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

Other information

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

AN:02473/2008

Issued:25/06/10

Dokument1

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

AN:02473/2008

Issued:25/06/10

Dokument1

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.

AN:02473/2008

Issued:25/06/10

Dokument1

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

AN:02473/2008

Issued:25/06/10

Dokument1

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

AN:02473/2008

Issued:25/06/10

Dokument1

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:

AN:02473/2008

Issued:25/06/10

Dokument1

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

AN:02473/2008

Issued:25/06/10

Dokument1

ProhibitionofSale, Supplyand/orUse

UKauthorisedveterinarymedicinalproduct.

POM-VPS

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

There are no news related to this product.