FRONTLINE

Main information

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

Documents

Localization

  • Available in:
  • FRONTLINE COMBO SPOT ON CAT
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0139/005
  • Authorization date:
  • 19-12-2011
  • EU code:
  • FR/V/0139/005
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

FrontlineComboSpotonCat

SUMMARYOFPRODUCTCHARACTERISTICS

FrontlineComboSpotonCat

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-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).

FrontlineComboSpotonCat

eu-frontline-combo-cat-201208-pi-p 3

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.

Thepotentialtoxicityoftheproductforkittensoflessthan8weeksofageincontactwithatreated

queenisnotdocumented.Specialcareshouldbetakeninthiscase.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnCat.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

Afteraccidentalexposuretheeyeshouldberinsedcarefullywithpurewater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

4.6 Adversereactions(frequencyandseriousness)

Donotoverdose.

Cats

FrontlineComboSpotonCat

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

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite

(scaling,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafteruse.

Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns)orvomitinghavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

4.7 Useduringpregnancy,lactationorlay

Cats

Theproductcanbeusedduringpregnancy andlactation .

Fortreatmentduringthelactatingperiod,seesection4.5 i)

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

FrontlineComboSpotonCat

eu-frontline-combo-cat-201208-pi-p 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.

FrontlineComboSpotonCat

eu-frontline-combo-cat-201208-pi-p 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

Natureofprimarypackaging

Agreenpipettecomposedofaheat-formedshell(polypropyleneandpolyacrylonitrile-methylate

copolymer)andafilm(polyethyleneterephthalate,aluminium,andpolyacrylonitrile-methylate

copolymer).

Salespresentation(s)andadministrativenumber(s)ofidentification

Blistercardof1x0.5mlpipettewithascoredtip

Boxof1blistercardof3x0.5mlpipetteswithascoredtip

Boxof2blistercardsof3x0.5mlpipetteswithascoredtip

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

FrontlineComboSpotonCat

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

Fiproniland(S)-methoprenemayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainers.

7. MARKETINGAUTHORISATIONHOLDER

MERIAL

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletednationally

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Tobecompletednationally

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

FrontlineComboSpotOnCat

LABELLINGANDPACKAGELEAFLET

FrontlineComboSpotOnCat

A.LABELLING

FrontlineComboSpotOnCat

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONCAT

Boxof3pipettes(or6pipettes)

CASEN°1:Thetextbelowcorrespondstothecaseswherealltheinformationofthepackage

leafletCANbeconveyedontheouterpackagingandcontainer.Consequently,inthatcase,no

separateleafletisprovidedincompliancewiththecurrentQRDTemplate.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL10%w/v(S)METHOPRENE12%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Clearambersolutioncontaining:

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

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

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

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

Excipient(s):q.s...................................................................................................0.5ml

3. PHARMACEUTICALFORM

Spot-onsolution

4. PACKAGESIZE

[ifinthecaseofaboxof3pipettes:]

3PIPETTESOF0.5ml

[ifinthecaseofaboxof6pipettes:]

6PIPETTESOF0.5ml

5. TARGETSPECIES

CATS

FERRETS

6. INDICATION(S)

Incats:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleasforsixweeksafterapplication.

FrontlineComboSpotonCat

-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).Theproducthasapersistentacaricidalefficacyfor upto 4

weeksagainstticks(basedonexperimentaldata).

Fipronilkillsfleaswithin24hoursandticksandlicewithin48hourspost-exposure.

7. METHODANDROUTE(S)OFADMINISTRATION

Spoton

METHODOFADMINISTRATION

1-Takethepipetteoutofitspackaging

2-Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.

3-Partthecoatonthebackoftheanimalatthebaseoftheneckinfrontoftheshoulderbladesuntil

theskinisvisible.Placethetipofthepipetteontheskinandsqueezethepipetteseveraltimestoempty

itscontentscompletelyanddirectlyontotheskininonespot.

