Closamectin

Main information

  • Trade name:
  • Closamectin Pour-On
  • Pharmaceutical form:
  • Pour-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Closamectin Pour-On
    Ireland
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0325/001
  • Authorization date:
  • 31-03-2010
  • EU code:
  • UK/V/0325/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:September2012

AN:00613/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ClosamectinPour-OnSolutionforCattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveIngredient(s)

Ivermectin 5mg/mL

Closantel(asclosantelsodium) 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,mitesandlice

ofcattle.

Gastrointestinalroundworms(adultsandfourthstagelarvae)

Ostertagiaostertagi(includinginhibitedO.ostertagi),Haemonchusplacei,

Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia spp,

Oesophagostomumradiatum,Nematodirushelvetianus(adult),Strongyloides

papillosus(adult).

Lungworms(adultandfourthstagelarvae)

Dictyocaulusviviparus

Trematodes(adultandlateimmatures)

Fasciolagigantica

Fasciolahepatica

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Treatmentofflukeat12weeks(mature)>95%efficacy.

Treatmentofflukeat7weeks(lateimmature)>95%efficacy.

Eyeworms(adult)

Thelaziaspp

Cattlegrubs(parasiticstages)

Hypodermabovis,Hypodermalineatum

Lice

Linognathusvituli,Haematopinuseurysternus,Damaliniabovis

MangeMites

Chorioptesbovis,Sarcoptesscabieivarbovis

4.3 Contraindications

Donotuseincasesofknownhypersensitivitytotheactivesubstances.

Donotapplytoareasofskinwhichhavemange,scabsorotherlesionsorto

areascontaminatedwithmudormanure.

Avermectinsmaynotbewelltoleratedinnon-targetspecies(casesof

intolerancewithfataloutcomearereportedindogs –especiallyCollies,Old

EnglishSheepdogsandrelatedbreedsorcrosses,andalsointurtles/tortoises).

Donotuseincattleproducingmilkforhumanconsumption.

Donotuseinnon-lactatingdairycowsincludingpregnantheiferswithin60days

ofcalving.

4.4 SpecialWarnings

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincrease

theriskofdevelopmentofresistanceandcouldultimatelyresultinineffective

therapy.

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overan

extendedperiodoftime.

Underdosingwhichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosingdevice.

Theeffectofrainonthepour-onformulationatthetimeofandafterapplication

hasnotbeeninvestigated.Formaximumeffectanimalsshouldbekeptindoors

orundercoverfollowingtreatment,whenthereisrainoranimminentriskof

rain.

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurther

investigatedusingappropriatetests(e.g.,FaecalEggCountReductionTest).

Revised:September2012

AN:00613/2012

Wheretheresultsofthetestsstronglysuggestresistancetoaparticular

anthelmintic,ananthelminticbelongingtoanotherpharmacologicalclassand

havingadifferentmodeofactionshouldbeused.

ResistancetoivermectinhasbeenreportedinCooperiasppincattle.

Thereforetheuseofthisproductshouldbebasedonlocalepidemiological

informationaboutthesusceptibilityoftheCooperiasppandrecommendations

onhowtolimitfurtherselectionforresistancetoanthelmintics.

4.5 SpecialPrecautionsforUse

i. Specialprecautionsforuseinanimals

Careshouldbetakentoensureanimalsarenotoverdosedbythe

applicationvolume,accidentalspillageororalingestion,asoverdosage

mayresultinsignsoftoxicitysuchasinco-ordinationandblindness.Itis

recommendedthatanimalsarenotclippedpriortotreatmenttoreduce

theriskofincreaseddrugabsorptionandhencebioavailability,ororal

ingestionthroughmutualgrooming.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Theveterinarymedicinalproductmaybeirritatingtohumanskinand

eyesandtheusershouldbecarefulnottoapplyittohimselforother

persons.Operatorsshouldwearnitrilerubberglovesandbootswitha

waterproofcoatwhenapplyingtheproduct.Protectiveclothingshould

bewashedafteruse.Ifaccidentalskincontactoccurs,washthe

affectedareaimmediatelywithsoapandwater.Ifaccidentaleye

exposureoccurs,flushtheeyesimmediatelywithwaterandgetmedical

attention.

