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

Main information

  • Trade name:
  • Eprizero 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:
  • Eprizero 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
    Malta
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0442/001
  • Authorization date:
  • 23-01-2013
  • EU code:
  • UK/V/0442/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:March2013

AN:01816/2011

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Eprizero5mg/mlPour-OnSolutionforBeefandDairyCattle(UK,AT,BE,BG,

CY,CZ,DK,EE,FR,EL,HU,IE,IT,LV,LT,LU,MT,PT,RO,SK,SI,ES)

Eprizerovet5mg/mlPour-OnSolutionforBeefandDairyCattle(SE)

Eprizerovet5mg/mlPour-OnSolutionforCattle(FI)

Eprizerovet(NO)

Eprizero5mg/mlPour-OnSolutionforCattle(PL)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutioncontains:

ActiveSubstance:

Eprinomectin 5mg

Excipients:

ButylatedHydroxytoluene(E321) 0.1mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Pour-onsolution

ACleartoVeryLightYellowSolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Beefanddairycattle

4.2 Indicationsforuse,specifyingthetargetspecies

Indicatedforthetreatmentandpreventionofthefollowingparasites

GastrointestinalRoundworms(adultsandfourthstagelarvae):

Ostertagiaspp.,Ostertagialyrata(adult),Ostertagiaostertagi(including

inhibitedO.ostertagi),Cooperiaspp.(includinginhibitedCooperiaspp),

Cooperiaoncophora,Cooperiapectinata,Cooperiapunctata,Cooperia

surnabada,Haemonchusplacei,Trichostrongylusspp.,Trichostrongylusaxei,

Trichostrongyluscolubriformis,Bunostomumphlebotomum,Nematodirus

helvetianus,Oesophagostomumspp.(adult),Oesophagostomumradiatum,

Trichurisspp(adult).

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AN:01816/2011

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Lungworms(adultsandfourthstagelarvae):

Dictyocaulusviviparus

Warbles(parasiticstages):

Hypodermabovis,H.lineatum

MangeMites:

Chorioptesbovis,Sarcoptesscabieivarbovis

Lice:

Damaliniabovis(bitinglice),Linognathusvituli(suckinglice),

Haematopinuseurysternus(suckinglice),Solenopotescapillatus(sucking

lice).

HornFlies:

Haematobiairritans.

ProlongedActivity

Appliedasrecommended,theproductpreventsreinfectionswith:

Parasite* ProlongedActivity

Dictyocaulusviviparus upto28days

Ostertagiaspp upto28days

Oesophagostomumradiatum upto28days

Cooperiaspp upto21days

Trichostrongylusspp upto21days

Haemonchusplacei upto14days

Nematodirushelvetianus upto14days

*Thefollowingparasitespeciesareincludedwithineachoftherelevantgenera:

Ostertagiaostertagi, O.lyrata,Cooperiaoncophora,C.punctata,C.

surnabada,Trichostronglusaxei,T.colubroformis.

4.3 Contraindications

Thisproductisformulatedonlyfortopicalapplicationtobeefanddairycattle,

includinglactatingdairycattle.Donotuseinotheranimalspecies.Donot

administerorallyorbyinjection.

Donotuseinanimalswithknownhypersensitivitytotheactiveingredientorany

oftheexcipients.

4.4 SpecialWarningsforeachtargetspecies

Thedetailsprovidedinsection4.10apply.

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Ifthereisariskforre-infestation,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.

Whilemiteandlousenumbersdeclinerapidlyfollowingtreatment,duetothe

feedinghabitsoftheparasites,insomecasesseveralweeksmayberequired

forcompleteeradication.

Foreffectiveuse,theproductshouldnotbeappliedtoareasofthebackline

coveredwithmudormanure.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Nottobeusedinotherspecies;avermectinscancausefatalitiesindogs.

Theproductshouldbeappliedonlytohealthyskin.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductmaybeirritatingtohumanskinandeyesandmaycause

hypersensitivity.

