Fiprokil Spot On Solution 50 mg for Cats

Main information

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

Documents

Localization

  • Available in:
  • Fiprokil Spot On Solution 50 mg for Cats
    Portugal
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0468/001
  • Authorization date:
  • 20-03-2013
  • EU code:
  • UK/V/0468/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:September2013

AN:00681/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BobMartinClear50mgspot-onsolutionforcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

One0.5mlpipettecontains:

Activesubstance:

Fipronil 50mg

Excipients:

ButylhydroxyanisoleE320 0.1mg

ButylhydroxytolueneE321 0.05mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clear,paleambersolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cats.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofflea(Ctenocephalidesspp.)infestations.

Fleaswillbekilledwithin24h.Theproducthasapersistentinsecticidalefficacyfor

upto5weeksagainstfleas(Ctenocephalidesspp.).

Althoughnoimmediatekillingeffectagainsttickshasbeendemonstrated,the

producthasshownanacaricidalefficacyagainstDermacentorreticulatus.Ifticksof

thisspeciesarepresentwhentheproductisapplied,alltheticksmaynotbekilled

withinthefirst48hoursbuttheywillbekilledwithinaweek.

4.3 Contraindications

Donotuseonkittenslessthan2monthsoldand/orweighinglessthan1kg.

Donotuseonsick(systemicdiseases,fever)orconvalescentanimals.

Donotuseinrabbits,asadversedrugreactionsandevendeathcouldoccur.

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Donotuseonanimalswithknownhypersensitivitytotheactivesubstanceortoany

ofexcipients.

4.4Specialwarningsforeachtargetspecies

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareas

suchascarpetsandsoftfurnishingswhichshouldbetreated,incaseofmassive

infestationandatthebeginningofthecontrolmeasures,withasuitableinsecticide

andvacuumedregularly.

Avoidfrequentswimmingorshampooingtheanimalbecausethemaintenanceof

effectivenessoftheproductinthesecaseshasnotbeentested.

Foroptimumcontroloffleaproblemsinamulti-pethousehold,alldogsandcatsin

thehouseholdshouldbetreatedwithasuitableinsecticide.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Avoidcontactwiththeanimal’seyes.Inthecaseofaccidentaleyecontact,

immediatelyandthoroughlyflushtheeyeswithwater.

Donotapplytheproductonwoundsordamagedskin.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoff,andtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Specificstudiesincatsinvestigatingthesafetyoftheproductfollowingrepeated

administrationoratover-dosagehavenotbeenconductedduetotheknownsafety

profileoftheactivesubstancesandexcipients.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contact

betweentheproductandthemouthoreyesshouldbeavoided.

Inthecaseofaccidentaleyecontact,immediatelyandthoroughlyflushtheeyeswith

water.Ifeyeirritationpersistsseekmedicaladviceandshowthepackageleafletor

thelabeltothephysician.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,washhandswith

soapandwater.Washhandsafteruse.

Donotsmoke,drinkoreatduringapplication.

Animalsorpeoplewithaknownhypersensitivitytofiproniloranyoftheother

ingredientsshouldavoidcontactwiththeproduct.Treatedanimalsshouldnotbe

handleduntiltheapplicationsiteisdry,andchildrenshouldnotbeallowedtoplay

withtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearly

evening,andthatrecentlytreatedanimalsshouldnotbeallowedtosleepwith

owners,especiallychildren.

Revised:September2013

AN:00681/2012

Otherprecautions

Theproductmayhaveadverseeffectsonpainted,varnishedorotherhousehold

surfacesorfurnishings.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlytothe

natureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionsattheapplicationsite(squamosis,localalopecia,pruritus,erythema)and

generalpruritusoralopeciahavebeenreportedafteruse.Exceptionally,

hypersalivation,reversibleneurologicsymptoms(hyperesthesia,depression,nervous

symptoms)orvomitinghavebeenobservedafteruse.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicor

embryotoxiceffects.Studieshavenotbeencarriedoutwiththisproductinpregnant

andlactatingqueens.Useinpregnancyandlactationonlyinaccordancewith

professionalveterinaryadviceandabenefit/riskassessment.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Routeofadministrationanddosage:

Externaluseonly.

