NOBILIS

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
    Ireland
  • 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.

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

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