NOBILIS E.COLI INAC

Main information

  • Trade name:
  • NOBILIS E.COLI INAC
  • Pharmaceutical form:
  • Emulsion for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NOBILIS E.COLI INAC
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Escherichia vaccine
  • Therapeutic area:
  • Chicken Broilers

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0017/001
  • Authorization date:
  • 21-01-2010
  • EU code:
  • NL/V/0017/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobilisE.coliinac(AT,DE,EL,IE,NL,PT,ES,UK)

NobilisE.Coli(BE,FR)

NobilisE.Coliinact(IT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perdoseof0.5ml:

Activesubstance:

F11-antigensuspension

containing100µgF11(E.colifimbrialantigen) 68.3mg

FT-antigensuspension

containing100µgFT(E.coliflagellartoxinantigen) 68.3mg

Adjuvant:

214.42mgliquidparaffin

Excipients:

0.675mgformalin(preservative)

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Emulsionforinjection

4. CLINICALPARTICULARS

4.1 Targetspecies

Chickens(broiler-breeders)

4.2 Indicationsforuse,specifyingthetargetspecies

Partialpassiveimmunisationofbroilerchickensduringtheirfirst7weeksoflifebyvaccinationofthe

broilerbreedersasahelpagainstpostnatalcolibacillosis(airsacdiseaseandsepticaemia)causedby

fimbrialF11-antigenandflagellarFt-toxincontainingE.coli.

4.3 Contraindications

None

4.4 Specialwarnings

None

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Vaccinatehealthychickensonly.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Totheuser:

Thisproductcontainsmineraloil.Accidentalinjection/selfinjectionmayresultinseverepainand

swelling,particularlyifinjectedintoajointorfinger,andinrarecasescouldresultinthelossofthe

affectedfingerifpromptmedicalattentionisnotgiven.Ifyouareaccidentallyinjectedwiththis

product,seekpromptmedicaladviceevenifonlyaverysmallamountisinjectedandtakethepackage

leafletwithyou.Ifpainpersistsformorethan12hoursaftermedicalexamination,seekmedicaladvice

again.

Tothephysician:

Thisproductcontainsmineraloil.Evenifsmallamountshavebeeninjected,accidentalinjectionwith

thisproductcancauseintenseswelling,whichmay,forexample,resultinischaemicnecrosisandeven

thelossofadigit.Expert,PROMPT,surgicalattentionisrequiredandmaynecessitateearlyincision

andirrigationoftheinjectedarea,especiallywherethereisinvolvementoffingerpulportendon.

4.6 Adversereactions(frequencyandseriousness)

Localtissuereactionsofagranulomatousnatureandinanumberofcasesnecrosisorabscesses

occur.Fiveweeksaftervaccinationthelocalreactionsareconsiderablydecreased.

4.7 Useduringpregnancy,lactationorlay

Donotuseinbirdsinlay.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Dataareavailablewhichdemonstratethatthisvaccinecanbeadministeredonthesamedaybutnot

mixedwithotherinactivatedvaccinesofthesamecompanyagainstavianinfectiousbronchitis,avian

infectiousbursitis,aviantenosynovitisandNewcastledisease.Theproductshouldbeadministerdat

differentsitesofinjection.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyveterinary

medicinalproductexcepttheproductsmentionedabove.Adecisiontousethisvaccinebeforeorafter

anyotherveterinarymedicinalproductthereforeneedstobemadeonacasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Intramuscularorsubcutaneousinjectioninbroilerbreederhens.

Vaccinationscheme:

Twoinjectionsof0.5ml,withanintervalofatleast6weeks.Firstvaccinationat6-12weeksofage,

revaccinationat14-18weeksofage.

Beforeuseallowthevaccinetoreachroomtemperature(15-25°C).

Shakewellbeforeuse.

Usesterilevaccinationequipment.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Ascomparedtothesingledosereaction,effectsafteradministrationofadoubledosehavethesame

character,buttheyaremoresevere.

4.11Withdrawalperiod(s)

Meatandoffal:35days

Eggs:zerodays.

5. IMMUNOLOGICALPROPERTIES

Activeimmunizationofbroilerbreedersinordertoprovidepassiveimmunitytobroilerchickensagainst

postnatalcolibacillosis.

ATCvetclassification:Domesticfowl,inactivatedbacterialvaccine,Escherichia.

ATCvetcode:QI01AB05

TheE.coliantigensareincorporatedinawaterinoilemulsioninordertoenhanceandprolongthe

productionofantibodiesagainstE.colifimbrialantigenandEcoliflagellartoxinantigen.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Liquidparaffin

Polysorbate

Sorbitanmono-oleate

Sodiumchloride

Formalin

Waterforinjections

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:10hours.

6.4 Specialprecautionsforstorage

Storeinarefrigerator(2

C-8

C).Donotfreeze.Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Cardboardboxwith1glass(hydrolyticTypeII)orPETvialof250or500mlwithanitrylrubber

stopperandsealedwithacodedaluminiumcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

(IntheMemberStatesrepresentedbythenationalcompanies.)

