Closamectin Solution for Injection for Sheep

Main information

  • Trade name:
  • Closamectin Solution for Injection for Sheep
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Closamectin Solution for Injection for Sheep
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0262/002
  • Authorization date:
  • 28-04-2010
  • EU code:
  • UK/V/0262/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

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Issued:25/06/10

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinaryMedicinalProduct

ClosamectinSolutionforInjectionforSheep

2. QualitativeandQuantitativeComposition

ActiveSubstance(s)

Ivermectin 5 mg/ml

Closantel(asclosantelsodiumdihydrate) 125 mg/ml

OtherSubstances

Containssodiumformaldehydesulphoxylate5 mg/ml(asantioxidant)

ForafulllistofexcipientsseeSection6.1

3. PharmaceuticalForm

Solutionforinjection.

Aclearambersolution.

4. ClinicalParticulars

4.1 TargetSpecies:

Sheep.

4.2 IndicationsforUse(Specifying theTargetSpecies):

Forthetreatmentofmixedtrematode(fluke)andnematodeorarthropodinfestationsdueto

gastrointestinalroundworms,trematodes,lungworms,nasalbotsandmitesofsheep.

Gastrointestinalroundworms

Ostertagiacircumcincta(includinginhibitedL4),Ostertagiatrifurcata(adultandL4),

Haemonchus contortus (including inhibited L4), Trichostrongylus axei (adult),

Trichostrongyluscolubriformis(adultandL4),T.vitrinus(adult)Cooperiacurticei(adult

andL4),Oesophagostomumcolumbianum(adultandL4),O.venulosum(adult)Chabertia

ovina(adultandL4)Nematodirusfilicollis(adultandL4),Trichurisovis(adult).

[L4= fourthstagelarvae]

Lungworms

Dictyocaulusfilaria(adultand4 th

stagelarvae)

Protostrongylusrufescens(adult)

LiverFluke(trematodes)

Fasciolagigantica, Fasciolahepatica

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Treatmentofflukeat12 weeks(mature)>95%efficacy.

Treatmentofflukeat7 weeks(lateimmature)100%efficacy.

NasalBots

Oestrusovis

MangeMites

Psoroptesovis(Treatmentrequiresasecondinjectionofanivermectin-onlycontaining

product7 dayslater. Seesection 4.4and 4.9).

Benzimidazole–resistantstrainsofHaemonchuscontortusandOstertagiacircumcinctaare

alsocontrolled.

4.3 Contraindications:

Donotuseintravenouslyorintramuscularly.

Avermectinsmaynotbewelltoleratedinallnon-targetspecies(casesofintolerancewith

fataloutcomearereportedindogs–especiallyCollies,OldEnglishSheepdogsandrelated

breedsorcrosses,andalsointurtles/tortoises).

Donotuseincasesofknownhypersensitivitytotheactivesubstancesortoanyofthe

excipients.

4.4 SpecialWarningsforEachTargetSpecies:

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextended

periodoftime.

Underdosingwhichmaybeduetounderestimationofbodyweight,misadministrationof

theproduct,orlackofcalibrationofthedosingdevice.

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusing

appropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetests

stronglysuggestresistancetoaparticularanthelmintic,ananthelminticbelongingtoanother

pharmacologicalclassandhavingadifferentmodeofactionshouldbeused.

ResistancetoivermectinandclosantelhasbeenreportedinHaemonchuscontortusinsheep.

Thereforetheuseofthisproductshouldbebasedonlocalepidemiologicalinformation

aboutthesusceptibilityoftheHaemonchuscontortusandrecommendationsonhowtolimit

furtherselectionforresistancetoanthelmintics.

Insheep,treatmentofpsoropticmange(sheepscab)withoneinjectionofthisproductwill

notbeeffectiveineliminatingallthemites.Asuitableivermectin–onlyinjectableproduct

mustbeadministeredsevendaysafterthetreatmentwiththisproducttotreatclinicalsigns

andtoeliminatethemites.

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Sheepscab(Psoroptesovis)isanextremelycontagiousexternalparasiteofsheep.To

ensurecompletecontrolgreatcaremustbetakentoavoidre-infestation,asmitesmaybe

viableforupto15daysoffthesheep.Itisimportantthatallsheepwhichhavebeenin

contactwithinfectedsheeparetreatedwithanappropriateproduct.Contactbetween

treated,infectedanduntreatedflocksmustbeavoideduntilatleastsevendaysafter

treatment.