Avoidskinandeyecontactwiththeproductduringtreatmentandwhenhandling

recentlytreatedanimals.

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AN:01816/2011

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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

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Administeronlybytopicalapplicationatthedoserateof1mlper10kgofbody

weight,correspondingtotherecommendeddoserateof0.5mgeprinomectin

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perkgb.w.Theproductshouldbeappliedtopicallybypouringalongthebackline

inanarrowstripextendingfromthewitherstothetailhead.

Rainfallatanytimebeforeoraftertreatmentwillnotaffecttheefficacyofthe

product.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible;accuracyofthedosingdevice(dosingcupordosinggun

deliverysystem)shouldbechecked.

Forbestresultsuseaspartofaprogramtocontrolbothinternalandexternal

parasitesofcattlebasedontheepidemiologyoftheseparasites.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inadultcattle,afteradministrationof5timestherecommendeddose(2.5mg

eprinomectin/kgbodyweight),mildhairlosswasobserved.Noothersignsof

toxicitywereseen.

Noantidotehasbeenidentified.

4.11Withdrawalperiod

Meat&offal:10days

Milk:zerohours.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Avermectins.

ATCVetCode:QP54AA04

5.1 Pharmacodynamicproperties

Modeofaction

Eprinomectinisamemberofthemacrocycliclactoneclassofendectocides.

Compoundsoftheclassbindselectivelyandwithhighaffinitytoglutamate-gated

chlorideionchannelswhichoccurininvertebratenerveormusclecells.This

leadstoanincreaseinthepermeabilityofthecellmembranetochlorideions

withhyperpolarizationofthenerveormusclecell,resultinginparalysisanddeath

oftheparasite.

Compoundsofthisclassmayalsointeractwithotherligand-gatedchloride

channels,suchasthosegatedbytheneurotransmittergamma-aminobutyricacid

(GABA).

Themarginofsafetyforcompoundsofthisclassisattributabletothefactthat

mammalsdonothaveglutamate-gatedchloridechannels;themacrocyclic

Issued:March2013

AN:01816/2011

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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.

Eprinomectinisstronglylinkedtoplasmaproteins(99%).Faecesisthemajor

routeofelimination.

5.3 Environmentalproperties

Likeothermacrocycliclactones,eprinomectinhasthepotentialtoadversely

affectnon-targetorganisms.Followingtreatment,excretionofpotentiallytoxic

levelsofeprinomectinmaytakeplaceoveraperiodofseveralweeks.Faeces

containingeprinomectinexcretedontopasturebytreatedanimalsmayreduce

theabundanceofdungfeedingorganismswhichmayimpactonthedung

degradation.

Eprinomectinisverytoxictoaquaticorganismsandmayaccumulatein

sediments

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

ButylatedHydroxytoluene(E321)

CetearylEthylhexanoateandIsopropylMyristate

PropyleneGlycolDicaprylocaprate

DenatoniumBenzoate

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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

poursystemandwhiteHDPEscrewcaps.

White1L,2.5Land5LHDPEbackpacksandwhitepolypropylenescrewcaps.

Notallpackssizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Extremelydangeroustofishandaquaticlife.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainer.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

Newry

Co.Down,BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm02000/4339

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9. DATEOFFIRSTAUTHORISATION

March2013

10. DATEOFREVISIONOFTHETEXT

March2013

APPROVED 8March2013

6-11-2018

FDA Approves Experior for Reduction of Ammonia Gas Released from Beef Cattle Waste

FDA Approves Experior for Reduction of Ammonia Gas Released from Beef Cattle Waste

FDA announced today the approval of Experior (lubabegron Type A medicated article), a beta-adrenergic agonist/antagonist drug that, when fed to beef cattle under specific conditions, results in less ammonia gas released as a by-product of their waste.

FDA - U.S. Food and Drug Administration

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