Controline

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
    Ireland
  • 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

______________________________________________________________________________________________________________________

Date Printed 06/02/2012 CRN 7009874 page number: 1

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

______________________________________________________________________________________________________________________

Date Printed 06/02/2012 CRN 7009874 page number: 2

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.

Irish Medicines Board

______________________________________________________________________________________________________________________

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.

Irish Medicines Board

______________________________________________________________________________________________________________________

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

______________________________________________________________________________________________________________________

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

25-6-2018

Ministers: voedselveiligheid verder versterken urgent

Ministers: voedselveiligheid verder versterken urgent

De Commissie Sorgdrager heeft een grondige analyse gemaakt van de wijze waarop de fipronilcrisis is afgehandeld en spreekt alle relevante actoren –het bedrijfsleven, de toezichthouders en departementen– aan op hun functioneren. Het beeld dat het rapport schetst is niet fraai. De pluimveehouders die nog steeds met de gevolgen van de crisis kampen, voelen het als geen ander.  De aanbevelingen om de voedselveiligheid verder te versterken worden opgevolgd. Dat schrijven de ministers Bruno Bruins en Carola Sc...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

25-6-2018

Commissie onderzoek fipronil in eieren: geef voedselveiligheid topprioriteit

Commissie onderzoek fipronil in eieren: geef voedselveiligheid topprioriteit

Bedrijven in de eierketen, de NVWA en de ministeries van VWS en LNV hebben onvoldoende voorrang gegeven aan voedselveiligheid. Bedrijven in de eierketen maken hun wettelijke verantwoordelijkheid niet waar. Bij de NVWA krijgt voedselveiligheid te weinig aandacht. Politiek en bestuur hebben een te beperkte opvatting over hun eigen rol ten aanzien van voedselveiligheid en komen pas in actie als zich een incident of crisis voordoet. Dat zijn de belangrijkste conclusies uit het rapport van de Commissie onderz...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

6-8-2018

Cetrotide (Merck Europe B.V.)

Cetrotide (Merck Europe B.V.)

Cetrotide (Active substance: Cetrorelix (as acetate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5373 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/233/T/67

Europe -DG Health and Food Safety

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

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

11-6-2018

Harvoni (Gilead Sciences Ireland UC)

Harvoni (Gilead Sciences Ireland UC)

Harvoni (Active substance: ledipasvir/sofosbuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3759 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3850/T/67

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