Closamectin Pour-On

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
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

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

Revised:September2012

AN:00613/2012

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

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Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

9-8-2018

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

The container can separate from the blade base exposing the blades, posing a laceration hazard to consumers.

Health Canada

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the CAT meeting 18-20 April 2018

Minutes of the CAT meeting 18-20 April 2018

Europe - EMA - European Medicines Agency

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration

22-8-2018

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5632 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/T/20

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

6-8-2018

Otezla (Celgene Europe B.V.)

Otezla (Celgene Europe B.V.)

Otezla (Active substance: apremilast) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5391 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3746/T/20

Europe -DG Health and Food Safety