Dosage

Onepipetteof0.5mlpercat,correspondingtoaminimumrecommendeddoseof5mg/kgforfipronil

and6mg/kgfor(S)-methoprene,bytopicalapplicationtotheskin.

Onepipetteof0.5mLperferretcorrespondingtoadoseof50mgforfiproniland60mgfor(S)-

methopreneperferret,bytopicalapplicationtotheskin.

8. WITHDRAWALPERIOD

[NOTAPPLICABLE]

9. SPECIALWARNING(S),IFNECESSARY

Forexternaluseonly.

Useduringpregnancyandlactation

FrontlineComboSpotOnCatcanbeusedduringpregnancy andlactation incats. Fortreatmentduring

thelactatingperiod,seesectionPrecautionsbelow.

Useonlyaccordingtobenefit/riskassessmentbyaresponsibleveterinarianinferrets.

Precautions

FrontlineComboSpotonCat

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincatsandferretsare

available.However,basedoninformationavailablefordogsshampooedasfrom2daysafter

applicationoftheproduct,itisnotrecommendedtobathanimalswithin2daysafterapplicationofthe

product.

Avoidthecontactwiththeanimal’seyes.

Theremaybeanattachmentofsingleticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Thepotentialtoxicityoftheproductforkittensoflessthan8weeksofageincontactwithatreated

queenisnotdocumented.Specialcareshouldbetakeninthiscase.

Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan8weeksoldand/or

weighinglessthan1kg.Theproductshouldnotbeusedinferretslessthan6monthsold.

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

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur. Inabsence

ofstudies,theuseoftheproductisnotrecommendedinnon-targetspecies.

UndesirableEffects

Donotoverdose.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedhere,pleaseinformyourveterinary

surgeon.

Cats

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite

(scaling,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafteruse.

Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns)orvomitinghavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

Overdose

Theriskofexperiencingadverseeffectsmayhoweverincreasewithoverdosing(seeUndesirable

Effects).

Cats

Noundesirableeffectswereobservedintargetanimalsafetystudiesincatsandkittensaged8weeks

andolderandweighingabout1kgtreatedonceamonthatfivetimestherecommendeddoseforsix

consecutivemonths.

Itchingmayoccurfollowingtreatment.

Overdoseapplicationoftheproductwillcauseastickyappearanceofhairsatthetreatmentspot.

However,shouldthisoccur,itwilldisappearwithin24hourspostapplication.

Ferrets

Inferretsaged6monthsandolderandtreatedonceevery2weeksforfourtreatments,atfivetimes

therecommendeddose,bodyweightlosswasobservedinsomeanimals.

FrontlineComboSpotonCat

Userwarnings

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnCat.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

Afteraccidentalexposuretheeyeshouldberinsedcarefullywithplainwater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

10. EXPIRYDATE

EXP{MM-YYYY}

11. SPECIALSTORAGECONDITIONS

Donotstoreabove30°C.Storeintheoriginalpackage.

Do notuseaftertheexpirydatestated onthepackageafterEXP.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Fiproniland(S)-methoprenemayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainers.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourveterinarysurgeon

howtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelptoprotectthe

environment.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

[Tobecompletednationally,bydefault:]

MERIAL

29, avenueTonyGarnier

69007 Lyon, FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

FrontlineComboSpotonCat

[Tobecompletednationally]

17. MANUFACTURER’SBATCHNUMBER

BN{number}

Additionalinformation:

[Manufacturer]

MERIAL

4 cheminduCalquet

31300Toulouse, France

FrontlineComboSpotonCat

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONCAT

Boxof3pipettes(or6pipettes)

CASEN°2:Thetextbelowcorrespondstothecaseswherealltheinformationofthepackage

leafletcannotbeconveyedontheouterpackagingandthecontainer(forexamplefor

multilingualpackaging).Consequentlyapackageleafletisadded(seethecorresponding

template).

