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

Main information

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

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0446/001
  • Authorization date:
  • 23-01-2013
  • EU code:
  • UK/V/0446/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:March2013

AN:01866/2011

Page1of9

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Eprivet5mg/mlPour-OnSolutionforBeefandDairyCattle(UK)

Noreprinec5mg/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):

Issued:March2013

AN:01866/2011

Page2of9

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.

Issued:March2013

AN:01866/2011

Page3of9

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.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductmaybeirritatingtohumanskinandeyesandmaycause

hypersensitivity.

Issued:March2013

AN:01866/2011

Page4of9

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

Nointeractionswithothermedicamentsandnootherformsofinteractionsare

known.

4.9 Amountstobeadministeredandadministrationroute

Issued:March2013

AN:01866/2011

Page5of9

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

ATCVetCode:QP54AA04

5.1 Pharmacodynamicproperties

Modeofaction

Eprinomectinisamemberofthemacrocycliclactoneclassofendectocides

whichhaveauniquemodeofaction.Compoundsoftheclassbindselectively

andwithhighaffinitytoglutamate-gatedchlorideionchannelswhichoccurin

invertebratenerveormusclecells.Thisleadstoanincreaseinthepermeability

Issued:March2013

AN:01866/2011

Page6of9

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

Likeothermacrocycliclactones,eprinomectinhasthepotentialtoadversely

affectnon-targetorganisms.Followingtreatment,excretionofpotentiallytoxic

levelsofeprinomectinmaytakeplaceoveraperiodofseveralweeks.Faeces

containingeprinomectinexcretedontopasturebytreatedanimalsmayreduce

theabundanceofdungfeedingorganismswhichmayimpactonthedung

degradation.

Issued:March2013

AN:01866/2011

Page7of9

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

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Extremelydangeroustofishandaquaticlife.Donotcontaminateponds,

waterwaysorditcheswiththeproductoremptycontainer.

7. MARKETINGAUTHORISATIONHOLDER

Issued:March2013

AN:01866/2011

Page8of9

NorbrookLaboratoriesLimited

StationWorks

Newry

Co.Down

BT356JP

NorthernIreland

Issued:March2013

AN:01866/2011

Page9of9

8. MARKETINGAUTHORISATIONNUMBER

Vm02000/4343

9. DATEOFFIRSTAUTHORISATION

March2013

10. DATEOFREVISIONOFTHETEXT

March2013

Approved:20/03/13

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

There are no news related to this product.