Norofip

Main information

  • Trade name:
  • Norofip 67 mg Spot-On Solution for Small Dogs
  • Pharmaceutical form:
  • Spot-on
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Norofip 67 mg Spot-On Solution for Small Dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • fipronil
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • IE/V/0305/001
  • Authorization date:
  • 20-02-2013
  • EU code:
  • IE/V/0305/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fleanil67mgSpot-OnSolutionforSmallDogs

Fleanilvet67mgSpot-OnSolutionforSmallDogs(FI)

FipronilNorbrook67mgSpot-OnSolutionforSmallDogs(NO)

Fleanil(DK)

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

One0.67mlpipettecontains:

Activesubstance:

Fipronil67mg

Excipients:

Butylhydroxyanisole(E320)0.134mg

Butylhydroxytoluene(E321)0.067mg

Forfulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Aclear,colourlesstopaleyellowsolution.

4. CLINICALPARTICULARS

4.1 TargetSpecies

Dogs.

4.2 IndicationsforUse,SpecifyingtheTargetSpecies

Forthetreatmentofinfestationsbyfleas(Ctenocephalidesfelis).Theproductshows

immediateinsecticidaleffectandpersistentinsecticidalactivityagainstnewinfestationsby

adultfleasforupto8weeks.

TheproducthasapersistentacaricidalefficacyagainstIxodesricinusforupto2weeks,

Rhipicephalussanguineusforupto3weeksandDermacentorreticulatusforupto4weeks.If

ticksofthesespeciesarepresentwhentheproductisapplied,alltickswillnotbekilledwithin

thefirst48hoursbuttheymaybekilledwithinaweek.

4.3 Contra-Indications

Donotuseindogsweighinglessthan2kg.

Intheabsenceofavailabledata,theproductshouldnotbeusedinpuppieslessthan8weeks

old.

Donotuseinsick(systemicdiseases,fever…)orconvalescentanimals.

Donotuseinrabbits,asadversereactionsandevendeathcouldoccur.

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Thisproductisspecificallydevelopedfordogs.Donotuseincats,asthiscouldleadto

overdosing.

Donotuseincasesofknownhypersensitivitytotheactiveortoanyoftheexcipients.

4.4 SpecialWarningsforEachTargetSpecies

Theproductdoesnotpreventticksfromattachingtotheanimals,butticksmaybekilledinthe

first24-48hoursafterattachmentpriortofullengorgementandthereforeminimisingtherisk

oftransmissionofdiseases.Oncedead,tickswilloftendropofftheanimal,butany

remainingticksmayeasilyberemovedbyagentlepull.

Foroptimalcontroloffleainfestationinmulti-pethousehold,alldogsandcatsinthehouse

shouldbetreatedwithasuitableinsecticide.

Theremaybeanattachmentofticks.Forthisreasontransmissionofinfectiousdiseases

cannotbecompletelyexcludedifconditionsareunfavourable.Fleasfrompetsofteninfestthe

animal’sbasket,beddingandregularrestingareassuchascarpetsandsoftfurnishingswhich

shouldbetreated,incaseofmassiveinfestationandatthebeginningofthecontrolmeasures,

withasuitableinsecticideandvacuumedregularly.

Avoidfrequentswimmingorshampooingoftheanimalbecausethemaintenanceof

effectivenessoftheproductinthesecaseshasnotbeentested.

4.5 SpecialPrecautionsforUse

(i)Specialprecautionsforuseinanimals

Avoidcontactwiththeanimal’seyes.Inthecaseofaccidentaleyecontactimmediatelyand

thoroughlyflushtheeyeswithwater.

Forexternaluseonly.

Animalsshouldbeweighedaccuratelypriortotreatment.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlick

itoff,andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Donotapplytheproductonwoundsordamagedskin.

(ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttotheanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contactoftheproduct

withthemouthandeyesshouldbeavoided.

