Closiver Pour-On Solution for Cattle

Main information

  • Trade name:
  • Closiver Pour-On Solution for Cattle
  • Pharmaceutical form:
  • Pour-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Closiver Pour-On Solution for Cattle
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin, combinations
  • Therapeutic area:
  • Cattle

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0368/001
  • Authorization date:
  • 23-02-2011
  • EU code:
  • UK/V/0368/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:May2011

AN:01861/2009

SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinaryMedicinalProduct

Closiver5mg/ml+200mg/mlPour-OnSolutionforCattle(UK)

ClosamectinVet5mg/ml+200mg/mlPour-OnSolutionforCattle(SE)

Closamectin5mg/ml+200mg/mlPour-OnSolutionforCattle

2. QualitativeandQuantitativeComposition

ActiveIngredient(s)

Ivermectin 5mg/mL

Closantel(asClosantelSodiumDihydrate) 200mg/mL

Excipients

BrilliantBlueFCF(E133) 0.1mg/mL

Forafulllistofexcipientsseesection6.1.

3. PharmaceuticalForm

Pour-Onsolution.

Aclearblue/greensolution.

4. ClinicalParticulars

4.1 TargetSpecies:

Cattle

4.2 IndicationsforUse,SpecifyingtheTargetSpecies:

Forthetreatmentofmixedtrematode(fluke)andnematodeorarthropod

infestationsduetoroundworms,lungworms,eyeworms,warbles,mitesandliceof

cattle.

Trematodes(adultandlateimmatures)

Fasciolagigantica

Fasciolahepatica

Treatmentofflukeat12weeks(mature)>95%efficacy.

Treatmentofflukeat7weeks(lateimmature)>95%efficacy.

Gastrointestinalroundworms(adultsandfourthstagelarvae)

Ostertagiaostertagi(includinginhibitedO.ostertagi),Haemonchusplacei,

Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia spp,

Oesophagostomumradiatum,Nematodirushelvetianus(adult),Strongyloides

papillosus(adult).

Issued:May2011

AN:01861/2009

Lungworms(adultandfourthstagelarvae)

Dictyocaulusviviparus

Eyeworms(adult)

Thelaziaspp

Cattlegrubs(parasiticstages)

Hypodermabovis,Hypodermalineatum

Lice

Linognathusvituli,Haematopinuseurysternus,Damaliniabovis

MangeMites

Chorioptesbovis,Sarcoptesscabieivarbovis

4.3 Contraindications:

Donotuseincasesofknownhypersensitivitytotheactivesubstances.

Donotapplytoareasofskinwhichhavemange,scabsorotherlesionsortoareas

contaminatedwithmudormanure.

DonotusetheproductbetweenDecemberandMarchinthosecountriesinwhich

Hypodermaspphavenotbeeneradicatedaskilledlarvaemaycause

hypersensitivityreactions.

Avermectinsmaynotbewelltoleratedinnon-targetspecies(casesofintolerance

withfataloutcomearereportedindogs –especiallyCollies,OldEnglishSheepdogs

andrelatedbreedsorcrosses,andalsointurtles/tortoises).

4.4 SpecialWarnings:

ThepresenceofliverflukeorHaemonchusinfestationshouldbeconfirmedbefore

thiscombinationproductisused.

Iftreatmentagainstliverflukeinfestationonlyisrequired,asingleactivesubstance

productshouldbeused.

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasethe

riskofdevelopmentofresistanceandcouldultimatelyresultinineffectivetherapy.

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overan

extendedperiodoftime.

Underdosing which may be due to underestimation of bodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosingdevice.

Theeffectofrainonthepour-onformulationatthetimeofandafterapplicationhas

notbeeninvestigated.Formaximumeffectanimalsshouldbekeptindoorsor

undercoverforupto48hoursfollowingtreatment,whenthereisrainoranimminent

riskofrain.

Issued:May2011

AN:01861/2009

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurther

investigatedusingappropriatetests(e.g.,FaecalEggCountReductionTest).

Wheretheresultsofthetestsstronglysuggestresistancetoaparticular

anthelmintic,ananthelminticbelongingtoanotherpharmacologicalclassand

havingadifferentmodeofactionshouldbeused.

Resistancetoivermectin(anavermectin)hasbeenreportedinCooperiaoncophora

incattlewithintheEU.Thereforetheuseofthisproductshouldbebasedonlocal

(regionalandfarm)epidemiologicalinformationaboutsusceptibilityofthe

gastrointestinalnematodesandrecommendationsonhowtolimitfurtherselection

forresistancetoanthelmintics.

