FRONTLINE COMBO SPOT ON DOG L

Main information

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

Documents

Localization

  • Available in:
  • FRONTLINE COMBO SPOT ON DOG L
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic area:

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0139/003
  • Authorization date:
  • 15-05-2011
  • EU code:
  • FR/V/0139/003
  • 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}

13-12-2018

Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

6-12-2018

Kroger Louisville Division Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

Kroger Louisville Division Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

Following a recall by Sunshine Mills, Inc., the Kroger Louisville division announced it has removed from sale Abound Chicken & Brown Rice Recipe dog food produced by the supplier. The dog food was sold in one Kroger store located at 2440 Bardstown Road in Louisville, KY. Only Abound Chicken & Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which ...

FDA - U.S. Food and Drug Administration

6-12-2018

King Soopers and City Market Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

King Soopers and City Market Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

Following a recall by Sunshine Mills, Inc., King Soopers announced it has removed from sale Abound Chicken & Brown Rice Recipe dog food produced by Sunshine Mills, Inc. sold in King Soopers and City Market stores, located in Colorado, Utah, New Mexico and Wyoming. Only Abound Chicken & Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which may caus...

FDA - U.S. Food and Drug Administration

5-12-2018

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible <em>Listeria monocytogenes</em> Health Risk

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible <em>Listeria monocytogenes</em> Health Risk

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily recalling 933 packages of Cow Pie fresh frozen meats for dogs and cats, produced in August 2017, because it has the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

5-12-2018

Public health risks associated with food‐borne parasites

Public health risks associated with food‐borne parasites

Published on: Tue, 04 Dec 2018 Parasites are important food‐borne pathogens. Their complex lifecycles, varied transmission routes, and prolonged periods between infection and symptoms mean that the public health burden and relative importance of different transmission routes are often difficult to assess. Furthermore, there are challenges in detection and diagnostics, and variations in reporting. A Europe‐focused ranking exercise, using multicriteria decision analysis, identified potentially food‐borne ...

Europe - EFSA - European Food Safety Authority Publications

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

29-11-2018

ELM Pet Foods Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

ELM Pet Foods Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

ELM Pet Foods, Inc is issuing a voluntary recall of Elm Chicken and Chickpea Recipe dog food because the products could contain elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

28-11-2018

ANF Pet Inc. Issues Voluntary Precautionary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

ANF Pet Inc. Issues Voluntary Precautionary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

ANF, Inc. is issuing a voluntary recall of select products of ANF Pet Lamb and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

27-11-2018

Sunshine Mills, Inc. Issues Voluntary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

Sunshine Mills, Inc. Issues Voluntary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

Sunshine Mills, Inc. is issuing a voluntary recall of select products of Evolve Puppy, Sportsman’s Pride Large Breed Puppy and Triumph Chicken and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

FDA Proposes Study with Intent of Eliminating Use of Dogs in Certain Types of Research

FDA Proposes Study with Intent of Eliminating Use of Dogs in Certain Types of Research

In keeping with the goals of reducing, replacing, and/or refining the use of animals in research, the U.S. Food and Drug Administration today released for public comment proposed research to validate an alternative approach for bioequivalence studies for certain animal drugs.

FDA - U.S. Food and Drug Administration

16-11-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to reduce use of animals through a study aimed at eliminating the use of dogs in certain trials

FDA - U.S. Food and Drug Administration

9-11-2018

In Association With Sunshine Mills, Lidl Voluntarily Recalls Orlando Brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food Due to Elevated Levels of Vitamin D.

In Association With Sunshine Mills, Lidl Voluntarily Recalls Orlando Brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food Due to Elevated Levels of Vitamin D.

In association with Sunshine Mills, Lidl is voluntarily recalling specific lots of Orlando brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food because the products may contain elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

9-11-2018

Natural Life Pet Products Expands Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products Expands Recall of Dry Food Due to Elevated Levels of Vitamin D

We regret to inform you that Natural Life® Chicken & Potato dry dog food has been confirmed to contain elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

3-11-2018

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

Nutrisca, of Saint Louis, Missouri is voluntarily recalling one formula of Nutrisca dry dog food (described below) due to it containing elevated levels of vitamin D.

FDA - U.S. Food and Drug Administration

3-11-2018

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products of Saint Louis, Missouri is voluntarily recalling our Chicken & Potato dry dog food (described below) due to it containing elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

25-10-2018

Xylitol and Your Dog: Danger, Paws Off

Xylitol and Your Dog: Danger, Paws Off

This sugar substitute, found in some human foods and dental products, can be poisonous to your dog.

FDA - U.S. Food and Drug Administration

10-10-2018

Spiraledge Inc. recalls Backless Yoga Chair

Spiraledge Inc. recalls Backless Yoga Chair

The chairs may have missing screws or washers, loose screws or inadequate spot welding, resulting in potential collapse of the chair and injury to the user.

Health Canada

13-9-2018

Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals

Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals

Bravo Packing, Inc. of Carneys Point, NJ is recalling all Performance Dog products, a frozen raw pet food, because it has the potential to be contaminated with Salmonella. Salmonella can cause illness in animals eating the products, as well as people who handle contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products, infected animals or any surfaces exposed to these products.

FDA - U.S. Food and Drug Administration

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

6-8-2018

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling 30 1-lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products.

