Closamectin Injection

Main information

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

Documents

Localization

  • Available in:
  • Closamectin Injection
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0262/001
  • Authorization date:
  • 22-09-2011
  • EU code:
  • UK/V/0262/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:January2012

AN:02043/2010

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinaryMedicinalProduct

ClosamectinSolutionforInjection

2. QualitativeandQuantitativeComposition

ActiveSubstance(s)

Ivermectin 0.5%w/v

Closantel(asclosantelsodiumdihydrate) 12.5%w/v

ForafulllistofexcipientsseeSection6.1

3. PharmaceuticalForm

Solutionforinjection.Aclearambersolutionfreefromvisibleparticles.

4. ClinicalParticulars

4.1 TargetSpecies:

Cattle.

4.2 IndicationsforUse(SpecifyingtheTargetSpecies):

Forthetreatmentofmixedtrematode(fluke)andnematodeorarthropod

infestationsduetogastrointestinalroundworms,lungworms,eyeworms,warbles,

mitesandliceofcattle.

Gastrointestinalroundworms

Ostertagiaostertagi(includinginhibitedlarvalstages),Ostertagialyrata(adult),

Haemonchusplacei(adultandimmature),Trichostrongylusaxei(adultand

immature),Trichostrongyluscolubriformis(adultandimmature),Cooperia

oncophora(adultandimmature),Cooperiapunctata(adultandimmature),

Cooperiapectinata(adultandimmature),Oesophagostomumradiatum(adultand

immature),Nematodirushelvetianus(adult),Nematodirusspathiger(adult),

Strongyloidespapillosus(adult),Bunostomumphlebotomum(adultandimmature),

Toxocaravitulorum(adult),Trichurisspp.

Lungworms

Dictyocaulusviviparus(adultand4 th

stagelarvae)

LiverFluke(trematodes)

Fasciolagigantica,Fasciolahepatica

Treatmentofflukeat12weeks(mature)>99%efficacy.

Treatmentofflukefrom7weeks(lateimmature)>90%efficacy

Revised:January2012

AN:02043/2010

Page2of7

Eyeworms(adult)

Thelaziaspp

Cattlegrubs(parasiticstages)

Hypodermabovis,Hypodermalineatum

Lice

Linognathusvituli,Haematopinuseurysternus,Solenopotescapillatus

MangeMites

Psoroptesovis(synPcommunisvarbovis),Sarcoptesscabieivarbovis

ClosamectinInjectionmayalsobeusedasanaidinthecontrolofthebitinglouse

DamaliniabovisandthemangemiteChorioptesbovis,butcompleteelimination

maynotoccur.

Persistentactivityincattle

Whencattlehavetograzeonpasturecontaminatedwithinfectivelarvaeofcattle

nematodes,treatmentwithClosamectinInjectionattherecommendeddoserateof

200

givermectinperkgbodyweightand5mgclosantelperkgbodyweight

controlsre-infectionwith:

Prolongedactivity

Dictyocaulusviviparus Upto21days

Ostertagiaostertagi Upto21days

Oesophagostomumradiatum Upto21days

Cooperiaspp Upto14days

Trichostrongylusaxei Upto14days

Haemonchusplacei Upto14days

4.3 Contraindications:

ClosamectinInjectionisnotforintravenousorintramuscularuse.

Avermectinsmaynotbewelltoleratedinallnon-targetspecies(casesof

intolerancewithfataloutcomearereportedindogs –especiallyCollies,Old

EnglishSheepdogsandrelatedbreedsorcrosses,andalsointurtles/tortoises).

Donotuseincasesofknownhypersensitivitytotheactiveingredients.

4.4 SpecialWarningsforEachTargetSpecies:

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasethe

riskofdevelopmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overan

extendedperiodoftime.

Underdosingwhichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosingdevice.

Revised:January2012

AN:02043/2010

Page3of7

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurther

investigatedusingappropriatetests(e.g.FaecalEggCountReductionTest).

Wheretheresultsofthetestsstronglysuggestresistancetoaparticular

anthelmintic,ananthelminticbelongingtoanotherpharmacologicalclassand

havingadifferentmodeofactionshouldbeused.

ResistancetoivermectinhasbeenreportedinCooperiasppincattle.Therefore

theuseofthisproductshouldbebasedonlocalepidemiologicalinformationabout

thesusceptibilityoftheCooperiasppandrecommendationsonhowtolimitfurther

selectionforresistancetoanthelmintics.

