Robonex Pour-on Beef and Dairy Cattle

Main information

  • Trade name:
  • Robonex Pour-on Beef and Dairy Cattle
  • Pharmaceutical form:
  • Topical Solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Robonex Pour-on Beef and Dairy Cattle
    Slovenia
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0443/001
  • Authorization date:
  • 23-01-2013
  • EU code:
  • UK/V/0443/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

AN:00049/2013

Revised:May2013

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Robonex5mg/mlPour-OnSolutionforBeefandDairyCattle(UK,IT)

Noreprinec5mg/mlPour-OnSolutionforBeefandDairyCattle(BE,LU,PT,ES)

Norprinomectin5mg/mlPour-OnSolutionforBeefandDairyCattle(FR)

Eprivet5mg/mlPour-OnSolutionforBeefandDairyCattle(IE)

Anamex5mg/mlPour-OnSolutionforBeefandDairyCattle(AT,BG,CY,CZ,

DK,EE,EL,HU,LV,LT,MT,RO,SK,SI)

Anamexvet5mg/mlPour-OnSolutionforBeefandDairyCattle(SE)

Anamexvet5mg/mlPour-OnSolutionforCattle(FI)

Anamexvet(NO)

Anamex5mg/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,

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Revised:May2013

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Trichostrongyluscolubriformis,Bunostomumphlebotomum,Nematodirus

helvetianus,Oesophagostomumspp.(adult),Oesophagostomumradiatum,

Trichurisspp(adult).

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

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Thedetailsprovidedinsection4.10apply.

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;avermectinscancausefatalitiesin

dogs.

Theproductshouldbeappliedonlytohealthyskin.

ii Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductmaybeirritatingtohumanskinandeyesandmaycause

hypersensitivity.

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Revised:May2013

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Avoidskinandeyecontactwiththeproductduringtreatmentand

whenhandlingrecentlytreatedanimals.

Usersshouldwearrubbergloves,bootsandawaterproofcoatwhen

applyingtheproduct.

Shouldclothingbecomecontaminated,removeassoonaspossible

andlaunderbeforere-use.

Ifaccidentalskincontactoccurs,washtheaffectedareaimmediately

withsoapandwater.

Ifaccidentaleyeexposureoccurs,flusheyesimmediatelywithwater.

Thisproductmaybetoxicafteraccidentalingestion.

Avoidaccidentalingestionoftheproductbyhandtomouthcontact.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Intheeventofingestion,washoutmouthwithwaterandseekmedical

advice.

Washhandsafteruse.

Thisproductisflammable.Keepawayfromsourcesofignition.

Inhalationoftheproductmaycauseirritation.

Useonlyinwellventilatedareasoroutdoors.

iiiOtherprecautions

Eprinomectinisverytoxictodungfaunaandaquaticorganismsand

mayaccumulateinsediments.

Therisktoaquaticecosystemsanddungfaunacanbereducedby

avoidingtoofrequentandrepeateduseofeprinomectin(and

productsofthesameanthelminticclass)incattle.

Therisktoaquaticecosystemswillbefurtherreducedbykeeping

treatedcattleawayfromwaterbodiesfortwotofourweeksafter

treatment.

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

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Administeronlybytopicalapplicationatthedoserateof1mlper10kgofbody

weight,correspondingtotherecommendeddoserateof0.5mgeprinomectin

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

AN:00049/2013

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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

IsopropylAlcohol

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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

CamloughRoad

Newry

Co.Down

BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm 02000/4340

9. DATEOFFIRSTAUTHORISATION

Date:26March2013

AN:00049/2013

Revised:May2013

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10. DATEOFREVISIONOFTHETEXT

Date:May2013

Approved: 07/06/2013

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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