FRONTLINE COMBO PACK CONSULT SPOT ON DOG XL

Main information

  • Trade name:
  • FRONTLINE COMBO PACK CONSULT SPOT ON DOG XL
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FRONTLINE COMBO PACK CONSULT SPOT ON DOG XL
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Fipronil, combinations
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0246/005
  • Authorization date:
  • 26-09-2012
  • EU code:
  • FR/V/0246/005
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

FrontlineComboPackConsultSpotonDogXL

SUMMARYOFPRODUCTCHARACTERISTICS

FrontlineComboPackConsultSpotonDogXL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOPACKCONSULTPACKCONSULTSPOT-ONDOGXL

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachpipetteof4.02mlcontains:

Fipronil...................................................................................................................402.00mg

(S)-methoprene.......................................................................................................361.80mg

Butylhydroxyanisole(E320)........................................................................................0.80mg

Butylhydroxytoluene(E321)........................................................................................0.40mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clearambersolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofdogsweighingover40kgbodyweight:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Treatmentoffleainfestations(Ctenocephalidesspp.).Insecticidalefficacyagainstnew

infestationswithadultfleaspersistsfor8weeks.Preventionofthemultiplicationoffleasbyinhibiting

thedevelopmentofeggs(ovicidalactivity)andlarvaeandpupae(larvicidalactivity)originatingfrom

eggslaidbyadultfleasforeightweeksafterapplication.

-Treatmentoftickinfestations(Ixodesricinus,Dermacentorvariabilis,Dermacentorreticulatus,

Rhipicephalussanguineus).Theproducthasapersistentacaricidalefficacyforupto4weeks

againstticks.

-Treatmentofinfestationswithbitinglice(Trichodectescanis).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

4.3 Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonpuppieslessthan8weeksold

Donotuseinrabbits,asadversereactionswithevenmortalitycouldoccur.Inabsenceof

studies,theuseoftheproductisnotrecommendedinnon-targetspecies.

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

Thisproductisspecificallydevelopedfordogs.Donotuseincatsandferrets,asthiscouldleadto

overdosing.

4.4 Specialwarningsfortargetspecies

FrontlineComboPackConsultSpotonCat

eu-frontline-combo-cat-201112-pi-a 3

Bathing/immersioninwaterwithin2daysafterapplicationoftheproductandmorefrequentbathing

thanonceaweekshouldbeavoided,asnostudyhasbeenperformedtoinvestigatehowthisaffects

theefficacyoftheproduct.Emollientshampooscanbeusedpriortotreatment,butreducetheduration

ofprotectionagainstfleastoapproximately5weekswhenusedweeklyafterapplicationofthe

product.Weeklybathingwitha2%chlorhexidinemedicatedshampoodidnotaffectefficacyagainst

fleasduringa6-weeklongstudy.

Dogsshouldnotbeallowedtoswiminwatercoursesfor2daysafterapplication(seesection6.6).

Theremaybeanattachmentofafewticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Avoidcontactwiththeanimal'seyes.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboPackConsultSpotOnDog.Avoidcontentscomingintocontactwiththefingers.If

thisoccurs,washhandswithsoapandwater.

Afteraccidentalocularexposuretheeyeshouldberinsedcarefullywithpurewater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

4.6 Adversereactions(frequencyandseriousness)

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite(skin

discoloration,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafter

use.Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,

othernervoussigns),vomitingorrespiratorysymptomshavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

Donotoverdose.

4.7 Useduringpregnancy,lactationorlay

Theproductcanbeusedduringpregnancyandlactation.

FrontlineComboPackConsultSpotonCat

eu-frontline-combo-cat-201112-pi-a 4

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Onepipetteof4.02ml(XL)perdogweighingover40kg,correspondingtoaminimumrecommended

doseof6.7mg/kgforfiproniland6mg/kgfor(S)-methoprene,bytopicalapplicationtotheskin.

Intheabsenceofsafetystudiestheminimumtreatmentintervalis4weeks.

Methodofadministration:

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.Partthecoatonthebackoftheanimalatthebaseofthe

neckinfrontoftheshoulderbladesuntiltheskinisvisible.Placethetipofthepipetteontheskinand

squeezethepipetteseveraltimestoemptyitscontentscompletelyanddirectlyontotheskininone

spot.

Temporarychangestothecoat(clumped/greasyhair)maybenotedattheapplicationsite.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesin8-week-oldpuppies,growingdogs

anddogsweighingabout2kgtreatedonceatfivetimestherecommendeddose.Theriskof

experiencingadverseeffects(seesection4.6)mayhoweverincreasewhenoverdosing,soanimals

shouldalwaysbetreatedwiththecorrectpipettesizeaccordingtobodyweight.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Theproductisaninsecticidalandacaricidalsolutionfortopicaluse,containinganassociationofan

adulticidalactiveingredient,fipronil,incombinationwithanovicidalandlarvicidalactiveingredient,(S)-

methoprene.

