Equimax Easy

Main information

  • Trade name:
  • Equimax Easy
  • Pharmaceutical form:
  • Chewable tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Equimax Easy
    Germany
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0258/001
  • Authorization date:
  • 23-07-2009
  • EU code:
  • UK/V/0258/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:June2013

AN:00550/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

EquimaxTabs150mg/20mgChewabletabletforHorses

ForDK,SE,FI,IS,NO:

EquimaxTabsVet,150mg/20mg,ChewabletabletforHorses

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachchewabletabletof3300mgcontains:

Activesubstances

Ivermectin. 20 mg

Praziquantel.150 mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Chewabletablet

White,circular,biconcavetabletwithbrownspots.

4. CLINICALPARTICULARS

4.1Targetspecies

Horses

4.2Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofmixedcestode,nematodeandarthropodinfestations,duetoadult

andimmatureroundworms,lungworms,botsandtapewormsinhorses:

Nematodes

Large-strongyles:

Strongylusvulgaris(adultandarteriallarvae)

Strongylusedentatus(adultandL4tissuelarvalstages)

Strongylusequinus(adultandL4larvalstage)

Triodontophorusspp.(adult)

Small-strongyles:

Cyathostomum(adultandnon-encystedmucosallarvae):Cylicocyclusspp.,

Cylicostephanusspp.,Gyalocephalusspp.

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Parascaris:Parascarisequorum(adultandlarvae).

Oxyuris:Oxyurisequi(adultandlarvae).

Trichostrongylus:Trichostrongylusaxei(adult).

Cestodes(Tapeworm):AnoplocephalaperfoliataAnoplocephalamagna,

Paranoplocephalamamillana

Dipteraninsects:Gasterophilusspp.(larvae).

Astapeworminfestationisunlikelytooccurinhorsesbeforetwomonthsofage,

treatmentoffoalsbelowthisageisnotconsiderednecessary.

4.3Contraindications

Donotuseinfoalsunder2weeksofage.

Donotuseinhorsesproducingmilkforhumanconsumption.

Donotuseinhorsesknowntobehypersensitivetotheactiveingredientsoranyofthe

otheringredients.

Theproducthasbeenformulatedforuseinhorsesonly.

Cats,Dogs(especiallyCollies,OldEnglishSheepdogsandrelatedbreedsorcrosses),

andalsoturtlesandtortoisesmaybeadverselyaffectedbytheconcentrationof

ivermectininthisproductiftheyareallowedtoingesttablets.

4.4Specialwarningsfortargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetherisk

ofdevelopmentofresistanceandcouldultimatelyresultinineffectivetherapy:

-toofrequentandrepeateduseofanthelminticsfromthesameclassoveran

extendedperiodoftime,

-underdosing,whichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosingdevice(if

any).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigated

usingappropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresultsof

thetest(s)stronglysuggestresistancetoaparticularanthelmintic,ananthelmintic

belongingtoanotherpharmacologicalclassandhavingadifferentmodeofaction

shouldbeused.

ResistancetoivermectinhasbeenreportedinParascarisequoruminhorsesina

numberofcountriesincludingonesintheEU.Thereforetheuseofthisproduct

shouldbebasedonnational(regional,farm)epidemiologicalinformationabout

susceptibilityofnematodesandrecommendationsonhowtolimitfurtherselectionfor

resistancetoanthelmintics

Theproductcanbeusedsafelyinstallions.

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4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Youngfoals,miniaturehorsesandtoybreedsweighinglessthan50kgmaybeunable

toingesttablets.Seektheadviceofyourveterinarysurgeon.

Avermectinsmaynotbewelltoleratedinnontargetspecies.Casesofintoleranceare

reportedindogs,especiallyCollies,OldEnglishSheepdogsandrelatedbreedsor

crosses,andalsointurtlesandtortoises.

Dogsandcatsshouldnotbeallowedtoingestspilledtabletsorhaveaccesstoused

packagingduetothepotentialforadverseeffectsrelatedtoivermectintoxicity.

Sinceivermectinishighlyboundtoplasmaproteins,specialcareshouldbetakenin

casesofsickanimalsorinnutritionalconditionsassociatedwithlowplasmaprotein

levels.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Avoidcontactwiththeeyes.Intheeventofaccidentalcontactwiththeeyes,rinse

immediatelywithplentyofwater.Incaseofeyeirritation,seekmedicalattention.

Donoteat,drinkorsmokewhilehandlingthisproduct.

Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleaflettothephysician.

4.6Adversereactions(frequencyandseriousness)

Colic,diarrhoeaandanorexiahavebeenreportedinveryrareoccasionspost

treatment,inparticularwhenthereisheavywormburden.Inveryrareoccasions,allergic

reactionssuchashypersalivation,lingualoedemaandurticaria,tachycardia,congested

mucusmembranes,andsubcutaneousoedemahavebeenreportedfollowingtreatment

withtheproduct.

4.7Useduringpregnancy,lactationorlay

Equimaxtabscanbeadministratedtohorsesatanystageofpregnancyorlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

TheeffectsofGABAagonistsareincreasedbyivermectin.

4.9Amountstobeadministeredandadministrationroute

Singleoraladministration.

