Rispoval RS+Pi3 Intranasal

Main information

  • Trade name:
  • RISPOVAL RS + PI3 Intranasal
  • Pharmaceutical form:
  • Injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RISPOVAL RS + PI3 Intranasal
    Slovenia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Bovine respiratory syncytial virus vaccine + Bovine parainfluenza virus vaccine
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0224/001
  • Authorization date:
  • 21-07-2011
  • EU code:
  • UK/V/0224/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:October2011

AN:00050/2010

Page1of3

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

RispovalRS+PI3IntraNasal

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perdoseof2mL:

Powder

Activesubstance:

-ModifiedliveBovineParainfluenzatype3virus(PI3V),thermosensitivestrain

RLB103, ≥10 5.0 and≤10 8.6 CCID

*

-ModifiedliveBovineRespiratorySyncytialvirus(BRSV)strain375,≥10 5.0

and≤10 7.2

CCID

*

*CCID

:CellCultureInfectiveDose50%

Diluent:

-Sodiumchloride 18mg

-Waterforinjection 2mL

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Powderanddiluentforsuspensionforintranasalapplication.Slightlycoloured

powderandclearcolourlessdiluent.Thereconstituted,dissolvedvaccineisa

pinkishsuspension.

4 CLINICALPARTICULARS

4.1TargetSpecies

Cattle

4.2IndicationsforUse,SpecifyingtheTargetSpecies

Foractiveimmunisationofmaternallyderivedantibodypositiveornegative

calvesfrom9daysofageagainstBRSVandPI3V,toreducethemeantitreand

durationofexcretionofbothviruses.

Onsetofprotectiveimmunity:5daysforBRSVand10daysforPI3Vaftera

singlevaccination.

Durationofprotectiveimmunity:12weeksfollowingasingledose.Theduration

ofprotectiveimmunityagainstthePI3VfractionmaybereducedinMDApositive

calvesvaccinatedbefore3weeksofage.

4.3Contraindications

None.

4.4SpecialwarningsforCattle

None.

Revised:October2011

AN:00050/2010

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4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Vaccinateonlyhealthyanimals.

Vaccinalvirusescanspreadfromvaccinatedtonon-vaccinatedcalvesandmay

causeaserologicalresponse,butwithoutcausingclinicalsigns.Inlaboratory

experimentsbasedonthedatausing3week-oldanimals,sheddingwas

observedforBRSVandPI3Vupto11and7daysrespectivelyaftervaccination

withonedosecontainingthemaximalviruscontent.

Animalsshouldpreferablybevaccinatedatleast10daysbeforeaperiodof

stressorhighinfectionrisklikere-groupingortransportofanimals,oratthestart

oftheautumnseason.Toachieveoptimalresults,itisrecommendedto

vaccinateallthecalveswithinthesameherd.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

None

4.6Adversereactions(frequencyandseriousness)

PublishedevidenceshowsthatonrareoccasionsrepeatedexposuretoRSV

maytriggerhypersensitivityreactions.Incolostrum-deprivedanimalsvaccinated

before3weeksofagewitha10xoverdoseofvaccine,transienttemperature

increase,nutritionalscour,abnormalfaecesanddemeanourwereobserved.

4.7Useduringpregnancy,lactationorlay

Donotuseduringpregnancy/lactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenused

withanyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebefore

orafteranyotherveterinarymedicinalproductthereforeneedstobemadeona

casebycasebasis.

4.9Amountstobeadministeredandadministrationroute

Reconstitutethevaccinebyasepticallyaddingalltheliquidtothevialcontaining

thepowdercomponents.Shakewell.

Vaccinationprogramme:

Asingledoseof2mlofreconstitutedvaccineshouldbegivenintranasallyusing

theintranasalapplicatorsprovidedtocattlefromtheageof9days.Itis

recommendedtochangeapplicatorsbetweenanimalstoavoidtransmitting

infectiousorganisms.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incolostrum-deprivedanimalsvaccinatedbefore3weeksofagewitha10x

overdoseofvaccine,transienttemperatureincrease,nutritionalscour,abnormal

faecesanddemeanourwereobserved.

4.11WithdrawalPeriod(s)

Zerodays

5. IMMUNOLOGICALPROPERTIES

TostimulateactiveimmunityagainstBRSVandPI3V.

Revised:October2011

AN:00050/2010

Page3of3

ATCVetcodeQI02AD07(immunologicalsforbovidae,cattle,liveviralvaccines,

bovineRespiratorysyncytialvirus+bovineParainfluenzavirus).

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Powder:

Bufferedlactosesolution

Gelatinsolution

Caseinhydrolysatesolution

HALSmedium

6.2Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterreconstitutionaccordingtodirections:2hours.

6.4SpecialPrecautionsforStorage

Storeandtransportrefrigerated(2°Cto8°C).Donotfreeze.Protectfromlight.

6.5Natureandcompositionofimmediatepackaging

Cardboardboxwithglassvial(s)of5or25dosesofpowderaccompaniedbyan

equalnumberofvial(s)containing10or50mlliquidcomponent.Bothvialshave

rubberstopperandaluminiumcap.Nasalapplicatorsforvaccinationarealso

provided.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productsorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriate

disinfectantapprovedforusebythecompetentauthorities.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLimited

RamsgateRoad

Sandwich

Kent

CT139NJ

8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4231

9. DATEOFTHEFIRSTAUTHORISATION

11 th

October2005

10. DATEOFREVISIONOFTHETEXT

October2011

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

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