Incasesofaccidentaleyecontact,immediatelyandthoroughlyrinsetheeyewithplainwater.

Ifeyeirritationpersistsseekmedicaladviceandshowthepackageleafletorthelabeltoa

physician.

Peoplewithaknownhypersensitivitytofipronilorexcipients(section6.1)shouldavoid

contactwiththeveterinaryproduct.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,washhandswithsoapand

water.

Washhandsafteruse.Donotsmoke,drinkoreatduringapplication.

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Treatedanimalsshouldnotbehandleduntilthisapplicationsiteisdry,andchildrenshould

notbeallowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itistherefore

recommendedthatanimalsarenottreatedduringtheday,butshouldbetreatedduringthe

earlyevening,andthatrecentlytreatedanimalsshouldnotbeallowedtosleepwithowners,

especiallychildren.

(iii)Otherprecautions

Fipronilmayadverselyaffectaquaticorganisms.Dogsshouldnotbeallowedtoswimin

watercoursesfor2daysafterapplication.

Thealcoholcarriermayhaveadverseeffectonpainted,varnishedorotherhouseholdsurfaces

orfurnishings.

Thisproductisflammable.Keepawayfromheat,sparks,openflameorothersourcesof

ignition.

4.6 Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlytothenature

ofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneousreactionsatthe

applicationsite(skindiscoloration,localalopecia,pruritus,erythema)andgeneralpruritusor

alopeciahavebeenreportedafteruse.Exceptionally,hypersalivation,reversibleneurological

signs(hyperaesthesia,depression,nervoussigns),vomitingorrespiratorysignshavebeen

observedafteruse.

Donotoverdose.

4.7 UseDuringPregnancy,LactationorLay

Laboratorystudiesusingfipronilhavenotproducedanyevidenceofateratogenicor

foetotoxiceffects.

Intheabsenceofstudiestoevaluatethesafetyofthisproductinpregnantorlactatinganimals

useonlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8 InteractionwithOtherMedicinalProductsandOtherFormsofInteraction

Noneknown.

4.9 AmountstobeAdministeredandAdministrationRoute

Routeofadministration:Bytopicalapplicationtotheskin.

Forexternaluseonly.Applytheproductdirectlytotheskinbasedonweightoftheanimal.

Dosage–

1pipetteof0.67mlperdogweighingover2kgandupto10kgbodyweightcorresponding

toaminimumrecommendeddoseof6.7mg/kgoffipronil.

MethodofAdministration:Holdupright.Tapthenarrowpartofthepipettetoensurethe

contentsarewithinthemainbodyofthepipette.Breakbackthesnap-offtopfromthespot-on

pipettealongthescoredline.Partthecoatbetweentheshoulderbladesuntiltheskinis

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visible.Placethetipofthepipetteontheskinandsqueezegentlyatoneortwospotsto

emptyitscontentsontotheskin.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlick

itoff,andtomakesurethattheanimalsdonotlickeachotherfollowingtreatment.

Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsincethiswill

causeastickyappearanceofhairsatthetreatmentspot.However,shouldthisoccur,itwill

disappearwithin48hourspostapplication.

Fortheoptimalcontrolofinfestationbyfleaandor/tickthetreatmentschedulecanbebased

onlocalepidemiologicalsituation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

4.10 Overdose(Symptoms,EmergencyProcedures,Antidotes),ifNecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesin8weekoldpuppies,

growingdogsanddogsweighingcirca2kgtreatedon3occasionsatfivetimesthe

recommendeddose.Theriskofexperiencingadverseeffects(seesection4.6)mayhowever

increasewhenoverdosing,soanimalsshouldalwaysbetreatedwiththecorrectpipettesize

accordingtobodyweight.

4.11 WithdrawalPeriods

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

PharmacotherapeuticGroup:Ectoparasiticidesfortopicaluse,includinginsecticides.