200µgofivermectinand1.5mgofpraziquantelperkgofbodyweightcorrespondingto

1tabletper100kgbodyweight.

Weight Dosage Weight Dosage

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Upto100kg 1tablet 501-600kg 6tablets

101-200kg 2tablets 601-700kg 7tablets

201-300kg 3tablets 701-800kg 8tablets

301-400kg 4tablets

401-500kg 5tablets

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possible.

Oncethecorrectdosehasbeendetermined,itshouldbeadministeredinthefollowing

way:

Presentthetabletinthepalmofyourhand.Repeatthisgestureuntilthecompletedose

hasbeenadministered. Duringtheinitialadministration,thetabletcanbecombined

withasmallamountoffoodoratreattoincreasetheacceptancebythehorse.

Intheeventthattherequireddoseisnotingestedanalternativetreatmentshouldbe

administered.Seektheadviceofyourveterinarypractitioner

Theveterinarysurgeonshouldgiveadviceregardingappropriatedosingprogrammes

andstockmanagementtoachieveadequateparasitecontrolforbothtapewormand

roundworminfestations.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Atolerancestudyperformedinfoalswithdosesupto5timestherecommended

dosagedidnotshowanyadversereactions.

4.11Withdrawalperiod(s)

Horses:Meatandoffal:35days.

Notpermittedforuseinhorsesproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Endectocides,ivermectin,combinations.

ATCvetcode:QP54AA51

5.1Pharmacodynamicproperties

Ivermectinisamacrocyclic-lactonederivativewhichhasabroadantiparasiticactivity

againstnematodesandarthropods.Itactsbyinhibitingnerveimpulses.Itsmodeof

actionincludestheglutamate-gatedchlorideionchannels.Ivermectinbindsselectively

andwithhighaffinitytoglutamate-gatedchlorideionchannelswhichoccurin

invertebratenerveandmusclecells.Thisleadstoanincreaseinthepermeabilityofthe

cellmembranetochlorideionswithhyperpolarisationofthenerveormusclecell,

resultinginparalysisanddeathoftherelevantparasites.Compoundsofthisclassmay

alsointeractwithotherligand-gatedchloridechannels,suchasthosegatedbythe

neurotransmittergamma-aminobutyricacid(GABA).Themarginofsafetyfor

compoundsofthisclassisattributabletothefactthatmammalsdonothaveglutamate-

gatedchloridechannels.

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Praziquantelisapyrazinoisoquinolinederivativewhichexertsitsanthelminticactivity

againstmanyspeciesofCestodesandTrematodes.Itprimarilyactsbyimpairingboth

motilityandfunctionofthesuckersofcestodes.Itsmodeofactionincludestheimpairing

ofneuromuscularco-ordinationbutalsoinfluencingthepermeabilityoftheintegumentof

theworms,whichleadstoexcessivecalciumandglucoseloss.Thisinducesspastic

paralysisoftheparasitemusculature.

5.2Pharmacokineticparticulars

Afteroraladministrationattherecommendeddosage,theivermectinpeakplasma

concentrationofaround12ng/mL(C

)wasreachedbetween4and8hours(T

).

Theoralmeanabsolutebioavailabilityofivermectinisaround9%.Ivermectinisapoorly

metabolisedcompound.Duetoitslipophilicnature,ivermectinisexcretedinbileand

ultimatelyeliminatedfromthebodyviathefaeces.Inhorses,about75%ofthe

administereddoseisexcretedviathefaecesafteranoraladministrationofivermectin

attherecommendeddose.Moreover90%ofthetotaldrugisexcretedwithin4days

post-administration.Approximately2%ofunchangedivermectinandmetabolitesare

excretedinurine.

Orally,praziquantelisrapidlyabsorbed,andthenrapidlyundergoesastrongfirstpass

effectinallthespeciesstudied.Afteroraladministrationattherecommendeddosage,

themeanmaximalpraziquantelconcentrationofaround0.3µg/mL(C

)isreachedin

arangeof0.2-2hours(T

).Theoralmeanabsolutebioavailabilityofpraziquantelis

around36%.Praziquantelisacompoundrapidlydistributedinbodytissuesduetoits

highlipidsolubility;theradioactivitytendstobelocalisedmainlyintheexcretionorgans,

i.e.liverandkidneys.Praziquantelisanextensivelymetabolisedcompoundinanimals.

Theexcretionoccursmainlyviaurine(approximately70-80%)within24hasavarietyof

metabolites.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Povidone

Crospovidone

Cellulose,microcrystalline

CiderApplemarc(pressedapplepulp)

Glucose,liquid

Starch,pregelatinised

Compressiblesugar

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:30months

Shelflifeafterfirstopeningtheimmediatepackaging:1year

6.4.Specialprecautionsforstorage

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Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

Cartonboxcontaining1,2,12,40or48polypropylenetubesof8tabletsclosedbya

childproofcap.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Donotcontaminate

surfacewatersorditcheswiththeproductorusedcontainer.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

VIRBACS.A.-1 ière

Avenue –2065m,L.I.D,06516Carros,Cedex,France

8. MARKETINGAUTHORISATIONNUMBER

Vm05653/4142

9. DATEOFFIRSTAUTHORISATION

5September2008

10. DATEOFREVISIONOFTHETEXT

June2013

Approved: 03/06/2013