Advantage 80 mg Feline and Bunny Spot-on Solution

Main information

  • Trade name:
  • Advantage 80
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Advantage 80
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • imidacloprid
  • Therapeutic area:
  • Cats, Rabbit

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0389/002
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0389/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:December2011

AN:01261/2010

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Advantage80mgfelineandbunnySpot-onsolution[UK]

Advantage80mgSpot-onsolutionforLargeCatsandLargePetRabbits[AT,DE,FR,

IE,IT]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each0.8mlpipettecontains:

Activesubstance:

Imidacloprid 80mg

Excipient(s):

Butylhydroxytoluene(E321) 0.8mg

Benzylalcohol 665.6mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution

Clearyellowtoslightlybrownishsolution

4. CLINICALPARTICULARS

4.1Targetspecies

Catsandpetrabbits

4.2Indicationsforuse,specifyingthetargetspecies

Forcatsof4kgandgreater:

Preventionandtreatmentoffleainfestations.

.

Forpetrabbitsof4kgandgreater:

Treatmentoffleainfestations.

Fleasarekilledwithinonedayfollowingtreatment.Onetreatmentpreventsfurtherflea

infestationforthreetofourweeksoncatsanduptooneweekonpetrabbits.The

productcanbeusedaspartofatreatmentstrategyforthecontrolofFleaAllergy

Issued:December2011

AN:01261/2010

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Dermatitis(FAD)incats,wherethishasbeenpreviouslydiagnosedbyaveterinary

surgeon.

4.3Contraindications

Donottreatunweanedkittensoflessthan8weeksofage.

Donotuseonrabbitsintendedforhumanconsumption.

Donotuseonpetrabbitsoflessthan10weeksofage.

Donotuseinanimalsthatareknowntobehypersensitivetotheactivesubstanceorany

oftheexcipients.

4.4Specialwarnings

Re-infestationfromemergenceofnewfleasintheenvironmentmaycontinuetooccurfor

sixweeksorlongeraftertreatmentisinitiated.Morethanonetreatmentmaytherefore

berequired,dependingontheleveloffleasintheenvironment.Toaidreductionin

environmentalchallenge,theadditionaluseofasuitableenvironmentaltreatment

againstadultfleasandtheirdevelopingstagesisrecommended.Inordertoreduce

furthertheenvironmentalchallenge,itisrecommendedthatalldogs,catsandrabbitsin

thehouseholdaretreated.Treatmentofnursingqueensanddoescontrolsflea

infestationsonbothdamandoffspring.

Theproductremainseffectiveiftheanimalbecomeswet,forexampleafterexposureto

heavyrain.However,re-treatmentmaybecomenecessary,dependingonthepresence

offleasintheenvironment.Inthesecasesdonottreatmorefrequentlythanonceweekly.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Thisproductisfortopicaluseandshouldnotbeadministeredorally.

Applyonlytoundamagedskin

Careshouldbetakentoavoidthecontentsofthepipettecomingintocontactwiththe

eyesormouthoftherecipientanimal.

Donotallowrecentlytreatedanimalstogroomeachother.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsthoroughlyafteruse.

Washoffanyskincontaminationwithsoapandwater.

Peoplewithknownskinsensitivitymaybeparticularlysensitivetothisproduct.

Avoidcontactoftheproductwiththeeyesormouth.

Iftheproductgetsintoeyesaccidentally,theeyesshouldbethoroughlyflushedwith

water.Ifskinoreyeirritationpersists,ortheproductisaccidentallyswallowed,obtain

medicalattention.

Donoteat,drinkorsmokeduringapplication.

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4.6Adversereactions(frequencyandseriousness)

Theproductisbittertastingandsalivationmayoccasionallyoccuriftheanimallicksthe

applicationsiteimmediatelyaftertreatment.Thisisnotasignofintoxicationanddisap-

pearswithinsomeminuteswithouttreatment(seealsosection4.9Amountstobe

administeredandadministrationroute).

Inveryrareoccasionsskinreactionssuchashairloss,redness,itchingandskinlesions

mayoccurincatsandrabbits.Agitation, excessivesalivationandnervoussignssuchas

incoordination,tremorsanddepressionhavealsobeenreportedbutexceptionallyin

cats.

4.7Useduringpregnancy,lactationorlay

Sincenoprimaryembryotoxic,teratogenicorreproductivetoxiceffectshavebeen

observedduringthestudieswithimidaclopridonratsandrabbitstheproductcanbe

usedinpregnantorlactatingdoes.Studiesonpregnantandlactatingqueenstogether

withtheiroffspringarelimited.Evidencesofarsuggeststhatnoadverseeffectsareto

beexpectedintheseanimals.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noincompatibilityhasbeenobservedbetweenthisproductattwicetherecommended

doseandthefollowingcommonlyusedveterinaryproducts:lufenuron,pyranteland

praziquantel(cats).Thecompatibilityoftheproductwasalsodemonstratedwithawide

rangeofroutinetreatmentsunderfieldconditionsincludingvaccination.