ATCVetCode:QP53AX15

5.1 PharmacodynamicProperties

Fipronilisaninsecticide/acaricideinthephenylpyrazolefamily.Itactsbyinhibitingthe

GABAcomplex,bindingtothechloridechannelandtherebyblockingpre-andpost-synaptic

transferofchlorideionsacrossthecellmembrane.Thisresultsinuncontrolledactivityofthe

centralnervoussystemanddeathininsectsandacarids.

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Fipronilexhibitsinsecticidalactivityagainstfleas(Ctenocephalidesfelis),andacaricidal

activityagainstticks(Rhipicephalussanguineus,Dermacentorreticulatus,Ixodesricinus)in

thedog.

Newlyarrivingfleasarekilledwithin24hoursoflandingontheanimal.Ticksifalready

presentatthetimeofapplicationoftheproduct,maynotalwaysbekilledinthefirst48hours,

howeverwillbekilledwithin9daysposttreatment.

Theproductiseffectiveagainstfleainfestation(Ctenocephalidesfelis)forapproximately8

weeksandagainsttickinfestationsforupto4weeks(seeindicationsforuse),dependingon

thetickspeciesandthelevelofchallenge.

5.2 PharmacokineticParticulars

Afteralocalapplicationoffiproniltothedog,itisslightlyabsorbedthroughtheskin.Low

levelsoffipronilmaybedetectedintheplasma,withaveryhighvariabilitybetweendogs.

Afterapplication,thereisagooddistributionofthechemicalonthehair,presentingagood

gradientofconcentrationbetweentheapplicationzoneandtheperipheralarea.

Fipronilismainlymetabolisedtoitssulfonederivative(RM1602),whichalsopossesses

insecticidalandacaricidalproperties.

Theconcentrationsoffipronilonthehairdecreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1 ListofExcipients

Butylhydroxyanisole(E320)

Butylhydroxytoluene(E321)

PovidoneK12

Polysorbate80

ButylAlcohol

DiethyleneGlycolMonoethylEther

6.2 Incompatibilities

Noneknown.

6.3 Shelf-Life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years

6.4 SpecialPrecautionsforStorage

Thismedicinalproductdoesnotrequireanyspecialtemperaturestorageconditions.

Storeintheoriginalcontainerinordertoprotectfromlightandmoisture.

6.5 NatureandCompositionofImmediatePackaging

0.67 ml pipette, moulded from a film composed of 3 layers: a

polypropylene/COC/polypropylene,solventfreelacquerlaminateandacopolymerof

polyethylene/EVOH/polyethylene.Thepipettesaresealedwithinachildresistant4-plyfoil

sachetcomposedofLDPE/nylon/aluminiumfoil/polyesterfilmandpresentedinanouterbox.

Boxesof1,2,3,4,6,8,12,24,30,60,90,120or150pipettes

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Notallpacksizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProductorWaste

MaterialsDerivedfromtheUseofSuchProducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

Theproductshouldnotenterwatercoursesasthismaybedangerousforfishandotheraquatic

organisms.Donotcontaminateponds,waterwaysorditcheswiththeproductorempty

containers.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited,

StationWorks,

Newry,

Co.Down,

BT356JP,

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER(S)

ManA2000

<MarketingAuthorisation–Tobecompletednationally>

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DD/MM/YYYY

10. DATEOFREVISIONOFTHETEXT

MonthYYYY

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ANNEXIII

LABELLINGANDPACKAGELEAFLET

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A.LABELLING

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PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Cartonof1,2,3,4,6,8,12,24,30,60,90,120or150pipettescontaining,0.67mlpipettes

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fleanil67mgSpot-OnSolutionforSmallDogs

Fipronil

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

One0.67mlpipettecontains:

67mgFipronil.

0.134mgButylhydroxyanisole(E320)

0.067mgButylhydroxytoluene(E321)

3. PHARMACEUTICALFORM

Spot-onsolution.

4. PACKAGESIZE

Cartonof1,2,3,4,6,8,12,24,30,60,90,120or150pipette(s)containing0.67ml.

5. TARGETSPECIES

Dogs.

6. INDICATION(S)

TicksandFleas.

Forthetreatmentofinfestationsbyfleas(Ctenocephalidesfelis).Theproductshowsimmediate

insecticidaleffectandpersistentinsecticidalactivityagainstnewinfestationsbyadultfleasforupto8

weeks.

TheproducthasapersistentacaricidalefficacyagainstIxodesricinusforupto2weeks,Rhipicephalus

sanguineusforupto3weeksandDermacentorreticulatusforupto4weeks.Ifticksofthesespecies

arepresentwhentheproductisapplied,alltickswillnotbekilledwithinthefirst48hoursbutthey

maybekilledwithinaweek.

7. METHODANDROUTE(S)OFADMINISTRATION

Fordogsweighing2-10kg.

Donotremovethepipettefromthesachetuntilrequiredforuse.

Forexternaluseonly.

Readthepackageleafletbeforeuse.

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8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP:mm/yyyy

11. SPECIALSTORAGECONDITIONS

Storeintheoriginalcontainerinordertoprotectfromlightandmoisture.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Disposal:readpackageleaflet.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

<SupplyCategory-Tobecompletednationally>

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited,

StationWorks,

Newry,

Co.Down,

BT356JP,

NorthernIreland

Distributedby:

<Tobecompletednationally>

16. MARKETINGAUTHORISATIONNUMBER(S)

ManA2000

<MarketingAuthorisation–Tobecompletednationally>

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17. MANUFACTURER’SBATCHNUMBER

BN:

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MINIMUMPARTICULARSTOAPPEARONSMALLIMEMEDIATEPACKAGINGUNITS

Sachetfor0.67mlpipette/blister

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fleanil67mgSpot-OnSolutionforSmallDogs

Fipronil

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

One0.67mlpipettecontains67mgFipronil

3. CONTENTBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

0.67ml

4. ROUTE(S)OFADMINISTRATION

Bytopicalapplicationtotheskin.

5. WITHDRAWALPERIOD

Notapplicable.

6. BATCHNUMBER

BN:

7. EXPIRYDATE

EXP:mm/yyyy

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

9. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited.

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MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGINGUNITS

0.67mlpipette/blister

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fleanil

2. STRENGTH

67mg

3. NAMEOFMARKETINGAUTHORISATIONHOLDER

Norbrook

4. EXPIRYDATE

mm/yyyy

5. BATCHNUMBER

XXXXXXX

6. THEWORDS“FORANIMALTREATMENTONLY”

<Pictogramofadog>

7. PHARMACEUTICALFORM

<Pictogramofaspot-onpipette>

8. VOLUME

0.67ml

9. TARGETANIMALWEIGHTRANGE

2–10kg

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B.PACKAGELEAFLET

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PACKAGELEAFLET:

Fleanil67mgSpot-OnSolutionforSmallDogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

NorbrookLaboratoriesLimited,

StationWorks,

Newry,

Co.Down,

BT356JP,

NorthernIreland,

UnitedKingdom

2.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fleanil67mgSpot-OnSolutionforSmallDogs

Fipronil

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENTS

One0.67mlpipettecontains:

67mgFipronil.

0.134mgButylhydroxyanisole(E320)

0.067mgButylhydroxytoluene(E321)

Aclear,colourlesstopaleyellowsolution.

4. INDICATIONS

Forthetreatmentofinfestationsbyfleas(Ctenocephalidesfelis).Theproductshowsimmediate

insecticidaleffectandpersistentinsecticidalactivityagainstnewinfestationsbyadultfleasforupto8

weeks.