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL10%w/v(S)METHOPRENE12%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Composition

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

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

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

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

Excipient(s):q.s...................................................................................................0.5ml

3. PHARMACEUTICALFORM

Spot-onsolution.

4. PACKAGESIZE

[ifinthecaseofaboxof3pipettes:]

3PIPETTESOF0.5ml

[ifinthecaseofaboxof6pipettes:]

6PIPETTESOF0.5ml

5. TARGETSPECIES

CATS

FERRETS

6. INDICATION(S)

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedinthepackageleaflet.Seethecorrespondingtemplate.]

7. METHODANDROUTE(S)OFADMINISTRATION

FrontlineComboSpotonCat

Spoton

METHODOFADMINISTRATION

1-Takethepipetteoutofitspackaging

2-Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.

3-Partthecoatonthebackoftheanimalatthebaseoftheneckinfrontoftheshoulderbladesuntil

theskinisvisible.Placethetipofthepipetteontheskinandsqueezethepipetteseveraltimestoempty

itscontentscompletelyanddirectlyontotheskininonespot.

8. WITHDRAWALPERIOD

<NOTAPPLICABLE>

9. SPECIALWARNING(S),IFNECESSARY

Forexternaluseonly.

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedinthepackageleaflet.Seethecorrespondingtemplate.]

10. EXPIRYDATE

EXP{MM-YYYY}

11. SPECIALSTORAGECONDITIONS

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedinthepackageleaflet.Seethecorrespondingtemplate.]

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedinthepackageleaflet.Seethecorrespondingtemplate.]

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

[Tobecompletednationally,bydefault:]

FrontlineComboSpotonCat

MERIAL

29, avenueTonyGarnier

69007 Lyon, FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

[Tobecompletednationally]

17. MANUFACTURER’SBATCHNUMBER

BN{number}

FrontlineComboSpotonCat

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONCAT

Blistercardof1pipette

Theinformationmentionedbelowisalltheinformationvisibleexternallyonthispackaging,

eitherontheblistercardoronthecombinedlabelpackage-leafletinsertedinit.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL10%w/v(S)METHOPRENE12%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

FIPRONIL(S)-METHOPRENE

3. PHARMACEUTICALFORM

Spot-onsolution.

4. PACKAGESIZE

1PIPETTEOF0.5ml

5. TARGETSPECIES

CATS

FERRETS

6. INDICATION(S)

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

7. METHODANDROUTE(S)OFADMINISTRATION

Spoton

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

8. WITHDRAWALPERIOD

NotApplicable

FrontlineComboSpotonCat

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

10. EXPIRYDATE

EXP{MM-YYYY}

11. SPECIALSTORAGECONDITIONS

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

[Tobecompletednationally,bydefault:]

MERIAL

29, avenueTonyGarnier

69007 Lyon, FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

[Tobecompletednationally]

17. MANUFACTURER’SBATCHNUMBER

BN{number}

FrontlineComboSpotonCat

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

FRONTLINECOMBOSPOTONCAT

1pipette

TheImmediatepackagingisapipette:theinformationbelowappearsontheshelloronthe

operculeofthepipette.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBO

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

FIPRONIL50mg(S)-METHOPRENE60mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

0.5ml

4. ROUTE(S)OFADMINISTRATION

[Pictogramofadropofproductfallingfromapipetteontheskinoftheanimalthusshowingtheroute

ofadministration]

5. WITHDRAWALPERIOD

NotApplicable

6. BATCHNUMBER

{number}

7. EXPIRYDATE

{MM-YYYY}

8. THEWORDS“FORANIMALTREATMENTONLY”

[Pictogramofacatandaferretindicatingtheveterinaryuse]

[InAddition]MERIAL

[Pictogramofacatandaferretindicatingthetargetspecies]

FrontlineComboSpotonCat

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

FRONTLINECOMBOSPOTONCAT

Boxof3pipettes:1blisterof3pipettes

Boxof6pipettes:2blistersof3pipettes

Theblisterpackageisthesameinbothcases:theinformationbelowappearsontheblistershell

orontheblistercapoftheblisterpackage.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL(S)METHOPRENE