ATCvetcode:QP53AX65,groupEctoparasiticidesfortopicaluseincl.insecticidesQP53.

5.1 Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.Itactsbyinteracting

withligand-gatedchloridechannels,inparticularthosegatedbytheneurotransmittergamma-

aminobutyricacid(GABA),therebyblockingpre-andpost-synaptictransferofchlorideionsacrosscell

membranes.Thisresultsinuncontrolledactivityofthecentralnervoussystemanddeathofinsectsor

acarines.Fipronilkillsfleaswithin24hoursandticks(Dermacentorreticulatus,Dermacentor

variabilis,Rhipicephalussanguineus,Ixodesscapularis,Ixodesricinus,Haemaphysalis

longicornis,Haemaphysalisflava,Haemaphysaliscampanulata)andlicewithin48hourspost-

exposure.

(S)-Methopreneisaninsectgrowthregulator(IGR)oftheclassofcompoundsknownasjuvenile

hormoneanaloguesthatinhibitthedevelopmentofimmaturestagesofinsects.Thiscompoundmimics

theactionofjuvenilehormoneandcausesimpaireddevelopmentanddeathofthedevelopingstagesof

fleas.Theon-animalovicidalactivityof(S)-methopreneresultsfromeitherdirectpenetrationofthe

eggshellofnewlylaideggsorfromabsorptionthroughthecuticleoftheadultfleas.(S)-methopreneis

FrontlineComboPackConsultSpotonCat

eu-frontline-combo-cat-201112-pi-a 5

alsoeffectiveinpreventingflealarvaeandpupaefromdeveloping,whichpreventscontaminationofthe

environmentoftreatedanimalswiththeimmaturestagesoffleas.

5.2 Pharmacokineticparticulars

Studiesofmetabolismoffipronilhavedemonstratedthatthemajormetaboliteisthesulfonederivative

offipronil.

(S)-methopreneisextensivelydegradedintocarbondioxideandacetatethataresubsequently

incorporatedintoendogenousmaterials.

Thepharmacokineticprofilesaftertopicalapplicationoffiproniland(S)-methopreneincombination

werestudiedindogsincomparisontointravenousdosingoffipronilor(S)-methoprenealone.This

establishedabsorptionandotherpharmacokineticparameters.Thetopicalapplicationresultedinlow

systemicabsorptionoffipronil(11%)withameanmaximumconcentration(C

)ofapproximately

35ng/mlfiproniland55ng/mloffipronilsulfoneinplasma.

Peakfipronilplasmaconcentrationsareslowlyattained(meant

approximately101h),anddecline

slowly(meanterminalhalf-lifeapproximately154h,highestvaluesareobservedformales).

Fipronilisextensivelymetabolisedtofipronilsulfoneaftertopicaladministration.

Plasmaconcentrationsof(S)-methoprenewerebelowthelimitofquantitation(20ng/ml)indogsafter

topicalapplication.

Both(S)-methopreneandfipronil,togetherwithitsmajormetabolite,arewelldistributedinthehaircoat

ofadogwithinonedayafterapplication.Theconcentrationsoffipronil,fipronilsulfoneandS-

methopreneinthehaircoatdecreasewithtimeandaredetectableforatleast60daysafterdosing.

Parasitesarekilledthroughcontactratherthansystemicexposure.

Nopharmacologicalinteractionbetweenfiproniland(S)-methoprenewasnoted.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Butylhydroxyanisole(E320)

Butylhydroxytoluene(E321)

Ethanol

Polysorbate80(E433)

Polyvidone

Diethyleneglycolmonoethylether

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4.Specialprecautionsforstorage

Donotstoreabove30°C.Storeintheoriginalpackage.

6.5 Natureandcompositionofimmediatepackaging

FrontlineComboPackConsultSpotonCat

eu-frontline-combo-cat-201112-pi-a 6

Barexpipette210-polypropylene.

Salespresentation(s)andadministrativenumber(s)ofidentification

Blistercardof1x4.02mlpipettewithascoredtip

Boxof1blistercardof3x4.02mlpipetteswithascoredtip

Boxof2blistercardsof3x4.02mlpipetteswithascoredtip

Boxof6blistercardof3x4.02mlpipetteswithascoredtip

Boxof10blistercardsof3x4.02mlpipetteswithascoredtip

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

Fiproniland(S)methoprenemayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainers.

7. MARKETINGAUTHORISATIONHOLDER

MERIAL

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletednationally.

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Tobecompletednationally

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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BROADLINE (Merial)

BROADLINE (Merial)

BROADLINE (Active substance: Fipronil/ S-methoprene/ Eprinomectin/ Praziquantel) - Centralised - Yearly update - Commission Decision (2018) 4164 of Fri, 29 Jun 2018

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CERTIFECT (Merial)

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