TheproducthasapersistentacaricidalefficacyagainstIxodesricinusforupto2weeks,Rhipicephalus

sanguineusforupto3weeksandDermacentorreticulatusforupto4weeks.Ifticksofthesespecies

arepresentwhentheproductisapplied,allticksmaynotbekilledwithinthefirst48hoursbutthey

willbekilledwithinaweek.

5. CONTRAINDICATIONS

Donotuseindogsweighinglessthan2kg.

Intheabsenceofavailabledata,theproductshouldnotbeusedinpuppieslessthan8weeksold.

Donotuseinsick(systemicdiseases,fever…)orconvalescentanimals.

Donotuseinrabbits,asadversereactionsandevendeathcouldoccur.

Thisproductisspecificallydevelopedfordogs.Donotuseincats,asthiscouldleadtooverdosing.

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Donotuseincasesofknownhypersensitivitytotheactiveortoanyoftheexcipients.

6. ADVERSEREACTIONS

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlytothenatureofthe

carrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneousreactionsattheapplication

site(skindiscoloration,localalopecia,pruritus,erythema)andgeneralpruritusoralopeciahavebeen

reportedafteruse.Exceptionally,hypersalivation,reversibleneurologicalsigns(hyperaesthesia,

depression,nervoussigns),vomitingorrespiratorysignshavebeenobservedafteruse.

Donotoverdose.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthispackageleaflet,pleaseinform

yourveterinarysurgeon.

7. TARGETSPECIES

Dogs.

8.DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Routeofadministration:Bytopicalapplicationtotheskin.

Forexternaluseonly.Applytheproductdirectlytotheskinbasedonweightoftheanimal.

Dosage–

1pipetteof0.67mlperdogweighingover2kgandupto10kgbodyweightcorrespondingtoa

minimumrecommendeddoseof6.7mg/kgoffipronil.

MethodofAdministration:Holdupright.Tapthenarrowpartofthepipettetoensurethecontentsare

withinthemainbodyofthepipette.Breakbackthesnap-offtopfromthespot-onpipettealongthe

scoredline.Partthecoatbetweentheshoulderbladesuntiltheskinisvisible.Placethetipofthe

pipetteontheskinandsqueezegentlyatoneortwospotstoemptyitscontentsontotheskin.

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9. ADVICEONCORRECTADMINISTRATION

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff,

andtomakesurethattheanimalsdonotlickeachotherfollowingtreatment.

Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsincethiswillcausea

stickyappearanceofhairsatthetreatmentspot.However,shouldthisoccur,itwilldisappearwithin

48hourspostapplication.

Fortheoptimalcontrolofinfestationbyfleaandor/tickthetreatmentschedulecanbebasedonlocal

epidemiologicalsituation.

Intheabsenceofsafetystudies,theminimumtreatmentintervalis4weeks.

Animalsshouldbeweighedaccuratelypriortotreatment.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thismedicinalproductdoesnotrequireanyspecialtemperaturestorageconditions.

Storeintheoriginalcontainerinordertoprotectfromlightandmoisture.

Donotuseaftertheexpirydatestatedonthelabel.

12. SPECIALWARNINGS

Theproductdoesnotpreventticksfromattachingtotheanimals,butticksmaybekilledinthefirst

24-48hoursafterattachmentpriortofullengorgementandthereforeminimisingtheriskof

transmissionofdiseases.Oncedead,tickswilloftendropofftheanimal,butanyremainingticksmay

easilyberemovedbyagentlepull.

Foroptimalcontroloffleainfestationinmulti-pethousehold,alldogsandcatsinthehouseshouldbe

treatedwithasuitableinsecticide.

Theremaybeanattachmentofticks.Forthisreasontransmissionofinfectiousdiseasescannotbe

completelyexcludedifconditionsareunfavourable.Fleasfrompetsofteninfesttheanimal’sbasket,

beddingandregularrestingareassuchascarpetsandsoftfurnishingswhichshouldbetreated,incase

ofmassiveinfestationandatthebeginningofthecontrolmeasures,withasuitableinsecticideand

vacuumedregularly.

