FRONTLINE COMBO PACK CONSULTSPOT ON DOG M

Main information

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

Documents

Localization

  • Available in:
  • FRONTLINE COMBO PACK CONSULTSPOT ON DOG M
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0246/003
  • Authorization date:
  • 26-09-2012
  • EU code:
  • FR/V/0246/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

FrontlineComboPackConsultSpotonDogM

SUMMARYOFPRODUCTCHARACTERISTICS

FrontlineComboPackConsultSpotonDogM

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FRONTLINECOMBOPACKCONSULTSPOT-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.Inabsenceof

studies,theuseoftheproductisnotrecommendedinnon-targetspecies.

Thisproductisspecificallydevelopedfordogs.Donotuseincatsandferrets,asthiscouldleadto

overdosing.

4.4 Specialwarningsfortargetspecies

FrontlineCOMBOPACKCONSULTSpotonCat

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

Bathing/immersioninwaterwithin2daysafterapplicationoftheproductandmorefrequentbathing

thanonceaweekshouldbeavoided,asnostudyhasbeenperformedtoinvestigatehowthisaffects

theefficacyoftheproduct.Emollientshampooscanbeusedpriortotreatment,butreducetheduration

ofprotectionagainstfleastoapproximately5weekswhenusedweeklyafterapplicationofthe

product.Weeklybathingwitha2%chlorhexidinemedicatedshampoodidnotaffectefficacyagainst

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

FrontlineComboPackConsultSpotOnDog.Avoidcontentscomingintocontactwiththefingers.If

thisoccurs,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.

FrontlineCOMBOPACKCONSULTSpotonCat

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

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

FrontlineCOMBOPACKCONSULTSpotonCat

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

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

FrontlineCOMBOPACKCONSULTSpotonCat

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

Barexpipette210-polypropylene.

Salespresentation(s) and administrativenumber(s)ofidentification

Blistercardof1x1.34mlpipettewithascoredtip

Boxof1blistercardof3x1.34mlpipetteswithascoredtip

Boxof2blistercardsof3x1.34mlpipetteswithascoredtip

Boxof6blistercardof3x1.34mlpipetteswithascoredtip

Boxof10blistercardsof3x1.34mlpipetteswithascoredtip

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.

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

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

6-4-2018

"Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with Salmonella

"Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with Salmonella

Health Canada is advising Canadians that one lot of “Organic Traditions Shatavari Powder” is being voluntarily recalled by Advantage Health Matters Inc. Company testing found Salmonella bacteria contamination, which may pose serious health risks. According to Advantage Health Matters Inc., 13 units from the affected lot were distributed. Of the 13 units, only 2 packages, sold at Choices Markets Yaletown (1202 Richards Street) in Vancouver, B.C., have not been recovered.

Health Canada

29-6-2018

BROADLINE (Merial)

BROADLINE (Merial)

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

Europe -DG Health and Food Safety

30-4-2018

CERTIFECT (Merial)

CERTIFECT (Merial)

CERTIFECT (Active substance: (S)-Methoprene, Fipronil, Amitraz) - Withdrawal - Commission Decision (2018)2687 of Mon, 30 Apr 2018

Europe -DG Health and Food Safety