Fiprokil Spot On Solution 268 mg for Large Dogs

Main information

  • Trade name:
  • Fiprokil Spot On Solution 268 mg for Large Dogs
  • Pharmaceutical form:
  • Spot-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fiprokil Spot On Solution 268 mg for Large Dogs
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0468/004
  • Authorization date:
  • 20-03-2013
  • EU code:
  • UK/V/0468/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:September2013

AN:00684/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BobMartinClear268mgspot-onsolutionforlargedogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

One2.68mlpipettecontains:

Activesubstance:

Fipronil 268mg

Excipients:

ButyhydroxyanisoleE320 0.536mg

ButylhydroxytolueneE321 0.268mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Spot-onsolution.

Clear,paleambersolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofflea(Ctenocephalidesspp.)andtick(Rhipicephalussanguineusand

Ixodesricinus)infestations.

Fleaswillbekilledwithin24h.Insecticidalefficacyagainstnewinfestationswithadult

fleaspersistsfor8weeks.

Theproducthasapersistentacaricidalefficacyfor4weeksagainstticks

(Rhipicephalussanguineus,Ixodesricinus,Dermacentorreticulatus).

Tickswillusuallybekilledwithin48haftercontactwithFipronil.However,ifticksof

somespecies(Dermacentorreticulatus)arealreadypresentwhentheproductis

applied,alloftheticksmaynotbekilledwithinthefirst48hours.

4.3 Contraindications

Donotuseonpuppieslessthan2monthsoldand/orweighinglessthan2kg.Donot

useonsick(e.g.systemicdiseases,fever…)orconvalescentanimals.

Revised:September2013

AN:00684/2012

Donotuseinrabbits,asadversereactionsandevendeathcouldoccur.

Thisproductisspecificallydevelopedfordogs.Donotuseincats,asthiscouldlead

tooverdosing.

Donotuseonanimalswithknownhypersensitivitytotheactivesubstanceortoany

oftheexcipients.

4.4Specialwarningsforeachtargetspecies

Avoidfrequentswimmingorshampooingtheanimalbecausethemaintenanceof

effectivenessoftheproductinthesecaseshasnotbeentested.

Theproductdoesnotpreventticksfromattachingtotheanimals.Iftheanimalhas

beentreatedpriortoexposuretotheticks,thetickswillbekilledinthefirst24-48

hoursafterattachment.Thiswillusuallybepriortoengorgement,minimisingbutnot

excludingtheriskoftransmissionofdiseases.Oncedead,tickswilloftendropoff

theanimal,butanyremainingticksmayberemovedwithagentletwist.

Fleasfrompetsofteninfesttheanimal'sbasket,beddingandregularrestingareas

suchascarpetsandsoftfurnishingswhichshouldbetreated,incaseofmassive

infestationandatthebeginningofthecontrolmeasures,withasuitableinsecticide

andvacuumedregularly.

Foroptimalcontroloffleainfestationinmulti-pethousehold,alldogsandcatsinthe

householdshouldbetreatedwithasuitableinsecticide.

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Animalsshouldbeweighedaccuratelypriortotreatment.

Avoidcont actwiththeanimal’seyes.Inthecaseofaccidentaleyecontact,

immediatelyandthoroughlyflushtheeyeswithwater.

Itisimportanttomakesurethattheproductisappliedtoanareawheretheanimal

cannotlickitoff,andtomakesurethatanimalsdonotlickeachotherfollowing

treatment.

Donotapplytheproductonwoundsordamagedskin.

ii) Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductcancausemucousmembraneandeyeirritation.Therefore,contact

betweentheproductandthemouthoreyesshouldbeavoided.

Inthecaseofaccidentaleyecontact,immediatelyandthoroughlyflushtheeyeswith

water.Ifeyeirritationpersistsseekmedicaladviceandshowthepackageleafletor

thelabeltothephysician.

Donotsmoke,drinkoreatduringapplication.

Avoidcontentscomingintocontactwiththefingers.Ifthisoccurs,washhandswith

soapandwater.Washhandsafteruse.

Revised:September2013

AN:00684/2012

Animalsorpeoplewithaknownhypersensitivitytofiproniloranyoftheother

ingredientsshouldavoidcontactwiththeproduct.

Treatedanimalsshouldnotbehandleduntiltheapplicationsiteisdry,andchildren

shouldnotbeallowedtoplaywithtreatedanimalsuntiltheapplicationsiteisdry.Itis

thereforerecommendedthatanimalsarenottreatedduringtheday,butshouldbe

treatedduringtheearlyevening,andthatrecentlytreatedanimalsshouldnotbe

allowedtosleepwithowners,especiallychildren.

iii) Environmentalwarning

Fipronilmayadverselyaffectaquaticorganisms.Dogsshouldnotbeallowedtoswim

inwatercoursesfor2daysafterapplication.

iv) Otherprecautions

Theproductmayhaveadverseeffectsonpainted,varnishedorotherhousehold

surfacesorfurnishings.

