Anamex 5 mg/ ml Pour-On Solution for Beef and Dairy Cattle

Main information

  • Trade name:
  • Anamex 5 mg/ ml Pour-On Solution for Beef and Dairy Cattle
  • Pharmaceutical form:
  • Topical Solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Anamex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • eprinomectin
  • Therapeutic area:
  • Cattle

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0447/001
  • Authorization date:
  • 23-01-2013
  • EU code:
  • UK/V/0447/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:March2013

AN:01867/2011

Page1of9

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Anamex5mg/mlPour-OnSolutionforBeefandDairyCattle(UK)

Eprizero5mg/mlPour-OnSolutionforBeefandDairyCattle(NL)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutioncontains:

ActiveSubstance:

Eprinomectin 5mg

Excipients:

ButylatedHydroxytoluene(E321)0.1mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Pour-onsolution

ACleartoVeryLightYellowSolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle(beefanddairycattle)

4.2 Indicationsforuse,specifyingthetargetspecies

Indicatedforthetreatmentandcontrolofinfectionsofthefollowingparasites

GastrointestinalRoundworms(adultsandfourthstagelarvae):

Ostertagiaspp.,Ostertagialyrata(adult),Ostertagiaostertagi(including

inhibitedL

4 ),Cooperiaspp.(includinginhibitedL

4 ),Cooperiaoncophora,

Cooperiapectinata,Cooperiapunctata,Cooperiasurnabada,Haemonchus

placei,Trichostrongylusspp.,Trichostrongylusaxei,Trichostrongylus

colubriformis, Bunostomum phlebotomum, Nematodirus helvetianus,

Oesophagostomumspp.(adult),Oesophagostomumradiatum,Trichurisspp

(adult).

Lungworms(adultsandfourthstagelarvae):

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Dictyocaulusviviparus

Warbles(parasiticstages):

Hypodermabovis,H.lineatum

MangeMites:

Chorioptesbovis,Sarcoptesscabiei

Lice:

Damaliniabovis(bitinglice),Linognathusvituli(suckinglice),

Haematopinuseurysternus(suckinglice),Solenopotescapillatus(sucking

lice).

HornFlies:

Haematobiairritans.

Whilemiteandlousenumbersdeclinerapidlyfollowingtreatment,duetothe

feedinghabitsoftheparasites,insomecasesseveralweeksmayberequired

forcompleteeradication.

ProlongedActivity

Appliedasrecommended,theproductcontrolsreinfectionswith:

Parasite* ProlongedActivity

Dictyocaulusviviparus upto28days

Ostertagiaspp upto28days

Oesophagostomumradiatum upto28days

Cooperiaspp upto21days

Trichostrongylusspp upto21days

Haemonchusplacei upto14days

Nematodirushelvetianus upto14days

*Thefollowingparasitespeciesareincludedwithineachoftherelevantgenera:

Ostertagiostertagi,O.lyrata,Cooperiaoncophora,C.punctata,C.surnabada,

Trichostronglusaxei,T.colubroformis.

Forbestresultsuseaspartofaprogramtocontrolbothinternalandexternal

parasitesofcattlebasedontheepidemiologyoftheseparasites.

4.3 Contraindications

Thisproductisformulatedonlyfortopicalapplicationtobeefanddairycattle,

includinglactatingdairycattle.Donotuseinotheranimalspecies.Donot

administerorallyorbyinjection.

Donotuseinanimalswithknownhypersensitivitytotheactiveingredientorany

oftheexcipients.

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4.4 SpecialWarningsforeachtargetspecies

Thedetailsprovidedinsection4.10apply.

Ifthereisariskforre-infection,theadviceofaveterinarianshouldbesought

regardingtheneedforandfrequencyofrepeatadministration.

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasethe

riskofdevelopmentofresistanceandcouldultimatelyresultinineffective

therapy:

-Toofrequentandrepeateduseofanthelminticsfromthesameclass,overan

extendedperiodoftime.

-Underdosing,whichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosingdevice(if

any).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurther

investigatedusingappropriatetests(e.g.FaecalEggCountReductionTest).

Wheretheresultsofthetest(s)stronglysuggestresistancetoaparticular

anthelmintic,ananthelminticbelongingtoanotherpharmacologicalclassand

havingadifferentmodeofactionshouldbeused.

