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
    France
  • 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

1/7

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.

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

2/7

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

3/7

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

4/7

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

5/7

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

6/7

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

7/7

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

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018


Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004,  06/12/2018,  Positive

Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004, 06/12/2018, Positive

Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004, 06/12/2018, Positive

Europe - EMA - European Medicines Agency

1-10-2018

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Active substance: Mycoplasma synoviae Strain MS-H live attenuated thermosensitive) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6404 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/161/T/11

Europe -DG Health and Food Safety

13-9-2018

 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...

Europe - EMA - European Medicines Agency

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety