Cevac Transmune Lyophilisate for Suspension for Injection with Solvent for Chicken

Main information

  • Trade name:
  • Cevac Transmune Lyophilisate for Suspension for Injection with Solvent for Chicken
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cevac Transmune Lyophilisate for Suspension for Injection with Solvent for Chicken
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • avian infectious bursal disease virus (gumboro disease)
  • Therapeutic area:
  • Chicken

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0253/002
  • Authorization date:
  • 01-05-2012
  • EU code:
  • UK/V/0253/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVACTRANSMUNElyophilisateforsuspensionforinjectionwithsolventforchicken

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Oneinovodose(0.05ml)orsubcutaneousdose(0.1ml)contains:

LiveattenuatedIBDvirus,strainWinterfield2512 atleast0.1CID

*

Excipients:

BDA(bursaldiseaseantibody) atleast90VNtitre**

Other qs1dose

Solvent qs1dose

*CID

(ChickenInfectiveDose50%)

**VNtitre(virusneutralisationtitre)

Forafulllistofexcipientsseesection6.1.

3. PHARMACEUTICALFORM

Lyophilisateforsuspensionforinjectionwithsolvent

Palebrownlyophilisateforreconstitutionwithawater-clear,colourlesssolventprovidedfor

injection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Chickens,18-day-oldembryonatedbroilerhatchingeggsor1-day-oldbroilerchickens,

fromhensvaccinatedagainstIBD.

4.2 Indicationsforusespecifyingthetargetspecies

Fortheactiveimmunisationofchickenstoreducemortality,clinicaldisease,weightloss

andacutelesionsofbursaofFabriciusassociatedwithinfectioncausedbyveryvirulent

AvianInfectiousBursalDisease(IBD)viruses.

Thereleaseofthevaccinevirusfromthecomplex(andthereforeimmunisation)is

influencedbythenaturaldeclineofmaternallyderivedantibodies(MDA),andhasbeen

foundnottooccuruntilMDAhasreachedrelativelylowlevels.

TheonsetofclinicalprotectiondependsontheinitialMDAlevel.Invaccinatedbroilersitis

achievedwithin1dayafterthefirstsignsofvaccineviruseffectinthebursaofFabricius.

Inpractice,thisisexpectedtooccurbetween21and32daysofageintargetbroiler

flocks.

Durationofimmunity:upto42daysofage.

Thevirulentchallengestestsconductedtosupporttheclaimwerecarriedoutonbroilers

havinganMDAELISAtitreof6,000(1-day-oldchick).

FieldtrialscarriedoutshowedthatvaccinevirusreplicationinthebursaofFabricius

occursinbroilershavingathatch,MDAtitrelevelsofupto14,000ELISAunits,butthe

protectionofthesebirdswasevaluatedonlybasedonserologicaldataandhistologyofthe

bursaofFabricius.

4.3Contraindications

Theuseofthisvaccineiscontraindicatedineggsorin1-day-oldchickenscomingfrom

broilerbreederflocksnotvaccinatedaccordingtoanIBDimmunisationprogram.(Referto

section4.5.)

Itiscontraindicatedtovaccinate1-day-oldchickenshatchedfromeggsvaccinatedinovo

withCevacTransmune.

4.4Specialwarningsforeachtargetspecies

Chickenembryosonthe18 th dayofincubation:

In-ovoinjectionequipmentmustbeusedforinovoadministration.Device(s)usedforthe

reconstitutionofthevaccineandforinjectionshouldbesterileandfreefromanyresidues

ofchemicaldisinfectant.

Thedeviceshouldbeproventosafelyandeffectivelydelivertheappropriate0.05mldose

ofthevaccinedirectlyintotheamnioticcavityortheembryo.

Beforeeveryin-ovoapplicationthevaccinationtechniquecanbecheckedbyuseofa

coloursolution.Themanufacturer'sinstructionsofthedevicemustbestrictlyfollowed.

Forcleaningoftheinstrumentonlyproductsapprovedbythemanufacturermaybeused.

Itisrecommendedtouse0.4-0.8mmdiameterneedles,havinglengthfrom25-28mm

andperforationairpressurebetween3.5bar(50psi)and5bar(72psi).

1-day-oldbroilerchickens

Automaticsyringemaybeusedforsubcutaneousadministration.Device(s)usedforthe

reconstitutionofthevaccineandforinjectionshouldbesterileandfreefromanyresidues

ofchemicaldisinfectant.Thedeviceshouldbeproventosafelyandeffectivelydeliverthe

appropriate0.1mldoseofthevaccine.Theinstructionsforuseofthisdeviceshouldbe

strictlyfollowed.

Thevaccinemustbeinoculatedundertheskinoftheneckofthe1-day-oldbroiler

chickens.Forcleaningoftheautomaticsyringe,onlyproductsapprovedbythe

manufacturermaybeused.

Residuesofchemicaldisinfectantontheinnersurfaceofdevicesandequipmentusedfor

reconstitutionandapplicationcandestroylivevirusanddecreasetheefficacyofthe

vaccine.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals:

Chickenembryosonthe18 th

dayofincubation

Thevaccinecontainsastrainof"intermediate-plus"virulence.InbirdswithoutMDAthe

inoculationofthevaccineresultsinsignificantimmunosupressionandbursaldamage.

Therefore,itisnotrecommendedtovaccinateeggscomingfromflockswithMDAtitre

levelsin1-day-oldchickenslowerthan3,000ELISAunits.

PreliminarysurveytobeusedtoestimateMDAlevelofthechicks:20,1-day-oldchicks

originatingfromthesamebreedingflockshouldbesampledtomeasuretheirserological

statustoIBDV.TheresultsofthissamplingwillindicateiftheMDAlevelcanbeexpected

tobeatleast3000ELISAunitsinthehatchesofthefollowing4weeksfromthisflock,and

thereforethattheyaresuitableforCevacTransmunevaccination.Accordingtoresultsand

needs,thissurveyhastoberepeatedatdifferenttimesofthelayingperiod.

Thevaccinevirusisexcretedbyvaccinatedbirdsandcanspreadtosusceptiblebirds

andcanbedetectedinunvaccinatedbirds4-7dayslater.Tocontrolthespreadofthe

virus,theimmunisationdevicesusedforinjectionandthehatcherypremisesshouldbe

decontaminatedaftervaccination.

Chickensfromvaccinatedeggsshouldnotbemixedwithchickensfromunvaccinated

eggs.

Precautionsshouldbetakenregardingbetween-housespread.Wholesitevaccinationis

recommended.Poultryhousesshouldbedecontaminatedbetweenbatchesofchickens.

Satisfactoryprotectioncanbeachievedonlyinproperlydevelopedembryosatthe18 th

day

ofhatching.Itissuggestedtocandletheeggstobeinjectedanddiscardeggscontaining

deadembryos.

1-day-oldbroilerchickens

Thevaccinecontainsastrainof"intermediate-plus"virulence.InbirdswithoutMDAthe

inoculationofthevaccineresultsinsignificantimmunosupressionandbursaldamage.

Therefore,itisnotrecommendedtovaccinatechickscomingfromflockswith1-day-old

MDAtitrelevelslowerthan3,000ELISAunits.

PreliminarysurveytobeusedtoestimateMDAlevelofthechicks:20,1-day-oldchicks

originatingfromthesamebreedingflockshouldbesampledtomeasuretheirserological

statustoIBDV.TheresultsofthissamplingwillindicateiftheMDAlevelcanbeexpected

tobeatleast3000ELISAunitsinthehatchesofthefollowing4weeksfromthisflock,and

thereforethattheyaresuitableforCevacTransmunevaccination.Accordingtoresultsand

needs,thissurveyhastoberepeatedatdifferenttimesofthelayingperiod.

Thevaccinevirusisexcretedbyvaccinatedbirdsandcanspreadtosusceptiblebirds

andcanbedetectedinunvaccinatedbirds4-7dayslater.Tocontrolthespreadofthe

virus,theimmunisationdevicesusedforinjectionandthehatcherypremisesshouldbe

decontaminatedaftervaccination.

Vaccinatedchickensshouldnotbemixedwithunvaccinatedchickens.

Precautionsshouldbetakenregardingbetween-housespread.Wholesitevaccinationis

recommended.Poultryhousesshouldbedecontaminatedbetweenbatchesofchickens.

Satisfactoryprotectioncanbeachievedonlyinhealthy1-day-oldchickens.

Specialprecautionstobetakenbythepersonadministeringthemedicinalproduct

toanimals:

Vaccinatingpersonnelshouldwashanddisinfecthandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Invaccinatedchickens,mildtomoderatelymphocytedepletionisobservedafterthe

vaccinetake,whichismaximalataround7daysaftervaccinetake.After7days,this

depletiondecreasesandisfollowedbylymphocyterepopulationandregenerationofthe

bursaofFabricius.Insomecases,thereplicationofthevaccinestrainmaybeprolonged

(e.g.duetopresenceofveryhighmaternalantibodytitresin1dayoldchicks),andbursa

scorescanreachamaximumof2.8between35and42daysofage,whichdoesnotaffect

theproductionparametersoftheflock.

4.7Useduringpregnancy,lactationorlay

Donotuseineggsintendedforhatchingoflayersorbroilerbreeders.

Donotusein1-day-oldchickensintendedforlayersorbroilerbreeders.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithany

otherveterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafteranyother

veterinarymedicinalproductthereforeneedstobemadeonacase-by-casebasis.

4.9Amountstobeadministeredandadministrationroute

Inovoadministration

Thevaccineistobeadministeredonceatthe18 th

dayofembryonationusingin-ovo

equipmentTheinjectionvolumeis0.05mlperdoseforinovoadministration.Thevaccine

isdeliveredtotheamnionsacor,rarely,intothebodyoftheembryocausingnodecrease

inhatchability.

Usesteriledevicesandequipmentforreconstitutionandforadministrationofthevaccine.

Subcutaneousadministration

Thevaccineistobeadministeredonceat1-dayofage,automaticsyringemaybeused.

Theinjectionvolumeis0.1mlperdoseforsubcutaneousadministration.Thevaccineis

deliveredundertheskinoftheneck.

Usesteriledevicesandequipmentforreconstitutionandforadministrationofthevaccine.

Reconstitutionofthevaccine

Inovoadministrationof0.05mlperdose:

1.Calculateandpreparetherequiredvolumeofthereconstitutedvaccineasfollows:

asinglevialcontaining2000dosesoffreezedriedcomponentreconstitutedin100ml

solvent,

asinglevialcontaining4000dosesoffreezedriedcomponentreconstitutedin200ml

solvent,

asinglevialcontaining5000dosesoffreezedriedcomponentreconstitutedin250ml

solvent,

twovials,containing2500dosesoffreezedriedcomponentreconstitutedin250ml

solvent,

twovials,containing5000dosesoffreezedriedcomponentreconstitutedin500ml

solvent.

2.Drawup2mlofthesolventandtransferintotheglassvialcontainingthelyophilised

component.

3.Completelydissolvethevaccinebyshakinggentlyandtransferitintotheplasticsolvent

bottle.

4.Rinsethevialwithanother2mlliquidandtransfertherinsingliquidintotheplastic

solventbottle.

5.Repeatthisrinsingoperation.

Administrationofthevaccine:

FollowtheUserManualinstructionsforthein-ovoinjectorequipment.

Thereconstitutedvaccineshouldbeusedwithin2hours.

Subcutaneousadministrationof0.1mlperdose:

1.Calculateandpreparetherequiredvolumeofthereconstitutedvaccineasfollows:

asinglevialcontaining2000dosesoffreezedriedcomponentreconstitutedin200ml

solvent,

asinglevialcontaining2500dosesoffreezedriedcomponentreconstitutedin250ml

solvent,

asinglevialcontaining4000dosesoffreezedriedcomponentreconstitutedin400ml

solvent,

asinglevialcontaining5000dosesoffreezedriedcomponentreconstitutedin500ml

solvent.

2.Drawup2mlofthesolventandtransferintotheglassvialcontainingthelyophilised

component.

3.Completelydissolvethevaccinebyshakinggentlyandtransferitintotheplasticsolvent

bottle.

4.Rinsethevialwithanother2mlliquidandtransfertherinsingliquidintotheplastic

solventbottle.

5.Repeatthisrinsingoperation.

Administrationofthevaccine:

FollowtheUserManualinstructionsfortheautomaticsyringe.

Thereconstitutedvaccineshouldbeusedwithin2hours.

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Noadversereactionswereobservedotherthanstatedinsection4.6,whena10-fold

overdosewasadministered.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Tostimulateactiveimmunityagainstveryvirulentinfectiousbursaldiseasevirusesin

broilerchickensfromhensvaccinatedagainstIBD.

ThevaccinecontainstheliveintermediateplusIBDVstrainWinterfield2512boundto

specificimmunoglobulins.Bothcomponentsformacomplexwhichisadministered

throughvaccination.

TheWinterfield2512vaccinevirus,appliedasanon-immune-complexvaccineresultsin

ameanhistologicallesionscoreof2.2inthebursaofFabricius,28daysaftervaccination

(afteroralvaccinationof1-day-oldSPFchickenwith10doses).Theseverityandduration

oflesionsislesssignificantfollowingadministrationoftheimmune-complexvaccine.

ATCvetcode:QI01AD09

Pharmacotherapeuticgroup:Liveviralvaccines

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lyophilisate:BDA(bursaldiseaseantibody)

cyclodextrin

sucrose

monosodiumglutamate

potassiumdihydrogenphosphate

dipotassiumhydrogenphosphate

Solvent: sodiumchloride

potassiumchloride

disodiumphosphatedihydrate

potassiumdihydrogenphosphate

waterforinjection

6.2.Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct,exceptthesolventsuppliedforuse

withtheproduct.

6.3Shelflife

Shelflifeofthelyophilisateaspackagedforsale:2years

Shelflifeofthesolventaspackagedforsale:43months

Shelf-lifeafterreconstitutionaccordingtodirections:2hours.

6.4.Specialprecautionsforstorage

Lyophilisate:storeandtransportrefrigerated(2

C –8

C).Protectfromlight.

Solvent:storebelow25

C.Donotfreeze.

6.5Natureandcompositionofimmediatepackaging

Lyophilisate:Cardboardboxwith20glassvials(TypeI)of10mlcontaining2000,2500,

4000or5000doses,closedwithabromobutylstopperandsealedwithaluminiumcaps

withplastictear-offcentres.

Solvent:Cardboardboxwith5or20plasticbottles(LDPE),of100,200,250,400or500

mlsolvent,closedwithabromobutylstopperandsealedwithaluminiumcapswithplastic

tear-offcentres.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproducts

orwastematerialsderivedfromtheuseofsuchproducts

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriate

disinfectantapprovedforusebythecompetentauthority.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER

9. DATEOFFIRSTAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

11. Prohibitionofsale,supplyand/oruse

Notapplicable