Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs

Main information

  • Trade name:
  • Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs
  • Pharmaceutical form:
  • Cutaneous spray, solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • fipronil
  • Therapeutic area:
  • Cats Non Food, Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0467/001
  • Authorization date:
  • 25-07-2012
  • EU code:
  • UK/V/0467/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:January2013

AN:00744/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Amflee2.5mg/mlcutaneousspray,solutionforcatsanddogs

Amfleevet2.5mg/mlcutaneousspray,solutionforcatsanddogs

FipronilKrka2.5mg/mlcutaneousspray,solutionforcatsanddogs

Amflee2.5mg/mlcutaneousspray,solutionforcatsanddogs(UnitedKingdom,

Austria,Belgium,Germany,Spain,France,Greece,Ireland,Italy,Luxembourg,

Netherlands,Portuguese)

Amfleevet2.5mg/mlcutaneousspray,solutionforcatsanddogs(Finland,Swedish,

Denmark)

FipronilKrka2.5mg/mlcutaneousspray,solutionforcatsanddogs(Norwegian)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains

Activesubstance:

Fipronil2.5mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Cutaneousspray,solution

Clear,colourlessliquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Catsanddogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofflea(Ctenocephalidesspp.)andtick(Ixodesricinus,Rhipicephalus

sanguineus)infestationsindogsandcats.

Treatmentofbitingliceinfestationsindogs(Trichodectescanis)andcats(Felicola

subrostratus).

TheproductcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergy

Dermatitis(FAD).

Insecticidalefficacyagainstnewinfestationswithadultfleaspersistsforupto2

monthsincatsandupto3monthsindogs,dependingonenvironmentalchallenge.

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Theproducthasapersistentacaricidalefficacyforupto4weeksagainstticks,

dependingonthelevelofenvironmentalchallenge.

4.3 Contraindications

Donotuseonsick(systemicdiseases,fever)orconvalescentanimals

Donotuseinrabbits,asadversereactionsandevendeathcouldoccur.

Donotuseincasesofhypersensitivitytotheactivesubstanceortoalcohol.

4.4 Specialwarningsforeachtargetspecies

Donotexceedtherecommendeddosage.

Avoidcontactwiththeanimal’seyes.

Donotspraydirectlyontoareasofbrokenskin.

Allowtreatedanimalstodryinawellventilatedroom(seealsosection4.5(ii)).

Donotconfineanimalsinanenclosedspaceorpetcarrieruntilthecoatistotallydry.

Intheabsenceofspecifictoleranceandefficacydata,theproductisnot

recommendedforthetreatmentofspeciesotherthancatsanddogs.

Whenusedaspartofastrategyforthetreatmentoffleaallergydermatitis,monthly

applicationstotheallergicpatientandtoothercatsanddogsinthehouseholdare

recommended.

Treatmentofbedding,carpetsandsoftfurnishingswithasuitableinsecticidewillaid

reductioninenvironmentalchallengeandmaximisethedurationofprotectionagainst

re-infestationprovidedbytheproduct.

Theproductisnotsuitablefordirecttreatmentoftheenvironment.

Foroptimumefficacy,itisnotrecommendedtobatheorshampooanimalsinthetwo

dayspriortoorfollowingtreatmentwiththeproduct.Bathingorshampooingupto

fourtimesintwomonthshasbeenshowntohavenosignificanteffectontheresidual

efficacyoftheproduct.Monthlytreatmentisrecommendedwhenmorefrequent

shampooingiscarriedout.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Itisimportanttomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Theremaybeanattachmentofsingleticks.Forthisreasonatransmissionof

infectiousdiseasescannotbecompletelyexcludedifconditionsareunfavourable.

Keeptreatedanimalsawayfromfiresorothersourcesofheat,andsurfaceslikelyto

beaffectedbythealcoholspray,foratleast30minutesfollowingsprayinganduntil

thefuristotallydry.Donotsprayonanakedflameoranyincandescentmaterial.

Forexternaluseonly.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contactof

theproductwithmouthandeyesshouldbeavoided.Afteraccidentalocularexposure

theeyeshouldberinsedcarefullywithplainwater.

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Operatorswithaknownhypersensitivitytotheactivesubstanceoralcoholorwith

asthmashouldavoidcontactwiththeproduct.Avoidcontentscomingintocontact

withthefingers.Ifthisoccurs,washhandswithsoapandwater.

Treatedanimalsshouldnotbehandleduntilthefurisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntilthefurisdry.Itisthereforerecommended

thatanimalsarenottreatedduringtheday,butshouldbetreatedduringtheearly

evening,andthatrecentlytreatedanimalsarenotallowedtosleepwithowners,

especiallychildren.

Sprayanimalsintheopenairorawellventilatedroom.

Donotbreathespray.Donotsmoke,drinkoreatduringapplication.

WearPVCornitrileglovesduringtreatmentofanimals.Itisrecommendedtoweara

waterproofapronfortheprotectionofclothing.Ifclothingbecomesheavilywetted

withtheproduct,itshouldberemovedandwashedbeforere-use

Disposeofglovesafteruseandthenwashhandswithsoapandwater.

Washsplashesfromskinwithsoapandwaterimmediately.Ifirritationoccurs,seek

medicaladvice.Peoplewithknownsensitivityorasthmamaybeparticularly

sensitivetotheproduct.Donotuseproductifyouhavepreviouslyexperienceda

reactiontoit.

Treatmentofmultipleanimals:Goodventilationisparticularlyimportantwhere

severalanimalsaretobetreated.Treatmultipleanimalsoutside,orreducethebuild

upofvapourbyremovingtheanimalsfromthetreatmentroomwhilethealcoholis

evaporatingandensurethatthetreatmentroomiswellventilatedbetweenindividual

treatments.Inaddition,ensurethatthedryingroomiswellventilated

andavoidhousingseveralrecentlytreatedanimalswithinthesameairspace.

