Eraquell Tabs, Ivermectin 20 mg, Chewable Tablets for Horses

Main information

  • Trade name:
  • Eraquell Tabs, Ivermectin 20 mg, Chewable Tablets for Horses
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Eraquell Tabs, Ivermectin 20 mg, Chewable Tablets for Horses
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin
  • Therapeutic area:
  • Horses

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0330/001
  • Authorization date:
  • 30-06-2010
  • EU code:
  • UK/V/0330/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued11/09/2009 –AN00984/2008

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

EraquellTabs,20mgChewabletabletsforHorses

EquimelTabs,20mgChewabletabletsforHorses(ES,PT)

Eraquellvet.,20mgChewabletabletsforHorses(DK,FI,IS,NO,SE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachchewabletabletof3300mgcontains:

Activesubstance

Ivermectin. 20 mg

Forfulllistofexcipientsseesection6.1.

3. PHARMACEUTICALFORM

Chewabletablet.

White,circular,biconcavetabletwithbrownspots.

4. CLINICALPARTICULARS

4.1 Targetspecies

Horses

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofnematodeandarthropodinfestations,duetoadultandimmatureroundwormsand

botsinhorses:

Nematodes

Large-strongyles:

Strongylusvulgaris(adultandarteriallarvae)

Strongylusedentatus(adultandL4tissuelarvalstages)

Strongylusequinus(adultandL4larvalstage)

Triodontophorusspp.(adult)

Small-strongyles:

Cyathostomum(adultandnon-encystedmucosallarvae):Cylicocyclusspp.,Cylicostephanus

spp.,Gyalocephalusspp.

Parascaris:Parascarisequorum(adultandlarvae).

Oxyuris:Oxyurisequi(adultandlarvae).

Trichostrongylus:Trichostrongylusaxei(adult).

Dipteraninsects:Gasterophilusspp.(larvae).

Issued11/09/2009 –AN00984/2008

4.3Contraindications

Donotuseinfoalsunder2weeksofage.

Donotuseinhorsesknowntobehypersensitivetotheactiveingredientoranyoftheotheringredients.

4.4 Specialwarningsfortargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

- toofrequentandrepeateduseofanthelminticsfromthesameclassoveranextendedperiodof

time,

- underdosing,whichmaybeduetounderestimationofbodyweight,misadministrationofthe

product,orlackofcalibrationofthedosingdevice(ifany).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusing

appropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)strongly

suggestresistancetoaparticularanthelmintic,ananthelminticbelongingtoanotherpharmacological

classandhavingadifferentmodeofactionshouldbeused.

ResistancetoivermectinhasbeenreportedinParascarisequoruminhorses.Thereforetheuseof

thisproductshouldbebasedonlocal(regional,farm)epidemiologicalinformationabout

susceptibilityofnematodesandrecommendationsonhowtolimitfurtherselectionforresistanceto

anthelmintics.

Theproductissafeforuseinstallions.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Avermectinsmaynotbewelltoleratedinnontargetspecies.Casesofintolerancearereportedindogs,

especiallyCollies,OldEnglishSheepdogsandrelatedbreedsorcrosses,andalsointurtlesand

tortoises.

Dogsandcatsshouldnotbeallowedtoingestspilledtabletsorhaveaccesstousedpackagingdueto

thepotentialforadverseeffectsrelatedtoivermectintoxicity.

Youngfoals,miniaturehorsesandtoybreedsweighinglessthan50kgmaybeunabletoingesttablets.

Seektheadviceofyourveterinarysurgeon.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteruse.Avoidcontactwiththeeyes.Incaseofeyeirritation,seekmedicalattention.

Donoteat,drinkorsmokewhilehandlingthisproduct.Intheeventofaccidentalingestion,seek

medicaladviceandshowtheleaflettothephysiciansothatheknowswhatyouhavetaken.

4.6 Adversereactions(frequencyandseriousness)

Colic,diarrhoeaandanorexiahavebeenreportedinveryrareoccasionsposttreatment,inparticular

whenthereisheavywormburden.Inveryrareoccasions,allergicreactionssuchashypersalivation,

lingualoedema,urticaria,tachycardia,congestedmucusmembranes,andsubcutaneousoedemahave

beenreportedfollowingtreatmentwiththeproduct.

Issued11/09/2009 –AN00984/2008

4.7 Useduringpregnancy,lactationorlay

Canbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Singleoraladministration.

200µgofivermectinperkgofbodyweightcorrespondingto1tabletper100kgbodyweight.

Weight Dosage Weight Dosage

Upto100kg 1tablet 401-500kg 5tablets

101-200kg 2tablets 501-600kg 6tablets

201-300kg 3tablets 601-700kg 7tablets

301-400kg 4tablets 701-800kg 8tablets

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossible.

Oncethecorrectdosehasbeendetermined,itshouldbeadministeredinthefollowingway:

Presentthetabletinthepalmofyourhand.

Presentingonetabletatatimemakesiteasierforthehorsetoacceptit,howevertheadministrationof

multipletabletsatonceisalsopossible.

