Virbamec Pour-on

Main information

  • Trade name:
  • Virbamec Pour-on
  • Pharmaceutical form:
  • Pour-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Virbamec Pour-on
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ENDECTOCIDES
  • Therapeutic area:

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0153/001
  • Authorization date:
  • 03-07-2012
  • EU code:
  • UK/V/0153/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

SUMMARYOFTHEPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Ivermectin.............................................................................5mg/ml

Excipient(s):

Forfulllistseesection6.1

3. PHARMACEUTICALFORM

Pour-Onsolution

Non-aqueouscolourlesspaletoyellowliquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle.

4.2 Indicationsforuse,specifyingthetargetspecies

VIRBAMECPour-Onisindicatedforthetreatmentofgastro-intestinalnematodes,lungworms,

warbles,choriopticandsarcopticmangemites,suckingandbitingliceofbeefandnon-lactatingdairy

cattle.

Gastro-intestinalroundworms(adultsand4thstagelarvae):

Ostertagiaostertagi (L4,adultsandinhibitedstages)

Haemonchusplacei (L4,adults)

Trichostrongylusaxei (L4,adults)

Trichostrongyluscolubriformis (L4,adults)

Cooperiaspp. (adults)

Cooperiapuntacta (adults)

Cooperiaoncophora (adults)

Oesophagostomumradiatum (L4,adults)

Strongyloidespapillosus (adults)

Trichurisspp. (adults)

Lungworms(adultsand4thstagelarvae):

Dictyocaulusviviparus

Warbles(parasiticstages):

Hypodermabovis

Hypodermalineatum

Mites:

Sarcoptesscabieivarbovis

Chorioptesbovis

Lice:

Suckinglice

Linognathusvituli

Haematopinuseurysternus

Bitinglice

Damaliniabovis

VIRBAMECPour-On,attherecommendeduselevelof500mcgivermectinperkgbodyweight,hasa

persistentactivityon:

Dictyocaulusviviparus: forupto28days

Ostertagiaspp: forupto21days

Oesophagostomumradiatum: forupto21days

Cooperiaspp.: forupto14days

Trichostrongylusaxei: forupto14days

VIRBAMECPour-OnhelpsinthecontrolofthemangemiteChorioptesbovisbutcomplete

eliminationmaynotoccur .

VIRBAMECPour-OnhasalsoapersistentactivityonthehornFly(Haematobiairritans)for28days,

partialefficacymaylastforupto35dayspostapplication.

OccasionallyvariableactivitymaybeobservedagainstHaemonchusplacei(L4),Cooperiaspp,

TrichostrongylusaxeiandTrichostrongyluscolubriformis.

ToobtainoptimalbenefitofVIRBAMECPour-On,theproductisrecommendedtobeusedaspartof

treatmentprograms,basedontheepidemiologyoftheparasitesinquestion.

4.3 Contraindications

Donotuseinanimalsknowntobehypersensitivetotheactivesubstanceortoanyoftheingredients.

Thisproductisforapplicationtoskinsurfaceonly,donotinjectorgiveorally.

Donotuseindairycows,duringlactationorthedryperiod,andinbeefcowsduringthelactation

periodwhenmilkisintendedforhumanconsumption.

Donotuseinpregnantdairyheiferswithin60dayspriortocalving.

4.4 Specialwarningsforeachtargetspecies

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskofthe

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextendedperiodof

time.

Underdosing,whichmaybeduetounderestimationofbodyweight,misadministrationofthe

product,orlackofcalibrationofthedosingdevice(ifany).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusingappropriate

tests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)stronglysuggest

resistancetoaparticularanthelmintic,ananthelminticbelongingtoanotherpharmacologicalclassand

havingadifferentmodeofactionshouldbeused.

Resistancetoivermectin(anavermectin)hasbeenreportedinCooperiaoncophoraincattlewithinthe

EU,inTeladorsagiaincattleindevelopedcountriessuchasNewZealandandHaemonchusincattle

outsidetheEU.Thereforetheuseofthisproductshouldbebasedonlocal(regional,farm)

epidemiologicalinformationaboutsusceptibilityofnematodesandrecommendationsonhowtolimit

furtherselectionforresistancetoanthelmintics.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Donotapplytoareasofskinwhichhavemangescabsorotherlesionsortoareascontaminatedwith

mudormanure.

Cattleshouldnotbetreatedwhenthehairorhideiswet.Rainfallingonanimalslessthantwohours

afterdosingmayresultinreducedefficacy.However,undersuchconditionsefficacyofVIRBAMEC

Pour-OnagainstinfectionsofOstertagiaostertagiorDictyocaulusviviparusincattlemaybe

maintained.Theinfluenceofextremeweatherconditionsonthelong-termperformance(persistent

activity)ofVIRBAMECPour-Onisnotknown.

Avermectinsmaynotbewelltoleratedinallnon-targetspecies.Casesofintolerancewithfatal

outcomearereportedindogs,especiallyCollies,OldEnglishSheepdogsandrelatedbreedsorcrosses,

andalsointurtles/tortoises.

Frequentandrepeatedusemayleadtothedevelopmentofresistance.

Theproductiseffectiveinallhypodermosisstages,however,itisveryimportanttotreatontime(at

theendofwarbleflyseason).TheeliminationofHypodermalarvaemaycausenegativereactionson

thehost,whentheyarefoundinvitalareas.KillingHypodermalineatum,iffoundinperioesophageal

tissue,maycausesalivationandtympanism.KillingHypodermabovis,iffoundinthevertebralcanal,

maycauseunsteadinessorparalysis.Cattleshouldbetreatedbeforeorafterthosestagesofwarble

flies.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

VIRBAMECPour-Onmaybeirritatingtohumanskinandeyesandtheusershouldbecarefulnotto

applyittohimselforotherpersons.Operatorsshouldwearnitrilerubbergloves,rubberbootsanda

waterproofcoatwhenapplyingtheproduct.Protectiveclothingshouldbewashedafteruse.

Ifaccidentalskincontactoccurs,washtheaffectedareaimmediatelywithsoapandwater.If

accidentaleyeexposureoccurs,flushtheeyesimmediatelywithwaterandgetmedicalattention.

Donotsmokeoreatwhilehandlingtheproduct.

Washhandsafteruse.

Useonlyinwellventilatedareasoroutdoors.

HIGHLYFLAMMABLE.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

Donotuseindairycowsduringlactationorthedryperiod,andinbeefcowsduringthelactation

periodwhenmilkisintendedforhumanconsumption.

Donotuseinpregnantdairyheiferswithin60dayspriortocalving.

Seealsopoint4.11.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotcombinetreatmentwithvaccinationagainstlungworminfection.Ifvaccinationisintended,an

intervalofatleast28daysbeforeorafterthedateofvaccinationshouldbetakenintoaccount.

4.9 Amountstobeadministeredandadministrationroute

Posology:

1mlper10kgbodyweight(basedonarecommendeddosagelevelof500mcgivermectinperkg

bodyweight).

Administration:

Pour-onuse.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccuratelyas

possible;accuracyofthedosingdeviceshouldbechecked.

Theformulationshouldbeappliedalongthemid-lineofthebackinanarrowstripbetweenthewithers

andtailhead.

500mland1LVIRBAMECPour-Onbottles

BothareequippedwithaSqueeze-Measure-PourSystem.

Attachthemeteringcupfirmlytothebottle.

Setthedosebyturningthetopsectionofthecuptoalignthecorrectbodyweight.Whenbodyweightis

betweenmarkings,usethehighersetting.

Holdthebottleuprightandsqueezeittodeliveraslightexcessoftherequireddoseasindicatedbythe

calibrationlines.

Whenthepressureisreleased,thedoseautomaticallyadjuststothecorrectlevel.Tiltthebottleand

dispensethesolution.

Important-Keepuprightwhenfillingandduringstorage.

Closecontainerwhennotinuseandstoreinanuprightposition.

2.5litrebackpackand5litrebackpack

Thesepresentationsareequippedwithstrapsandaventedcap.

Theyshouldbeusedinconjunctionwithanappropriatedosinggun.

ConnectthePour-Onapplicatortothepackasfollows:

Attachtheopenendofthedraw-offtubingtothePour-Onapplicator.

Attachdraw-offtubingtothecapwiththestem.Replaceshippingcapwiththecapthathasthe

draw-offtubing.Tightenthedraw-offcap.

GentlyprimethePour-Onapplicator,checkingforleaks.

Followmanufacturer’sdirectionsforcorrectuseandcareoftheequipment.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Studieshavedemonstratedawidesafetymargin.Nosignoftoxicityappearedintrialsupto5mg/kg

(10timestherecommendeddoserate).Noantidotehasbeenidentified.

Incaseofoverdose,symptomatictreatmentshouldbegiven.Thesymptomsofoverdosecanbe

trembling,convulsionsandcoma.

4.11 Withdrawalperiod(s)

Cattle:

Meatandoffal:28days.

