Alfamed Fipronil 67 mg Spot-On Solution for Small Dogs

Main information

  • Trade name:
  • Alfamed Fipronil 67 mg Spot-On Solution for Small Dogs
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Alfamed Fipronil 67 mg Spot-On Solution for Small Dogs
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0397/002
  • Authorization date:
  • 21-03-2012
  • EU code:
  • UK/V/0397/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:August2012

AN:00102/2011

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ALFAMEDFIPRONIL(BE)/FIPROLINE(HU,RO)/VETFLEA(UK) 67mgSpot-on

solutionforsmalldogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

One0.67mlpipettecontains:

Activesubstance:

Fipronil 67mg

Excipients:

ButyhydroxyanisoleE3200.134mg

ButylhydroxytolueneE3210.067mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clear,colourlesstoyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs.

4.2Indicationsforuse

Treatmentofflea(Ctenocephalidesspp.)andtick(Dermacentorreticulatus)

infestations.

Insecticidalefficacyagainstnewinfestationswithadultfleaspersistsforupto8weeks.

Theproducthasapersistentacaricidalefficacyforupto4weeksagainstticks

(Rhipicephalussanguineus,Ixodesricinus,Dermacentorreticulatus).Ifticksofsome

species(RhipicephalussanguineusandIxodesricinus)arepresentwhentheproduct

isapplied,alltheticksmaynotbekilledwithinthefirst48hoursbuttheymaybekilled

withinaweek.

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergy

Dermatitis(FAD)wherethishasbeenpreviouslydiagnosedbyaveterinarysurgeon.

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4.3Contraindications

Donotuseonpuppieslessthan2monthsoldand/orweighinglessthan2kginthe

absenceofavailabledata.

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

Donotuseinrabbits,asadversereactionsandevendeathcouldoccur.

Thisproductisspecificallydevelopedfordogs.Donotuseincats,asthiscouldleadto

overdosing.

Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyofexcipients.

4.4Specialwarningsforeachtargetspecies

Shampooinganhourpriortotreatmentdoesnotaffecttheefficacyoftheproduct

againstfleas.

Bathing/immersioninwaterwithintwodaysafterapplicationoftheproductshouldbe

avoided.Weeklyimmersioninwaterforoneminutereducestheperiodofpersistent

insecticidalefficacyagainstfleasbyoneweek.

Theproductdoesnotpreventticksfromattachingtotheanimals.Iftheanimalhasbeen

treatedpriortoexposuretotheticks,thetickswillbekilledinthefirst24-48hoursafter

attachment.Thiswillusuallybepriortoengorgement,minimisingbutnotexcludingthe

riskoftransmissionofdiseases.Oncedead,tickswilloftendropofftheanimal,butany

remainingticksmayberemovedwithagentlepull.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuch

ascarpetsandsoftfurnishingswhichshouldbetreated,incaseofmassiveinfestation

andatthebeginningofthecontrolmeasures,withasuitableinsecticideandvacuumed

regularly.

WhenusedaspartofastrategyforthetreatmentofFleaAllergyDermatitis,monthly

applicationstotheallergicpatientandtootherdogsinthehouseholdare

recommended.

Foroptimalcontroloffleainfestationinmulti-pethousehold,alldogsandcatsinthe

householdshouldbetreatedwithasuitableinsecticide.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Animalsshouldbeweighedaccuratelypriortotreatment.

Avoidcontactwiththeanimal’seyes.Inthecaseofaccidentaleyecontact,immediately

rinsetheeyeswithcleanwater.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoffandtomakesurethatanimalsdonotlickeachotherfollowingtreatment

Donotapplytheproductonwoundsordamagedskin.

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Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contact

betweentheproductandthemouthoreyesshouldbeavoided.

Inthecaseofaccidentaleyecontact,immediatelyrinsetheeyeswithcleanwater.Ifeye

irritationpersistsseekmedicaladviceandshowthepackageleafletorthelabeltothe

physician.

Donotsmoke,drinkoreatduringapplication.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,washhandswithsoap

andwater.Washhandsafteruse.

Peoplewithaknownhypersensitivitytofipronilorexcipients(seesection6.1.)should

avoidcontactwiththeveterinarymedicinalproduct.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildren

shouldnotbeallowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itis

thereforerecommendedthatanimalsarenottreatedduringtheday,butshouldbe

treatedduringtheearlyevening,andthatrecentlytreatedanimalsshouldnotbeallowed

tosleepwithowners,especiallychildren.

