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
    Portugal
  • 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

Page2of3

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

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

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