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

Main information

  • Trade name:
  • Robonex pour on pour bovins
  • Pharmaceutical form:
  • Topical Solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Robonex pour on pour bovins
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • eprinomectin
  • Therapeutic area:
  • Cattle Food, Cattle Lactating

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0444/001
  • Authorization date:
  • 23-01-2013
  • EU code:
  • UK/V/0444/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:March2013

AN:01864/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Noreprinec5mg/mlPour-OnSolutionforBeefandDairyCattle(UK)

Robonex5mg/mlPour-OnSolutionforBeefandDairyCattle(BE,FR,IE)

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).

Lungworms(adultsandfourthstagelarvae):

Issued:March2013

AN:01864/2011

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.

Ifthereisariskforre-infestation,theadviceofaveterinarianshouldbesought

regardingtheneedforandfrequencyofrepeatadministration.

Issued:March2013

AN:01864/2011

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.

Usersshouldwearrubbergloves,bootsandawaterproofcoatwhenapplyingthe

product.

Issued:March2013

AN:01864/2011

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

perkgb.w.Theproductshouldbeappliedtopicallybypouringalongthebackline

inanarrowstripextendingfromthewitherstothetailhead.

Issued:March2013

AN:01864/2011

Rainfallatanytimebeforeoraftertreatmentwillnotaffecttheefficacyofthe

product.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible;accuracyofthedosingdevice(dosingcupordosinggun

deliverysystem)shouldbechecked.

Forbestresultsuseaspartofaprogramtocontrolbothinternalandexternal

parasitesofcattlebasedontheepidemiologyoftheseparasites.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inadultcattle,afteradministrationof5timestherecommendeddose(2.5

mgeprinomectin/kgbodyweight),mildhairlosswasobserved.Noothersigns

oftoxicitywereseen.

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

lactoneshavealowaffinityforothermammalianligand-gatedchloridechannels,

andtheydonotreadilycrosstheblood-brainbarrier.

Issued:March2013

AN:01864/2011

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

IsopropylAlcohol

6.2 Incompatibilities

Issued:March2013

AN:01864/2011

Nomajorincompatibilityhasbeenidentified.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months

6.4 Specialprecautionsforstorage

Donotstoreabove30°C.Keepcontainerintheoutercarton.Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Translucent250mLand1LHDPEcontainerswithintegralsqueezemeasure

poursystemandwhiteHDPEcaps.

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

Vm02000/4341

9. DATEOFFIRSTAUTHORISATION

20March2013

10. DATEOFREVISIONOFTHETEXT

March2013

Issued:March2013

AN:01864/2011

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FDA - U.S. Food and Drug Administration

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