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

September2010

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

PARTICULARSTOAPPEARONTHEOUTERPACKAGEANDONTHEIMMEDIATE

LABEL

{NATURE/TYPE}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobilisE.coliinac(AT,DE,EL,IE,NL,PT,ES,UK)

NobilisE.Coli(BE,FR)

NobilisE.Coliinact(IT)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Perdoseof0.5ml

F11-antigensuspension

containing100µgF11(E.colifimbrialantigen) 68.3mg

FT-antigensuspension

containing100µgFT(E.coliflagellartoxinantigen) 68.3mg

adjuvant:liquidparaffin

preservative:formalin

3. PHARMACEUTICALFORM

Emulsionforinjection

4. PACKAGESIZE

500or1000doses

5. TARGETSPECIES

Chickens(broiler-breeders)

6. INDICATION(S)

Passiveimmunisationagainstcolibacillosis(airsacdiseaseandsepticaemia)

7. METHODANDROUTE(S)OFADMINISTRATION

s.c.ori.m.injection

Shakewellbeforeuse

Readthepackageleafletbeforeuse[Comment:mentionedonthepackagingitemonlyonce]

8. WITHDRAWALPERIOD

Withdrawalperiod:

Meatandoffal:35days

Eggs:zerodays

9. SPECIALWARNING(S),IFNECESSARY

Accidentalinjectionisdangerous

Readthepackageleafletbeforeuse[Comment:mentionedonthepackagingitemonlyonce]

10. EXPIRYDATE

EXP{month/year}

Oncebroachedusewithin10hours

11. SPECIALSTORAGECONDITIONS

Storeinarefrigerator(2ºC–8ºC)

Donotfreeze

Protectfromlight

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse[Comment:mentionedonthepackagingitemonlyonce]

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription(orthenationalwordingorabbreviation,if

applicable)

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

(orthenationalrepresentative)

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot{number}

PACKAGELEAFLET

NobilisE.coliinac(AT,DE,EL,IE,NL,PT,ES,UK)

NobilisE.Coli(BE,FR)

NobilisE.Coliinact(IT)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

IntervetInternationalB.V.

WimdeKörverstraat35

NL-5831ANBoxmeer

(orthenationalrepresentativeofthemarketingauthorisationholder)

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobilisE.coliinac(AT,DE,EL,IE,NL,PT,ES,UK)

NobilisE.Coli(BE,FR)

NobilisE.Coliinact(IT)

Emulsionforinjection

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Perdoseof0.5ml:

Activesubstance:

F11-antigensuspension

containing100microgramF11(E.colifimbrialantigen) 68.3mg

FT-antigensuspension

containing100microgramFT(E.coliflagellartoxinantigen) 68.3mg

Adjuvant:

liquidparaffin

Excipients:

formalin(preservative)

4. INDICATION(S)

Partialpassiveimmunisationofbroilerchickensduringtheirfirst7weeksoflifebyvaccinationofthe

broilerbreedersasahelpagainstpostnatalcolibacillosis(airsacdiseaseandsepticaemia)causedby

fimbrialF11-antigenandflagellarFt-toxincontainingE.coli.

5. CONTRAINDICATIONS

None

6. ADVERSEREACTIONS

Localtissuereactionsofagranulomatousnatureandinanumberofcasesnecrosisorabscesses

occur.Fiveweeksaftervaccinationthelocalreactionsareconsiderablydecreased.

Ascomparedtothesingledosereaction,effectsafteradministrationofadoubledosehavethesame

character,buttheyaremoresevere.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Chickens(broiler-breeders)

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Intramuscularorsubcutaneousinjectioninbroilerbreederhens.

Vaccinationscheme:

Twoinjectionsof0.5ml,withanintervalofatleast6weeks.Firstvaccinationat6-12weeksofage,

revaccinationat14-18weeksofage.

9. ADVICEONCORRECTADMINISTRATION

Beforeuseallowthevaccinetoreachroomtemperature(15-25°C).

Shakewellbeforeuse.

Usesterilevaccinationequipment.

10. WITHDRAWALPERIOD

Withdrawalperiod:

Meatandoffal:35days

Eggs:zerodays.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storeinarefrigerator(2

C–8

C).

Donotfreeze.

Protectfromlight.

Donotuseaftertheexpirydatestatedonthelabel.

Shelf-lifeafterfirstopeningthecontainer:10hours.

12. SPECIALWARNING(S)

Vaccinatehealthychickensonly.

Donotuseinbirdsinlay.Totheuser:Thisproductcontainsmineraloil.Accidentalinjection/self

injectionmayresultinseverepainandswelling,particularlyifinjectedintoajointorfinger,andinrare

casescouldresultinthelossoftheaffectedfingerifpromptmedicalattentionisnotgiven.Ifyouare

accidentallyinjectedwiththisproduct,seekpromptmedicaladviceevenifonlyaverysmallamountis

injectedandtakethepackageleafletwithyou.Ifpainpersistsformorethan12hoursaftermedical

examination,seekmedicaladviceagain.

Tothephysician:Thisproductcontainsmineraloil.Evenifsmallamountshavebeeninjected,

accidentalinjectionwiththisproductcancauseintenseswelling,whichmay,forexample,resultin

ischaemicnecrosisandeventhelossofadigit.Expert,PROMPT,surgicalattentionisrequiredand

maynecessitateearlyincisionandirrigationoftheinjectedarea,especiallywherethereisinvolvement

offingerpulportendon.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyveterinary

medicinalproductexcepttheinactivatedvaccinesofthesamecompanyagainstavianinfectious

bronchitis,avianinfectiousbursitis,aviantenosynovitisandNewcastledisease.Adecisiontousethis

vaccinebeforeorafteranyotherveterinarymedicinalproductthereforeneedstobemadeonacase

bycasebasis.

Donotmixwithanyotherveterinarymedicinalproduct.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

September2010

15. OTHERINFORMATION

ATCvetclassification:Domesticfowl,inactivatedbacterialvaccine,Escherichia.

ATCvetcode:QI01AB05

TheE.coliantigensareincorporatedinawaterinoilemulsioninordertoenhanceandprolongthe

productionofantibodiesagainstE.colifimbrialantigenandE.coliflagellartoxinantigen.

CardboardboxcontainingoneglasorPETvialof250ml(500doses)or500ml(1000doses).

Notallpacksizesmaybemarketed.

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