Norofip 67 mg Spot-On Solution for Small Dogs

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
    Hungary
  • 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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Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

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