Otherprecautions

Fipronilmayadverselyaffectaquaticorganisms.Dogsshouldnotbeallowedtoswimin

watercoursesfor2daysafterapplication.

Theproductmayhaveadverseeffectsonpainted,varnishedorotherhousehold

surfacesorfurnishings.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlytothe

natureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneousreactions

ontheapplicationsite(skindiscoloration,localalopecia,pruritus,erythema)and

generalpruritusoralopeciahavebeenreportedafteruse.Exceptionally,

hypersalivation,reversibleneurologicsymptoms(hyperesthesia,depression,nervous

symptoms),vomitingorrespiratorysymptomshavebeenobservedafteruse.

4.7Useduringpregnancyandlactation

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicor

embryotoxiceffect.Studieshavenotbeencarriedoutwiththisproductinpregnantand

lactatingbitches.Useinpregnancyandlactationonlyinaccordancewithprofessional

veterinaryadviceandabenefit/riskassessment.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

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Routeofadministrationanddosage:

Externaluseonly.

Administerbytopicalapplicationtotheskinaccordingtothebodyweightasfollows:

1pipetteof0.67mlperdogweighingover2kgandupto10kgbodyweight.

Methodofadministration:

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethatthecontents

arewithinthemainbodyofthepipette.Breakthesnap-offtopofthespot-onpipette

alongthescoredline.

Partthepet’scoatuntilitsskinisvisible.Placethetipofthepipettedirectlyagainstthe

baredskinandsqueezegentlyseveraltimestoemptyitscontentsRepeatthis

procedureatoneortwodifferentpointsalongthepet’sback.

(Note:theshapeofthemarketedpipettescanbedifferentaswellasthepicturesonthe

marketedboxes/packageleaflets.)

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoff,andtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsincethis

willcauseastickyappearanceofhairsatthetreatmentspot.However,shouldthis

occur,itwilldisappearwithin24hourspostapplication.

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Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestationthetreatmentschedulecanbebased

onthelocalepidemiologicalsituation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesin2month-old

puppies,growingdogsanddogsweighingabout2kgtreatedwiththetherapeuticdose

onfiveconsecutivedays.Theriskofadverseeffects(seesection4.6)mayincreasein

casesofoverdose.

4.11Withdrawalperiod

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

5.1Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.Itactsby

inhibitingtheGABAcomplex,bindingtothechloridechannelandtherebyblockingpre-

andpost-synaptictransferofchlorideionsacrosscellmembranes.Thisresultsin

uncontrolledactivityofthecentralnervoussystemanddeathofinsectsoracarids.

Fipronilexhibitsaninsecticidalandacaricidalactivityagainstfleas(Ctenocephalides

spp),ticks(Rhipicephalusspp,Dermacentorspp,IxodessppincludingIxodesricinus)

inthedog.

Fleaswillbekilledwithin24h.Tickswillusuallybekilledwithin48haftercontactwith

Fipronil,howeverifticksofsomespecies(RhipicephalussanguineusandIxodes

ricinus)arealreadypresentwhentheproductisapplied,alloftheticksmaynotbekilled

withinthefirst48hours.

5.2Pharmacokineticparticulars

Fipronilismainlymetabolisedtoitssulfonederivative(RM1602),whichalsopossesses

insecticidalandacaricidalproperties.Theconcentrationsoffipronilonthehair

decreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ButylhydroxyanisoleE320

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ButylhydroxytolueneE321

Benzylalcohol

Diethyleneglycolmonoethylether

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Storebelow30°C.Storeinadryplace.Storeintheoriginalpackage.

6.5Natureandcompositionofimmediatepackaging

Whitemulti-layerplasticsingle-dosepipettescontaininganextractiblevolumeof0.67

ml.

Theinternallayersincontactwiththeproductaremadeofpolyacrylonitrile-methacrylate.

Thewhiteexternalcomplexiscomposedofpolypropylene/cyclicolefinecopolymer/

polypropylene.

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

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,waterwaysor

ditcheswiththeproductoremptycontainer.

7. MARKETINGAUTHORISATIONHOLDER

ALFAMED

13èmeRue –L.I.D.

06517CarrosCedex

France

8. MARKETINGAUTHORISATIONNUMBER

Vm17902/4021

9. DATEOFFIRSTAUTHORISATION

20August2012

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10.DATEOFREVISIONOFTHETEXT

August2012