.

4.5 SpecialPrecautionsforUse:

(i) Specialprecautionsforuseinanimals

None.

(ii) Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproductto animals

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Directcontactoftheproductwiththeskinshouldbekepttoaminimum.Washhandsafter

use.Takecaretoavoidself-injection.Inadvertentself-injectionmayresultinlocal

irritationand/orpainattheinjectionsite.

4.6 AdverseReactions(Frequencyand Seriousness):

Transitoryswellinghasoccasionallybeenobservedattheinjectionsite.Occasionallythis

swellingisaccompaniedbypainanddiscomfort.Thisswellingcompletelyresolveswithin

14 daysoftreatment.

4.7 UseDuring Pregnancy, LactationorLay:

ClosamectinInjectioncanbeadministeredtosheepatanystageofpregnancyorlactation

providedthatthemilkisnotintendedforhumanconsumption.(Seesection4.11).

4.8 InteractionswithOtherMedicamentsand OtherFormsofInteraction:

Donotadministerconcomitantlywithchlorinatedcompounds.TheeffectofGABA

agonistsareincreasedbyivermectin.Pleasereferto Section4.3oftheSPC.

4.9 Amountsto beAdministered and AdministrationRoute:

ClosamectinInjectionshouldbeadministeredatadosagerateof200

givermectinperkg

bodyweightand5mgclosantelperkgbodyweight(1mlper25kg).Itshouldonlybe

injectedsubcutaneouslyintotheneck.Asterile16-gauge,one-inchneedleisrecommended.

ForthetreatmentandcontrolofsheepscabaninjectionofClosamectinInjectionforSheep

maybeadministeredbutmustbefollowedwithasecondinjectionofanivermectinonly

productsevendaysaftertheinitialinjectiontotreatclinicalsignsofscabandtoeliminate

mites.Thisinjectionshouldbeadministeredattheothersideoftheneck.

Thisproductdoesnotcontainanantimicrobialpreservative.Swabseptumbeforeremoving

eachdose.Useadrysterileneedleandsyringe.For250mland500mlpacksizes,useofa

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multipledosesyringeisrecommended.Torefillthesyringe,useofadraw-offneedleis

recommendedto avoidexcessivebroachingofthestopper.

Donotexceed40broachingspervial.Ifmorethan40broachingsarerequired,useofa

drawoffneedleisrecommended.

Thetimingfortreatmentshouldbebasedonepidemiologicalfactorsandshouldbe

customisedforeachindividualfarm.Aswithotheranthelmintics,veterinaryadviceshould

besoughtonappropriatedosingprogrammesandstockmanagementtoachieveadequate

parasitecontrolandreducethelikelihoodofresistancedeveloping.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccurately

aspossible;accuracyofthedosingdeviceshouldbechecked.

Ifanimalsaretobetreatedcollectivelyratherthanindividuallytheyshouldbegrouped

accordingtotheirbodyweightanddosedaccordingly,inordertoavoidunder-orover-

dosing.

4.10 Overdose(Symptoms,EmergencyProceduresand Antidotes)(ifnecessary):

Doselevelsupto4.0mg/kgivermectin(20timestherecommendeddosage)administered

subcutaneously,resultinataxiaanddepressioninsheep.

Closantellikeothersalicylanilidesisapotentuncouplerofoxidativephosphorylationand

thesafetyindexisnotashighasisthecaseofmanyotheranthelmintics.Howeverwhere

usedasdirectedthereareunlikelytobeanyuntowardeffects.Signsofoverdosagecan

includelossofappetite,decreasedvision,loosefaecesandincreasedfrequencyof

defaecation.Highdosesmaycauseblindness,hyperventilation,hyperthermia,general

weakness,inco-ordination,convulsions,tachycardiaandinextremecasesdeath.Treatment

ofoverdosageissymptomaticasnoantidotehasbeenidentified.

4.11 WithdrawalPeriod:

Meatandoffal:28 days

Milk:Notpermittedforuseinanimalsproducingmilkforhumanconsumption,including

pregnantanimalsintendedto producemilkforhumanconsumption.