Notpermittedforuseinlactatingcowsproducingmilkforhumanconsumption.Donotusein

pregnantcows,whichareintendedtoproducemilkforhumanconsumption,within60daysof

expectedparturition.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Endectocide

ATCvetcode:QP54AA01

5.1 Pharmacodynamicproperties

Ivermectinisabroadspectrumendectocideoftheavermectinfamily.Ivermectinisisolatedafter

purificationandhydrogenationoftheavermectinfamilycompoundswhichareobtainedfromthe

fermentationofthesoilorganismStreptomycesavermitilis.

Ivermectinisamacrocyclic-lactonederivativewhichhasabroadandpotentantiparasiticactivity

againstnematodesandarthropods.Itactsbyinhibitingnerveimpulses.Ivermectinbindsselectively

andwithhighaffinitytoglutamate-gatedchlorideionchannelswhichoccurininvertebratenerveand

musclecells.Thisleadstoanincreaseinthepermeabilityofthecellmembranetochlorideionswith

hyperpolarizationofthenerveormusclecell,resultinginparalysisanddeathoftherelevantparasites.

Compoundsofthisclassmayalsointeractwithotherligand-gatedchloridechannels,suchasthose

gatedbytheneurotransmittergamma-aminobutyricacid(GABA).Themarginofsafetyfor

compoundsofthisclassisattributabletothefactthatmammalsdonothaveglutamate-gatedchloride

channels.Themacrocycliclactoneshavealowaffinityforothermammalianligand-gatedchloride

channelsandtheydonotreadilycrosstheblood-brainbarrier.

5.2 Pharmacokineticparticulars

Afteradministrationoftherecommendeddosagetocattlevaryinginter-individualivermectinplasma

levelswereobservedwithmeanvaluesofC

andt

of17ng/mland170h,respectively.

Aftertopicaladministrationof0.5mgivermectinperkgbodyweight,liverandfat(thetargettissues),

generallyhadthehighestresidues.Excretionoccursmainlythroughfaecesand,inlesserproportion,

viaurine.

5.3 Environmentalproperties

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

CrodamolCAPorCetearylethylhexanoateandisopropylmyristate

Triethanolamine

Isopropylalcohol

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:6months.

6.4. Specialprecautionsforstorage

Highlyflammable-Donotsmoke.Keepawayfromheat,sparks,openflamesorothersourcesof

ignition.

Storetheproductintheoriginalcontainerandkeeptightlyclosed.

Keepthecontainerintheoutercartoninordertoprotectfromlight.

Thecontainershouldbestoredinanuprightposition.

Ifstoredatlowtemperaturesbelow0°C,VIRBAMECPour-Onmayappearcloudy.Allowingtowarm

atroomtemperaturewillrestorethenormalappearancewithoutaffectingefficacy.

6.5 Natureandcompositionofimmediatepackaging

VIRBAMECPour-Onisavailableineither500mland1litrepackswithasqueeze-measure-pour

systemora2.5litreor5.0litrebackpackwithadraw-offcap.

Size:500ml

Container:Opaquehighdensitypolyethylenebottle.

Closure:Lowdensitypolyethylenesealfittedwithachildresistantscrewcap.

Dosingdevice:separatemeasuringchamber,madeofpolyproylene,capableofdeliveringdosesof10

to25mlat5mlintervals.

Size:1000ml

Container:Opaquehighdensitypolyethylenebottle.

Closure:Lowdensitypolyethylenesealfittedwithachildresistantscrewcap.

Dosingdevice:separatemeasuringchamber,madeofpolyproylene,capableofdeliveringdosesof10

to25mlat5mlintervals

Size:2.5L

Container:Opaquehighdensitypolyethylenepack.

Closure:Lowdensitypolyethylenesealfittedwithachildresistantscrewcap.

Dosingdevice:madeofpolyproylene,tobeusedinconjunctionwithadosinggun.

Size:5.0L

Container:Opaquehighdensitypolyethylenepack.

Closure:Lowdensitypolyethylenesealfittedwithachildresistantscrewcap.

Dosingdevice:madeofpolyproylene,tobeusedinconjunctionwithadosinggun.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

IvermectinisEXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Treatedanimals

shouldnothavedirectaccesstosurfacewatersorditches.Donotcontaminatesurfacewatersor

ditcheswiththeproductorusedcontainer.

7. MARKETINGAUTHORISATIONHOLDER

VIRBACDEPORTUGAL-LABORATÓRIOS,LDA

RuadoCentroEmpresarial

Edifício13,Escritório3,Piso1

QuintadaBeloura

P2710693Sintra

PORTUGAL

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

March2002.