Avoidfrequentswimmingorshampooingoftheanimalbecausethemaintenanceofeffectivenessof

theproductinthesecaseshasnotbeentested.

Specialprecautionsforuseinanimals

Avoidcontactwiththeanimal’seyes.Inthecaseofaccidentaleyecontactimmediatelyand

thoroughlyflushtheeyeswithwater.

Forexternaluseonly

Animalsshouldbeweighedaccuratelypriortotreatment.

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Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimalcannotlickitoff,

andtomakesurethatanimalsdonotlickeachotherfollowingtreatment.

Donotapplytheproductonwoundsordamagedskin.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttotheanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contactoftheproductwith

mouthandeyesshouldbeavoided.

Incasesofaccidentaleyecontact,immediatelyandthoroughlyrinsetheeyewithplainwater.Ifeye

irritationpersistsseekmedicaladviceandshowthepackageleafletorthelabeltoaphysician.

Peoplewithaknownhypersensitivitytofipronilorotheringredientsshouldavoidcontactwiththe

veterinaryproduct.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,washhandswithsoapandwater.

Washhandsafteruse.Donotsmoke,drinkoreatduringapplication.

Treatedanimalsshouldnotbehandleduntilthisapplicationsiteisdry,andchildrenshouldnotbe

allowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itisthereforerecommendedthat

animalsarenottreatedduringtheday,butshouldbetreatedduringtheearlyevening,andthatrecently

treatedanimalsshouldnotbeallowedtosleepwithowners,especiallychildren.

UseDuringPregnancy,LactationorLay

Intheabsenceofstudiestoevaluatethesafetyofthisproductinpregnantorlactatinganimalsuseonly

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Otherprecautions

Fipronilmayadverselyaffectaquaticorganisms.Dogsshouldnotbeallowedtoswiminwatercourses

for2daysafterapplication.

Thealcoholcarriermayhaveadverseeffectonpainted,varnishedorotherhouseholdsurfacesor

furnishings.

Noadverseeffectswereobservedintargetanimalsafetystudiesin8weekoldpuppies,growingdogs

anddogsweighingcirca2kgtreatedon3occasionsatfivetimestherecommendeddose.Theriskof

experiencingadverseeffectsmayhoweverincreasewhenoverdosing,soanimalsshouldalwaysbe

treatedwiththecorrectpipettesizeaccordingtobodyweight.

Thisproductisflammable.Keepawayfromheat,sparks,openflameorothersourcesofignition.

ForAnimalTreatmentOnly.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

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Theproductshouldnotenterwatercoursesasthismaybedangerousforfishandotheraquatic

organisms.Donotcontaminateponds,waterwaysorditcheswiththeproductoremptycontainers.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

MonthYYYY

15. OTHERINFORMATION

<SupplyCategory-Tobecompletednationally>

ManA2000

<MA.Number-Tobecompletednationally>

ModeofAction

Fipronilisaninsecticide/acaricideinthephenylpyrazolefamily.ItactsbyinhibitingtheGABA

complex,bindingtothechloridechannelandtherebyblockingpre-andpost-synaptictransferof

chlorideionsacrossthemembrane.Thisresultsinuncontrolledactivityofthecentralnervoussystem

anddeathininsectsandacarids.

PackageInformation

0.67ml,pipettemouldedfromafilmcomposedof3layers:apolypropylene/COC/polypropylene,

solventfreelacquerlaminateandacopolymerofpolyethylene/EVOH/polyethylene.Thepipettesare

sealedwithinachildresistant4-plyfoilsachetcomposedofLDPE/nylon/aluminiumfoil/polyester

filmandpresentedinanouterbox.

Boxesof1,2,3,4,6,8,12,24,30,60,90,120or150pipettes

Notallpacksizesmaybemarketed.

Distributedby:

<Tobecompletednationally>

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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