Bovilis IBR marker Live

Main information

  • Trade name:
  • Bovilis IBR marker Live
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bovilis IBR marker Live
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • bovine rhinotracheitis virus (IBR)
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0105/001
  • Authorization date:
  • 20-12-2011
  • EU code:
  • NL/V/0105/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

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PARTICULARSTOAPPEARONTHEOUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BovilisIBRMarkerLive

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Perdose(2ml):

BHV-1,strainGK/D(gE¯):10 5.7

-10 7.3

TCID

.

3. PHARMACEUTICALFORM

Lyophilisateforsuspensionfori.m.injection./intranasalapplication.

4. PACKAGESIZE

1,2,5,10,25,50or100doses/10x1,2,5,10,25,50or100doses

5. TARGETSPECIES

Cattle

6. INDICATION(S)

ActiveimmunisationagainstBHV-1infectionincattle

7. METHODANDROUTE(S)OFADMINISTRATION

I.M./intranasal

1doseof2ml.

Readthepackageleafletbeforeuse.(Thissentencewillonlybementionedonce)

8. WITHDRAWALPERIOD

Withdrawalperiod:zerodays

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.(Thissentencewillonlybementionedonce)

10. EXPIRYDATE

<EXP{month/year}>

Usewithin3hoursafterreconstitution.

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11. SPECIALSTORAGECONDITIONS

Storeat2-8°Cinthedark

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.(Thissentencewillonlybementionedonce)

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Subjecttomedicalprescription(tobereplacedbythenationalsymbol/abbreviation/text)

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Thenationalrepresentativeof

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

<nationalnumber>

17. MANUFACTURER’SBATCHNUMBER

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

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

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MINIMUMPARTICULARSTOAPPEARONIMMEDIATELABEL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BovilisIBRMarkerLive

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

BHV-1,strainGK/D(gE¯):10 5.7

-10 7.3

TCID

50 perdose(2ml)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

1,2,5,10,25,50or100doses

4. ROUTE(S)OFADMINISTRATION

I.M./intranasal

5. WITHDRAWALPERIOD

Withdrawalperiod:zerodays

(notapplicableforMRP/DCP,accordingtotemplate)

6. BATCHNUMBER

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

7. EXPIRYDATE

<EXP{month/year}>

usewithin3hoursafterreconstitution

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

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PACKAGELEAFLET

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

Thenationalrepresentativeof

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

Manufacturerresponsibleforbatchrelease:

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BovilisIBRmarkerLive

Lyophilisateandsolventforsuspensionforintramuscularinjectionorintranasalapplication.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Perdoseof2mlreconstitutedvaccine(pinkaqueoussuspension):

BovineHerpesVirus-1,strainGK/D(gE¯):10 5.7 -10 7.3 TCID

.

4. INDICATION(S)

Activeimmunisationofcattletoreducetheintensityanddurationoftheclinicalrespiratorysigns

inducedbyaninfectionwithBHV-1andtoreducenasalexcretionoffieldvirus.

Onsetofimmunity:

Anincreaseinimmunitywasdemonstrated4daysafterintranasalvaccinationand14daysafter

intramuscularvaccinationof3montholdseronegativeanimals.

Durationofimmunity:

Afterintranasaladministrationto2weekoldcalveswithoutmaternalantibodies,immunitylastsatleast

untiltheageof3-4months,whentheanimalsshouldberevaccinated.Inthepresenceofmaternally

derivedantibodies,theprotectionofthevaccinemaynotbecompleteuntilthisrevaccination.

Revaccinationat3-4monthsofageresultsinprotectiveimmunitythatlastsforatleast6months.

Singleintranasalorintramuscularvaccinationof3montholdanimalsprovidesprotectiveimmunity

(reductionofclinicalsignsandreductionofviralexcretion),whichwasdemonstratedviachallenge3

weeksaftervaccination.Reductionofviralexcretionismaintainedforatleast6monthsaftersingle

vaccination.

Noinformationisavailableontheefficacyofthevaccinetopreventalatentwildvirusinfectionorto

preventwildvirusre-excretioninthelatentcarrier.

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

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5. CONTRAINDICATIONS

Donotvaccinateunhealthyanimals.

6. ADVERSEREACTIONS

Aslighttransientriseintemperature(1

C)canoccurupto5dayspostvaccination.

Anincreaseofnasaldischargecanbeobservedafterintranasalvaccination.