Todatenoresistancetoeprinomectin(amacrocycliclactone)hasbeenreported

withintheEU.Howeverresistancetoothermacrocycliclactoneshasbeen

reportedinparasitespeciesincattlewithintheEU.Therefore,useofthisproduct

shouldbebasedonlocal(regional,farm)epidemiologicalinformationabout

susceptibilityofnematodesandrecommendationsonhowtolimitfurther

selectionforresistancetoanthelmintics.

Foreffectiveuse,theproductshouldnotbeappliedtoareasofthebackline

coveredwithmudormanure.Theproductshouldbeappliedonlyonhealthy

skin.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Nottobeusedinotherspecies;avermectinscancausefatalitiesindogs,

especiallyCollies,OldEnglishSheepdogsandrelatedbreedsandcrosses,and

alsointurtles/tortoises.

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ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductmaybeirritatingtohumanskinandeyesandmaycause

hypersensitivity.

Avoidskinandeyecontactwiththeproductduringtreatmentandwhenhandling

recentlytreatedanimals.

Usersshouldwearrubbergloves,bootsandawaterproofcoatwhenapplyingthe

product.

Shouldclothingbecomecontaminated,removeassoonaspossibleandlaunder

beforere-use.

Ifaccidentalskincontactoccurs,washtheaffectedareaimmediatelywithsoap

andwater.

Ifaccidentaleyeexposureoccurs,flusheyesimmediatelywithwater.

Thisproductmaybetoxicafteraccidentalingestion.

Avoidaccidentalingestionoftheproductbyhandtomouthcontact.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Intheeventofingestion,washoutmouthwithwaterandseekmedicaladvice.

Washhandsafteruse.

Thisproductisflammable.Keepawayfromsourcesofignition.

Inhalationoftheproductmaycauseirritation.

Useonlyinwellventilatedareasoroutdoors.

iii. Otherprecautions

Eprinomectinisverytoxictodungfaunaandaquaticorganismsandmay

accumulateinsediments.

Therisktoaquaticecosystemsanddungfaunacanbereducedbyavoidingtoo

frequentandrepeateduseofeprinomectin(andproductsofthesame

anthelminticclass)incattle.

Therisktoaquaticecosystemswillbefurtherreducedbykeepingtreatedcattle

awayfromwaterbodiesfortwotofourweeksaftertreatment.

4.6 Adversereactions(frequencyandseriousness)

Noundesirableeffectshavebeenidentifiedwhentheproductisusedatthe

recommendeddoserate.

4.7 Useduringpregnancy,lactationorlay

Maybeusedindairycattleduringallstagesoflactation.

Studieshavedemonstratedawidesafetymargin.Studiesconductedatthree

timestherecommendeduselevelof0.5mgeprinomectin/kgb.w.hadno

adverseeffectonbreedingperformanceofcowsorbulls.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

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AN:01867/2011

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Nointeractionswithothermedicamentsandnootherformsofinteractionsare

known.

4.9 Amountstobeadministeredandadministrationroute

Pour-Onuse

Forsingletopicalapplication.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible;accuracyofthedosingdeviceshouldbechecked.

Therecommendeddoserateis0.5mgeprinomectinperkgbodyweight

(equivalentto1ml/10kgbodyweight).Theproductshouldbeappliedtopically

bypouringalongthebacklineinanarrowstripextendingfromthewitherstothe

tailhead.

ToavoidsecondaryreactionsduetothedeathofHypodermalarvaeinthe

oesophagusorinthespine,itisrecommendedtoadministertheproductatthe

endofwarbleflyactivityandbeforethelarvaereachtheirrestingsites.

Rainfallbeforeoraftertreatmentwillnotaffecttheefficacyoftheproduct.The

influenceofextremeweatherconditionsonlongtermeffectoftheproductis

unknown.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inadultcattle,afteradministrationof5timestherecommendeddose(2.5mg

eprinomectin/kgbodyweight),mildhairlosswasobserved.Noothersignsof

toxicitywereseen.

Noantidotehasbeenidentified.

