FRONTLINE COMBO PACK CONSULT SPOT ON CAT

Main information

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

Documents

Localization

  • Available in:
  • FRONTLINE COMBO PACK CONSULT SPOT ON CAT
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0246/001
  • Authorization date:
  • 26-09-2012
  • EU code:
  • FR/V/0246/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

FrontlineComboPackConsultSpotonCat

SUMMARYOFPRODUCTCHARACTERISTICS

FrontlineComboPackConsultSpotonCat

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOPACKCONSULTSPOT-ONCAT

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachpipetteof0.5mlcontains:

Fipronil............................................................................................................50.00mg

(S)-methoprene...............................................................................................60.00mg

Butylhydroxyanisole(E320)...............................................................................0.10mg

Butylhydroxytoluene(E321)..............................................................................0.05mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clearambersolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Catsandferrets.

4.2 Indicationsforuse,specifyingthetargetspecies

Incats:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleasforsixweeksafterapplication.

-Eliminationofticks(Ixodesricinus,Dermacentorvariabilis,Rhipicephalussanguineus).The

producthasapersistentacaricidalefficacyforupto2weeksagainstticks(basedonexperimental

data).

- Eliminationofbitinglice(Felicolasubrostratus).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

Inferrets:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticks.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleas.

-Eliminationofticks(Ixodesricinus,).Theproducthasapersistentacaricidalefficacyfor4weeks

againstticks(basedonexperimentaldata).

FrontlineComboPackConsultSpotonCat

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4.3 Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan8weeksoldand/or

weighinglessthan1kg.Theproductshouldnotbeusedonferretslessthan6monthsold.

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

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur.Inabsence

ofstudies,theuseoftheproductisnotrecommendedinnon-targetspecies.

4.4 Specialwarningsfortargetspecies

Avoidthecontactwiththeanimal’seyes.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincatsandferretsare

available.However,basedoninformationavailablefordogsshampooedasfrom2daysafter

applicationoftheproduct,itisnotrecommendedtobathanimalswithin2daysafterapplicationofthe

product.

Theremaybeanattachmentofsingleticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Thepotentialtoxicityoftheproductforkittensoflessthan8weeksofageincontactwitha treated

queenisnotdocumented.Specialcareshouldbetakeninthiscase.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboPackConsultSpotOnCat.Avoidcontentscomingintocontactwiththefingers.If

thisoccurs,washhandswithsoapandwater.

Afteraccidentalexposuretheeyeshouldberinsedcarefullywithpurewater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

4.6 Adversereactions(frequencyandseriousness)

Donotoverdose.

Cats

FrontlineComboPackConsultSpotonCat

eu-frontline-combo-cat-201208-pi-a 4

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite

(scaling,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafteruse.

Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns)orvomitinghavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

4.7 Useduringpregnancy,lactationorlay

Cats

Theproductcanbeusedduringpregnancy.

Fortreatmentduringthelactatingperiod,seesection4.5i).

Ferrets

Laboratorystudiesincatshavenotproducedanyevidenceofteratogenic,foetotoxicormaternotoxic

effects.Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinferretsduring

pregnancyandlactation.Useonlyaccordingtotherisk-benefitassessmentbytheresponsible

veterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Onepipetteof0.5mlpercat,correspondingtoaminimumrecommendeddoseof5mg/kgforfipronil

and6mg/kgfor(S)-methoprene,bytopicalapplicationtotheskin.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

Onepipetteof0.5mLperferretcorrespondingtoadoseof50mgforfiproniland60mgfor(S)-

methopreneperferret,bytopicalapplicationtotheskin.

Theminimumtreatmentintervalis4weeks.

Methodofadministration:

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.Partthecoatonthebackoftheanimalatthebaseofthe

neckinfrontoftheshoulderbladesuntiltheskinisvisible.Placethetipofthepipetteontheskinand

squeezethepipetteseveraltimestoemptyitscontentscompletelyanddirectlyontotheskininone

spot.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theriskofexperiencingadverseeffectsmayincreasewithoverdosing(seesection4.6).

Incats

Noundesirableeffectswereobservedintargetanimalsafetystudiesincatsandkittensaged8weeks

andolderandweighingabout1kgtreatedonceamonthatfivetimestherecommendeddoseforsix

consecutivemonths.

Itchingmayoccurfollowingtreatment.

Overdoseapplicationoftheproductwillcauseastickyappearanceofhairsatthetreatmentspot.

However,shouldthisoccur,itwilldisappearwithin24hourspostapplication.