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

MERIAL

3. EXPIRYDATE

{MM-YYYY}

4. BATCHNUMBER

{number}

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

[or]

ADUS.VET.-USAGEVETERINAIRE-FORVETERINARYUSE

6. ADDITIONALINFORMATION

0.5ml

FIPRONIL10%w/v(S)METHOPRENE12%w/v

FrontlineComboSpotOnCat

B.PACKAGELEAFLET

FrontlineComboSpotOnCat

FRONTLINECOMBOSPOT-ONCAT

Boxof3pipettes

Boxof6pipettes

TheleafletdescribedbelowappliestoCaseN°2whereapackageleafletisaddedin

thepackaging.

InCaseN°1noleafletisneeded.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

[Tobecompletednationally,bydefault:]

MERIAL

29, avenueTonyGarnier

69007 Lyon, FRANCE

MERIAL

4 cheminduCalquet

31300 Toulouse

France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL10%w/v(S)METHOPRENE12%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

FrontlineComboSpotOnCatisaclearambersolutioncontaining:

Fipronil50.00mg

(S)-methoprene60.00mg

Butylhydroxyanisole(E320)0.10mg

Butylhydroxytoluene(E321)0.05mg

Excipient(s):q.s0.5ml.

4. INDICATION(S)

Incats:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleasforsixweeksafterapplication.

-Eliminationofticks(Ixodesricinus,Dermacentorvariabilis,Rhipicephalussanguineus).The

producthasapersistentacaricidalefficacyforupto2weeksagainstticks(basedonexperimental

data).

FrontlineComboSpotonCat

- Eliminationofbitinglice(Felicolasubrostratus).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

Inferrets:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticks.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleas.

-Eliminationofticks(Ixodesricinus).Theproducthasapersistentacaricidalefficacyfor4weeks

againstticks(basedonexperimentaldata).

5. CONTRAINDICATIONS

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan8weeksoldand/or

weighinglessthan1kg.Theproductshouldnotbeusedinferretslessthan6monthsold.

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

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur. Inabsence

ofstudies,theuseoftheproductisnotrecommendedinnon-targetspecies.

6. ADVERSEREACTIONS

Donotoverdose.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

Cats

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite

(scaling,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafteruse.

Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns)orvomitinghavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

7. TARGETSPECIES

Targetspecies:Cats,Ferrets.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Routeofadministration:external,bytopicalapplicationtotheskin.

Dosage:

Onepipetteof0.5mlpercat.Intheabsenceofsafetystudies,theminimumtreatmentintervalis

4weeks.

Onepipetteof0.5mlperferret.Theminimumtreatmentintervalis4weeks.

9. ADVICEONCORRECTADMINISTRATION

Methodofadministration:seeouterpackaging.

10. WITHDRAWALPERIOD

FrontlineComboSpotonCat

[NotApplicable]

11. SPECIALSTORAGEPRECAUTIONS

Storage

Do notstoreabove30

C. Storeintheoriginalpackage.

Keepoutofthereachandsightofchildren.

DonotuseaftertheexpirydatestatedonthecartonafterEXP.

12. SPECIALWARNING(S)

Precautions

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincatsandferretsare

available.However,basedoninformationavailablefordogsshampooedasfrom2daysafter

applicationoftheproduct,itisnotrecommendedtobathanimalswithin2daysafterapplicationofthe

product.

Avoidthecontactwiththeanimal’seyes.

Theremaybeanattachmentofsingleticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Thepotentialtoxicityoftheproductforkittensoflessthan8weeksofageincontactwithatreated

queenisnotdocumented.Specialcareshouldbetakeninthiscase.

Overdose

Theriskofexperiencingadverseeffectmayhoweverincreasewithoverdosing(seesection6Adverse

reactions).