FDA - U.S. Food and Drug Administration

24-7-2018

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA is aware of a shortage of Percorten™-V (desoxycorticosterone pivalate injectable suspension), which is approved for use as replacement therapy for mineralocorticoid deficit in dogs with primary adrenocortical insufficiency, more commonly known as Addison’s Disease.

FDA - U.S. Food and Drug Administration

23-7-2018

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA has awarded five grants totaling $650,000 to provide funding for studies to support the approval or conditional approval of three different products, including a cancer drug for dogs.

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

12-7-2018

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA is alerting pet owners and veterinary professionals about reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients.

FDA - U.S. Food and Drug Administration

29-6-2018

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo

FDA is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo, a prescription gel that is given to dogs by mouth to treat noise aversion.

FDA - U.S. Food and Drug Administration

28-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on developments in the romaine outbreak investigation, recent outbreaks and the use of modern tools to advance food safety

Statement from FDA Commissioner Scott Gottlieb, M.D., on developments in the romaine outbreak investigation, recent outbreaks and the use of modern tools to advance food safety

Being able to identify outbreaks is key to being able to take quick action to prevent additional illnesses and find the source of the contamination. In recent years, the FDA and the Centers for Disease Control and Prevention (CDC) have advanced new tools that make it easier and faster to identify outbreaks of human illness and to link them back to the food source that is the culprit responsible for the illnesses. But our improved ability to spot outbreaks has also caused some to question whether we are e...

FDA - U.S. Food and Drug Administration

12-6-2018

Dave’s Pet Food Voluntarily Recalls 95% Premium Beef Canned Dog Food Due to Potentially Elevated Levels of Thyroid Hormone

Dave’s Pet Food Voluntarily Recalls 95% Premium Beef Canned Dog Food Due to Potentially Elevated Levels of Thyroid Hormone

Dave’s Pet Food of Agawam, MA is recalling a single lot of Dave’s Dog Food 95% premium beef cans because the products potentially contain elevated levels of beef thyroid hormone.

FDA - U.S. Food and Drug Administration

7-6-2018

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Heartworm disease can be fatal to pets, but it is also preventable. Learn more about the dangers of heartworm disease and the importance of year-round prevention.

FDA - U.S. Food and Drug Administration

23-5-2018

Merrick Pet Care Voluntarily Recalls Limited Amount of Good Buddy and Backcountry Treats Containing Beef Due to Potentially Elevated Levels of Thyroid Hormone

Merrick Pet Care Voluntarily Recalls Limited Amount of Good Buddy and Backcountry Treats Containing Beef Due to Potentially Elevated Levels of Thyroid Hormone

Merrick Pet Care, of Amarillo, Texas, is initiating a voluntary recall of a limited amount of beef dog treat varieties due to the potential that they contain elevated levels of a naturally-occurring beef thyroid hormone.

FDA - U.S. Food and Drug Administration

23-5-2018

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

FDA’s CVM is evaluating the design of studies intended to support the standard of effectiveness for new animal drugs to prevent heartworm disease in dogs. The FDA is requesting public input on evaluating these products to assist in the potential development of alternative study designs.

FDA - U.S. Food and Drug Administration

11-1-2018

Is My Dog or Cat a Healthy Weight? Important Questions to Ask the Vet

Is My Dog or Cat a Healthy Weight? Important Questions to Ask the Vet

Just as obesity has become a serious problem in people, it's also a growing problem in pets, one that can seriously harm your pet's health.

FDA - U.S. Food and Drug Administration

10-8-2017

Bravecto® may cause convulsions in dogs on rare occasions

Bravecto® may cause convulsions in dogs on rare occasions

The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy.

Danish Medicines Agency

23-10-2013

Danish Pharmacovigilance Update, 29 August 2013

Danish Pharmacovigilance Update, 29 August 2013

In this issue of Danish Pharmacovigilance Update: Cases of acquired haemophilia following treatment with clopidogrel (Plavix® etc.)

Danish Medicines Agency

14-11-2018

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Active substance: clopidogrel) - Centralised - Yearly update - Commission Decision (2018)7602 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

7-9-2018

Consumer story: Georgia and breast implant associated cancer

Consumer story: Georgia and breast implant associated cancer

Learn how to spot the warning signs for breast implant associated cancer in our new consumer story

Therapeutic Goods Administration - Australia

29-6-2018

As many parts of the U.S. face an excessive heat warning, know how to spot heat stroke–and know when it's time to get medical help.  http://bit.ly/2tO5WkM pic.twitter.com/wF6D2CbUEe

As many parts of the U.S. face an excessive heat warning, know how to spot heat stroke–and know when it's time to get medical help. http://bit.ly/2tO5WkM pic.twitter.com/wF6D2CbUEe

As many parts of the U.S. face an excessive heat warning, know how to spot heat stroke–and know when it's time to get medical help. http://bit.ly/2tO5WkM  pic.twitter.com/wF6D2CbUEe

FDA - U.S. Food and Drug Administration

19-6-2018

Iscover (Sanofi-Aventis groupe)

Iscover (Sanofi-Aventis groupe)

Iscover (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2018)3888 of Tue, 19 Jun 2018

Europe -DG Health and Food Safety

30-5-2018

Plavix (Sanofi Clir SNC)

Plavix (Sanofi Clir SNC)

Plavix (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2018)3470 of Wed, 30 May 2018

Europe -DG Health and Food Safety

3-5-2018

Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Active substance: Clopidogrel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2776 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/975/T/60

Europe -DG Health and Food Safety