4.5 SpecialPrecautionsforUse:

(i)Specialprecautionsforuseinanimals

None.

(ii)Specialprecautionstobetakenbythepersonadministeringthemedical

veterinaryproducttoanimals

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Directcontactoftheproductwiththeskinshouldbekepttoaminimum.Wash

handsafteruse.Takecaretoavoidself-injection.Inadvertentself-injectionmay

resultinlocalirritationand/orpainattheinjectionsite.

4.6 AdverseReactions(FrequencyandSeriousness):

Transitorydiscomforthasbeenobservedinsomecattlefollowingsubcutaneous

administration.Tissueswellingsattheinjectionsitearecommonupto48hours

afterinjectionwhichresolvethereafterwithouttreatment.Hardnessonpalpation

maybeobservedupto7daysfollowingadministration.

4.7 UseDuringPregnancy,LactationorLay:

ClosamectinInjectioncanbeadministeredtocattleatanystageofpregnancyor

lactationprovidedthatthemilkisnotintendedforhumanconsumption.

4.8 InteractionswithOtherMedicamentsandOtherFormsofInteraction:

Noneknown.

4.9 AmountstobeAdministeredandAdministrationRoute:

ClosamectinInjectionshouldbeadministeredatadosagerateof200

g

ivermectinperkgbodyweightand5mgclosantelperkgbodyweight(1mlper25

kg).Itshouldonlybeinjectedsubcutaneouslyintotheneck.Amaximumdoseof

10mlshouldbeadministeredatanyonesitewithanyresidualvolume

administeredatanothersiteintheneck.Asterile16-gauge,one-inchneedleis

recommended.

Thisproductdoesnotcontainanantimicrobialpreservative.Swabseptumbefore

removingeachdose.Useadrysterileneedleandsyringe.For250mland500ml

Revised:January2012

AN:02043/2010

Page4of7

packsizes,useofamultipledosesyringeisrecommended.Torefillthesyringe,

useofadraw-offneedleisrecommendedtoavoidexcessivebroachingofthe

stopper.

Thetimingfortreatmentshouldbebasedonepidemiologicalfactorsandshouldbe

customisedforeachindividualfarm.Aswithotheranthelmintics,veterinaryadvice

shouldbesoughtonappropriatedosingprogrammesandstockmanagementto

achieveadequateparasitecontrolandreducethelikelihoodofresistance

developing.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible;accuracyofthedosingdeviceshouldbechecked.

Ifanimalsaretobetreatedcollectivelyratherthanindividuallytheyshouldbe

groupedaccordingtotheirbodyweightanddosedaccordingly,inordertoavoid

under-orover-dosing.

4.10Overdose(Symptoms,EmergencyProceduresandAntidotes)(ifnecessary):

Singledosesof4.0mg/kgivermectin(20timestherecommendeddosage)

administeredsubcutaneously,resultinataxiaanddepression.Noantidotehas

beenidentified.Symptomatictreatmentmaybebeneficial.

Closantellikeothersalicylanilidesisapotentuncouplerofoxidative

phosphorylationandthesafetyindexisnotashighasisthecaseofmanyother

anthelmintics.Howeverwhereusedasdirectedthereareunlikelytobeany

untowardeffects.Signsofoverdosagecanincludelossofappetite,decreased

vision,loosefaecesandincreasedfrequencyofdefaecation.Highdosesmay

causeblindness,hyperventilation,hyperthermia,generalweakness,inco-

ordination,convulsions,tachycardiaandinextremecasesdeath.Treatmentof

overdosageissymptomaticasnoantidotehasbeenidentified.

Oralclosanteldosesinexcessof82.5mg/kgincattlemaycauseblindness,

hyperventilation,hyperthermia,generalweakness,in-coordination,convulsions,

tachycardiaandinextremecasesdeath.

4.11WithdrawalPeriod:

Cattlemustnotbeslaughteredforhumanconsumptionwithin49daysof

treatment.

Donotuseincattleproducingmilkforhumanconsumption.

Donotuseinnon-lactatingdairycowsincludingpregnantheiferswithin60daysof

calving.

Donotuseanyclosantel-containingproductsduringthe49daywithdrawalperiod.