Cats

Noundesirableeffectswereobservedintargetanimalsafetystudiesincatsandkittensaged8weeks

andolderandweighingabout1kgtreatedonceamonthatfivetimestherecommendeddoseforsix

consecutivemonths.

Itchingmayoccurfollowingtreatment.

Overdoseapplicationoftheproductwillcauseastickyappearanceofhairsatthetreatmentspot.

However,shouldthisoccur,itwilldisappearwithin24hourspostapplication.

Ferrets

Inferretsaged6monthsandolderandtreatedonceevery2weeksforfourtreatments,atfivetimes

therecommendeddose,bodyweightlosswasobservedinsomeanimals.

Userwarnings

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnCat.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

Afteraccidentalexposuretheeyeshouldberinsedcarefullywithplainwater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

FrontlineComboSpotonCat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Fiproniland(S)-methoprenemayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainers.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourveterinarysurgeon

howtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelptoprotectthe

environment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Useduringpregnancy,lactationorlay

Theproductcanbeusedduringpregnancy andlactation incats. Fortreatmentduringthelactating

period,seesectionPrecautionsabove.

Useonlyaccordingtobenefit/riskassessmentbyaresponsibleveterinarianinferrets.

Pharmacodynamicproperties

Fipronilkillsfleaswithin24hoursandticksandlicewithin48hourspost-exposure.

Blistercardof1x0.5mlpipette

Boxof1blistercardof3x0.5mlpipettes

Boxof2blistercardsof3x0.5mlpipettes

Notallpacksizesmaybemarketed.

FrontlineComboSpotonCat

FRONTLINECOMBOSPOT-ONCAT

Blistercardof1pipette

Thispackagingcontainsacombinedlabelpackage-leaflet.Theinformationmentionedbelow

appearsontheinteriorsideofthiscombinedlabelpackage-leaflet.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

[Tobecompletednationally,bydefault:]

MERIAL

29, avenueTonyGarnier

69007 Lyon, FRANCE

MERIAL

4 cheminduCalquet

31300Toulouse

France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONCAT

FIPRONIL10%w/v(S)METHOPRENE12%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

FrontlineComboSpotOnCatisaclearambersolutioncontaining:

Fipronil50.00mg

(S)-methoprene60.00mg

Butylhydroxyanisole(E320)0.10mg

Butylhydroxytoluene(E321)0.05mg

Excipient(s):q.s0.5ml.

4. INDICATION(S)

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).

FrontlineComboSpotonCat

Inferrets:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticks.

-Eliminationoffleas(Ctenocephalidesspp.).Insecticidalefficacyagainstnewinfestationswith

adultfleaspersistsfor4weeks.Preventionofthemultiplicationoffleasbyinhibitingthe

developmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originatingfromeggs

laidbyadultfleas.

-Eliminationofticks(Ixodesricinus).Theproducthasapersistentacaricidalefficacyfor4weeks

againstticks(basedonexperimentaldata).

5. CONTRAINDICATIONS

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan8weeksoldand/or

weighinglessthan1kg.Theproductshouldnotbeusedinferretslessthan6monthsold.

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

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur. Inabsence

ofstudies,theuseoftheproductisnotrecommendedinnon-targetspecies.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeksincatsandinferrets.

6. ADVERSEREACTIONS

Donotoverdose.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

Cats

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite

(scaling,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafteruse.

Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns)orvomitinghavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

7. TARGETSPECIES

Cat

Ferret

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Routeofadministration:external,bytopicalapplicationtotheskin.

Dosage:

Onepipetteof0.5mlpercatcorrespondingtoaminimumrecommendeddoseof5mg/kgforfipronil

and6mg/kgfor(S)-methoprene.

Onepipetteof0.5mLperferretcorrespondingtoadoseof50mgforfiproniland60mgfor(S)-

methopreneperferret,bytopicalapplicationtotheskin.

9. ADVICEONCORRECTADMINISTRATION

Methodofadministration

Tackthepipetteoutofitspackaging.

