Controline 67 mg Spot-on Solution for small dogs

Main information

  • Trade name:
  • Controline 67 mg Spot-on Solution for small dogs
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Controline 67 mg Spot-on Solution for small dogs
    Hungary
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • IE/V/0280/001
  • Authorization date:
  • 21-12-2011
  • EU code:
  • IE/V/0280/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1NAMEOFTHEVETERINARYMEDICINALPRODUCT

Controline50mgSpot-onSolutionforCats.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

One0.5mlpipettecontains:

Activesubstance:

Fipronil 50mg

Excipients:

ButylhydroxyanisoleE320 0.1mg

ButylhydroxytolueneE321 0.05mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Spot-onsolution.

Clear,paleambersolution.

4CLINICALPARTICULARS

4.1TargetSpecies

Cats.

4.2Indicationsforuse,specifyingthetargetspecies

Treatmentofflea(Ctenocephalidesspp)infestations.

Theproducthasapersistentinsecticidalefficacyforupto5weeksagainstfleas(Ctenocephalidesspp.).

Theproducthasnotdemonstratedanimmediateacaricidaleffectagainstticksbuthasdemonstratedpersistent

acaricidalefficacyforupto2weeksagainstIxodesricinusand1weekagainstDermacentorreticulatusand

Rhipicephalussanguineus.Ifticksofthesespeciesarepresentwhentheproductisapplied,alltheticksmaynotbe

killedwithinthefirst48hoursbuttheymaybekilledwithinaweek.

TheproductcanbeusedaspartofatreatmentstrategyforFleaAllergicDermatitis,wherethishasbeenpreviously

diagnosedbyaveterinarysurgeon.

4.3Contraindications

Intheabsenceofavailabledata,theproductshouldnotbeusedonkittenslessthan2monthsoldand/orweighingless

than1kg.

Donotuseonsick(systemicdiseases,fever…)orconvalescentanimals.

Donotuseinrabbits,asadversedrugreactionsandevendeathcouldoccur.

Irish Medicines Board

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4.4Specialwarningsforeachtargetspecies

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareassuchascarpetsandsoftfurnishings

whichshouldbetreated,incaseofmassiveinfestationandatthebeginningofthecontrolmeasures,withasuitable

insecticideandvacuumedregularly.

Theproductdoesnotpreventticksfromattachingtotheanimals.Iftheanimalhasbeentreatedpriortoexposuretothe

ticks,Thetickswillbekilledinthefirst24-48hoursafterattachment.Thiswillusuallybepriortoengorgement,

minimisingbutnotexcludingtheriskoftransmissionofdiseases.Oncedead,tickswilloftendropofftheanimal,but

anyremainingticksmayberemovedwithagentlepull.

Avoidfrequentswimming/bathingorshampooingtheanimalbecausethemaintenanceofeffectivenessoftheproduct

inthesecaseshasnotbeentested.

Foroptimumcontroloffleaproblemsinamulti-pethousehold,alldogsandcatsinthehouseholdshouldbetreated

withasuitableinsecticide.

WhenusedaspartofastrategyforthetreatmentofFleaAllergyDermatitis,monthlyapplicationstotheallergicpatient

andtoothercatsanddogsinthehouseholdarerecommended.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Avoidcontactwiththeanimal’seyes.Inthecaseofaccidentaleyecontact,immediatelyandthoroughlyflushtheeyes

withwater.Donotapplytheproductonwoundsordamagedskin.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contactbetweentheproductandthemouthor

eyesshouldbeavoided.

Inthecaseofaccidentaleyecontact,immediatelyandthoroughlyflushtheeyeswithwater.Ifeyeirritationpersists

seekmedicaladviceandshowthepackageleafletorthelabeltothephysician.

Donotsmoke,drinkoreatduringapplication.Avoidcontentscomingintocontactwiththeskin.Ifthisoccurs,wash

handswithsoapandwater.Washhandsafteruse.

Animalsoroperatorswithaknownhypersensitivitytofipronilorexcipients(seesection6.1.)shouldavoidcontact

withtheveterinarymedicinalproduct.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildrenshouldbekeptawayfromtreated

animalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthatanimalsarenottreatedduringtheday,but

shouldbetreatedduringtheearlyevening,andthatrecentlytreatedanimalsshouldnotbeallowedtosleepwith

owners,especiallychildren.

Otherprecautions

Thealcoholcarriermayhaveadverseeffectsonpainted,varnishedorotherhouseholdsurfacesorfurnishings.