4.5 SpecialPrecautionsforUse:

(i)Specialprecautionsforuseinanimals:

None

(ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals:

Thisproductmaybeirritatingtohumanskinandeyesorcausehypersensitivity.

Avoidskinand/oreyecontactwiththeproductduringtreatment,whenhandling

recentlytreatedanimalsorwhencleaningtheusedequipment.Operators

shouldwearnitrilerubberglovesandbootswithawaterproofcoatwhen

applyingtheproduct.Protectiveclothingshouldbewashedafteruse.If

accidentalskincontactoccurs,washtheaffectedareaimmediatelywithsoap

andwater.Ifaccidentaleyeexposureoccurs,flushtheeyesimmediatelywith

waterandgetmedicalattention.

Thisproductmaybetoxicafteraccidentalingestion.Avoidingestionbyhand-to-

mouthcontact.Donoteat,drinkorsmokewhilsthandlingtheproduct.If

accidentalingestionoccurs,getmedicalattentionandshowthepackageleaflet

tothephysician.Washhandsafteruse.

Thisproductisflammable.Keepawayfromsourcesofignition.Useonlyinwell

ventilatedareasoroutdoors.

(iii)OtherPrecautionsRegardingtheEnvironment.

Theproductisverytoxictoaquaticorganismsanddunginsects.

Treatedcattleshouldnothavedirectaccesstoponds,streamsorditchesfor14

daysaftertreatment.

Longtermeffectsondunginsectscausedbycontinuousorrepeatedusecannotbe

excludedthereforerepeattreatmentsonapasturewithinaseasonshouldonlybe

givenontheadviceofaveterinarian.

Issued:May2011

AN:01861/2009

4.6 AdverseReactions(FrequencyandSeriousness):

Undesirableeffectsarenotexpectedwhentheproductisusedattherecommended

doserate.

4.7 UseDuringPregnancy,LactationorLay:

ClosiverPour-Oncanbeadministeredtocattle(includingdairy,beef/sucklercattle)

atanystageofpregnancyorlactationprovidedthatthemilkisnotintendedfor

humanconsumption.SeeSection4.11.

4.8 InteractionswithOtherMedicinalProductsandOtherFormsofInteraction:

Noneknown.

4.9 AmountstobeAdministeredandAdministrationRoute:

Pour-onuse.

Theveterinarymedicinalproductshouldbeadministeredtopicallyatadosagerate

of500

givermectinperkgbodyweightand20mgclosantelperkgbodyweight(1

mLper10kg).

Theformulationshouldbeappliedalongthemidlineofthebackinanarrowstrip

betweenthewithersandthetailhead.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible;accuracyofthedosingdeviceshouldbechecked.

Ifanimalsaretobetreatedcollectivelyratherthanindividually,theyshouldbe

groupedaccordingtotheirbodyweightanddosedaccordingly,inordertoavoid

under-oroverdosing.

Thetimingfortreatmentshouldbebasedonlocalepidemiologicalfactorsand

shouldbecustomisedforeachindividualfarm.Acomprehensiveparasitecontrol

programmeshouldbeestablishedbyaveterinaryprofessional.Itshouldbe

confirmedthatmixedinfestationsarepresentbeforetheproductisprescribed.

Theefficacyprofileoftheproductissuchthatasingletreatmentsevenweeksafter

housingwillcontrolinfestationfortheentirehousedperiod.

Theproductshouldnotberepeatedlyapplied(within7weeks)tocattle.

Issued:May2011

AN:01861/2009

4.10Overdose(Symptoms,EmergencyProceduresandAntidotes)(ifnecessary):

Atdosesofthreetimestherecommendeddose,nosignificantclinicalsignswere

recorded.

Ivermectin

Noantidotehasbeenidentified.Symptomatictreatmentmaybebeneficial.

Closantellikeothersalicylanilidesisapotentuncouplerofoxidativephosphorylation

andthesafetyindexisnotashighasisthecaseofmanyotheranthelmintics.

Howeverwhereusedasdirectedthereareunlikelytobeanyuntowardeffects.

Signsofoverdosagecanincludeslightlossofappetite,loosefaeces,decreased

visionandincreasedfrequencyofdefecation.Highdosesmaycauseblindness,

hyperventilation,generalweaknessandinco-ordination,hyperthermia,convulsions,

tachycardiaandinextremecasesdeath.Treatmentofoverdosageissymptomatic

asnoantidotehasbeenidentified.

4.11WithdrawalPeriods:

Meatandoffal:28days

Donotuseincattleproducingmilkforhumanconsumption.

Donotuseinpregnantanimalsintendedtoproducemilkforhumanconsumption.