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.Partthecoatonthebackoftheanimalatthebaseofthe

FrontlineComboSpotonCat

neckinfrontoftheshoulderbladesuntiltheskinisvisible.Placethetipofthepipetteontheskinand

squeezethepipetteseveraltimestoemptyitscontentscompletelyanddirectlyontotheskininone

spot.

10. WITHDRAWALPERIOD

NotApplicable

11. SPECIALSTORAGEPRECAUTIONS

Storage

Do notstoreabove30

C. Storeintheoriginalpackage.

Keep outofthereachand sightofchildren.

Do notuseaftertheexpirydatestated onthepackageafterEXP.

12. SPECIALWARNING(S)

Precautions

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Nodataontheeffectofbathing/shampooingontheefficacyoftheproductincatsandferretsare

available.However,basedoninformationavailablefordogsshampooedasfrom2daysafter

applicationoftheproduct,itisnotrecommendedtobathanimalswithin2daysafterapplicationofthe

product.

Avoidthecontactwiththeanimal’seyes.

Theremaybeanattachmentofsingleticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Thepotentialtoxicityoftheproductforkittensoflessthan8weeksofageincontactwithatreated

queenisnotdocumented.Specialcareshouldbetakeninthiscase.

Overdose

Theriskofexperiencingadverseeffectmayhoweverincreasewithoverdosing(seeUndesirable

Effects).

Cats

Noundesirableeffectswereobservedintargetanimalsafetystudiesincatsandkittensaged8weeks

andolderandweighingabout1kgtreatedonceamonthatfivetimestherecommendeddoseforsix

consecutivemonths.

Itchingmayoccurfollowingtreatment.

Overdoseapplicationoftheproductwillcauseastickyappearanceofhairsatthetreatmentspot.

However,shouldthisoccur,itwilldisappearwithin24hourspostapplication.

Ferrets

Inferretsaged6monthsandolderandtreatedonceevery2weeksforfourtreatments,atfivetimes

therecommendeddose,bodyweightlosswasobservedinsomeanimals.

UserWarnings

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnCat.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

FrontlineComboSpotonCat

Afteraccidentalexposuretheeyeshouldberinsedcarefullywithpurewater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Fiproniland(S)-methoprenemayadverselyaffectaquaticorganisms.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainers.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourveterinarysurgeon

howtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelptoprotectthe

environment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Useduringpregnancy,lactationorlay

Theproductcanbeusedduringpregnancy andlactation incats. Fortreatmentduringthelactating

period,seesectionPrecautionsabove.

Useonlyaccordingtobenefit/riskassessmentbyaresponsibleveterinarianinferrets.

Pharmacodynamicproperties

Fipronilkillsfleaswithin24hoursandticksandlicewithin48hourspost-exposure.

Blistercardof1x0.5mlpipette

Boxof1blistercardof3x0.5mlpipettes

Boxof2blistercardsof3x0.5mlpipettes

Notallpacksizesmaybemarketed.

FrontlineComboSpotonCat

ADDITIONALINFORMATIONTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONCAT

Boxof3pipettes(or6pipettes)

Boxof1pipette(onlyhighlightedtext)

Eliminatesfleasonyourcatandprotectsagainstre-infestationfor4weeks.

Inhibitsthedevelopmentoffleaeggs,flealarvaeandpupae(for6weeksincats),thuspreventing

contaminationofyourpet’senvironmentforthesameperiod.

Eliminatesticksonyourcatandprotectsagainstre-infestationforupto2weeks.

Eliminatesbitingliceonyourcat.

CanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis(FAD)incats.

Preventscontaminationoftheenvironmentoftreatedanimalswiththeimmaturestagesoffleas.

Eliminatesfleasonyourferretandprotectsagainstre-infestationfor4weeks.

Eliminatesticksonyourferretandprotectsagainstre-infestationforupto4weeks.

{icons}