Donotsmokeoreatwhilsthandlingtheproduct.Washhandsafteruse.

Useonlyinwellventilatedareasoroutdoors.

iii. OtherPrecautionsRegardingtheEnvironment

Treatedcattleshouldnothavedirectaccesstoponds,streamsor

ditchesfor14daysaftertreatment.

4.6 AdverseReactions(FrequencyandSeriousness)

Undesirableeffectsarenotexpectedwhentheproductisusedatthe

recommendeddoserate

Inveryrarecases,neurologicalsignssuchasblindnesshavebeenobserved

afteruseoftheproduct.

Revised:September2012

AN:00613/2012

4.7 UseDuringPregnancy,LactationorLay

ClosamectinPour-Oncanbeadministeredtocattle(includingdairy,

beef/sucklercattle)atanystageofpregnancyorlactationprovidedthatthemilk

isnotintendedforhumanconsumption.SeeSection4.11.

4.8 InteractionswithOtherMedicinalProductsandOtherFormsof

Interaction

Noneknown.

4.9 AmountstobeAdministeredandAdministrationRoute

Theveterinarymedicinalproductshouldbeadministeredtopicallyatadosage

rateof500

givermectinperkgbodyweightand20mgclosantelperkg

bodyweight(1mLper10kg).

Theformulationshouldbeappliedalongthemidlineofthebackinanarrow

stripbetweenthewithersandthetailhead.

Assessbodyweightcarefullypriortoadministration.

Thetimingfortreatmentshouldbebasedonepidemiologicalfactorsandshould

becustomisedforeachindividualfarm.Adosingprogrammeshouldbe

establishedbyaveterinaryprofessional.

HANDYDOSINGGUIDE ANIMALSSHOULDBEWEIGHEDANDGROUPED

ACCORDINGTOBODYWEIGHTTOAVOID

UNDEROROVER-DOSING*

BODYWEIGHT DOSE

VOLUME NUMBEROFFULLDOSESPERPACK

250ml

500ml 1litre 2.5litre 5litre

100kg* 10ml 25 50 100 250 500

150kg 15ml 16 33 66 166 333

200kg 20ml 12 25 50 125 250

250kg 25ml 10 20 40 100 200

300kg 30ml 8 16 33 83 166

350kg 35ml 7 14 28 71 142

400kg 40ml 6 12 25 62 125

450kg 45ml 5 11 22 55 111

500kg 50ml 5 10 20 50 100

550kg 55ml 4 9 18 45 90

600kg 60ml 4 8 16 41 83

*Doserate1mlper10kgbodyweight

Revised:September2012

AN:00613/2012

4.10Overdose(Symptoms,EmergencyProceduresandAntidotes)(if

necessary)

Atdosesofthreetimestherecommendeddose,nosignificantclinicalsigns

wererecorded.

Ivermectin

Noantidotehasbeenidentified.Symptomatictreatmentmaybebeneficial.

Closantellikeothersalicylanilidesisapotentuncouplerofoxidative

phosphorylationandthesafetyindexisnotashighasisthecaseofmanyother

anthelmintics.Howeverwhereusedasdirectedthereareunlikelytobeany

untowardeffects.Signsofoverdosagecanincludeslightlossofappetite,loose

faeces,decreasedvisionandincreasedfrequencyofdefecation.Highdoses

maycauseblindness,hyperventilation,generalweaknessandinco-ordination,

hyperthermia,convulsions,tachycardiaandinextremecasesdeath.Treatment

ofoverdosageissymptomaticasnoantidotehasbeenidentified.

4.11WithdrawalPeriods

Cattlemustnotbetreatedwithin28daysofslaughterforhumanconsumption.

Donotuseincattleproducingmilkforhumanconsumption.

Donotuseinnon-lactatingdairycowsincludingpregnantheiferswithin60days

ofcalving.