10. DATEOFREVISIONOFTHETEXT

ANNEXII

A. MANUFACTURINGAUTHORISATIONHOLDER(S)RESPONSIBLEFOR

BATCHRELEASE

B. CONDITIONSORRESTRICTIONSOFTHEMARKETING

AUTHORISATIONREGARDINGSUPPLYORUSE

C. CONDITIONSORRESTRICTIONSOFTHEMARKETING

AUTHORISATIONWITHREGARDTOSAFEANDEFFECTIVEUSE

D. STATEMENTOFTHEMRLs

E. SPECIFICOBLIGATIONSTOBEFULFILLEDBYTHEMARKETING

AUTHORISATIONHOLDER

A. MANUFACTURINGAUTHORISATIONHOLDER(S)RESPONSIBLEFORBATCH

RELEASE

Nameandaddressofthemanufacturer(s)responsibleforbatchrelease

VIRBAC

1èreavenue–2065m–L.I.D.–06516Carros-France

B. CONDITIONSORRESTRICTIONSOFTHEMARKETINGAUTHORISATION

REGARDINGSUPPLYORUSE

Tobesuppliedonlyonveterinaryprescription.

C. CONDITIONSORRESTRICTIONSOFTHEMARKETINGAUTHORISATIONWITH

REGARDTOTHESAFEANDEFFECTIVEUSEOFTHEPRODUCT

Notapplicable.

D. STATEMENTOFTHEMRLs

Notapplicable.

E. SPECIFICOBLIGATIONSTOBEFULFILLEDBYTHEMARKETING

AUTHORISATIONHOLDER

Notapplicable.

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

500mlbottle

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

2. STATEMENTOFACTIVESUBSTANCES

Activesubstance:Ivermectin.

3. PHARMACEUTICALFORM

Pour-Onsolution

4. PACKAGESIZES

500ml

5. TARGETSPECIES

Cattle

6. METHODANDROUTE(S)OFADMINISTRATION

1mlper10kgbodyweight.Assessbodyweightasaccuratelyaspossiblebeforecalculatingthedosage.

Applyalongthemid-lineofthebackinanarrowstripbetweenthewithersandtailhead.

7. WITHDRAWALPERIOD

Meatandoffal:28days.

Notpermittedforuseinlactatingcowsproducingmilkforhumanconsumption.Donotusein

pregnantcows,whichareintendedtoproducemilkforhumanconsumption,within60daysof

expectedparturition.

8. EXPIRYDATE

EXP{month/year}

9. SPECIALSTORAGECONDITIONS

Afterthefirstopeningofthecontainer:6months.

Highlyflammable-Donotsmoke.Keepawayfromheat,sparks,openflamesorothersourcesof

ignition.

Storetheproductintheoriginalcontainerinordertoprotectfromlightandkeeptightlyclosedinan

uprightposition.Storagetemperature:none.

Ifstoredatlowtemperaturesbelow0°C,VIRBAMECPour-Onmayappearcloudy.Allowingtowarm

atroomtemperaturewillrestorethenormalappearancewithoutaffectingefficacy.

10. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

IvermectinisEXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Treatedanimals

shouldnothavedirectaccesstosurfacewatersorditches.Donotcontaminatesurfacewatersor

ditcheswiththeproductorusedcontainer.

11. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

12. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

13. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBACDEPORTUGAL-LABORATÓRIOS,LDA

RuadoCentroEmpresarial

Edifício13,Escritório3,Piso1

QuintadaBeloura

P2710693Sintra

PORTUGAL

14. MARKETINGAUTHORISATIONNUMBER(S)

15. MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

1litrebottle

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

2. STATEMENTOFACTIVESUBSTANCES

Activesubstance:Ivermectin.

3. PHARMACEUTICALFORM

Pour-Onsolution

4. PACKAGESIZES

1L

5. TARGETSPECIES

Cattle

6. METHODANDROUTE(S)OFADMINISTRATION

1mlper10kgbodyweight.Assessbodyweightasaccuratelyaspossiblebeforecalculatingthedosage.

Applyalongthemid-lineofthebackinanarrowstripbetweenthewithersandtailhead.

7. WITHDRAWALPERIOD

Meatandoffal:28days.

Notpermittedforuseinlactatingcowsproducingmilkforhumanconsumption.Donotusein

pregnantcows,whichareintendedtoproducemilkforhumanconsumption,within60daysof

expectedparturition.

8. EXPIRYDATE

EXP{month/year}

9. SPECIALSTORAGECONDITIONS

Afterthefirstopeningofthecontainer:6months.

Highlyflammable-Donotsmoke.Keepawayfromheat,sparks,openflamesorothersourcesof

ignition.

Storetheproductintheoriginalcontainerinordertoprotectfromlightandkeeptightlyclosedinan

uprightposition.Storagetemperature:none.

