Norofas Pour-On Solution for Cattle

Main information

  • Trade name:
  • Norofas Pour-On Solution for Cattle
  • Pharmaceutical form:
  • Pour-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Norofas Pour-On Solution for Cattle
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin, combinations
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0369/001
  • Authorization date:
  • 10-12-2011
  • EU code:
  • UK/V/0369/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:July2013

AN:00254/2013

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NorofasPour-OnSolutionforCattle(UK)

ClosamectinPour-OnSolutionforCattle(FR)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveIngredient(s)

Ivermectin 5mg/mL

Closantel(asclosantelsodium) 200mg/mL

Excipients

BrilliantBlueFCF(E133) 0.1mg/mL

Forafulllistofexcipientsseesection6.1.

3. PHARMACEUTICALFORM

Pour-Onsolution.

Aclearblue/greensolution.

4. CLINICALPARTICULARS

4.1 TargetSpecies

Cattle

4.2 IndicationsforUse,SpecifyingtheTargetSpecies

Forthetreatmentofmixedtrematode(fluke)andnematodeor

arthropodinfestationsduetoroundworms,lungworms,eyeworms,

warbles,mitesandliceofcattle.

Gastrointestinalroundworms(adultsandfourthstagelarvae)

Ostertagiaostertagi(includinginhibitedO.ostertagi),Haemonchus

placei,Trichostrongylusaxei,Trichostrongyluscolubriformis,Cooperia

spp,Oesophagostomumradiatum,Nematodirushelvetianus(adult),

Strongyloidespapillosus(adult).

Lungworms(adultandfourthstagelarvae)

Dictyocaulusviviparus

Trematodes(adultandlateimmatures)

Fasciolagigantica

Fasciolahepatica

Treatmentofflukeat12weeks(mature).

Revised:July2013

AN:00254/2013

Page2of8

Treatmentofflukeat7weeks(lateimmature).

Eyeworms(adult)

Thelaziaspp

Cattlegrubs(parasiticstages)

Hypodermabovis,Hypodermalineatum

Lice

Linognathusvituli,Haematopinuseurysternus,Damaliniabovis

MangeMites

Chorioptesbovis,Sarcoptesscabieivarbovis

4.3 Contraindications

Donotuseincasesofknownhypersensitivitytotheactivesubstances.

Donotapplytoareasofskinwhichhavemange,scabsorotherlesions

ortoareascontaminatedwithmudormanure.

Avermectinsmaynotbewelltoleratedinnon-targetspecies(casesof

intolerancewithfataloutcomearereportedindogs –especiallyCollies,

OldEnglishSheepdogsandrelatedbreedsorcrosses,andalsoin

turtles/tortoises).

4.4 SpecialWarnings

Careshouldbetakentoavoidthefollowingpracticesbecausethey

increasetheriskofdevelopmentofresistanceandcouldultimately

resultinineffectivetherapy.

Toofrequentandrepeateduseofanthelminticsfromthesameclass,

overanextendedperiodoftime.

Underdosingwhichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosing

device.

Theeffectofrainonthepour-onformulationatthetimeofandafter

applicationhasnotbeeninvestigated.Formaximumeffectanimals

shouldbekeptindoorsorundercoverfollowingtreatment,whenthere

israinoranimminentriskofrain.

Suspectedclinicalcasesofresistancetoanthelminticsshouldbe

furtherinvestigatedusingappropriatetests(e.g.,FaecalEggCount

ReductionTest).Wheretheresultsofthetestsstronglysuggest

resistancetoaparticularanthelmintic,ananthelminticbelongingto

anotherpharmacologicalclassandhavingadifferentmodeofaction

shouldbeused.

Revised:July2013

AN:00254/2013

Page3of8

ResistancetoivermectinhasbeenreportedinCooperiasppincattle.

Thereforetheuseofthisproductshouldbebasedonlocal

epidemiologicalinformationaboutthesusceptibilityoftheCooperiaspp

andrecommendationsonhowtolimitfurtherselectionforresistanceto

anthelmintics.

4.5 SpecialPrecautionsforUse

i. Specialprecautionsforuseinanimals

ItisnotadvisabletoadministertheproductwhenHypoderma

lineatumlarvaearelocalisedintheperiaesophagicregion,or

whenHypodermabovislarvaearesituatedinthespinalcanal.

Seekprofessionalveterinaryadvicetodeterminethebestperiod

ofuse.

Careshouldbetakentoensureanimalsarenotoverdosedby

theapplicationvolume,accidentalspillageororalingestion,as

overdosagemayresultinsignsoftoxicitysuchasinco-

ordinationandblindness.Itisrecommendedthatanimalsare

notclippedpriortotreatmenttoreducetheriskofincreased

drugabsorptionandhencebioavailability,ororalingestion

throughmutualgrooming.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductmaybeirritatingtohumanskinandeyesandusers

shouldbecarefulnottoaccidentallysplashitonthemselvesor

others.Wearnitrilerubberglovesandbootswithawaterproof

coatwhenapplyingtheproduct.Protectiveclothingshouldbe

washedafteruse.Ifaccidentalskincontactoccurs,washthe

affectedareaimmediatelywithsoapandwater.Ifaccidental

eyeexposureoccurs,flushtheeyesimmediatelywithwaterand

getmedicalattention.