Otherprecautions

Fipronilmayadverselyaffectaquaticorganisms.Dogsshouldnotbeallowedtoswimin

watercoursesfor2daysafterapplication.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlytothe

natureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionserythema,pruritusoralopeciahavebeenreportedafteruse.Exceptionally,

hypersalivation,reversibleneurologicalsigns(hyperaesthesia,depression,nervous

signs),vomitingorrespiratorysignshavebeenobservedafteruse.

Donotoverdose(seesection4.10).

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesdidnotrevealanyteratogeniceffectoffipronilintheratand

rabbit.

Theformulationisverywelltoleratedbypuppiesfollowingtreatmentofthelactating

bitch.

Dataarenotavailableontreatmentofpregnantqueensornursingqueens.

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4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Routeofadministration:mechanicalpumpsprayforexternaluse;withthepump

delivering0.5ml(100mlbottle)or1.5ml(250mlbottle)or3ml(500mlbottle)spray

perpump..

Methodofadministration:

Adjustthepumpnozzletospraysetting.

Spraytheentirebodyoftheanimal,andapplyfromadistanceofapproximately10-

20cm.

Applyagainstthelayofthehairandmakesurethattheentirecoatoftheanimalis

dampened.Rufflethecoat,especiallyinlonghairedanimals,sothattheproduct

penetratesdowntotheskin.

Fortreatmentoftheheadregion,andwhentreatingyoungornervouspets,

applicationmaybecarriedoutbysprayingontoaglovedhandandrubbingthe

productintothecoat.Allowtodrynaturally.Donottoweldry.

Posology:Inordertodampenthecoatdowntotheskin,dependingonthelengthof

hair,apply3to6mlperkgbodyweight,(7.5to15mgofactiveingredientperkg

bodyweight)i.e.6to12pumpapplicationsperkgbodyweightofthe100ml

presentation,or2to4pumpapplicationsofthe250ml,oror1to2pump

application(s)ofthe500mlpresentation.

The100mlpackcontainsapproximately8treatmentsforashorthairedmedium

sizedcat(4kg).The250mlpackcontainsapproximately4treatmentsforashort

hairedmediumsizeddog(20kg).The500mlpackcontainsapproximately4

treatmentsforashorthairedlargesizeddog(40kg).

Properties:Theformulationcontainsacoatingagent.Therefore,sprayingbuildsup

afilmandmakesthefurglossy.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

Foroptimalcontroloffleaand/ortickinfestationthetreatmentscheduleshouldbe

basedonthelocalepidemiologicalsituation.

Puppiesandkittensfrom2daysofagemaybesafelytreated.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theriskofexperiencingadverseeffects(seesection4.6)mayincreasewhen

overdosing,soanimalsshouldalwaysbetreatedwiththecorrectdoseaccordingto

bodyweight.

Startanappropriatesymptomatictreatmentincaseofoverdosing.

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4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse,fipronil

ATCvetcode:QP53AX15

5.1 Pharmacodynamicproperties

Fipronilexhibitsinsecticidalandacaricidalactivityagainstfleas(Ctenocephalides

spp),ticks(Rhipicephalusspp.,Ixodesspp.)andlice(Trichodectesspp.andFelicola

spp.)inthedogandcat.

Fipronilisamemberofthephenylpyrazolefamilyofbroadspectrum,non-systemic,

insecticides/acaricides,whichactsbyblockingtheGABAreceptortokillthetarget

parasiteoncontact.Theproductmayaidinthecontrolofanumberofectoparasite

speciesindogsandcats.TheproductisactiveagainstIxodesspp.includingIxodes

ricinus,importantasthevectorofLymedisease.Treatmentwiththeproducthasbeen

showntoresultinasignificantreductionintheincidenceoffleaallergydermatitisin

bothdogsandcats.

5.2 Pharmacokineticparticulars

Absorption

Theamountoffipronilabsorbedbytheskininthedog,afterapplicationofthespray

tothecoatandskinisextremelyslighttonegligible.

Distribution

Thepersistenceoffipronilonthehairisverylong(onaverage52.5±11.5days),

giventhatthelimitofquantificationoftheassaymethodis0.25µg/g.

Biotransformation

Inallspeciesfipronilismainlymetabolisedtoitssulphonederivative(RM1602),

whichalsopossessesinsecticidalandacaricidalproperties.

TheRM1602detectedonthehairaftersprayapplicationindogsmaybeexplained

byitspresenceintheoriginalrawmaterial.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Copovidone

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Isopropylalcohol

Purifiedwater

6.2Incompatibilities

Notknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:1year

6.4.Specialprecautionsforstorage

Storebelow25

C.

Highlyflammable.

Protectfromdirectsunlight.

6.5Natureandcompositionofimmediatepackaging

Opaque,white100mlhighdensitypolyethylenebottlefittedwithalowdensity

polyethylene/polypropylenepumpsprayercapableofdelivering0.5mlperspray.

Opaque,white250mlhighdensitypolyethylenebottlefittedwithalowdensity

polyethylene/polypropylenepumpsprayercapableofdelivering1.5mlperspray.

Opaque,white500mlhighdensitypolyethylenebottlefittedwithalowdensity

polyethylene/polypropylenepumpsprayercapableofdelivering3.0mlperspray.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,waterways

orditcheswiththeproductoremptycontainers.

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7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.

Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4058

9. DATEOFFIRSTAUTHORISATION

7January2013

10 DATEOFREVISIONOFTHETEXT

January2013

Approved: 07/01/2013