Ifstoredatlowtemperaturesbelow0°C,VIRBAMECPour-Onmayappearcloudy.Allowingtowarm

atroomtemperaturewillrestorethenormalappearancewithoutaffectingefficacy.

10. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

IvermectinisEXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Treatedanimals

shouldnothavedirectaccesstosurfacewatersorditches.Donotcontaminatesurfacewatersor

ditcheswiththeproductorusedcontainer.

11. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

12. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

13. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBACDEPORTUGAL-LABORATÓRIOS,LDA

RuadoCentroEmpresarial

Edifício13,Escritório3,Piso1

QuintadaBeloura

P2710693Sintra

PORTUGAL

14. MARKETINGAUTHORISATIONNUMBER(S)

15. MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

2.5litrepack

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

2. STATEMENTOFACTIVESUBSTANCES

Activesubstance:Ivermectin.

3. PHARMACEUTICALFORM

Pour-Onsolution

4. PACKAGESIZES

2.5L

5. TARGETSPECIES

Cattle

6. METHODANDROUTE(S)OFADMINISTRATION

1mlper10kgbodyweight.Assessbodyweightasaccuratelyaspossiblebeforecalculatingthedosage.

Applyalongthemid-lineofthebackinanarrowstripbetweenthewithersandtailhead.

7. WITHDRAWALPERIOD

Meatandoffal:28days.

Notpermittedforuseinlactatingcowsproducingmilkforhumanconsumption.Donotusein

pregnantcows,whichareintendedtoproducemilkforhumanconsumption,within60daysof

expectedparturition.

8. EXPIRYDATE

EXP{month/year}

9. SPECIALSTORAGECONDITIONS

Afterthefirstopeningofthecontainer:6months.

Highlyflammable-Donotsmoke.Keepawayfromheat,sparks,openflamesorothersourcesof

ignition.

Storetheproductintheoriginalcontainerinordertoprotectfromlightandkeeptightlyclosedinan

uprightposition.Storagetemperature:none.

Ifstoredatlowtemperaturesbelow0°C,VIRBAMECPour-Onmayappearcloudy.Allowingtowarm

atroomtemperaturewillrestorethenormalappearancewithoutaffectingefficacy.

10. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

IvermectinisEXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Treatedanimals

shouldnothavedirectaccesstosurfacewatersorditches.Donotcontaminatesurfacewatersor

ditcheswiththeproductorusedcontainer.

11. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

12. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

13. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBACDEPORTUGAL-LABORATÓRIOS,LDA

RuadoCentroEmpresarial

Edifício13,Escritório3,Piso1

QuintadaBeloura

P2710693Sintra

PORTUGAL

14. MARKETINGAUTHORISATIONNUMBER(S)

15. MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

5litrepack

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

2. STATEMENTOFACTIVESUBSTANCES

Activesubstance:Ivermectin.

3. PHARMACEUTICALFORM

Pour-Onsolution

4. PACKAGESIZES

5L

5. TARGETSPECIES

Cattle

6. METHODANDROUTE(S)OFADMINISTRATION

1mlper10kgbodyweight.Assessbodyweightasaccuratelyaspossiblebeforecalculatingthedosage.

Applyalongthemid-lineofthebackinanarrowstripbetweenthewithersandtailhead.

7. WITHDRAWALPERIOD

Meatandoffal:28days.

Notpermittedforuseinlactatingcowsproducingmilkforhumanconsumption.Donotusein

pregnantcows,whichareintendedtoproducemilkforhumanconsumption,within60daysof

expectedparturition.

8. EXPIRYDATE

EXP{month/year}

9. SPECIALSTORAGECONDITIONS

Afterthefirstopeningofthecontainer:6months.

Highlyflammable-Donotsmoke.Keepawayfromheat,sparks,openflamesorothersourcesof

ignition.

Storetheproductintheoriginalcontainerinordertoprotectfromlightandkeeptightlyclosedinan

uprightposition.Storagetemperature:none.

Ifstoredatlowtemperaturesbelow0°C,VIRBAMECPour-Onmayappearcloudy.Allowingtowarm

atroomtemperaturewillrestorethenormalappearancewithoutaffectingefficacy.

10. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

IvermectinisEXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Treatedanimals

shouldnothavedirectaccesstosurfacewatersorditches.Donotcontaminatesurfacewatersor

ditcheswiththeproductorusedcontainer.

11. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

12. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

13. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBACDEPORTUGAL-LABORATÓRIOS,LDA

RuadoCentroEmpresarial

Edifício13,Escritório3,Piso1

QuintadaBeloura

P2710693Sintra

PORTUGAL

14. MARKETINGAUTHORISATIONNUMBER(S)

15. MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGINGUNITS

500mlbottle

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Ivermectin.............................................................................0.5 %w/v(5mg/ml)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

500ml

4. WITHDRAWALPERIOD

Meatandoffal:28days.

5. SPECIALSTORAGECONDITIONS

Afterthefirstopeningofthecontainer:6months.

Highlyflammable-Donotsmoke.Keepawayfromheat,sparks,openflamesorothersourcesof

ignition.

Storetheproductintheoriginalcontainerinordertoprotectfromlightandkeeptightlyclosedinan

uprightposition.Storagetemperature:none.

Ifstoredatlowtemperaturesbelow0°C,VIRBAMECPour-Onmayappearcloudy.Allowingtowarm

atroomtemperaturewillrestorethenormalappearancewithoutaffectingefficacy.

6. BATCHNUMBER

<Batch><Lot><BN>

7. EXPIRYDATE

<EXP{month/year}>

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

9. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBACDEPORTUGAL-LABORATÓRIOS,LDA

RuadoCentroEmpresarial

Edifício13,Escritório3,Piso1

QuintadaBeloura

P2710693Sintra

PORTUGAL

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGINGUNITS

1litrebottle

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Ivermectin.............................................................................0.5 %w/v(5mg/ml)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

1L

4. WITHDRAWALPERIOD

Meatandoffal:28days.

5. SPECIALSTORAGECONDITIONS

Afterthefirstopeningofthecontainer:6months.

Highlyflammable-Donotsmoke.Keepawayfromheat,sparks,openflamesorothersourcesof

ignition.

Storetheproductintheoriginalcontainerinordertoprotectfromlightandkeeptightlyclosedinan

uprightposition.Storagetemperature:none.

Ifstoredatlowtemperaturesbelow0°C,VIRBAMECPour-Onmayappearcloudy.Allowingtowarm

atroomtemperaturewillrestorethenormalappearancewithoutaffectingefficacy.

6. BATCHNUMBER

<Batch><Lot><BN>

7. EXPIRYDATE

<EXP{month/year}>

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

9. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBACDEPORTUGAL-LABORATÓRIOS,LDA

RuadoCentroEmpresarial

Edifício13,Escritório3,Piso1

QuintadaBeloura

P2710693Sintra

PORTUGAL

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGINGUNITS

2.5litrepack

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Ivermectin.............................................................................0.5 %w/v(5mg/ml)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

2.5L

4. WITHDRAWALPERIOD

Meatandoffal:28days.

5. SPECIALSTORAGECONDITIONS

Afterthefirstopeningofthecontainer:6months.

Highlyflammable-Donotsmoke.Keepawayfromheat,sparks,openflamesorothersourcesof

ignition.

Storetheproductintheoriginalcontainerinordertoprotectfromlightandkeeptightlyclosedinan

uprightposition.Storagetemperature:none.

Ifstoredatlowtemperaturesbelow0°C,VIRBAMECPour-Onmayappearcloudy.Allowingtowarm

atroomtemperaturewillrestorethenormalappearancewithoutaffectingefficacy.

6. BATCHNUMBER

<Batch><Lot><BN>

7. EXPIRYDATE

<EXP{month/year}>

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

9. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBACDEPORTUGAL-LABORATÓRIOS,LDA

RuadoCentroEmpresarial

Edifício13,Escritório3,Piso1

QuintadaBeloura

P2710693Sintra

PORTUGAL

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGINGUNITS

5litrepack

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Ivermectin.............................................................................0.5 %w/v(5mg/ml)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

5L

4. WITHDRAWALPERIOD

Meatandoffal:28days.

5. SPECIALSTORAGECONDITIONS

Afterthefirstopeningofthecontainer:6months.

Highlyflammable-Donotsmoke.Keepawayfromheat,sparks,openflamesorothersourcesof

ignition.

Storetheproductintheoriginalcontainerinordertoprotectfromlightandkeeptightlyclosedinan

uprightposition.Storagetemperature:none.

Ifstoredatlowtemperaturesbelow0°C,VIRBAMECPour-Onmayappearcloudy.Allowingtowarm

atroomtemperaturewillrestorethenormalappearancewithoutaffectingefficacy.