4.6Adversereactions(frequencyandseriousness)

Iflickingoccurs,abriefperiodofhypersalivationmaybeobservedduemainlytothe

natureofthecarrier.

Amongtheextremelyraresuspectedadversereactions,transientcutaneous

reactionsontheapplicationsite(skindiscoloration,localalopecia,pruritus,

erythema)andgeneralpruritusoralopeciahavebeenreportedafteruse.

Exceptionally,hypersalivation,reversibleneurologicsymptoms(hyperesthesia,

depression,nervoussymptoms),vomitingorrespiratorysymptomshavebeen

observedafteruse.

4.7Useduringpregnancyandlactation

Laboratorystudiesusingfipronilhavenotshownanyevidenceofteratogenicor

embryotoxiceffect.Studieshavenotbeencarriedoutwiththisproductinpregnant

andlactatingbitches.Useinpregnancyandlactationonlyinaccordancewith

professionalveterinaryadviceandabenefit/riskassessment.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Routeofadministrationanddosage:

Externaluseonly.Administerbytopicalapplicationtotheskinaccordingtothe

bodyweightasfollows:1pipetteof2.68mlperdogweighingover20kgandupto40

kgbodyweight.

Fordogsover60kg,usetwopipettesof2.68ml.

Revised:September2013

AN:00684/2012

Methodofadministration:

Removethepipettefromtheblisterpackaging.Holdthepipetteinanuprightposition

andsnapoffthetopsectionofthecap,therebyopeningthepipette.

Partyourd og’scoatuntiltheskinisvisible.Placethetipofthepipettedirectly

againstthebaredskinandsqueezegently.Emptyapproximatelyhalfthecontentsat

eachoftwopointsalongthedog’sback,preferablyatthebaseoftheheadand

betweentheshoulderblades.Squeezethepipetteseveraltimestoensuredosingis

complete.Avoidapplyingthesolutionontothefuranddonotrubintotheskin.

Applicationofthesolutionasdirectedminimisesthepossibilitythattheanimalwilllick

thesolutionoff.Donotallowpetstolickeachotheraftertreatment.

Careshouldbetakentoavoidexcessivewettingofthehairwiththeproductsince

thiswillcauseastickyappearanceofhairsatthetreatmentspot.However,should

thisoccur,itwillusuallydisappearwithin24-48hourspostapplication.Crystalsmay

beseenonthehairandslightscalingmayoccurwithin24-48hoursafterapplication.

Treatmentschedule:

Foroptimalcontroloffleaand/ortickinfestationthetreatmentschedulecanbebased

onthelocalepidemiologicalsituation.

Theminimumintervalbetweentwotreatmentsis4weeks.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectswereobservedintargetanimalsafetystudiesin2month-old

puppies,growingdogsanddogsweighingabout2kgtreatedwith5timesthe

therapeuticdoseonceamonthfor3consecutivemonths.Theriskofadverseeffects

(seesection4.6)mayincreaseincasesofoverdose.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX15

Revised:September2013

AN:00684/2012

5.1 Pharmacodynamicproperties

Fipronilisaninsecticideandacaricidebelongingtothephenylpyrazolefamily.Itacts

byinhibitingtheGABAcomplex,bindingtothechloridechannelandtherebyblocking

pre-andpost-synaptictransferofchlorideionsacrosscellmembranes.Thisresults

inuncontrolledactivityofthecentralnervoussystemanddeathofinsectsoracarids.

Fipronilexhibitsaninsecticidalandacaricidalactivityagainstfleas(Ctenocephalides

spp),ticks(Rhipicephalusspp,IxodessppincludingIxodesricinus)inthedog.

5.2Pharmacokineticparticulars

Fipronilismainlymetabolisedtoitssulfonederivative(RM1602),whichalso

possessesinsecticidalandacaricidalproperties.Theconcentrationsoffipronilonthe

hairdecreasewithtime.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ButylhydroxyanisoleE320

ButylhydroxytolueneE321

Benzylalcohol

Diethyleneglycolmonoethylether

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Storebelow25

C,inadryplaceintheoriginalpackaging.

6.5Natureandcompositionofimmediatepackaging

Whiteopaqueorpurpleorpinktranslucentpolypropylenesingle-dosepipettes

containinganextractablevolumeof2.68mlpackagedinaclearPVCblisterclosedby

heatsealingwithaluminiumfoilandplacedinacartonboxorblistercard.

Blistercardsorboxesof1,2,3,4,5or6pipettes.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

Revised:September2013

AN:00684/2012

requirements.Fipronilmayadverselyaffectaquaticorganisms.Donotcontaminate

ponds,waterwaysorditcheswiththeproductoremptycontainer.

7. MARKETINGAUTHORISATIONHOLDER

BobMartinUKLtd.

WemberhamLane

Yatton

Somerset

BS494BS

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm00715/4121

9. DATEOFFIRSTAUTHORISATION

15December2011

10.DATEOFREVISIONOFTHETEXT

September2013

APPROVED 20/09/13

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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