5. PharmacologicalProperties

ATCvetcode:QP54AA51

Pharmacotherapeuticgroup:Endectocides

5.1 PharmacodynamicProperties:

Ivermectinisanendectocidewithactivityagainstawiderangeofinternalandexternal

parasites.Ivermectinisamacrocyliclactoneandactsbyinhibitingnerveimpulses.Itbinds

selectivelyandwithhighaffinitytoglutamate-gatedchlorideionchannelswhichoccurin

invertebratenerveandmusclecells.Thisleadstoanincreaseinthepermeabilityofthecell

membranetochlorideionswithhyperpolarizationofthenerveormusclecell,resultingin

paralysisanddeathoftherelevantparasites.Compoundsofthisclassmayalsointeractwith

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otherligand-gatedchloridechannels,suchasthosegatedbytheneurotransmittergamma-

aminobutyricacid(GABA).Themarginofsafetyforcompoundsofthisclassisattributable

tothefactthatmammalsdonothaveglutamate-gatedchloridechannels.Themacrocylic

lactoneshavealowaffinityforothermammalianligand-gatedchloridechannelsandthey

do notreadilycrosstheblood-brainbarrier.

Closantelisamemberofthesalicylanilideclassofanthelmintics.Salicylanilidesare

hydrogen(proton)ionophores(referredto asoxidativephosphorylaseuncouplers.)

Thechemicalstructureofsalicylanilidesillustratethepossessionofadetachableproton.

Thistypeofmoleculeislipophilicandisknowntoshuttleprotonsacrossmembranes,in

particulartheinnermitochondrialmembrane.Closantelactsbyuncouplingoxidative

phosphorylation.

Closantelisaparasiticidewithflukicideactivityandefficacyagainstcertainotherhelminths

andarthropods.Incattle,treatmentwithClosamectinSolutionforInjectionwhenflukeare

fiveweeksandgreaterhasbeenshowntoreducesubsequentreproductivecapacityandegg

shedding.

5.2 PharmacokineticProperties:

AftersubcutaneousadministrationofClosamectinInjectiontosheepatadoserateof200

g

ivermectinperkgand5mgclosantelperkgthefollowingparameterswereobserved:

IvermectinCmaxof24.52ng/mlandAUCof2082.93ng.h/ml;

ClosantelCmaxof70.4

g/mlandAUCof41043

g.h/ml.

Ivermectinbindsextensivelytoplasmaproteins.Duetoitshighlipophilicnature,

ivermectinisextensivelydistributed.Ittendstoaccumulateinfattissue,whichactsasa

drugreservoirandthehighestlevelsofivermectinarefoundinliverandfat.Ivermectinis

onlypartiallymetabolised.Ivermectinismainlyeliminatedinthefaecesasunaltereddrug

andfaecalexcretionaccountsfor90%ofthedoseadministeredwith<2%ofthedose

excretedinurine.Ivermectinisalsoexcretedbythemammarygland.

Salicylanilidesarepoorlymetabolisedandareexcretedmainlyunchanged.Themain

excretionrouteisthefaecesviathebile.Closantelisextensivelyboundtoplasmaproteins,

almostexclusivelytoalbumin.Thedistributiontotissuesispoor.Closantelhasalong

eliminationhalflife.

6. PharmaceuticalParticulars

6.1 ListofExcipients:

PovidoneK12

SodiumFormaldehydeSulphoxylate

Macrogol200

GlycerolFormal

6.2 MajorIncompatibilities:

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Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

6.3 Shelf-Life:

Shelf-lifeoftheveterinaryproductaspackagedforsale:18 months.

Shelf-lifeafterfirstopeningofimmediatepackaging:28 days.

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25°C.

Protectfromlight.

Discardunusedmaterial.

6.5 Natureand CompositionofImmediatePackaging:

100ml,250mland500mlTypeIglassmultidosevialsandaluminiumcapscompletewith

bromobutylbungsandaluminiumseals.

Notallpack sizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProductorWaste

MaterialsDerived fromtheUseofSuchProducts, ifappropriate:

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Donotcontaminate

surfacewatersorditcheswiththeproductorusedcontainer.Anyunusedproductorwaste

materialsderivedfromsuchveterinarymedicinalproductsshouldbedisposedofin

accordancewithlocalrequirements.

7. MarketingAuthorisationHolder

Norbrook LaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co Down,BT356JP

NorthernIreland

8 MarketingAuthorisationNumber

Vm02000/4299

9. DateofFirstAuthorisation/RenewaloftheAuthorisation

25 June2010

10. DateofRevisionoftheText

25 June2010

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ProhibitionofSale, Supplyand/orUse

UKauthorisedveterinarymedicinalproduct.

POM-VPS