4.9Amountstobeadministeredandadministrationroute

DosageandTreatmentSchedule

Cat/Rabbit(kgbw) Product Numberof

Pipettes Imidacloprid

(mg/kgbw)

≥4kg Advantage ® 80forLarge

CatsandLargePet

Rabbits 1x0.8ml minimumof10

MethodofAdministration

Removeonepipettefromthepackage.Holdpipetteinanuprightposition,twistandpull

offcap.Usereversedcaptotwistandremovesealfrompipette.

Issued:December2011

AN:01261/2010

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AdministrationtotheCat

Partthehaironthecat'sneckatthebaseoftheskulluntiltheskinisvisible.Placethe

tipofthepipetteontheskinandsqueezefirmlyseveraltimestoemptythecontents

directlyontotheskin.

AdministrationtotheRabbit

Partthehairontherabbit’sneckatthebaseoftheskulluntiltheskinisvisible.Placethe

tipofthetubeontheskinandsqueezefirmlyseveraltimestoemptythecontentsdirectly

ontotheskin.

AllSpecies

Theproductisbittertastingandsalivationmayoccasionallyoccuriftheanimallicksthe

applicationsiteimmediatelyaftertreatment.Thisisnotasignofintoxicationand

disappearswithinsomeminuteswithouttreatment.Applicationatthebaseoftheskull

willminimizetheopportunityforthecattolicktheproduct.

Applyonlytoundamagedskin.Donotallowrecentlytreatedanimalstogroomeach

other.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incats,noadverseclinicalsignswereproducedusingdosesoffivetimesthe

therapeuticlevelweeklyforeightconsecutiveweeks.

Inrabbits,noadverseclinicalsignswereseenusingdosesofupto45mg/kgbody

weight(4timesthetherapeuticlevel)weeklyfor4consecutiveweeks.

Inrarecasesofoverdoseorlickingoftreatedfur,nervoussystemdisorders(suchas

twitching,tremors,ataxia,mydriasis,miosis,lethargy)canoccurincats.

Issued:December2011

AN:01261/2010

Page5of7

Poisoningfollowinginadvertentoraluptakeinanimalsisunlikely.Inthisevent,treatment

shouldbesymptomaticunderveterinarymedicalattention.Thereisnoknownspecific

antidotebutadministrationofactivatedcharcoalmaybebeneficial.

4.11Withdrawalperiod(s)

Donotuseonrabbitsintendedforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antiparasiticagent

ATCvetcode:QP53AX17

5.1Pharmacodynamicproperties

Imidacloprid,1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamineisan

ectoparasiticidebelongingtoagroupofchloronicotinylcompounds.Chemically,itis

moreaccuratelydescribedasachloronicotinylnitroguanidine.

Thesubstancehasahighaffinityforthenicotinergicacetylcholinereceptorsinthepost-

synapticregionofthecentralnervoussystem(CNS).Theensuinginhibitionof

cholinergictransmissionininsectsresultsinparalysisanddeath.Duetotheweak

natureoftheinteractionwithmammaliannicotinergicreceptorsitesandthepostulated

poorpenetrationthroughtheblood/brainbarrierinmammals,ithasvirtuallynoeffecton

themammalianCNS.Theminimalpharmacologicalactivityinmammalsissupportedby

safetystudiesinvolvingsystemicadministrationofsub-lethaldosestorabbits,miceand

rats.

Infurtherstudies,inadditiontotheadulticidefleaefficacyofimidacloprid,alarvicidal

fleaefficacyinthesurroundingsofthetreatedpethasbeendemonstrated.Larval

stagesinthepet’ssurroundingsarekilledfollowingcontactwithatreatedanimal.

5.2Pharmacokineticparticulars

Theproductisindicatedforcutaneousadministration.Followingtopicalapplicationin

cats,thesolutionisquicklydistributedovertheanimal.Acutedermalstudiesintherat

andtargetanimaloverdoseandserumkineticstudieshaveestablishedthatsystemic

absorptionisverylow,transientandnotrelevantfortheclinicalefficacy.Thishasbeen

furtherdemonstratedbyastudyinwhichfleaswerenotkilledafterhavingfedon

previouslytreatedanima lsoncetheanimal’sskinandfurhadbeencleanedofallactive

material.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Issued:December2011

AN:01261/2010

Page6of7

ButylhydroxytolueneE321

Benzylalcohol

Propylenecarbonate

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:

5years

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Keeptheblisterintheoutercarton

6.5Natureandcompositionofimmediatepackaging

Packsizes 0.8mlsolutionperpipette

Blisterpackcontaining2,3,4,or6unitdosepipettes

Container Whitepolypropylenepipetteswithcaps

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

Bayerplc

AnimalHealthDivision

BayerHouse

StrawberryHill

Newbury

Berkshire

RG141JA

8. MARKETINGAUTHORISATIONNUMBER

Issued:December2011

AN:01261/2010

Page7of7

Vm00010/4178

9. DATEOFFIRSTAUTHORISATION

7December2011

10.DATEOFREVISIONOFTHETEXT

December2011

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