Fiprokil Spot On Solution 402 mg for Extra large Dogs

Main information

  • Trade name:
  • Fiprokil Spot On Solution 402 mg for Extra large Dogs
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fiprokil Spot On Solution 402 mg for Extra large Dogs
    Portugal
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0468/005
  • Authorization date:
  • 20-03-2013
  • EU code:
  • UK/V/0468/005
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:September2013

AN:00685/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BobMartinClear402mgspot-onsolutionforextralargedogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

One4.02mlpipettecontains:

Activesubstance:

Fipronil 402mg

Excipients:

ButyhydroxyanisoleE320 0.804mg

ButylhydroxytolueneE321 0.402mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clear,paleambersolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofflea(Ctenocephalidesspp.)andtick(Rhipicephalussanguineusand

Ixodesricinus)infestations.

Fleaswillbekilledwithin24h.Insecticidalefficacyagainstnewinfestationswithadult

fleaspersistsfor8weeks.

Theproducthasapersistentacaricidalefficacyfor4weeksagainstticks

(Rhipicephalussanguineus,Ixodesricinus,Dermacentorreticulatus).

Tickswillusuallybekilledwithin48haftercontactwithFipronil.However,ifticksof

somespecies(Dermacentorreticulatus)arealreadypresentwhentheproductis

applied,alloftheticksmaynotbekilledwithinthefirst48hours.

Revised:September2013

AN:00685/2012

4.3 Contraindications

Donotuseonpuppieslessthan2monthsoldand/orweighinglessthan2kg.Donot

useonsick(e.g.systemicdiseases,fever…)orconvalescentanimals.

Donotuseinrabbits,asadversereactionsandevendeathcouldoccur.

Thisproductisspecificallydevelopedfordogs.Donotuseincats,asthiscouldlead

tooverdosing.

Donotuseonanimalswithknownhypersensitivitytotheactivesubstanceortoany

oftheexcipients.

4.4Specialwarnings<foreachtargetspecies>

Avoidfrequentswimmingorshampooingtheanimalbecausethemaintenanceof

effectivenessoftheproductinthesecaseshasnotbeentested.

Theproductdoesnotpreventticksfromattachingtotheanimals.Iftheanimalhas

beentreatedpriortoexposuretotheticks,thetickswillbekilledinthefirst24-48

hoursafterattachment.Thiswillusuallybepriortoengorgement,minimisingbutnot

excludingtheriskoftransmissionofdiseases.Oncedead,tickswilloftendropoff

theanimal,butanyremainingticksmayberemovedwithagentletwist.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareas

suchascarpetsandsoftfurnishingswhichshouldbetreated,incaseofmassive

infestationandatthebeginningofthecontrolmeasures,withasuitableinsecticide

andvacuumedregularly.

Foroptimalcontroloffleainfestationinmulti-pethousehold,alldogsandcatsinthe

householdshouldbetreatedwithasuitableinsecticide.

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Animalsshouldbeweighedaccuratelypriortotreatment.

Avoidcontactwiththeanimal’seyes.Inthecaseofaccidentaleyecontact,

immediatelyandthoroughlyflushtheeyeswithwater.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoff,andtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Donotapplytheproductonwoundsordamagedskin.

ii) Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contact

betweentheproductandthemouthoreyesshouldbeavoided.

Revised:September2013

AN:00685/2012

Inthecaseofaccidentaleyecontact,immediatelyandthoroughlyflushtheeyeswith

water.Ifeyeirritationpersistsseekmedicaladviceandshowthepackageleafletor

thelabeltothephysician.

Donotsmoke,drinkoreatduringapplication.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,washhandswith

soapandwater.Washhandsafteruse.

Animalsorpeoplewithaknownhypersensitivitytofiproniloranyoftheother

ingredientsshouldavoidcontactwiththeproduct.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildren

shouldnotbeallowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itis

thereforerecommendedthatanimalsarenottreatedduringtheday,butshouldbe

treatedduringtheearlyevening,andthatrecentlytreatedanimalsshouldnotbe

allowedtosleepwithowners,especiallychildren.

iii) Environmentalwarning

Fipronilmayadverselyaffectaquaticorganisms.Dogsshouldnotbeallowedtoswim

inwatercoursesfor2daysafterapplication.

iv) Otherprecautions

Theproductmayhaveadverseeffectsonpainted,varnishedorotherhousehold

surfacesorfurnishings.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlytothe

natureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionsontheapplicationsite(skindiscoloration,localalopecia,pruritus,

erythema)andgeneralpruritusoralopeciahavebeenreportedafteruse.