5. PHARMACOLOGICALPROPERTIES

ATCVetCode: QP54AA51

PharmacotherapeuticGroup:Ivermectin,combinations.

5.1 PharmacodynamicProperties

Ivermectinisanendectocidewithactivityagainstawiderangeofinternaland

externalparasites.Ivermectinisamacrocyliclactoneandactsbyinhibiting

nerveimpulses.Itbindsselectivelyandwithhighaffinitytoglutamate-gated

chlorideionchannelswhichoccurininvertebratenerveandmusclecells.This

leadstoanincreaseinthepermeabilityofthecellmembranetochlorideions

withhyperpolarizationofthenerveormusclecell,resultinginparalysisand

deathoftherelevantparasites.Compoundsofthisclassmayalsointeractwith

otherligand-gatedchloridechannels,suchasthosegatedbythe

neurotransmittergamma-aminobutyricacid(GABA).Themarginofsafetyfor

compoundsofthisclassisattributabletothefactthatmammalsdonothave

glutamate-gatedchloridechannels.Themacrocyliclactoneshavealowaffinity

forothermammalianligand-gatedchloridechannelsandtheydonotreadily

crosstheblood-brainbarrier.

Revised:September2012

AN:00613/2012

Closantelisamemberofthesalicylanilideclassofanthelmintics.

Salicylanilidesarehydrogen(proton)ionophores(referredtoasoxidative

phosphorylaseuncouplers.)

Thechemicalstructureofsalicylanilidesillustratethepossessionofa

detachableproton.Thistypeofmoleculeislipophilicandisknowntoshuttle

protonsacrossmembranes,inparticulartheinnermitochondrialmembrane.

Closantelactsbyuncouplingoxidativephosphorylation.

Closantelisaparasiticidewithflukicideactivityandefficacyagainstcertain

otherhelminthsandarthropods.

5.2 PharmacokineticProperties

AftertopicaladministrationofClosamectinPour-Ontocattleatadoserateof

500µgivermectinperkgand20mgclosantelperkgthefollowingparameters

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

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

Ivermectinisonlypartiallymetabolised.Incattle,onlyabout1to2%is

excretedintheurinetheremainderisexcretedinthefaeces,approximately

60%ofwhichisexcretedasunaltereddrug.Theremainderisexcretedas

metabolitesordegradationproducts.Salicylanilidesarepoorlymetabolised

andareexcretedmainlyunchanged.About90%ofclosantelisexcreted

unchangedinthefaecesandurineincattle.

6. PHARMACEUTICALPARTICULARS

6.1 ListofExcipient(s)

BrilliantBlueFCF(E133)Dye

AnhydrousEthanol

Macrogol,

CetearylEthylhexanoate

IsopropylMyristate

Povidone

DenatoniumBenzoate

Trolamine

Isopropylalcohol,

6.2 Incompatibilities

Noneknown.

6.3 Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductispackagedforsale:18months.

Revised:September2012

AN:00613/2012

6.4 SpecialPrecautionsforStorage

Donotstoreabove25°C.

Storeuprightinoriginalcontainer.

Protectfromlight.

Discardunusedmaterial.Avoidintroductionofcontamination.

Ifstoredattemperaturesbelow0

C,ClosamectinPour-OnSolutionforCattle

mayappearcloudy.Allowingtowarmatroomtemperaturewillrestorethe

normalappearancewithoutaffectingefficacy.

Flammable –keepawayfromheat,sparks,openflameorothersourcesof

ignition.

6.5 NatureandCompositionofImmediatePackaging

Translucent250mL,500mLand1LHDPEcontainerswithwhiteHDPEcaps

andwhite1L,2.5Land5LHDPEbackpackswithwhitepolypropylenescrew

caps.

Notallpackssizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinal

ProductorWasteMaterialsDerivedfromtheUseofSuchProducts,if

appropriate

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Donot

contaminatesurfacewatersorditcheswiththeproductorusedcontainer.Any

unusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

CoDown,BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm 02000/4280

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

04August2009

10. DATEOFREVISIONOFTHETEXT

September2012