Alfamed Fipronil 50 mg Spot-On Solution for Cats

Main information

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

Documents

Localization

  • Available in:
  • Alfamed Fipronil 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/0397/001
  • Authorization date:
  • 21-03-2012
  • EU code:
  • UK/V/0397/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:August2012

AN:00101/2011

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ALFAMEDFIPRONIL(BE)/FIPROLINE(HU,RO)/VETFLEA(UK)50mgSpot-on

solutionforcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

One0.5mlpipettecontains:

Activesubstance:

Fipronil 50mg

Excipients:

ButylhydroxyanisoleE3200.1mg

ButylhydroxytolueneE3210.05mg

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).Ifticksofsome

species(RhipicephalussanguineusandIxodesricinus)arepresentwhentheproduct

isapplied,alltheticksmaynotbekilledwithinthefirst48hoursbuttheymaybe

killedwithinaweek.

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergy

Dermatitis(FAD)wherethishasbeenpreviouslydiagnosedbyaveterinarysurgeon.

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4.3 Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan

2monthsoldand/orweighinglessthan1kg.

Donotuseonsick(systemicdiseases,fever)orconvalescentanimals.

Donotuseinrabbits,asadversedrugreactionsandevendeathcouldoccur.

Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyofexcipients.

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/shampooingontheefficacyoftheproductincatsare

available.However,basedoninformationavailablefordogs,shampooinganhour

priortotreatmentdoesnotaffecttheefficacyoftheproductagainstfleas.

WhenusedaspartofastrategyforthetreatmentofFleaAllergyDermatitis,monthly

applicationstotheallergicpatientandtoothercatsinthehouseholdare

recommended.

Foroptimumcontroloffleaproblemsinamulti-pethousehold,alldogsandcatsin

thehouseholdshouldbetreatedwithasuitableinsecticide.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Avoidcontactwiththeanimal’seyes.Inthecaseofaccidentaleyecontact,

immediatelyrinsetheeyeswithcleanwater.

Donotapplytheproductonwoundsordamagedskin.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contact

betweentheproductandthemouthoreyesshouldbeavoided.

Inthecaseofaccidentaleyecontact,immediatelyrinsetheeyeswithcleanwater.If

eyeirritationpersistsseekmedicaladviceandshowthepackageleafletorthelabel

tothephysician.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,washhandswith

soapandwater.Washhandsafteruse.

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Donotsmoke,drinkoreatduringapplication.

Peoplewithaknownhypersensitivitytofipronilorexcipients(seesection6.1.)should

avoidcontactwiththeveterinarymedicinalproduct.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildren

shouldnotbeallowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itis

thereforerecommendedthatanimalsarenottreatedduringtheday,butshouldbe

treatedduringtheearlyevening,andthatrecentlytreatedanimalsshouldnotbe

allowedtosleepwithowners,especiallychildren.

Otherprecautions

Thealcoholcarriermayhaveadverseeffectsonpainted,varnishedorother

householdsurfacesorfurnishings.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlytothe

natureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionsattheapplicationsite(squamosis,localalopecia,pruritus,erythema)and

generalpruritusoralopeciahavebeenreportedafteruse.Exceptionally,

hypersalivation,reversibleneurologicsymptoms(hyperesthesia,depression,nervous

symptoms)orvomitinghavebeenobservedafteruse.

4.7Useduringpregnancyandlactation

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicor

embryotoxiceffects.Studieshavenotbeencarriedoutwiththisproductinpregnant

andlactatingqueens.Useinpregnancyandlactationonlyinaccordancewith

professionalveterinaryadviceandabenefit/riskassessment.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Routeofadministrationanddosage:

Externaluseonly.

Administerbytopicalapplicationtotheskin1pipetteof0.5mlperanimal.

Methodofadministration:

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethatthe

contentsarewithinthemainbodyofthepipette.Breakthesnap-offtopofthespot-on

pipettealongthescoredline.

Partthepet’scoatuntilitsskinisvisible.Placethetipofthepipettedirectlyagainst

thebaredskinandsqueezegentlyseveraltimestoemptyitscontentsRepeatthis

procedureatoneortwodifferentpointsalongtheca t’sback,preferablyatthebase

oftheheadandbetweentheshoulders.

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(Note:theshapeofthemarketedpipettescanbedifferentaswellasthepictureson

themarketedboxes/packageleaflets.)

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoff,andtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsince

thiswillcauseastickyappearanceofhairsatthetreatmentspot.However,should

thisoccur,itwilldisappearwithin24hourspostapplication.

Whitedepositsmayalsobeseenatthesiteforupto48hoursafterapplication.

Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestationthetreatmentschedulecanbebased

onthelocalepidemiologicalsituation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesincatsandkittens

aged2monthsandolderandweighingabout1kgtreatedatfivetimesthe

recommendeddose(dailytherapeuticdoseappliedonfiveconsecutivedays)for

threeconsecutivemonthsexceptforitchingandvomitingthatoccurredonce.The

riskofadverseeffectsmayincreaseincasesofover-dose.

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4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

5.1 Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.Itacts

byinhibitingtheGABAcomplex,bindingtothechloridechannelandtherebyblocking

pre-andpost-synaptictransferofchlorideionsacrosscellmembranes.Thisresults

inuncontrolledactivityofthecentralnervoussystemanddeathofinsectsoracarids.

Fipronilexhibitsaninsecticidalandacaricidalactivityagainstfleas(Ctenocephalides

spp)andticks(Rhipicephalusspp,Dermacentorspp,Ixodesspp.includingIxodes

ricinus)inthecat.

Fleaswillbekilledwithin24h.Tickswillusuallybekilledwithin48haftercontact

withFipronil,howeverifticksofsomespecies(RhipicephalussanguineusandIxodes

ricinus)arepresentwhentheproductisapplied,alltheticksmaynotbekilledwithin

thefirst48hours.

5.2 Pharmacokineticparticulars

Invitro,fipronilismainlymetabolisedwithsubcellularliverfractionstoitssulfone

derivative.However,thismaybeoflimitedr elevance‘invivo’asfipronilispoorly

absorbedinthecat.Theconcentrationsoffipronilonthehairdecreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ButylhydroxyanisoleE320

ButylhydroxytolueneE321

Benzylalcohol

Diethyleneglycolmonoethylether

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Storebelow30

C.Storeinadryplace.Storeintheoriginalpackage.

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6.5 Natureandcompositionofimmediatepackaging

Whitemulti-layerplasticsingle-dosepipettecontaininganextractiblevolumeof0.5

ml.

Theinternallayersincontactwiththeproductaremadeofpolyacrylonitrile-

methacrylate.Thewhiteexternalcomplexiscomposedofpolypropylene/cyclic

olefinecopolymer/polypropylene.

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

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,waterways

orditcheswiththeproductoremptycontainer.

7. MARKETINGAUTHORISATIONHOLDER

ALFAMED

13èmeRue –L.I.D.

06517CarrosCedex

France

8. MARKETINGAUTHORISATIONNUMBER

Vm17902/4020

9. DATEOFFIRSTAUTHORISATION

20August2012

10. DATEOFREVISIONOFTHETEXT

August2012