Administerbytopicalapplicationtotheskin1pipetteof0.5mlperanimal.

Removethepipettefromtheblisterpackaging.Holdthepipetteinanuprightposition

andsnapoffthetopsectionofthecap,therebyopeningthepipette.

Partthepet’scoatuntiltheskinisvisible.Placethetipofthetubedirectlyagainstthe

baredskinandsqueezegently.Emptyapproximatelyhalfthecontentsateachoftwo

pointsalongthecat’sback.Thefirstapplicationpointisatthebaseoftheheadand

Revised:September2013

AN:00681/2012

thesecondapplicationpointisbetweentheshoulderblades.Squeezethetube

severaltimestoensuredosingiscomplete.Avoidapplyingthesolutionontothefur

anddonotrubintotheskin.

Applicationofthesolutionasdirectedminimisesthepossibilitythattheanimalwilllick

thesolutionoff.

Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsince

thiswillcauseastickyappearanceofhairsatthetreatmentspot.However,should

thisoccur,itwillusuallydisappearwithin24-48hourspostapplication.Crystalsmay

beseenonthehairandslightscalingmayoccurwithin24-48hoursafterapplication.

Treatmentschedule:

Foroptimalcontroloffleainfestationthetreatmentschedulecanbebasedonthe

localepidemiologicalsituation.

Theminimumintervalbetweentwotreatmentsis4weeks.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thetoxicityoftheveterinarymedicinalproductwhenadministeredtotheskinisvery

low.Theriskofexperiencingadverseeffects(seesection4.6)mayincreaseincases

ofover-dose,soanimalsshouldalwaysbetreatedwiththecorrectproductaccording

tospeciesandbodyweight.

Noadverseeffectswereobservedinatargetanimalsafetystudyineightweeks-old

catsweighingabout1kgtreatedwith5timesthetherapeuticdosemonthlyforthree

months.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

5.1 Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.Itacts

byinhibitingtheGABAcomplex,bindingtothechloridechannelandtherebyblocking

pre-andpost-synaptictransferofchlorideionsacrosscellmembranes.Thisresults

inuncontrolledactivityofthecentralnervoussystemanddeathofinsectsoracarids.

Fipronilexhibitsaninsecticidalandacaricidalactivityagainstfleas(Ctenocephalides

spp)andacaricidalactivityagainstticks(Dermacentorreticulatus)inthecat.

Revised:September2013

AN:00681/2012

5.2Pharmacokineticparticulars

Invitro,fipronilismainlymetabolisedwithsubcellularliverfractionstoitssulfone

derivative.However,thismaybeoflimitedrelevance‘invivo’asfipronilispoorly

absorbedinthecat.Theconcentrationsoffipronilonthehairdecreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ButylhydroxyanisoleE320

ButylhydroxytolueneE321

Benzylalcohol

Diethyleneglycolmonoethylether

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Storebelow25°C,inadryplaceintheoriginalpackaging.

6.5Natureandcompositionofimmediatepackaging

Whiteopaqueorpinkorgreentranslucentpolypropylenesingle-dosepipettescontaining

anextractablevolumeof0.5mlpackagedinaclearPVCblisterclosedbyheatsealing

withaluminiumfoilandplacedinacartonboxorblistercard.

Blistercardsorboxesof1,2,3,4,5or6pipettes.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,waterways

orditcheswiththeproductoremptycontainer.

Revised:September2013

AN:00681/2012

7. MARKETINGAUTHORISATIONHOLDER

BobMartinUKLtd.

WemberhamLane

Yatton

Somerset

BS494BS

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm00715/4119

9. DATEOFFIRSTAUTHORISATION

Date:14December2011

10. DATEOFREVISIONOFTHETEXT

Date:September2013

APPROVED 20/09/13