5. PharmacologicalProperties

ATCVetCode: QP54AA51

PharmacotherapeuticGroup: Ivermectin,combinations.

5.1 PharmacodynamicProperties:

Ivermectinisanendectocidewithactivityagainstawiderangeofinternaland

externalparasites.Ivermectinisamacrocyliclactoneandactsbyinhibitingnerve

impulses.Itbindsselectivelyandwithhighaffinitytoglutamate-gatedchlorideion

channelswhichoccurininvertebratenerveandmusclecells.Thisleadstoan

increaseinthepermeabilityofthecellmembranetochlorideionswith

hyperpolarizationofthenerveormusclecell,resultinginparalysisanddeathofthe

relevantparasites.Compoundsofthisclassmayalsointeractwithotherligand-

gatedchloridechannels,suchasthosegatedbytheneurotransmittergamma-

aminobutyricacid(GABA).Themarginofsafetyforcompoundsofthisclassis

attributabletothefactthatmammalsdonothaveglutamate-gatedchloride

channels.Themacrocyliclactoneshavealowaffinityforothermammalianligand-

gatedchloridechannelsandtheydonotreadilycrosstheblood-brainbarrier.

Closantelisamemberofthesalicylanilideclassofanthelmintics.Salicylanilides

arehydrogen(proton)ionophores(referredtoasoxidativephosphorylase

uncouplers.)

Issued:May2011

AN:01861/2009

Thechemicalstructureofsalicylanilidesillustratethepossessionofadetachable

proton.Thistypeofmoleculeislipophilicandisknowntoshuttleprotonsacross

membranes,inparticulartheinnermitochondrialmembrane.Closantelactsby

uncouplingoxidativephosphorylation.

Closantelisaparasiticidewithflukicideactivityandefficacyagainstcertainother

helminthsandarthropods.

5.2 PharmacokineticProperties:

AftertopicaladministrationofClosiverPour-Ontocattleatadoserateof500µg

ivermectinperkgand20mgclosantelperkgthefollowingparameterswere

observed:Ivermectin –Cmaxof19.13ng/mLandAUCof2440ng.hr/mL;Closantel

–Cmaxof68.5µg/mLandAUCof35207µg.hr/mL.

Ivermectinisonlypartiallymetabolised.Incattle,onlyabout1to2%isexcretedin

theurinetheremainderisexcretedinthefaeces,approximately60%ofwhichis

excretedasunaltereddrug.Theremainderisexcretedasmetabolitesor

degradationproducts.Salicylanilidesarepoorlymetabolisedandareexcreted

mainlyunchanged.About90%ofclosantelisexcretedunchangedinthefaeces

andurineincattle.

6. PharmaceuticalParticulars

6.1 ListofExcipient(s):

BrilliantBlueFCF(E133)Dye

AnhydrousEthanol

Macrogol200

CetearylEthylhexanoate

IsopropylMyristate

PovidoneK30

DenatoniumBenzoate

Trolamine

Isopropylalcohol

6.2 Incompatibilities:

Noneknown.

6.3 Shelf-Life:

Shelf-lifeoftheveterinarymedicinalproductispackagedforsale:1year.

Issued:May2011

AN:01861/2009

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25°C.

Storeuprightinoriginalcontainer.

Protectfromlight.

Discardunusedmaterial.Avoidintroductionofcontamination.

Replacethecapsecurelyafteruse.

Ifstoredattemperaturesbelow0

C,ClosiverPour-OnSolutionforCattlemay

appearcloudy.Allowingtowarmatroomtemperaturewillrestorethenormal

appearancewithoutaffectingefficacy.

Accidentalspillageoringestioncouldbedetrimentalorevenfatalthereforecare

shouldbetakenwhenhandlingandstoringthisproduct.

Flammable –keepawayfromheat,sparks,openflameorothersourcesofignition.

6.5 NatureandCompositionofImmediatePackaging:

Translucent250mLand1LHDPEcontainerswithintegralsqueezemeasurepour

systemandwhiteHDPEcaps.

White1L,2.5Land5LHDPEbackpacksforusewithadosinggundeliverysystem

andwhitepolypropylenescrewcaps.

Notallpackssizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProduct

orWasteMaterialsDerivedfromtheUseofSuchProducts,ifappropriate:

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Donotcontaminate

surfacewatersorditcheswiththeproductorusedcontainer.Anyunused

veterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

Issued:May2011

AN:01861/2009

7. MarketingAuthorisationHolder

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

CoDown

BT356JP

NorthernIreland

8. MarketingAuthorisationNumber

Vm02000/4311

9. DateofFirstAuthorisation

19May2011

10. DateofRevisionoftheText

May2011