FRONTLINE

Main information

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

Documents

Localization

  • Available in:
  • FRONTLINE COMBO SPOT ON DOG XL
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0139/004
  • Authorization date:
  • 15-05-2011
  • EU code:
  • FR/V/0139/004
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

FrontlineComboSpotonDogMPILMay2011MERIAL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONDOGM

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachpipetteof1.34mlcontains:

Fipronil...................................................................................................................134.00mg

(S)-methoprene.......................................................................................................120.60mg

Butylhydroxyanisole(E320)........................................................................................0.27mg

Butylhydroxytoluene(E321)........................................................................................0.13mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution

Clearambersolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofdogsweighing10-to-20kgbodyweight:

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Treatmentoffleainfestations(Ctenocephalidesspp.)..Insecticidalefficacyagainstnew

infestationswithadultfleaspersistsfor8weeks.Preventionofthemultiplicationoffleasbyinhibiting

ofthedevelopmentofeggs(ovicidalactivity)andlarvaeandpupae(larvicidalactivity)originatingfrom

eggslaidbyadultfleasforeightweeksafterapplication.

-Treatmentoftickinfestations(Ixodesricinus,Dermacentorvariabilis,Dermacentorreticulatus,

Rhipicephalussanguineus).Theproducthasapersistentacaricidalefficacyforupto4weeks

againstticks.

-treatmentofinfestationswithbitinglice(Trichodectescanis).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

4.3 Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonpuppieslessthan8weeksold.

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

Donotuseinrabbits,asadversereactionswithevenmortalitycouldoccur.

Thisproductisspecificallydevelopedfordogs.Donouseincats,asthiscouldleadtooverdosing.

4.4 Specialwarningsfortargetspecies

Bathing/immersioninwaterwithin2daysafterapplicationoftheproductandmorefrequentbathing

thanonceaweekshouldbeavoided,asnostudyhasbeenperformedtoinvestigatehowthisaffects

theefficacyoftheproduct.Emollientshampooscanbeusedpriortotreatment,butreducetheduration

ofprotectionagainstfleastoapproximately5weekswhenusedweeklyafterapplicationofthe

product.Weeklybathingwitha2%chlorhexidinemedicatedshampoodidnotaffectefficacyagainst

fleasduringa6weeklongstudy.

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

FrontlineComboSpotOnDog.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

Afteraccidentaloccularexposuretheeyeshouldberinsedcarefullyinpurewater.

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,other

nervoussigns),vomitingorrespiratorysymptomshavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

Donotoverdose.

4.7 Useduringpregnancy,lactationorlay

Theproductcanbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Onepipetteof1.34ml(M)perdogweighingover10kgandupto20kg,correspondingtoaminimum

recommendeddoseof6.7mg/kgforfiproniland6mg/kgfor(S)-methoprene,bytopicalapplicationto

theskin.

Intheabsenceofsafetystudiestheminimumtreatmentintervalis4weeks.

Methodofadministration:

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.Partthecoatonthebackoftheanimalatthebaseofthe

neckinfrontoftheshoulderbladesuntiltheskinisvisible.Placethetipofthepipetteontheskinand

squeezethepipetteseveraltimestoemptyitscontentscompletelyanddirectlyontotheskininone

spot.

Temporarychangestothecoat(clumped/greasyhair)maybenotedattheapplicationsite.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesin8week-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.Itactsbyinteractingwith

ligand-gatedchloridechannels,inparticularthosegatedbytheneurotransmittergamma-aminobutyric

acid(GABA),therebyblockingpre-andpost-synaptictransferofchlorideionsacrosscellmembranes.

Thisresultsinuncontrolledactivityofthecentralnervoussystemanddeathofinsectsoracarines.

Fipronilkillsfleaswithin24hoursandticks(Dermacentorreticulatus,Dermacentorvariabilis,

Rhipicephalussanguineus,Ixodesscapularis,Ixodesricinus,Haemaphysalislongicornis,

Haemaphysalisflava,Haemaphysaliscampanulata)andlicewithin48hourspost-exposure.

