Nobilis Salenvac T

Main information

  • Trade name:
  • Nobilis Salenvac T
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Nobilis Salenvac T
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Salmonella vaccine
  • Therapeutic area:
  • Chicken Broilers, Chicken Layers

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0182/001
  • Authorization date:
  • 12-09-2010
  • EU code:
  • UK/V/0182/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:December2010

AN:00063/2010

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobilisSalenvacT

Suspensionforinjectionforchickens

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perdoseof0.5ml:

Activesubstances:

InactivatedcellsofSalmonellaEnteritidis,strainPT4: ≥1RP*

InactivatedcellsofSalmonellaTyphimurium,strainDT104: ≥1RP*

Excipients:

Adjuvant:aluminiumhydroxide: 125mg

Preservative:thiomersal: 0.065mg

Foralistofexcipients,seesection6.1.

*RP=relativepotency=meanantibodyresponseinrabbitpotencytestequaltoor

greaterthanareferencebatchwhichwasshowntobeefficaciousinchickens

3. PHARMACEUTICALFORM

Suspensionforinjection

4. CLINICALPARTICULARS

4.1 Targetspecies

Chickens(breedersandlayers)

4.2 Indicationsforuse,specifyingthetargetspecies

Fortheactiveimmunisationofchickensandthepassiveimmunisationofthe

progenytoreducecaecumcolonisationandfaecalexcretionwithS.Enteritidisand

S.Typhimurium.

Activeimmunity:

Onsetofimmunity:4weeksafterthesecondadministration

Durationofimmunity:untilapproximately56-60weeksofageforchickens

vaccinatedat12and16weeks.

Minorindication:Inexceptionalcircumstanceschickensfromonedayofagemaybe

vaccinatedinordertoprotecttheminanenvironmentwheretheyarelikelyto

becomeinfectedatanearlystageintherearingphase(epidemiologicallyindicated

Revised:December2010

AN:00063/2010

Page2of6

byrecentoutbreakofSalmonellaorhighinfectionpressureonthesite).

Onsetofimmunity:4weeksafterthesecondadministration.

Passiveimmunity:

Onsetofimmunity:dayoneafterhatching.

Durationofimmunity:until14daysafterhatching.

Passiveimmunityistransferredfrom4weeksafterthesecondvaccinationupto59

weeksofageoftheparentbird.

4.3 Contraindications

Donotuseinlayingbirds.

4.4 Specialwarnings

None

4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Nostudieshavebeenperformedtoevaluatetheeffectofmaternallyderived

antibodiesontheresponsetovaccination.Therefore,forusein1dayoldchicks,

whereepidemiologicallyindicated,onlybirdsfromnon-vaccinatedandnon-infected

parentflocksshouldbevaccinatedwithNobilisSalenvacT.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Inthecaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshow

thepackageleafletorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Thevaccinecontainsanadjuvantandvaccinationmayresultintemporaryswellings

attheinjectionsite.

Inchickensof4weeksofageandabove(receivingadoseof0.5ml),vaccination

mayrarelyresultintransientsmallpalpablenodulesattheinjectionsite(reachinga

maximumsizeof1cm 2

),evidentimmediatelyaftervaccinationandgenerallylasting

only1-2days.Vaccinationmayalsobeassociatedwithtransientdullness,lethargy

andlameness,lastingupto2days.

Inone-day-oldchicks(receiving0.1ml)thereactionsaremorenoticeable.

Itshouldbetakenintoaccountthatpost-vaccinationinjectionsiteswellingsare

generallymoreevidentthanwhenadministering0.5mltobirdsof4weeksofageor

older,andoccasionally,thewholethighmaybecomeswollen.Thesereactionsare

temporaryandinthemajorityofcasesresolvedwithin7days.Exceptionally,a

swellingmaystillbedetectable15daysafterinoculation.Inaddition,after

Revised:December2010

AN:00063/2010

Page3of6

vaccinationasignificantproportionofthebirdsmayshowsignsoflethargy,dullness

andlameness,andareductionofweightgain.