Donotsmokeoreatwhilsthandlingtheproduct.Washhands

afteruse.Useonlyinwellventilatedareasoroutdoors.

iii. OtherPrecautions

Theproductisverytoxictoaquaticorganismsanddunginsects.

Treatedcattleshouldnothavedirectaccesstoponds,streams

orditchesfor14daysaftertreatment.

Longtermeffectsondunginsectscausedbycontinuousor

repeatedusecannotbeexcludedthereforerepeattreatmentson

Revised:July2013

AN:00254/2013

Page4of8

apasturewithinaseasonshouldonlybegivenontheadviceof

aveterinarian.

4.6 AdverseReactions(FrequencyandSeriousness)

Undesirableeffectsarenotexpectedwhentheproductisusedatthe

recommendeddoserate.

Inveryrarecases,neurologicalsignssuchasblindnesshavebeen

observedafteruseoftheproduct.

4.7 UseDuringPregnancy,LactationorLay

NorofasPour-Oncanbeadministeredtocattle(includingdairy,

beef/sucklercattle)atanystageofpregnancyorlactationprovidedthat

themilkisnotintendedforhumanconsumption.SeeSection4.11.

4.8 InteractionswithOtherMedicinalProductsandOtherFormsof

Interaction

Noneknown.

4.9 AmountstobeAdministeredandAdministrationRoute

Theveterinarymedicinalproductshouldbeadministeredtopicallyata

dosagerateof500

givermectinperkgbodyweightand20mg

closantelperkgbodyweight(1mLper10kg).

Theformulationshouldbeappliedalongthemidlineofthebackina

narrowstripbetweenthewithersandthetailhead.

Assessbodyweightcarefullypriortoadministration.

Thetimingfortreatmentshouldbebasedonepidemiologicalfactors

andshouldbecustomisedforeachindividualfarm.Adosing

programmeshouldbeestablishedbyaveterinaryprofessional.

HANDYDOSINGGUIDE ANIMALSSHOULDBEWEIGHEDAND

GROUPEDACCORDINGTOBODYWEIGHT

TOAVOIDUNDEROROVER-DOSING*

BODYWEIGHT DOSE

VOLUME NUMBEROFFULLDOSESPERPACK

250ml

500ml 1litre 2.5

litre 5litre

100kg* 10ml 25 50 100 250 500

150kg 15ml 16 33 66 166 333

200kg 20ml 12 25 50 125 250

250kg 25ml 10 20 40 100 200

300kg 30ml 8 16 33 83 166

350kg 35ml 7 14 28 71 142

400kg 40ml 6 12 25 62 125

Revised:July2013

AN:00254/2013

Page5of8

450kg 45ml 5 11 22 55 111

500kg 50ml 5 10 20 50 100

550kg 55ml 4 9 18 45 90

600kg 60ml 4 8 16 41 83

*Doserate1mlper10kgbodyweight

4.10Overdose(Symptoms,EmergencyProceduresandAntidotes)(if

necessary)

Atdosesofthreetimestherecommendeddose,nosignificantclinical

signswererecorded.

Ivermectin

Noantidotehasbeenidentified.Symptomatictreatmentmaybe

beneficial.

Closantellikeothersalicylanilidesisapotentuncouplerofoxidative

phosphorylationandthesafetyindexisnotashighasisthecaseof

manyotheranthelmintics.Howeverwhereusedasdirectedthereare

unlikelytobeanyuntowardeffects.Signsofoverdosagecaninclude

slightlossofappetite,loosefaeces,decreasedvisionandincreased

frequencyofdefecation.Highdosesmaycauseblindness,

hyperventilation,generalweaknessandinco-ordination,hyperthermia,

convulsions,tachycardiaandinextremecasesdeath.Treatmentof

overdosageissymptomaticasnoantidotehasbeenidentified.

4.11WithdrawalPeriods

Meatandoffal:28days.

Milk:Notauthorisedforuseincattleproducingmilkforhuman

consumptionincludingduringthedryperiod.Donotuseduringthe

secondhalfofpregnancyinheiferswhichareintendedtoproducemilk

forhumanconsumption.

Duetothesignificantlikelihoodofcross-contaminationofnon-treated

animalswiththisproductduetogrooming(licking),allanimalsina

groupshouldbetreatedatthesametimeandtreatedanimalsshould

bekeptseparatelyfromnon-treatedanimalsthroughoutthewithdrawal

period.Non-compliancewiththisrecommendationmayleadto

residuesviolationsinnon-treatedanimals.