(S)-Methopreneisaninsectgrowthregulator(IGR)oftheclassofcompoundsknownasjuvenile

hormoneanaloguesthatinhibitthedevelopmentofimmaturestagesofinsects.Thiscompoundmimics

theactionofjuvenilehormoneandcausesimpaireddevelopmentanddeathofthedevelopingstagesof

fleas.Theon-animalovicidalactivityof(S)-methopreneresultsfromeitherdirectpenetrationofthe

eggshellofnewlylaideggsorfromabsorptionthroughthecuticleoftheadultfleas.(S)-methopreneis

alsoeffectiveinpreventingflealarvaeandpupaefromdeveloping,whichpreventscontaminationofthe

environmentofthetreatedanimalswiththeimmaturestagesoffleas.

5.2 Pharmacokineticparticulars

Studiesofmetabolismoffipronilhavedemonstratedthatthemajormetaboliteisthesulfonederivative

offipronil.

(S)-methopreneisextensivelydegradedintocarbondioxideandacetatethataresubsequently

incorporatedintoendogenousmaterials.

Thepharmacokineticprofilesaftertopicalapplicationoffiproniland(S)-methopreneincombination

werestudiedindogsincomparisontointravenousdosingoffipronilor(S)-methoprenealone.This

establishedabsorptionandotherpharmacokineticparameters.Thetopicalapplicationresultedinlow

systemicabsorptionoffipronil(11%)withameanmaximumconcentration(C

)ofapproximately35

ng/mlfiproniland55ng/mloffipronilsulfoneinplasma.

Peakfipronilplasmaconcentrationsareslowlyattained(meant

approximately101h),anddecline

slowly(meanterminalhalf-lifeapproximately154h,highestvaluesareobservedformales).

Fipronilisextensivelymetabolisedtofipronilsulfoneaftertopicaladministration.

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

topicalapplication.

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

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

Natureofprimarypackaging

Agreenpipettecomposedofaheat-formedshell(polypropyleneandpolyacrylonitrile-methylate

copolymer)andafilm(polyethyleneterephthalate,aluminium,andpolyacrylonitrile-methylate

copolymer).

Salespresentation(s) and administrativenumber(s)ofidentification

Blistercardof1x1.34mlpipettewithascoredtip

Boxof1blistercardof3x1.34mlpipetteswithascoredtip

Boxof2blistercardsof3x1.34mlpipetteswithascoredtip

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.

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONDOGM

Boxof3pipettes(or6pipettes)

CASEN°1:Thetextbelowcorrespondstothecaseswherealltheinformationofthepackage

leafletCANbeconveyedontheouterpackagingandcontainer.Consequently,inthatcase,no

separateleafletisprovidedincompliancewiththecurrentQRDTemplate.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONDOGM

FIPRONIL10%w/v(S)METHOPRENE9%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Clearambersolutioncontaining:

Fipronil..........................................................................................................134.00mg

(S)-methoprene.............................................................................................120.60mg

Butylhydroxyanisole(E320)...............................................................................0.27mg

Butylhydroxytoluene(E321)..............................................................................0.13mg

Excipient(s):q.s.................................................................................................1.34ml

3. PHARMACEUTICALFORM

Spot-onsolution

4. PACKAGESIZE

[ifinthecaseofaboxof3pipettes:]

3PIPETTESOF1.34ml

[ifinthecaseofaboxof6pipettes:]

6PIPETTESOF1.34ml

5. TARGETSPECIES

DOGM10–20kg

6. INDICATION(S)

Forthetreatmentofdogsweighing10to20kgbodyweight

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Treatmentoffleainfestations(Ctenocephalidesspp.).Insecticidalefficacyagainstnew

infestationswithadultfleaspersistsfor8weeks.Preventionofthemultiplicationoffleasby

inhibitingthedevelopmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originating

fromeggslaidbyadultfleasforeightweeksafterapplication.

-Treatmentoftickinfestations(Ixodesricinus,Dermacentorvariabilis,Dermacentorreticulatus,

Rhipicephalussanguineus).Theproducthasapersistentacaricidalefficacyforupto4weeks

againstticks(basedonexperimentaldata).

.

- Treatmentofinfestationswithbitinglice(Trichodectescanis).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

Fipronilkillsfleaswithin24hoursandticksandlicewithin48hourspost-exposure.