6. BATCHNUMBER

<Batch><Lot><BN>

7. EXPIRYDATE

<EXP{month/year}>

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

9. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBACDEPORTUGAL-LABORATÓRIOS,LDA

RuadoCentroEmpresarial

Edifício13,Escritório3,Piso1

QuintadaBeloura

P2710693Sintra

PORTUGAL

B.PACKAGELEAFLET

PACKAGELEAFLET

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisationholder

VIRBACDEPORTUGAL-LABORATÓRIOS,LDA

RuadoCentroEmpresarial

Edifício13,Escritório3,Piso1

QuintadaBeloura

P2710693Sintra

PORTUGAL

Manufacturer

VIRBAC

1èreavenue–2065m–L.I.D.–06516Carros-France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAMEC

Pour-Onsolutionforcattle5mg/ml

3. STATEMENTOFTHEACTIVESUBSTANCE

Ivermectin.............................................................................0.5 %w/v(5mg/ml)

4. INDICATION(S)

VIRBAMECPour-onisindicatedforthetreatmentofgastro-intestinalnematodes,lungworms,

warbles,choriopticandsarcopticmangemites,suckingandbitingliceofbeefandnon-lactatingdairy

cattle.

Gastro-intestinalroundworms(adultsand4thstagelarvae):

Ostertagiaostertagi (L4,adultsandinhibitedstages)

Haemonchusplacei (L4,adults)

Trichostrongylusaxei (L4,adults)

Trichostrongyluscolubriformis (L4,adults)

Cooperiaspp. (adults)

Cooperiapuntacta (adults)

Cooperiaoncophora (adults)

Oesophagostomumradiatum (L4,adults)

Strongyloidespapillosus (adults)

Trichurisspp. (adults)

Lungworms(adultsand4thstagelarvae):

Dictyocaulusviviparus

Warbles(parasiticstages):

Hypodermabovis

Hypodermalineatum

Mites:

Sarcoptesscabieivarbovis

Chorioptesbovis

Lice:

Suckinglice

Linognathusvituli

Haematopinuseurysternus

Bitinglice

Damaliniabovis

VIRBAMECPour-On,attherecommendeduselevelof500mcgivermectinperkgbodyweight,hasa

persistentactivityon:

Dictyocaulusviviparus: forupto28days

Ostertagiaspp: forupto21days

Oesophagostomumradiatum: forupto21days

Cooperiaspp.: forupto14days

Trichostrongylusaxei: forupto14days

VirbamecPouronhelpsinthecontrolofthemangemiteChorioptesbovisbutcompleteelimination

maynotoccur .

VIRBAMECPour-OnhasalsoapersistentactivityonthehornFly(Haematobiairritans)for28days,

partialefficacymaylastforupto35dayspostapplication.

OccasionallyvariableactivitymaybeobservedagainstHaemonchusplacei(L4),Cooperiaspp,

TrichostrongylusaxeiandTrichostrongyluscolubriformis.

ToobtainoptimalbenefitofVIRBAMECPour-on,theproductisrecommendedtobeusedaspartof

treatmentprograms,basedontheepidemiologyoftheparasitesinquestion

5. CONTRAINDICATIONS

Donotuseinanimalsknowntobehypersensitivetotheactivesubstance.

Thisproductisforapplicationtoskinsurfaceonly,donotinjectorgiveorally.

Donotuseindairycows,duringlactationorthedryperiod,andinbeefcowsduringthelactation

periodwhenmilkisintendedforhumanconsumption.

Donotuseinpregnantdairyheiferswithin60dayspriortocalving.

6. ADVERSEREACTIONS

Noneknown.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

7. TARGETSPECIES

Cattle

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Posology:

1mlper10kgbodyweight(basedonarecommendeddosagelevelof500mcgivermectinperkg

bodyweight).

Administration:

Topicaladministration.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccuratelyas

possible;accuracyofthedosingdeviceshouldbechecked.

Theformulationshouldbeappliedalongthemid-lineofthebackinanarrowstripbetweenthewithers

andtailhead.

9. ADVICEONCORRECTADMINISTRATION

500mland1LVIRBAMECPour-onbottles

BothareequippedwithaSqueeze-Measure-PourSystem.

Attachthemeteringcupfirmlytothebottle.

Setthedosebyturningthetopsectionofthecuptoalignthecorrectbodyweight.Whenbodyweightis

betweenmarkings,usethehighersetting.

Holdthebottleuprightandsqueezeittodeliveraslightexcessoftherequireddoseasindicatedbythe

calibrationlines.

Whenthepressureisreleased,thedoseautomaticallyadjuststothecorrectlevel.Tiltthebottleand

dispensethesolution.

Important-Keepuprightwhenfillingandduringstorage.

Closecontainerwhennotinuseandstoreinanuprightposition.

2.5litrebackpackand5litrebackpack

Thesepresentationsareequippedwithstrapsandaventedcap.

