Nobilis Salenvac

Main information

  • Trade name:
  • salenvac
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • salenvac
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic area:

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0102/001
  • Authorization date:
  • 09-08-2010
  • EU code:
  • UK/V/0102/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:October2010

AN:01657/2009

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobilisSalenvac

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perml:

Activesubstance:

FormalinkilledcellsofSalmonellaEnteritidisphagetype4 2x10 9

Adjuvant:

Alhydrogel,(containing3%aluminiumhydroxide) 250mg

Excipient:

Thiomersal(preservative) 0.13mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Chickens:-layersandbreeders

4.2 Indicationsforuse,specifyingthetargetspecies

FortheactiveimmunisationofpoultryagainstSalmonellaEnteritidis,toreduce

sheddingofS.Enteritidisintotheenvironment.

AntibodiesagainstS.Enteritidisdevelopwithinafewweeksofthesecondvaccination.

Asecondpeakisachievedshortlyafterathirdvaccination.Theseantibodieshavebeen

showntopersistforatleast60weeks.Passiveimmunitywillbetransferredviatheegg

totheprogenyforatleast57weeks.

4.3 Contraindications

Donotuseinlayingbirds.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

CrossreactionsintestsforS.Pullorumarepossiblebutatalowlevelandmaybe

distinguishedfromtrueinfectionwhendilutionsofseraaretested,orfollowingheat

inactivation.WhereserologyispositiveforS.Pullorum,thediagnosisshouldbe

confirmedbybacteriology.Hygienicmeasuresandmonitoringshouldnotbeneglected.

Revised:October2010

AN:01657/2009

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Inthecaseofaccidentalselfinjection,seekmedicaladviceimmediatelyandshowthe

packageinsertorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Thevaccinecontainsanadjuvantandmaycauseatemporarynoduleatthesiteof

injection,upto5mmindiameter,lastingforupto2to3days.

4.7 Useduringpregnancy,lactationorlay

Donotuseinlayingbirds.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithany

otherveterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafterany

otherveterinarymedicinalproductthereforeneedstobemadeonacasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Dose

0.1mltoday-oldchicksfollowedby0.5mlat4weeksofageandaboosterdoseof

0.5mlat18weeksofage.

Administrationisbyintramuscularinjection.

Therecommendedvaccinationschedulehasbeenshownunderexperimental

conditionstoreducediarrhoea,excretionofSalmonellaEnteritidisPT4,infectionof

certaintissuesandeggcontaminationbySalmonellaEnteritidisPT4following

challenge.Nodataareavailableontheseeffectsinfieldconditions.Experimentally,it

hasalsobeenshownthatascheduleoftwodosesof0.5mlbyintramuscularinjection,

administeredrespectivelyat12and16weeksofage,canproducesimilarresults,but

thecontaminationofeggshasonlybeeninvestigatedinastudyinvolvingsmallnumbers.

Theuseofanautomaticvaccinatorisrecommended.Sincethebottleisnon-collapsible,

avaccinatorwithaventeddraw-offspikeorsimilardevicemustbeused.The

instructionssuppliedwithsuchequipmentshouldbenotedandcareshouldbetakento

ensurethedeliveryofthefulldose,particularlywiththefinalfewdosesfromthebottle.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thevaccinehasbeenshowntobesafeattwicetherecommendeddose.Noeffects

otherthanthoserecordedfollowingadministrationofonedosewereobserved.

4.11Withdrawalperiod

Zerodays.

5. IMMUNOLOGICALPROPERTIES

TostimulateactiveimmunityagainstSalmonellaEnteritidis

Inactivatedbacterialvaccine.ATCvetcode:QI01AB01

Revised:October2010

AN:01657/2009

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Aluminiumhydroxidegel

Tris

Maleicacid

Sodiumchloride

Formaldehyde

Thiomersal

Waterforinjection

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelflife

Unopened:3years.

Usebroachedvialsimmediately.

Partlyusedpacksshouldbesafelydestroyedattheendofaday'soperationsas

punctureoftherubbercapscouldcauseaccidentalcontaminationoftheremaining

contents.

6.4. Specialprecautionsforstorage

Storeandtransportrefrigerated(2

C –8

C)

Protectfromlight.

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Cartonboxwithlowdensitymultidosepolyethylenecontainersof250mland500ml

sealedwithanaluminiumcapoverarubberstopper.Containersandclosuresconform

toPh.Eur.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

Revised:October2010

AN:01657/2009

7. MARKETINGAUTHORISATIONHOLDER

IntervetUKLtd.

WaltonManor

Walton

MiltonKeynes

Bucks.MK77AJ

8. MARKETINGAUTHORISATIONNUMBER

Vm01708/4389

9. DATEOFRENEWALOFTHEAUTHORISATION

20June2010

10 DATEOFREVISIONOFTHETEXT

October2010