Repeatthisgestureuntilthecompletedosehasbeenadministered.

Duringtheinitialadministration,thetabletcanbecombinedwithasmallamountoffoodoratreatto

increasetheacceptancebythehorse.

Intheeventthattherequireddoseisnotingestedanalternativetreatmentshouldbeadministered.

Seektheadviceofyourveterinarysurgeon.

Theveterinarysurgeonshouldgiveadviceregardingappropriatedosingprogrammesandstock

managementtoachieveadequateparasitecontrolforbothroundwormandbotinfestations.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Atolerancestudyperformedwiththeproductinadulthorseswithdosesupto5timesthe

recommendeddosagedidnotshowanyadversereactions.

Safetystudieswereconductedwithaveterinarymedicinalproductcontainingpraziquantelandthe

samedoseofivermectin(EQUIMAXoralgel),inmares,stallionsandfoals.

Administrationtomaresat3timestherecommendeddosageat14-dayintervalsduringthewhole

gestationandlactationperiodsdidnotresultinanyabortion,noranyadverseeffectduringgestation,at

parturitionoronthemaresgeneralhealth,noranyabnormalityinthefoals.

Administrationtostallionsat3timestherecommendeddosagedidnotshowanyadverseeffectin

particularonthereproductiveperformances.

Administrationtofoalswithdosesupto5timestherecommendeddosagedidnotshowanyadverse

reaction.

4.11Withdrawalperiod(s)

Meatandoffal:35days.

Issued11/09/2009 –AN00984/2008

Notauthorisedforuseinlactatinganimalsproducingmilkforhumanconsumption.

Issued11/09/2009 –AN00984/2008

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Endectocides,ivermectin.

ATCvetcode:QP54AA01

5.1 Pharmacodynamicproperties

Ivermectinisamacrocyclic-lactonederivativewhichhasabroadantiparasiticactivityagainst

nematodesandarthropods.Itactsbyinhibitingnerveimpulses.Itsmodeofactionincludesthe

glutamate-gatedchlorideionchannels.Ivermectinbindsselectivelyandwithhighaffinitytoglutamate-

gatedchlorideionchannelswhichoccurininvertebratenerveandmuscle cells.Thisleadstoan

increaseinthepermeabilityofthecellmembranetochlorideionswithhyperpolarisationofthenerveor

musclecell,resultinginparalysisanddeathoftherelevantparasites. Compoundsofthisclassmayalso

interactwithotherligand-gatedchloridechannels,suchasthosegatedbytheneurotransmittergamma-

aminobutyricacid(GABA).Thehighmarginofsafetyforcompoundsofthisclassisattributabletothe

factthat,inmammals,glutamatereceptorsinchlorideionchannelsdonotoccur;themacrocyclic

lactoneshavealowaffinitytoothermammalianligand-gatedchlorideionchannelsandtheydonot

readilycrosstheblood-brainbarrier.

5.2 Pharmacokineticparticulars

Afteroraladministrationoftheproductattherecommendeddosagetohorses,theivermectinpeak

plasmaconcentrationofaround14ng/mL(C

)wasreachedataTmaxof9

6h.andtheoral

meanabsolutebioavailabilityofivermectinisaround16%.

Theterminalhalf-lifevariesbetween2and5daysaftervariousroutesofadministrations.Ivermectinis

apoorlymetabolisedcompound.Duetoitslipophilicnature,ivermectinisexcretedinbileandultimately

eliminatedfromthebodyviathefaeces.Inhorses,about75%oftheadministereddoseisexcretedvia

thefaecesafteranoraladministrationofivermectinattherecommendeddose.Moreover90%of the

totaldrugisexcretedwithin4dayspost-administration.Approximately2%ofunchangedivermectin

andmetabolitesareexcretedinurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Povidone

Crospovidone

Cellulose,microcrystalline

CiderApplemarc(pressedapplepulp)

Glucose,liquid

Starch,pregelatinised(maizestarch)

Compressiblesugar

Magnesiumstearate

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:36months

Shelflifeafterfirstopeningtheimmediatepackaging:12months

6.4.Specialprecautionsforstorage

Issued11/09/2009 –AN00984/2008

Thisveterinarymedicinalproductdoesnotrequireanyspecialstoragecondition.

Issued11/09/2009 –AN00984/2008

6.5 Natureandcompositionofimmediatepackaging

Cartonboxcontaining1,2,12,40or48polypropylenetubesof8tabletsclosedbyapolyethylenechild

proofcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.EXTREMELYDANGEROUS

TOFISHANDAQUATICLIFE.Donotcontaminatesurfacewatersorditcheswiththeproductor

usedcontainer.

7. MARKETINGAUTHORISATIONHOLDER

VIRBAC-1 ère Avenue–2065mL.I.D,06516Carros,Cedex,France

8. MARKETINGAUTHORISATIONNUMBER

Vm05653/4159

9. DATEOFFIRSTAUTHORISATION

11September2009

10 DATEOFREVISIONOFTHETEXT

11September2009