Inferrets

FrontlineComboPackConsultSpotonCat

eu-frontline-combo-cat-201208-pi-a 5

Inferretsaged6monthsandolderandtreatedonceevery2weeksforfourtreatments,atfivetimes

therecommendeddose,bodyweightlosswasobservedinsomeanimals.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Theproductisaninsecticidalandacaricidalsolutionfortopicaluse,containinganassociationofan

adulticidalactiveingredient,fipronil,incombinationwithanovicidalandlarvicidalactiveingredient,(S)-

methoprene.

ATCvetcode:QP53AX65,groupEctoparasiticidesfortopicaluseQP53.

5.1 Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.Itactsbyinteracting

withligand-gatedchloridechannels,inparticularthosegatedbytheneurotransmittergamma-

aminobutyricacid(GABA),therebyblockingpre-andpost-synaptictransferofchlorideionsacrosscell

membranes.Thisresultsinuncontrolledactivityofthecentralnervoussystemanddeathofinsectsor

acarines.Fipronilkillsfleaswithin24hours,ticks(Dermacentorvariabilis,Rhipicephalus

sanguineus,Ixodesscapularis,Ixodesricinus,Haemaphysalislongicornis,Haemaphysalis

flava,Haemaphysaliscampanulata)andlicewithin48hourspost-exposure.

(S)-Methopreneisaninsectgrowthregulator(IGR)oftheclassofcompoundsknownasjuvenile

hormoneanaloguesthatinhibitthedevelopmentofimmaturestagesofinsects.Thiscompoundmimics

theactionofjuvenilehormoneandcausesimpaireddevelopmentanddeathofthedevelopingstagesof

fleas.Theon-animalovicidalactivityof(S)-methopreneresultsfromeitherdirectpenetrationofthe

eggshellofnewlylaideggsorfromabsorptionthroughthecuticleoftheadultfleas.(S)-methopreneis

alsoeffectiveinpreventingflealarvaeandpupaefromdeveloping,whichpreventscontaminationofthe

environmentoftreatedanimalswiththeimmaturestagesoffleas.

5.2 Pharmacokineticparticulars

Studiesofmetabolismoffipronilhavedemonstratedthatthemajormetaboliteisthesulfonederivative

offipronil.

(S)-methopreneisextensivelydegradedintocarbondioxideandacetatethataresubsequently

incorporatedintoendogenousmaterials.

Thepharmacokineticprofilesaftertopicalapplicationoffiproniland(S)-methopreneincombination

werestudiedincatsincomparisontointravenousdosingoffipronilor(S)-methoprenealone.This

establishedabsorptionandotherpharmacokineticparametersunderconditionsmimickingclinical

practice.Thetopicalapplication,withadditionalpotentialoralexposurefromlicking,resultedinoverall

systemicabsorptionoffipronil(18%)withameanmaximumconcentration(C

)ofapproximately

100ng/mlfiproniland13ng/mloffipronilsulfoneinplasma.

Peakfipronilplasmaconcentrationsarerapidlyattained(meant

approximately6h)anddeclinewith

ameanterminalhalf-lifeofapproximately25h.

Fipronilisslightlymetabolisedtofipronilsulfoneincats.

Plasmaconcentrationsof(S)-methopreneweregenerallybelowthelimitofquantitation(20ng/ml)in

catsaftertopicalapplication.

FrontlineComboPackConsultSpotonCat

eu-frontline-combo-cat-201208-pi-a 6

Both(S)-methopreneandfipronil,togetherwithitsmajormetabolite,arewell-distributedinthehaircoat

ofcatswithinonedayafterapplication.Theconcentrationsoffipronil,fipronilsulfoneand(S)-

methopreneinthehaircoatdecreasewithtimeandaredetectableforatleast59daysafterdosing.

Parasitesarekilledthroughcontactratherthanbysystemicexposure.

Nopharmacologicalinteractionbetweenfiproniland(S)-methoprenewasnoted.

Thepharmacokineticprofileoftheproducthasnotbeeninvestigatedinferrets.

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

Barexpipette210-polypropylene.

Salespresentation(s)andadministrativenumber(s)ofidentification

Blistercardof1x0.5mlpipettewithascoredtip

Boxof1blistercardof3x0.5mlpipetteswithascoredtip

Boxof2blistercardsof3x0.5mlpipetteswithascoredtip

Boxof6blistercardsof3x0.5mlpipetteswithascoredtip

Boxof10blistercardsof3x0.5mlpipetteswithascoredtip

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

Fiproniland(S)-methoprenemayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainers.

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eu-frontline-combo-cat-201208-pi-a 7

7. MARKETINGAUTHORISATIONHOLDER

MERIAL

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletednationally

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Tobecompletednationally

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

22-11-2018

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BROADLINE (Merial)

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