RISPOVAL

Main information

  • Trade name:
  • RISPOVAL 3-BRSV-Pi3-BVD
  • Pharmaceutical form:
  • Powder and solvent for suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RISPOVAL 3-BRSV-Pi3-BVD
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Live and Inactivated viral vaccines
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0146/001
  • Authorization date:
  • 24-07-2011
  • EU code:
  • FR/V/0146/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Rispoval3BRSVPi3BVD

Lyophilisateandsuspensionforsuspensionforinjectionforcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onedose(4ml)contains:

ActiveIngredient(s):

Lyophilisedfraction

Parainfluenza3virus,modifiedlivestrainRLB103 10 5.0 to10 8.6 CCID

50

BovineRespiratorySyncytialVirus,modifiedlivestrain375 10 5.0 to10 7.2 CCID

50

Liquidfraction

BovineVirusDiarrhoeaVirusType1,inactivatedstrains5960(cytopathic)and6309(non-cytopathic),

toinduceaGMTseroneutralisationtitreinguineapigsofatleast3.0log

2

Adjuvant:

Alhydrogel2% 0.8ml(equivalentto24.36mgofaluminium

hydroxide)

CCID

50= CellCultureInfectiousDose50%

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Lyophilisateandsuspensionforsuspensionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle

4.2 Indicationsforuse,specifyingthetargetspecies

Activeimmunisationofcalvesfrom12weeksofageto:

-reducevirusexcretionandtheclinicalsignscausedbybovinePi3virus,

-reducevirusexcretioncausedbyBRSVinfection,

-reducevirusexcretionandtheseverityoftheleucopeniainducedbyBVDVtype1infection.

Onsetofimmunity:3weeksaftervaccination

Durationofimmunity: 6months(demonstratedbychallengestudies)aftervaccinationforBRSV

andBVDVType1.Durationofimmunityhasnotbeenestablishedforbovine

Pi3virus.

EfficacyhasnotbeendemonstratedagainstBVDVType2strains.

4.3 Contraindications

None.

4.4 Specialwarningsforcattle

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Donouseinunhealthyanimals.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackageleafletorthe

labeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Theadministrationofthevaccinecanleadtoatransientandmildhyperthermiawhichcanlastfor2

daysandtoatransient,minorlocalinflammationreactionofupto0.5cmwhichdisappearswithin15

days.Inveryrarecases,thevaccinemaycausehypersensitivityreactions.Incaseofanaphylactic

reaction,symptomatictreatmentshouldbeprovided.

4.7 Useduringpregnancyandlactation

Donotuseduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafteranyotherveterinary

medicinalproductthereforeneedstobedecidedonacasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Reconstitutethevaccinebymixingthelyophilisedfractionwiththesolvent.Shakewell.

Administeronedose(4ml)ofthereconstitutedvaccinebyintramuscularrouteaccordingtothe

followingvaccinationscheme:

Firstinjection:from12weeksofage

Secondinjection:3to4weekslater.

Animalsshouldbepreferablyvaccinatedatleast3weeksbeforeaperiodofstressorhighinfection

risklikere-groupingortransportofanimals,orthestartofautumnseason.IfprotectionagainstBRSV

andBVDVtype1isrequired,thenanimalsshouldbere-vaccinatedafter6months.Thedurationof

immunityofthePi3componentisnotknown.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Reactionsafteradministrationofanoverdoseofvaccinearenotdifferentfromthoseafterthesingle

dose.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Liveandinactivatedviralvaccines

ATCvetcode:QI02AH

TostimulateanactiveimmunityagainstPi3,BRSVandBVDVtype1.

Thevaccinehasabroadcross-neutralisingabilityagainstvariouscurrentEuropeanstrainsofBVDV

typeIasmeasuredinvitrobyvirusneutralisationtest.Crossneutralisationatalowerlevelhasalso

beendemonstratedtoBVDVType2strains.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Bufferedlactosesolution

Gelatinsolution

Caseinhydrolysatesolution

HALSmedium

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:24months

Shelf-lifeafterreconstitutionaccordingtodirections:2hours

6.4.Specialprecautionsforstorage

Storeandtransportrefrigerated(+2°Cto+8°C).Donotfreeze.Protectfromheatandlight

6.5 Natureandcompositionofimmediatepackaging

TypeIglassvialcontaining5doses(20ml)liquidfraction,closedwithchlorobutylrubberstopper

andsealedwithaluminiumcap

TypeIglassvialcontaining5dosesoflyophilisedfraction,closedwithbromobutylrubberstopper

andsealedwithaluminiumcap.

Cardboardboxcontaining1x5dosevialoflyophilisedfractionand1x5dose(20ml)vialofsolvent.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriatedisinfectantapproved

forusebythecompetentauthorities.

7. MARKETINGAUTHORISATIONHOLDER

<TOBEADAPTEDFOREACHCOUNTRY>

8. MARKETINGAUTHORISATIONNUMBER(S)

<TOBEADAPTEDFOREACHCOUNTRY>

9. DATEOFRENEWALOFTHEAUTHORISATION

<NEWDATETOBEDETERMINED>

10 DATEOFREVISIONOFTHETEXT

<NEWDATETOBEDETERMINED>

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable

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