Ifanadditionalivermectinonlyproductisadministeredwithinthe49day

withdrawalperiodsetforClosamectinInjection,careshouldbetakentoobserve

thelongestoverallwithdrawalperiod.

Revised:January2012

AN:02043/2010

Page5of7

5. PharmacologicalProperties

ATCvetcode:QP54AA51

Pharmacotherapeuticgroup:Anthelmintic

5.1 PharmacodynamicProperties:

Ivermectinisanendectocidewithactivityagainstawiderangeofinternaland

externalparasites.Ivermectinisamacrocyliclactoneandactsbyinhibitingnerve

impulses.Itbindsselectivelyandwithhighaffinitytoglutamate-gatedchlorideion

channelswhichoccurininvertebratenerveandmusclecells.Thisleadstoan

increaseinthepermeabilityofthecellmembranetochlorideionswith

hyperpolarizationofthenerveormusclecell,resultinginparalysisanddeathof

therelevantparasites.Compoundsofthisclassmayalsointeractwithother

ligand-gatedchloridechannels,suchasthosegatedbytheneurotransmitter

gamma-aminobutyricacid(GABA).Themarginofsafetyforcompoundsofthis

classisattributabletothefactthatmammalsdonothaveglutamate-gatedchloride

channels.Themacrocyliclactoneshavealowaffinityforothermammalianligand-

gatedchloridechannelsandtheydonotreadilycrosstheblood-brainbarrier.

Closantelisamemberofthesalicylanilideclassofanthelmintics.Salicylanilides

arehydrogen(proton)ionophores(referredtoasoxidativephosphorylase

uncouplers.)

Thechemicalstructureofsalicylanilidesillustratethepossessionofadetachable

proton.Thistypeofmoleculeislipophilicandisknowntoshuttleprotonsacross

membranes,inparticulartheinnermitochondrialmembrane.Closantelactsby

uncouplingoxidativephosphorylation.

Closantelisaparasiticidewithflukicideactivityandefficacyagainstcertainother

helminthsandarthropods.TreatmentwithClosamectinwhenflukearefiveweeks

andgreaterhasbeenshowntoreducesubsequentreproductivecapacityandegg

shedding.

5.2 PharmacokineticProperties:

AftersubcutaneousadministrationofClosamectinInjectiontocattleatadoserate

of200ugivermectinperkgand5mgclosantelperkgthefollowingparameters

wereobserved:IvermectinCmaxof57.3ng/mlandAUCof7106ng.hr/ml;

ClosantelCmaxof63.4ug/mlandAUCof21996ug.hr/ml.Ivermectinisonly

partiallymetabolised.Incattle,onlyabout1-2%isexcretedintheurinethe

remainderisexcretedinthefaeces,approximately60%ofwhichisexcretedas

unaltereddrug.Theremainderisexcretedasmetabolitesordegradation

products.Salicylanilidesarepoorlymetabolisedandareexcretedmainly

unchanged.About90%ofclosantelisexcretedunchangedinthefaecesand

urineincattle.

Revised:January2012

AN:02043/2010

Page6of7

6. PharmaceuticalParticulars

6.1 ListofExcipients:

PovidoneK12

SodiumFormaldehydeSulphoxylate

Macrogol200

GlycerolFormal

6.2 MajorIncompatibilities:

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnot

bemixedwithotherveterinarymedicinalproducts.

6.3 Shelf-Life:

Shelf-lifeoftheveterinaryproductaspackagedforsale:18months.

Shelf-lifeafterfirstopeningofimmediatepackaging:28days.

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25°C.

Protectfromlight.

Discardunusedmaterial.

6.5 NatureandCompositionofImmediatePackaging:

100ml,250mland500mlmultidosevialsandaluminiumcapscompletewith

bromobutylbungsandaluminiumseals.Notallpacksizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProduct

orWasteMaterialsDerivedfromtheUseofSuchProducts,ifappropriate:

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Donotcontaminate

surfacewatersorditcheswiththeproductorusedcontainer.Anyunusedproduct

orwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

7. MarketingAuthorisationHolder

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

CoDown,BT356JP

NorthernIreland

8 MarketingAuthorisationNumber

Vm02000/4254

Revised:January2012

AN:02043/2010

Page7of7

9. DateofFirstAuthorisation

28July2006

10. DateofRevisionoftheText

January2012

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

There are no news related to this product.