At10-foldoverdose,noothereffectshavebeenobserved.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cattle

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

ReconstitutethevaccinewiththesolventUnisolve

Numberofdosespervial Volume(ml)ofsolventneeded

1 2

2 4

5 10

10 20

25 50

50 100

100 200

Dosage:asingledoseof2mlreconstitutedvaccineperanimal

Methodofadministration:

-fromtheageof3monthsonward:intranasalorintramuscular.

-atanagebetween2weeksand3months:intranasal

Vaccinationschedule:

-Basicvaccination:

Vaccinateeachanimalwithonesingledose.

-Revaccination:

Whenthefirstvaccinationisgivenbetweentheageof2weeksand3months,theanimalsshouldbe

revaccinatedwithasingledoseattheageof3-4months.Afterwards,revaccinateevery6months.

Whenvaccinationisstartedaftertheanimalsare3monthsold,theanimalsshouldberevaccinatedwith

asingledoseevery6months.

9. ADVICEONCORRECTADMINISTRATION

Forintranasaladministration(1mlineachnostril),theuseofanozzleisrecommended.

Usesterilevaccinationequipmentfreefromdisinfectants.Topreventthespreadofanyinfective

agentstheintranasalequipmentshouldbechangedateachanimal.

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

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10. WITHDRAWALPERIOD

Zerodays

11. SPECIALSTORAGEPRECAUTIONS

Freeze-driedvaccine:storeat2-8

Cinthedark.

Solvent:storebelow25

C

Vaccineafterreconstitution:storebelow25°C,usewithin3hours.

Donotuseaftertheexpirydatestatedonthelabel

Keepoutofthereachandsightofchildren.

12. SPECIALWARNING(S)

Thepresenceofmaternalantibodiescaninfluencetheefficacyofthevaccination.Thereforeitis

recommendedtoascertaintheimmunestatusofcalvesbeforevaccinationisstarted.

Animalsbetweentheageof2weeksand3monthsshouldbevaccinatedviatheintranasalrouteonly

andtheanimalsshouldberevaccinatedviatheintranasalorintramuscularroutewhentheanimalsare

3-4monthsold.

Afterintranasaladministration,thevaccinevirusmayspreadtoin-contactcattle.Cattlewhichneedto

remaintotallyfreefromBHV-1antibodiesshouldbeseparatedfromintranasallyvaccinatedanimals.

Canbeusedduringpregnancyandlactation.

Noinformationisavailableontheuseofthisvaccineinbreedingbulls.

Noinformationisavailableonthesafetyandefficacyfromtheconcurrentuseofthisvaccinewithany

other,except-incattlefrom3weeksofageonwards-withIntervetsinactivatedBovipastRSPvaccine

(wherethisproductisauthorised).Itisthereforerecommendedthatnoothervaccinesshouldbe

administeredwithin14daysbeforeandaftervaccinationwiththisproduct.

Onlyreconstitutewiththesolventsuppliedforusewiththeproduct.

Donotmixwithanyothervaccineorimmunologicalproduct.

Donotusetogetherwithimmunosuppressiveagents

Incaseofaccidentalselfinjection,seekmedicaladviceimmediatelyandshowthepackageleafletor

thelabeltothephysician.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Disposeofwastematerialbyboiling,incineration,orimmersioninanappropriatedisinfectantin

accordancewithnationalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

4May2007

15. OTHERINFORMATION

NL/V/0105/001/II/002Day90label-leaflet –10-5-2007ConcurrentUse

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Thevaccinestimulatesactiveimmunityagainstbovineherpesvirustype1(BHV-1).Thevaccinedoes

notelicitantibodiestoglycoproteinEofBHV-1(markervaccine).Thisenablesdiscriminationbetween

cattlevaccinatedwiththisproductandcattleinfectedwithBHV-1fieldvirusorvaccinatedwith

conventionalnon-markerBHV-1vaccines.

ATC-vetcode:QI02AD01,liveherpesvirusvaccine

Presentations:

Freeze-driedvaccine:

Cardboardboxwith1or10vialsofglass(hydrolytictypeI)withrubberstopperandmetalcap.

contentspervial:

1,2,5,10,25,50or100doses

Solvent:

Cardboardboxwith1or10vialsofglass(hydrolytictypeII)orplastic(polyethyleneterephthalate)

withrubberstopperandmetalcap.

contentspervial:

Glass: 2,4,10or20ml

GlassorPET: 50,100or200ml

Notallpacksizesmaybemarketed

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