7. METHODANDROUTE(S)OFADMINISTRATION

Spoton

METHODOFADMINISTRATION

1-Takethepipetteoutofitspackaging

2-Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.

3-Partthecoatonthebackoftheanimalatthebaseoftheneckinfrontoftheshoulderbladesuntil

theskinisvisible.Placethetipofthepipetteontheskinandsqueezethepipetteseveraltimesto

emptyitscontentscompletelyanddirectlyontotheskininonespot.

Dosage

Onepipetteof1.34ml(S)perdogweighingover10andupto20kg,correspondingtoaminimum

recommendeddoseof6.7mg/kgforfiproniland6mg/kgfor(S)-methoprene,bytopicalapplicationto

theskin.

Temporarychangestothecoat(clumped/greasyhair)maybenotedattheapplicationsite.

8. WITHDRAWALPERIOD

[NOTAPPLICABLE]

9. SPECIALWARNING(S),IFNECESSARY

Forexternaluseonly

Useduringpregnancyandlactation

FrontlineComboSpotOnDogcanbeusedduringpregnancyandlactation

Precautions

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Bathing/immersioninwaterwithin2daysafterapplicationoftheproductandmorefrequentbathing

thanonceaweekshouldbeavoided,asnostudyhasbeenperformedtoinvestigatehowthisaffects

theefficacyoftheproduct.Emollientshampooscanbeusedpriortotreatment,butreducetheduration

ofprotectionagainstfleastoapproximately5weekswhenusedweeklyafterapplicationofthe

product.Weeklybathingwitha2%chlorhexidinemedicatedshampoodidnotaffectefficacyagainst

fleasduringa6weeklongstudy.

Avoidcontactwiththeanimal'seyes.

Dogsshouldnotbeallowedtoswiminwatercoursesfor2daysafterapplication(SeesectionDisposal

ofwastematerials).

Theremaybeanattachmentofafewticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavorable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonpuppieslessthan8weeksold

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

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur.

Thisproductisspecificallydevelopedfordogs.Donouseincats,asthiscouldleadtooverdosing.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

UndesirableEffects

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite(skin

discoloration,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafter

use.Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns),vomitingorrespiratorysymptomshavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

Donotoverdose.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedhere,pleaseinformyourveterinary

surgeon.

Overdose

Noadverseeffectswereobservedintargetanimalsafetystudiesin8week-oldpuppies,growingdogs

anddogsweighingabout2kgtreatedonceatfivetimestherecommendeddose.

Theriskofexperiencingadverseeffectmayhoweverincreasewithoverdosing(seeUndesirable

Effect)soanimalsshouldalwaysbetreatedwiththecorrectpipettesizeaccordingtobodyweight.

Userwarnings

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnDog.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

Afteraccidentalexposuretheeyeshouldberinsedcarefullywithpurewater.

Washhandsafteruse.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsarenotallowedtosleepwithowners,especiallychildren.

Donotsmoke,drinkoreatduringapplication.

10. EXPIRYDATE

EXP{MM-YYYY}

11. SPECIALSTORAGECONDITIONS

Donotstoreabove30

C.Storeintheoriginalpackage.

DonotuseaftertheexpirydatestatedonthepackageafterEXP.

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

69007Lyon,FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

[Tobecompletednationally]

17. MANUFACTURER’SBATCHNUMBER

BN{number}

Additionalinformation:

[Manufacturer]

MERIAL

4cheminduCalquet

31300Toulouse,France

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONDOGM

Boxof3pipettes(or6pipettes)

CASEN°2:Thetextbelowcorrespondstothecaseswherealltheinformationofthepackage

leafletcannotbeconveyedontheouterpackagingandthecontainer(forexamplefor

multilingualpackaging).Consequentlyapackageleafletisadded(seethecorresponding

template).

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONDOGM

FIPRONIL10%w/v(S)METHOPRENE9%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Composition

Fipronil..........................................................................................................134.00mg

(S)-methoprene.............................................................................................120.60mg

Butylhydroxyanisole(E320)...............................................................................0.27mg

Butylhydroxytoluene(E321)..............................................................................0.13mg

Excipient(s):q.s..................................................................................................1.34ml

3. PHARMACEUTICALFORM

Spot-onsolution.

4. PACKAGESIZE

[ifinthecaseofaboxof3pipettes:]

3PIPETTESOF1.34ml

[ifinthecaseofaboxof6pipettes:]

6PIPETTESOF1.34ml

5. TARGETSPECIES

DOGM10–20kg

6. INDICATION(S)

Readthepackageleafletbeforeuse

[Moreinformationisprovidedinthepackageleaflet.Seethecorrespondingtemplate.]

7. METHODANDROUTE(S)OFADMINISTRATION

Spoton

METHODOFADMINISTRATION

1-Takethepipetteoutofitspackaging

2-Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.

3-Partthecoatonthebackoftheanimalatthebaseoftheneckinfrontoftheshoulderbladesuntil

theskinisvisible.Placethetipofthepipetteontheskinandsqueezethepipetteseveraltimesto

emptyitscontentscompletelyanddirectlyontotheskininonespot.

8. WITHDRAWALPERIOD

[NOTAPPLICABLE]

9. SPECIALWARNING(S),IFNECESSARY

Forexternaluseonly

Readthepackageleafletbeforeuse

[Moreinformationisprovidedinpackagingleaflet.Seethecorrespondingtemplate.]

10. EXPIRYDATE

EXP{MM-YYYY}

11. SPECIALSTORAGECONDITIONS

Readthepackageleafletbeforeuse

[Moreinformationisprovidedinpackagingleaflet.Seethecorrespondingtemplate.]

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse

[Moreinformationisprovidedinpackagingleaflet.Seethecorrespondingtemplate.]

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

[Tobecompletednationally,bydefault:]

MERIAL

29,avenueTonyGarnier

69007Lyon,FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

[Tobecompletednationally]

17. MANUFACTURER’SBATCHNUMBER

BN{number}

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONDOGM

Blistercardof1pipette

Theinformationmentionedbelowisalltheinformationvisibleexternallyonthispackaging,

eitherontheblistercardoronthecombinedlabelpackage-leafletinsertedinit.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONDOGM

FIPRONIL10%w/v(S)METHOPRENE9%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

FIPRONIL(S)METHOPRENE

3. PHARMACEUTICALFORM

Spot-onsolution.

4. PACKAGESIZE

1PIPETTEOF1.34ml

5. TARGETSPECIES

DOGM10–20kg

6. INDICATION(S)

Readthepackageleafletbeforeuse

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

7. METHODANDROUTE(S)OFADMINISTRATION

Spoton

Readthepackageleafletbeforeuse

[Moreinformationisprovidedontheinteriorsideofthecombinedlabelpackageleaflet,seethe

correspondingpackageleaflettemplate.]

8. WITHDRAWALPERIOD

[NotApplicable]

9. SPECIALWARNING(S),IFNECESSARY

ForDogsfrom8weeksofage

Readthepackageleafletbeforeuse

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

69007Lyon,FRANCE

16. MARKETINGAUTHORISATIONNUMBER(S)

[Tobecompletednationally]

17. MANUFACTURER’SBATCHNUMBER

BN{Number}

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

FRONTLINECOMBOSPOTONDOGM

1pipette

TheImmediatepackagingisapipette:theinformationbelowappearsontheshelloronthe

operculeofthepipette.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBO

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

FIPRONIL134mg(S)-METHOPRENE120.6mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

1.34ml

4. ROUTE(S)OFADMINISTRATION

[Pictogramofadropofproductfallingfromapipetteontheskinoftheanimalthusshowingtheroute

ofadministration]

5. WITHDRAWALPERIOD

[NotApplicable]

6. BATCHNUMBER

{Number}

7. EXPIRYDATE

{MM-YYYY}

8. THEWORDS“FORANIMALTREATMENTONLY”

[Pictogramofadogindicatingtheveterinaryuse]

{InAddition}

MERIAL

[Pictogramofadogindicatingthetargetspecies]

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

FRONTLINECOMBOSPOTONDOGM

Boxof3pipettes:1blisterof3pipettes

Boxof6pipettes:2blistersof3pipettes

Theblisterpackageisthesameinbothcases:theinformationbelowappearsontheblistershell

orontheblistercapoftheblisterpackage.

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ONDOGM

FIPRONIL(S)METHOPRENE

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

MERIAL

3. EXPIRYDATE

{MM/YYYY}

4. BATCHNUMBER

{number}

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly

[or]

ADUS.VET.-USAGEVETERINAIRE-FORVETERINARYUSE

6. ADDITIONALINFORMATION

1.34ml

FIPRONIL10%w/vMETHOPRENE9%w/v

B.PACKAGELEAFLET

FRONTLINECOMBOSPOT-ON DOGM

Boxof3pipettes

Boxof6pipettes

TheleafletdescribedbelowappliestoCaseN°2whereapackageleafletisaddedinthe

packaging.

IncaseN°1noleafletisadded.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

[Tobecompletednationally,bydefault:]

MERIAL

29,avenueTonyGarnier

69007Lyon,FRANCE

MERIAL

4cheminduCalquet

31300Toulouse

France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ON DOGM

FIPRONIL10%w/v(S)METHOPRENE9%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

FrontlineComboSpotOnDogisaclearambersolutioncontaining:

Fipronil134.00mg

(S)-methoprene120.60mg

Butylhydroxyanisole(E320)0.27mg

Butylhydroxytoluene(E321)0.13mg

Excipient(s):q.s1.34ml

4. INDICATION(S)

Forthetreatmentofdogsweighing10to20kgbodyweight

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Treatmentoffleainfestations(Ctenocephalidesspp.).Insecticidalefficacyagainstnew

infestationswithadultfleaspersistsfor8weeks.Preventionofthemultiplicationoffleasby

inhibitingthedevelopmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originating

fromeggslaidbyadultfleasforeightweeksafterapplication.

-Treatmentoftickinfestations(Ixodesricinus,Dermacentorvariabilis,Dermacentorreticulatus,

Rhipicephalussanguineus).Theproducthasapersistentacaricidalefficacyforupto4weeks

againstticks(basedonexperimentaldata).

- Treatmentofinfestationswithbitinglice(Trichodectescanis).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

5. CONTRAINDICATIONS

Intheabsenceofavailabledata,theproductshouldnotbeusedonpuppieslessthan8weeksold.

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

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur.

Thisproductisspecificallydevelopedfordogs.Donouseincats,asthiscouldleadtooverdosing.

6. ADVERSEREACTIONS

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite(skin

discoloration,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafter

use.Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns),vomitingorrespiratorysymptomshavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

Donotoverdose.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Targetspecies:Dogs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Routeofadministration:external,bytopicalapplicationtotheskin

Dosageforadogfrom10to20kgofweight:Onepipetteof1.34mlperdog.Intheabsenceofsafety

studies,theminimumtreatmentintervalis4weeks.

Temporarychangestothecoat(clumped/greasyhair)maybenotedattheapplicationsite.

9. ADVICEONCORRECTADMINISTRATION

Methodofadministration:seeouterpackaging

10. WITHDRAWALPERIOD

[NotApplicable]

11. SPECIALSTORAGEPRECAUTIONS

Storage

Donotstoreabove30

C.Storeintheoriginalpackage.

Keepoutofthereachandsightofchildren.

DonotuseaftertheexpirydatestatedonthecartonafterEXP

12. SPECIALWARNING(S)

Precautions:

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Bathing/immersioninwaterwithin2daysafterapplicationoftheproductandmorefrequentbathing

thanonceaweekshouldbeavoided,asnostudyhasbeenperformedtoinvestigatehowthisaffects

theefficacyoftheproduct.Emollientshampooscanbeusedpriortotreatment,butreducetheduration

ofprotectionagainstfleastoapproximately5weekswhenusedweeklyafterapplicationofthe

product.Weeklybathingwitha2%chlorhexidinemedicatedshampoodidnotaffectefficacyagainst

fleasduringa6weeklongstudy.

Dogsshouldnotbeallowedtoswiminwatercoursesfor2daysafterapplication(seesectiondisposal

ofwastematerials)

Avoidthecontactwiththeanimal’seyes.

Theremaybeanattachmentofafewticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Overdose

Noundesirableeffectswereobservedintargetanimalsafetystudiesin8week-oldpuppies,growing

dogsanddogsweighingabout2kgtreatedonceamonthatfivetimestherecommendeddose.

Theriskofexperiencingadverseeffectmayhoweverincreasewithoverdosing(seeUndesirable

Effects)soanimalsshouldalwaysbetreatedwiththecorrectpipettesizeaccordingtobodyweight.

Userwarnings

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnDog.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

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

Theproductcanbeusedduringpregnancyandlactation.

Pharmacodynamicproperties

Fipronilkillsfleaswithin24hoursandticksandlicewithin48hourspost-exposure.

Blistercardof1x1.34mlpipette

Boxof1blistercardof3x1.34mlpipettes

Boxof2blistercardsof3x1.34mlpipettes

Notallpacksizesmaybemarketed.

FRONTLINECOMBOSPOT-ON DOGM

Blistercardof1pipette

Thispackagingcontainsacombinedlabelpackage-leaflet.Theinformationmentionedbelow

appearsontheinteriorsideofthiscombinedlabelpackage-leaflet.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

[Tobecompletednationally,bydefault:]

MERIAL

29,avenueTonyGarnier

69007Lyon,FRANCE

MERIAL

4cheminduCalquet

31300Toulouse

France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOSPOT-ON DOGM

FIPRONIL10%w/v(S)METHOPRENE9%w/v

[Wherethereissufficientspace,‘w/v’willbeaddedafterthepercentagesoftheactivesubstances.

Wherethereisalackofspace,anasteriskwillbeaddednexttothepercentageswithanexplanatory

noteplacedclosetotheProductname.]

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

FrontlineComboSpotOnDogisaclearambersolutioncontaining:

Fipronil134.00mg

(S)-methoprene120.60mg

Butylhydroxyanisole(E320)0.27mg

Butylhydroxytoluene(E321)0.13mg

Excipient(s):q.s1.34ml

4. INDICATION(S)

Forthetreatmentofdogsweighing10to20kgbodyweight

-Tobeusedagainstinfestationswithfleas,aloneorinassociationwithticksand/orbitinglice.

-Treatmentoffleainfestations(Ctenocephalidesspp.).Insecticidalefficacyagainstnew

infestationswithadultfleaspersistsfor8weeks.Preventionofthemultiplicationoffleasby

inhibitingthedevelopmentofeggs(ovicidalactivity),larvaeandpupae(larvicidalactivity)originating

fromeggslaidbyadultfleasforeightweeksafterapplication.

-Treatmentoftickinfestations(Ixodesricinus,Dermacentorvariabilis,Dermacentorreticulatus,

Rhipicephalussanguineus).Theproducthasapersistentacaricidalefficacyforupto4weeks

againstticks(basedonexperimentaldata).

- Treatmentofinfestationswithbitinglice(Trichodectescanis).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis

(FAD).

5. CONTRAINDICATIONS

Intheabsenceofavailabledata,theproductshouldnotbeusedonpuppieslessthan8weeksold.

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

Donotuseinrabbits,asadversedrugreactionswithevenmortalitycouldoccur.

Thisproductisspecificallydevelopedfordogs.Donouseincats,asthiscouldleadtooverdosing.

6. ADVERSEREACTIONS

Amongtheveryraresuspectedadversereactions,transientskinreactionsontheapplicationsite(skin

discoloration,localhairloss,itching,redness)andgeneralitchingorhairlosshavebeenreportedafter

use.Excessivesalivation,reversiblenervoussigns(increasedsensitivitytostimulation,depression,other

nervoussigns),vomitingorrespiratorysymptomshavealsobeenobservedafteruse.

Iflickingoccurs,abriefperiodofexcessivesalivationmaybeobservedduemainlytothenatureofthe

carrier.

Donotoverdose.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Dogs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Routeofadministration:external,bytopicalapplicationtotheskin

Dosageforadogfrom10to20kgofweight:Onepipetteof1.34mlperdog.correspondingtoa

minimumrecommendeddoseof6.7mg/kgforfiproniland6mg/kgfor(S)-methoprene.Intheabsence

ofsafetystudies,theminimumtreatmentintervalis4weeks.

9. ADVICEONCORRECTADMINISTRATION

Methodofadministration:

Tackthepipetteoutofitspackaging.

Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethecontentsremainwithinthe

mainbodyofthepipette.Snapbackthetip.Partthecoatonthebackoftheanimalatthebaseofthe

neckinfrontoftheshoulderbladesuntiltheskinisvisible.Placethetipofthepipetteontheskinand

squeezethepipetteseveraltimestoemptyitscontentscompletelyanddirectlyontotheskininone

spot.

Temporarychangestothecoat(clumped/greasyhair)maybenotedattheapplicationsite.

10. WITHDRAWALPERIOD

[NotApplicable]

11. SPECIALSTORAGEPRECAUTIONS

Storage

Donotstoreabove30

C.Storeintheoriginalpackage.

Keepoutofthereachandsightofchildren.

DonotuseaftertheexpirydatestatedonthecartonafterEXP

12. SPECIALWARNING(S)

Precautions:

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Bathing/immersioninwaterwithin2daysafterapplicationoftheproductandmorefrequentbathing

thanonceaweekshouldbeavoided,asnostudyhasbeenperformedtoinvestigatehowthisaffects

theefficacyoftheproduct.Emollientshampooscanbeusedpriortotreatment,butreducetheduration

ofprotectionagainstfleastoapproximately5weekswhenusedweeklyafterapplicationofthe

product.Weeklybathingwitha2%chlorhexidinemedicatedshampoodidnotaffectefficacyagainst

fleasduringa6weeklongstudy.

Dogsshouldnotbeallowedtoswiminwatercoursesfor2daysafterapplication(seesectiondisposal

ofwastematerials).

Avoidthecontactwiththeanimal’seyes.

Theremaybeanattachmentofafewticks.Forthisreasonatransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsand

softfurnishingswhichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthe

controlmeasures,withasuitableinsecticideandvacuumedregularly.

Overdose

Noundesirableeffectswereobservedintargetanimalsafetystudiesin8week-oldpuppies,growing

dogsanddogsweighingabout2kgtreatedonceamonthatfivetimestherecommendeddose.

Theriskofexperiencingadverseeffectmayhoweverincreasewithoverdosing(seeUndesirable

Effects)soanimalsshouldalwaysbetreatedwiththecorrectpipettesizeaccordingtobodyweight.

Userwarnings

Thisproductcancausemucousmembrane,skinandeyeirritation.Therefore,contactoftheproduct

withmouth,skinandeyesshouldbeavoided.

Animalsoroperatorswithaknownhypersensitivitytoinsecticidesoralcoholshouldavoidcontactwith

FrontlineComboSpotOnDog.Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,

washhandswithsoapandwater.

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

Theproductcanbeusedduringpregnancyandlactation.

Pharmacodynamicproperties

Fipronilkillsfleaswithin24hoursandticksandlicewithin48hourspost-exposure.

Blistercardof1x1.34mlpipette

Boxof1blistercardof3x1.34mlpipettes

Boxof2blistercardsof3x1.34mlpipettes

Notallpacksizesmaybemarketed.

ADDITIONALINFORMATIONTOAPPEARONTHEOUTERPACKAGE

FRONTLINECOMBOSPOTONDOGM10-20kg

Boxof3pipettes(or6pipettes)

Boxof1pipette(onlyhighlightedtext)

Killsfleasonyourdogandprotectsagainstre-infestationfor8weeks.

Inhibitsthedevelopmentoffleaeggs,flealarvaeandpupaefor8weeks,thuspreventingcontamination

ofyourdog’senvironmentforthesameperiod.

Killsticksonyourdogandprotectsagainstre-infestationforupto4weeks.

Killsbitinglice.

ThedurationofprotectionofFRONTLINECOMBOSpot-Onisnotaffectedbyimmersioninwateror

weeklyshampooingwitha2%Chlorhexidineshampooforupto6weekswhencarriedout2daysafter

treatment.

CanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergyDermatitis(FAD)

Preventscontaminationoftheenvironmentoftreatedanimalswiththeimmaturestagesoffleas.

{icons}