Theyshouldbeusedinconjunctionwithanappropriatedosinggun.

ConnectthePour-Onapplicatortothepackasfollows:

Attachtheopenendofthedraw-offtubingtothePour-Onapplicator.

Attachdraw-offtubingtothecapwiththestem.Replaceshippingcapwiththecapthathasthe

draw-offtubing.Tightenthedraw-offcap.

GentlyprimethePour-Onapplicator,checkingforleaks.

Followmanufacturer’sdirectionsforcorrectuseandcareoftheequipment.

10. SPECIALPRECAUTIONSFORUSEINANIMALS

Donotapplytoareasofskinwhichhavemangescabsorotherlesionsortoareascontaminatedwith

mudormanure.

Cattleshouldnotbetreatedwhenthehairorhideiswet.Rainfallingonanimalslessthantwohours

afterdosingmayresultinreducedefficacy.However,undersuchconditionsefficacyofVIRBAMEC

Pour-OnagainstinfectionsofOstertagiaostertagiorDictyocaulusviviparusincattlemaybe

maintained.Theinfluenceofextremeweatherconditionsonthelong-termperformance(persistent

activity)ofVIRBAMECPour-Onisnotknown.

Avermectinsmaynotbewelltoleratedinallnon-targetspecies.Casesofintolerancewithfatal

outcomearereportedindogs,especiallyCollies,OldEnglishSheepdogsandrelatedbreedsorcrosses,

andalsointurtles/tortoises.

Frequentandrepeatedusemayleadtothedevelopmentofresistance.

Theproductiseffectiveinallhypodermosisstages,however,itisveryimportanttotreatontime(at

theendofwarbleflyseason).TheeliminationofHypodermalarvaemaycausenegativereactionson

thehost,whentheyarefoundinvitalareas.KillingHypodermalineatum,iffoundinperioesophageal

tissue,maycausesalivationandtympanism.KillingHypodermabovis,iffoundinthevertebralcanal,

maycauseunsteadinessorparalysis.Cattleshouldbetreatedbeforeorafterthosestagesofwarble

flies.

11. WITHDRAWALPERIOD

Meatandoffal:28days.

Notpermittedforuseinlactatingcowsproducingmilkforhumanconsumption.Donotusein

pregnantcows,whichareintendedtoproducemilkforhumanconsumption,within60daysof

expectedparturition.

12. SPECIALSTORAGEPRECAUTIONS

Highlyflammable-Donotsmoke.Keepawayfromheat,sparks,openflamesorothersourcesof

ignition.

Storetheproductintheoriginalcontainerandkeeptightlyclosed.

Keepthecontainerintheoutercartoninordertoprotectfromlight.

Thecontainershouldbestoredinanuprightposition.

Storagetemperature:none.

Ifstoredatlowtemperaturesbelow0°C,VIRBAMECPour-Onmayappearcloudy.Allowingtowarm

atroomtemperaturewillrestorethenormalappearancewithoutaffectingefficacy.

13. SPECIALWARNINGS

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskofthe

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusingappropriate

tests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)stronglysuggest

resistancetoaparticularanthelmintic,ananthelminticbelongingtoanotherpharmacologicalclassand

havingadifferentmodeofactionshouldbeused.

Resistancetoivermectin(anavermectin)hasbeenreportedinCooperiaoncophoraincattlewithinthe

EU,inTeladorsagiaincattleindevelopedcountriesuchasNewZealandandHaemonchusincattle

outsidetheEU.Thereforetheuseofthisproductshouldbebasedonlocal(regional,farm)

epidemiologicalinformationaboutsusceptibilityofnematodesandrecommendationsonhowtolimit

furtherselectionforresistancetoanthelmintics.

VIRBAMECPour-Onmaybeirritatingtohumanskinandeyesandtheusershouldbecarefulnotto

applyittohimselforotherpersons.Operatorsshouldwearnitrilerubbergloves,rubberbootsanda

waterproofcoatwhenapplyingtheproduct.Protectiveclothingshouldbewashedafteruse.

Ifaccidentalskincontactoccurs,washtheaffectedareaimmediatelywithsoapandwater.If

accidentaleyeexposureoccurs,flushtheeyesimmediatelywithwaterandgetmedicalattention.

Donotsmokeoreatwhilehandlingtheproduct.

Washhandsafteruse.

Useonlyinwellventilatedareasoroutdoors.

HIGHLYFLAMMABLE.

14. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

IvermectinisEXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Treatedanimals

shouldnothavedirectaccesstosurfacewatersorditches.Donotcontaminatesurfacewatersor

ditcheswiththeproductorusedcontainer.

15. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED