalsoutside,or

reducethebuildupofvapourbyremovingtheanimalsfromthetreatment

roomwhilethealcoholisevaporatingandensurethatthetreatmentroomis

wellventilatedbetweenindividualtreatments.Inaddition,ensurethatthe

dryingroomiswellventilatedandavoidhousingseveralrecentlytreated

animalswithinthesameairspace.

iii.Otherprecautions

Fipronilmayadverselyaffectaquaticorganism.Dogsshouldnotbeallowed

toswiminwatercoursesfor2daysafterapplication.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlyto

thenatureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionserythemasuchaspruritusoralopeciahavebeenreportedafteruse.

Exceptionally,hypersalivation,reversibleneurologicalsigns(hyperaesthesia,

depression,nervoussigns),vomitingorrespiratorysignshavebeenobserved

afteruse.

Revised:August2011

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4.7Useduringpregnancyandlactation

Laboratorystudiesdidnotrevealanyteratogeniceffectoffipronilintheratand

rabbit.Fipronilisverywelltoleratedbypuppiesfollowingtreatmentofthelactating

bitch.Dataisnotavailablefromspecificstudiesduringpregnancyinbitches,

pregnancyinqueensorinnursingqueens.Thesafetyoftheveterinarymedicinal

producthasnotbeenestablished,therefore,useonlyinaccordancewiththe

risk/benefitassessmentbytheveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Routeofadministration:

Mechanicalpumpsprayforexternaluseonly.

Thepumpdelivers0.5ml(100mlbottle)or1.5ml(250mlbottle)or3ml(500ml

bottle)sprayperpump.

Dosage:

Inordertodampenthecoatdowntotheskin,apply3to6mlperkgbodyweight,

(7.5to15mgofactiveingredientperkgbodyweight),dependingonthelengthof

hair.

Thisdosagecanbeachievedwith6to12pumpapplicationsperkgbodyweightof

the100mlpresentation,or2to4pumpapplicationsofthe250mlpresentationor

1to2pumpapplication(s)ofthe500mlpresentation.

Dependingonthecoatlength,

the100mlpresentationallows4to8treatmentsofa4kgcatorupto3

treatmentsofa10kgdog,

the250mlpresentationallows2to4treatmentsofa20kgdog,

the500mlpresentationallows2to4treatmentsofa40kgdog.

Methodofadministration:

Forthe250and500mlbottles,adjustthepumpnozzletospraysetting.

Spraytheentirebodyoftheanimal,andapplyfromadistanceofapproximately

10-20cm.Applyagainstthelayofthehairandmakesurethattheentirecoatof

theanimalisdampened.Rufflethecoat,especiallyinlonghairedanimals,sothat

theproductpenetratesdowntotheskin.Fortreatmentoftheheadregion,and

whentreatingyoungornervouspets,applicationmaybecarriedoutbyspraying

ontoaglovedhandandrubbingtheproductintothecoat.Allowtodrynaturally.Do

nottoweldry.

Revised:August2011

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Properties:

Theformulationcontainsacoatingagent.Therefore,sprayingbuildsupafilmand

makesthefurglossy.

Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestation,thetreatmentschedulecanbe

basedonthelocalepidemiologicalsituation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

Puppiesandkittensfrom2daysofagemaybesafelytreated.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theriskofadverseeffectsmayincreaseincasesofoverdose.

Startanappropriatesymptomatictreatmentincaseofoverdosing.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

5.1Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidefromthephenylpyrazolefamily.Itactsby

inhibitingtheGABAcomplex,bindingtothechloridechannelandtherebyblocking

pre-andpost-synaptictransferofchlorideionsacrossthemembrane.Thisresults

inuncontrolledactivityofthecentralnervoussystemanddeathininsectsand

acarids.

Fipronilexhibitsinsecticidalandacaricidalactivityagainstfleas(Ctenocephalides

spp),ticks(Rhipicephalusspp.Ixodesspp)andlice(Trichodectesspp.and

Felicolaspp).inthedogandcat.

5.2Pharmacokineticparticulars

Absorption

Theamountoffipronilabsorbedbytheskininthedog,afterapplicationofthe

spraytothecoatandskinisextremelyslighttonegligible.

Distribution

Thepersistenceoffipronilonthehairisverylong(onaverage52.5±11.5days),

giventhatthelimitofquantificationoftheassaymethodis0.25µg/g.

Biotransformation

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Inallspeciesfipronilismainlymetabolisedtoitssulphonederivative(RM1602),

whichalsopossessesinsecticidalandacaricidalproperties.

TheRM1602detectedonthehairaftersprayapplicationindogsmaybe

explainedbyitspresenceintheoriginalrawmaterial.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Copovidone

IsopropylAlcohol

Water,Purified

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:1year.

6.4.Specialprecautionsforstorage

Highlyflammable.

Donotstoreabove25°C.

Protectfromdirectsunlight.

6.5Natureandcompositionofimmediatepackaging

100mlfilledinhighdensitypolyethylenewhiteopaquebottlehermeticallyclosed

withamechanicalpumpspraydelivering0.5mlperspray(plungerinlowdensity

polyethylene).

250mlfilledinhighdensitypolyethylenewhiteopaquebottlehermeticallyclosed

withamechanicaltriggerpumpdelivering1.5mlperspray(plungerinlowdensity

polyethylene).

500mlfilledinhighdensitypolyethylenewhiteopaquebottlehermeticallyclosed

withamechanicaltriggerpumpdelivering3mlperspray(plungerinlowdensity

polyethylene).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

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Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainer.

Revised:August2011

AN:00540/2011

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7. MARKETINGAUTHORISATIONHOLDER

FrancodexSanteAnimaleS.A.S.

ère

avenue –2065m–L.I.D.

06516CarrosCedex

FRANCE

+33(0)492087304

+33(0)492087348

8. MARKETINGAUTHORISATIONNUMBER

Vm

32991/4000

9. DATEOFFIRSTAUTHORISATION

Date:17April2009

10 DATEOFREVISIONOFTHETEXT

Date:August2011

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