5. PHARMACOLOGICALPROPERTIES

ATCVetCode:QP54AA51

PharmacotherapeuticGroup:Ivermectin,combinations.

Revised:July2013

AN:00254/2013

Page6of8

5.1 PharmacodynamicProperties

Ivermectinisanendectocidewithactivityagainstawiderangeof

internalandexternalparasites.Ivermectinisamacrocyliclactoneand

actsbyinhibitingnerveimpulses.Itbindsselectivelyandwithhigh

affinitytoglutamate-gatedchlorideionchannelswhichoccurin

invertebratenerveandmusclecells.Thisleadstoanincreaseinthe

permeability of the cell membrane to chloride ions with

hyperpolarizationofthenerveormusclecell,resultinginparalysisand

deathoftherelevantparasites.Compoundsofthisclassmayalso

interactwithotherligand-gatedchloridechannels,suchasthosegated

bytheneurotransmittergamma-aminobutyricacid(GABA).The

marginofsafetyforcompoundsofthisclassisattributabletothefact

thatmammalsdonothaveglutamate-gatedchloridechannels.The

macrocyliclactoneshavealowaffinityforothermammalianligand-

gatedchloridechannelsandtheydonotreadilycrosstheblood-brain

barrier.

Closantelisamemberofthesalicylanilideclassofanthelmintics.

Salicylanilidesarehydrogen(proton)ionophores(referredtoas

oxidativephosphorylaseuncouplers.)

Thechemicalstructureofsalicylanilidesillustratethepossessionofa

detachableproton.Thistypeofmoleculeislipophilicandisknownto

shuttleprotonsacrossmembranes,inparticulartheinnermitochondrial

membrane.Closantelactsbyuncouplingoxidativephosphorylation.

Closantelisaparasiticidewithflukicideactivityandefficacyagainst

certainotherhelminthsandarthropods.

5.2 PharmacokineticProperties

AftertopicaladministrationofNorofasPour-Ontocattleatadoserate

of500µgivermectinperkgand20mgclosantelperkgthefollowing

parameterswereobserved:

Ivermectin –Cmaxof19.13ng/mLandAUCof2440ng.hr/mL

Closantel –Cmaxof68.5µg/mLandAUCof35207µg.hr/mL.

Ivermectin,Tmax=48hours,terminalhalf-life=80.00hours

Closantel,Tmax=120hours,terminalhalf-life=267.55hours

Ivermectinisonlypartiallymetabolised.Incattle,onlyabout1to2%is

excretedintheurinetheremainderisexcretedinthefaeces,

approximately60%ofwhichisexcretedasunaltereddrug.The

remainderisexcretedasmetabolitesordegradationproducts.

Salicylanilidesarepoorlymetabolisedandareexcretedmainly

unchanged.About90%ofclosantelisexcretedunchangedinthe

faecesandurineincattle.

Revised:July2013

AN:00254/2013

Page7of8

6. PHARMACEUTICALPARTICULARS

6.1 ListofExcipient(s)

BrilliantBlueFCF(E133)Dye

AnhydrousEthanol

Macrogol

CetearylEthylhexanoate

IsopropylMyristate

Povidone

DenatoniumBenzoate

Trolamine

Isopropylalcohol

6.2 Incompatibilities

Noneknown.

6.3 Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18

months.

6.4 SpecialPrecautionsforStorage

Donotstoreabove25°C.

Storeuprightinoriginalcontainer.

Protectfromlight.

Discardunusedmaterial.Avoidintroductionofcontamination.

Replacethecapsecurelyafteruse.

Ifstoredattemperaturesbelow0

C,NorofasPour-OnSolutionfor

Cattlemayappearcloudy.Allowingtowarmatroomtemperaturewill

restorethenormalappearancewithoutaffectingefficacy.

Flammable –keepawayfromheat,sparks,openflameorother

sourcesofignition.

6.5 NatureandCompositionofImmediatePackaging

Translucent250mL,500mLand1LHDPEcontainerswithwhite

HDPEcapsandwhite1L,2.5Land5LHDPEbackpackswithwhite

polypropylenescrewcaps.

Notallpackssizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinary

MedicinalProductorWasteMaterialsDerivedfromtheUseof

SuchProducts,ifappropriate

Revised:July2013

AN:00254/2013

Page8of8

EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Donot

contaminatesurfacewatersorditcheswiththeproductorused

container.Anyunusedveterinarymedicinalproductorwastematerials

derivedfromsuchveterinarymedicinalproductsshouldbedisposedof

inaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

CoDown

BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm :02000/4312

9. DATEOFFIRSTAUTHORISATION

Date:23June2011

10. DATEOFREVISIONOFTHETEXT

Date:July2013

Approved:29/08/2013

9-11-2011

Danish Pharmacovigilance Update, 20 October 2011

Danish Pharmacovigilance Update, 20 October 2011

In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.

Danish Medicines Agency

There are no news related to this product.