Revised:December2010

AN:00063/2010

Page4of6

4.7 Useduringpregnancy,lactationorlay

Donotvaccinatebirdsinlay.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Vaccinationcausesaserologicalresponseinthechickenswhichmayinterferewith

asurveillanceprogrammebasedsolelyonserologicalscreeningwithout

confirmatorybacteriology.Thevaccineshouldthereforenotbeusedwhen

serologicaldetectionaloneisusedtoassessflocksforinfectionwithS.Enteritidis

and/orS.Typhimurium.Vaccinationalsomaycausecrossreactionsintheplate

agglutinationtestforS.Pullorum/Gallinarum.Specificserologicalmethodsor

bacteriologyshouldbeusedforthedifferentialdiagnosis.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwith

anyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafter

anyotherveterinarymedicinalproductthereforeneedstobemadeonacaseby

casebasis.

4.9 Amountstobeadministeredandadministrationroute

Standardvaccination:

Intramuscularinjectionofonedoseof0.5ml.

Foractiveimmunisationoflayersandbreeders:

Twovaccinations,withanintervaloffourweeksshouldbegiven.

Therecommendedageforvaccinationis12and16weeksofage.

Emergencyvaccination(whenepidemiologicallyindicatedinhigh-risk

environments):

Intramuscularinjectionofonedoseof0.1mlinone-day-oldchicks.

Afteranintervalof4weeksarepeatvaccinationwithadoseof0.5mlshouldbe

given.

Forpassiveimmunisationofprogenyofbreeders:

Twovaccinations,withanintervalofatleastfourweeksshouldbegiven.

Therecommendedageforfirstvaccinationisat6-12weeksofageandforthe

secondvaccinationat13-16weeksofage.

Incasetheinductionofactive-andpassiveimmunityisintendedinbreedersand

theiroffspring,thevaccinationschemeforactiveimmunisationshouldbefollowed.

Hygienemeasuresandgoodhusbandrypracticesshouldalsoplayanimportantpart

ofacontrolprogrammetoreducetheincidenceofSalmonellainfection.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Similarreactionstothoseseenafterasingledose(see4.6),butmorepronounced

afterdoubledose.

Revised:December2010

AN:00063/2010

Page5of6

4.11Withdrawalperiod

Zerodays

5. IMMUNOLOGICALPROPERTIES

TostimulateactiveimmunityandpassiveimmunityoftheprogenyagainstS.

EnteritidisandS.Typhimurium.Forthepassiveimmunisationschemeupon

challengewithS.EnteritidisorS.Typhimurium,nosignificantreductionof

Salmonellapositivesamplesofliverandspleenwasdemonstrated.

Inactivatedbacterialvaccine.ATCvetcode:QI01AB01

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Aluminiumhydroxidegel

Tris

Maleicacid

Sodiumchloride

Formaldehyde

Thiomersal

Waterforinjection

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelflife

Unopenend:3years.

Usebroachedcontainersimmediately

6.4 Specialprecautionsforstorage

Storeandtransportrefrigerated(2-8

C).

Donotfreeze.

Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Cartonboxwithamultidoselowdensitypolyethylenebottleof250mlor500ml

sealedwithanaluminiumcapoverarubberstopper.Containersandclosures

conformtoPh.Eur.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productsorwastematerialsderivedfromtheuseofsuchproducts

Revised:December2010

AN:00063/2010

Page6of6

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetUKLtd

WaltonManor

Walton

MiltonKeynes

Buckinghamshire

MK77AJ

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 01708/4472

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

17-08-2000

10. DATEOFREVISIONOFTHETEXT

December2010

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Theimport,sale,supplyand/oruseofNobilisSalenvacTisormaybeprohibitedincertain

MemberStatesonthewholeorpartoftheirterritorypursuanttonationalanimalhealth

policy.Anypersonintendingtoimport,sell,supplyand/oruseNobilisSalenvacTmust

consulttherelevantMemberStatescompetentauthoritiesonthecurrentvaccination

policiespriortotheimport,sale,supplyand/oruse.

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