Exceptionally,hypersalivation,reversibleneurologicsymptoms(hyperesthesia,

depression,nervoussymptoms),vomitingorrespiratorysymptomshavebeen

observedafteruse.

4.7Useduringpregnancyandlactation

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicor

embryotoxiceffect.Studieshavenotbeencarriedoutwiththisproductinpregnant

andlactatingbitches.Useinpregnancyandlactationonlyinaccordancewith

professionalveterinaryadviceandabenefit/riskassessment.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Routeofadministrationanddosage:

Revised:September2013

AN:00685/2012

Externaluseonly.Administerbytopicalapplicationtotheskinaccordingtothe

bodyweightasfollows:1pipetteof4.02mlperdogweighingover40kgandupto60

kgbodyweight.

Fordogsover60kg,usetwopipettesof2.68ml.

Methodofadministration:

Removethepipettefromtheblisterpackaging.Holdthepipetteinanuprightposition

andsnapoffthetopsectionofthecap,therebyopeningthepipette.

rtyourdog’scoatuntiltheskinisvisible.Placethetipofthepipettedirectly

againstthebaredskinandsqueezegently.Emptyapproximatelyhalfthecontentsat

eachoftwopointsalongthedog’sback,preferablyatthebaseoftheheadand

betweentheshoulderblades.Squeezethepipetteseveraltimestoensuredosingis

complete.Avoidapplyingthesolutionontothefuranddonotrubintotheskin.

Applicationofthesolutionasdirectedminimisesthepossibilitythattheanimalwilllick

thesolutionoff.Donotallowpetstolickeachotheraftertreatment.

Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsince

thiswillcauseastickyappearanceofhairsatthetreatmentspot.However,should

thisoccur,itwillusuallydisappearwithin24-48hourspostapplication.Crystalsmay

beseenonthehairandslightscalingmayoccurwithin24-48hoursafterapplication.

Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestationthetreatmentschedulecanbebased

onthelocalepidemiologicalsituation.

Theminimumintervalbetweentwotreatmentsis4weeks.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesin2month-old

puppies,growingdogsanddogsweighingabout2kgtreatedwith5timesthe

therapeuticdoseonceamonthfor3consecutivemonths.Theriskofadverseeffects

(seesection4.6)mayincreaseincasesofoverdose.

4.11Withdrawalperiod(s)

Notapplicable.

Revised:September2013

AN:00685/2012

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

5.1 Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.Itacts

byinhibitingtheGABAcomplex,bindingtothechloridechannelandtherebyblocking

pre-andpost-synaptictransferofchlorideionsacrosscellmembranes.Thisresults

inuncontrolledactivityofthecentralnervoussystemanddeathofinsectsoracarids.

Fipronilexhibitsaninsecticidalandacaricidalactivityagainstfleas(Ctenocephalides

spp),ticks(Rhipicephalusspp,IxodessppincludingIxodesricinus)inthedog.

5.2Pharmacokineticparticulars

Fipronilismainlymetabolisedtoitssulfonederivative(RM1602),whichalso

possessesinsecticidalandacaricidalproperties.Theconcentrationsoffipronilonthe

hairdecreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ButylhydroxyanisoleE320

ButylhydroxytolueneE321

Benzylalcohol

Diethyleneglycolmonoethylether

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Storebelow25

C,inadryplaceintheoriginalpackaging.

6.5Natureandcompositionofimmediatepackaging

Whiteopaqueorpurpleorredtranslucentpolypropylenesingle-dosepipettescontaining

anextractablevolumeof4.02mlpackagedinaclearPVCblisterclosedbyheatsealing

withaluminiumfoilandplacedinacartonboxorblistercard.

Blistercardsorboxesof1,2,3,4,5or6pipettes.

Notallpacksizesmaybemarketed.

Revised:September2013

AN:00685/2012

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminate

ponds,waterwaysorditcheswiththeproductoremptycontainer.

7. MARKETINGAUTHORISATIONHOLDER

BobMartinUKLtd.

WemberhamLane

Yatton

Somerset

BS494BS

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm00715/4123

9. DATEOFFIRSTAUTHORISATION

14December2011

10.DATEOFREVISIONOFTHETEXT

September2013

APPROVED 20/09/13

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