Thisproductisflammable.Keepawayfromheat,sparks,openflameorothersourcesofignition.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlytothenatureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneousreactionsattheapplicationsite(squamosis,

localalopecia,pruritus,erythema)andgeneralpruritusoralopeciahavebeenreportedafteruse.Exceptionally,

hypersalivation,reversibleneurologicsymptoms(hyperesthesia,depression,nervoussymptoms)orvomitinghavebeen

Irish Medicines Board

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4.7Useduringpregnancy,lactationorlay

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicorembryotoxiceffects.Studieshavenot

beencarriedoutwiththisproductinpregnantandlactatingqueens.Useinpregnancyandlactationonlyinaccordance

withprofessionalveterinaryadviceandabenefit/riskassessment.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Routeofadministrationanddosage:

Externaluseonly.

Administerbytopicalapplicationtotheskin1pipetteof0.5mlperanimal.

Methodofadministration:

Removethepipettefromtheblisterpackaging.Holdthepipetteupright.Tapthenarrowpartofthepipettetoensurethe

contentsarewithinthemainbodyofthepipette.Twistandpullthesnap-offtopofthepipettetoenablethecontentsto

beexpelled.

Partthepet’scoatuntiltheskinisvisible.Placethetipofthepipettedirectlyagainstthebaredskinandsqueezegently

toemptyitscontentsattwopointsalongthecat’sback,preferablyatthebaseoftheheadand2-3cmfurtherback,

emptyingapproximatelyhalfthevolumeateachsite.Squeezethepipetteseveraltimestoensuredosingiscomplete.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff,andtomakesure

thatanimalsdonotlickeachotherfollowingtreatment.

Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsincethiswillcauseastickyappearanceof

hairsatthetreatmentspot.However,shouldthisoccur,itwilldisappearwithin24hourspostapplication.Scalingand

crystallinedepositsonthehairsmayalsobeobservedatthesiteofapplicationforupto48hours.

Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestationthetreatmentschedulecanbebasedonthelocalepidemiological

situation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesincatsandkittensaged2monthsandolderand

weighingabout1kgtreatedatfivetimestherecommendeddoseover3consecutivemonths.Theriskofadverseeffects

mayincreaseincasesofover-dose.

4.11WithdrawalPeriod(s)

Notapplicable.

5PHARMACOLOGICALorIMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

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Date Printed 06/02/2012 CRN 7009874 page number: 3

5.1Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.ItactsbyinhibitingtheGABA

complex,bindingtothechloridechannelandtherebyblockingpre-andpost-synaptictransferofchlorideionsacross

cellmembranes.Thisresultsinuncontrolledactivityofthecentralnervoussystemanddeathofinsectsoracarids.

Fipronilexhibitsinsecticidalactivityagainstfleas(Ctenocephalidesspp)andacaricidalactivityagainstticksinthecat.

Fleaswillbekilledwithin48hours.Tickswillusuallybekilledwithin48hoursaftercontactwithFipronil,howeverif

Ixodesricinus,DermacentorreticulatusorRhipicephalussanguineusticksarepresentwhentheproductisapplied,all

theticksmaynotbekilledwithinthefirst48hours.

5.2Pharmacokineticproperties

Absorption

Absorptionoffipronilthroughtheskinisnegligible.

Distribution

Aftertopicalapplication,theproductwillspreadfromthesiteoftreatmenttocovertheentiresurfaceoftheanimal

within24-48hours.

Biotransformation

Fipronilismainlymetabolisedtoitssulfonederivative,whichalsopossessesinsecticidalandacaricidalproperties.

Elimination

Theconcentrationsoffipronilonthehairdecreasewithtime

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ButylhydroxyanisoleE320

ButylhydroxytolueneE321

Benzylalcohol

Diethyleneglycolmonoethylether

6.2Incompatibilities

Noneknown.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18months.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Storeinadryplace.Storeintheoriginalcontainer.

6.5Natureandcompositionofimmediatepackaging

Whiteopaque,pinktranslucentorgreentranslucentpolypropylenesingle-dosepipettecontaininganextractiblevolume

of0.5mlpackagedinaclearPVCblisterclosedbyheatsealingwithaluminiumfoilandplacedinacarton

Packsizesof1,2,3,4,6,8,9,10,12,15,18,20,21,24,30,60,90or150pipettes.

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Date Printed 06/02/2012 CRN 7009874 page number: 4

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwastematerials

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproductsshouldbe

disposedofinaccordancewithlocalrequirements.

Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminateponds,waterwaysorditcheswiththeproductor

emptycontainer.

7MARKETINGAUTHORISATIONHOLDER

ChanellePharmaceuticalsManufacturingLtd.,

Loughrea,

Co.Galway,

Ireland.

8MARKETINGAUTHORISATIONNUMBER(S)

VPA10987/096/001

9DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

February2012

Irish Medicines Board

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Date Printed 06/02/2012 CRN 7009874 page number: 5

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