4.11Withdrawalperiod

Cattle(meat&offal):10days

Cattle(milk):zerohours.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiparasiticproducts,Avermectins

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AN:01867/2011

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ATCVetCode:QP54AA04

5.1 Pharmacodynamicproperties

Modeofaction

Eprinomectinisamemberofthemacrocycliclactoneclassofendectocides

whichhaveauniquemodeofaction.Compoundsoftheclassbindselectively

andwithhighaffinitytoglutamate-gatedchlorideionchannelswhichoccurin

invertebratenerveormusclecells.Thisleadstoanincreaseinthepermeability

ofthecellmembranetochlorideionswithhyperpolarizationofthenerveor

musclecell,resultinginparalysisanddeathoftheparasite.

Compoundsofthisclassmayalsointeractwithotherligand-gatedchloride

channels,suchasthosegatedbytheneurotransmittergamma-aminobutyricacid

(GABA).

Themarginofsafetyforcompoundsofthisclassisattributabletothefactthat

mammalsdonothaveglutamate-gatedchloridechannels;themacrocyclic

lactoneshavealowaffinityforothermammalianligand-gatedchloridechannels,

andtheydonotreadilycrosstheblood-brainbarrier.

5.2 Pharmacokineticproperties

Thebioavailabilityoftopicallyappliedeprinomectinincattleisabout30%with

mostabsorptionoccurringbyabout10daysaftertreatment.Eprinomectinisnot

extensivelymetabolizedincattlefollowingtopicaladministration.Inallbiological

matrices,theB1acomponentofeprinomectinisthesinglemostabundant

residue.

EprinomectinconsistsofthecomponentsB

(

90%)andB

(

10%)which

differbyamethyleneunitandisnotextensivelymetabolizedincattle.

Metabolitesamounttoapproximately10%ofthetotalresiduesinplasma,milk,

edibletissuesandfaeces.

Themetabolismprofileisnearlyidentical,qualitativelyandquantitatively,inthe

abovebiologicalmatricesanddoesnotchangesignificantlywithtimeafter

administrationofeprinomectin.ThepercentcontributionofB

andB

tothe

overallmetaboliteprofileremainsconstant.Theratioofthetwodrugcomponents

inthebiologicalmatricesisidenticaltothatintheformulationdemonstratingthat

thetwoeprinomectincomponentsaremetabolizedwithnearlyequalrate

constants.Sincethemetabolismandthetissuedistributionofthetwo

componentsarequitesimilar,thepharmacokineticsofthetwocomponents

wouldbealsosimilar.

Sincethetwocomponentsofthecloselyrelatedavermectinandivermectinwere

foundtobeequallyefficacious,itmaybeconcludedthatthisalsoappliestothe

twoeprinomectincomponents.

5.3 Environmentalproperties

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Likeothermacrocycliclactones,eprinomectinhasthepotentialtoadversely

affectnon-targetorganisms.Followingtreatment,excretionofpotentiallytoxic

levelsofeprinomectinmaytakeplaceoveraperiodofseveralweeks.Faeces

containingeprinomectinexcretedontopasturebytreatedanimalsmayreduce

theabundanceofdungfeedingorganismswhichmayimpactonthedung

degradation.

Eprinomectinisverytoxictoaquaticorganismsandmayaccumulatein

sediments.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

ButylatedHydroxytoluene(E321)

CetearylEthylhexanoateandIsopropylMyristate

PropyleneGlycolDicaprylocaprate

DenatoniumBenzoate

IsopropylAlcohol

6.2 Incompatibilities

Nomajorincompatibilityhasbeenidentified.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months

6.4 Specialprecautionsforstorage

Donotstoreabove30°C.Keepcontainerintheoutercarton.Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Translucent250mLand1LHDPEcontainerswithintegralsqueezemeasure

poursystemandwhiteHDPEcaps.

White1L,2.5Land5LHDPEbackpacksforusewithadosinggundelivery

systemandwhitepolypropylenescrewcaps.

Notallpackssizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

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Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Extremelydangeroustofishandaquaticlife.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainer.

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7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

Newry

Co.Down

BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm02000/4344

9. DATEOFFIRSTAUTHORISATION

March2013

10. DATEOFREVISIONOFTHETEXT

March2013

Approved:19/03/13