NOBILIS

Main information

  • Trade name:
  • NOBILIS RHINO CV
  • Pharmaceutical form:
  • Powder for nebuliser solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NOBILIS RHINO CV
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Avian rhinotracheitis virus vaccine
  • Therapeutic area:
  • Chicken

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0151/001
  • Authorization date:
  • 02-04-2010
  • EU code:
  • FR/V/0151/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobilisRhinoCV

ES:NobilisRT11/94;IT:Nobilis ® RTCV1194;AT,DE:NobilisRhino

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Perdosemin.10 1.5 TCID

andmax.10 3.7 TCID

ofliveattenuatedavianrhinotracheitisvirusstrain11/94.

Foralistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Lyophilisateforsuspensionforoculonasalorsprayapplication.

4. CLINICALPARTICULARS

4.1 Targetspecies

Chicken.

4.2 Indicationsforuse,specifyingthetargetspecies

Forbroilers,futurelayersandbreedersfromonedayofage.

Broilers,futurelayersandbreeders

Activeimmunisationinordertoreducethefrequencyandtheseverityofclinicalsignsduetoinfectionwith

avianrhinotracheitisvirus(avianmetapneumovirus).Theonsetofimmunityis3weeksandthedurationof

immunityis16weekspost-vaccination.

Futurelayersandbreeders

PrimingwithNobilisRhinoCV,followedbyasecondvaccinationwithaninactivatedvaccinecontainingthe

avianrhinotracheitisvirusstrainBut1#8544beforetheonsetoflayresultsinareductionoftheclinicalsigns

includingeggdrop,causedbyinfectionwithavianrhinotracheitisvirus.Protectiveimmunityismaintainedfor

thenormallayingperiod.

4.3 Contraindications

None.

4.4 Specialwarnings

None.

TissueCultureInfectiveDose50%

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Onlyvaccinatehealthybirds.

Inordertoreducethecirculationofthevaccinestrain,allsusceptibleanimalsonthesitehavetobe

vaccinatedproperlyandpreferablyatthesametime.Thevaccineviruscanspreadtoothersusceptible

specieswithwhichtheyhavedirectcontact.Itwasshownthatthespreadinghasnegligibleimpacton

turkeys,whichtogetherwithchickensconstitutethespeciesthataremostsusceptibletoavianrhinotracheitis

virus.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Notapplicable.

4.6 Adversereactions(frequencyandseriousness)

Inalowpercentageofflocks(lessthan10%),vaccinationcanleadtoslightnasaldischargeorcoughingby

somebirdsbetween2to7daysafteradministrationfor1to2days.

4.7 Useduringlay

Donotuseinbirdsinlayand/orwithin4weeksbeforetheonsetofthelayingperiod.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Safetyandefficacydataareavailablewhichdemonstratethatthisvaccinecanbeadministeredonthesame

daybutnotmixedwithvaccinesagainstinfectiousbronchitiscontainingstrainH120andagainstNewcastle

diseasecontainingstrainsClone30orC2andinfectiousbronchitisvaccine(strainIBMa5)whengivenon

day1(theefficacyoftheIBMa5vaccinehasnotbeeninvestigated).

Intervet’slivevaccineagainstGumborodisease(infectiousbursaldisease)containingtheD78straincanbe

given7daysafterNobilisRhinoCV.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyotherveterinary

medicinalproductexcepttheproductsmentionedabove

Adecisiontousethisvaccinebeforeorafteranyotherveterinaryproductthereforeneedstobemadeona

casebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Oculonasaladministrationviaeye-ornose-dropmethodorviacoarsespray,onedoseperbirdfrom1dayold.

Oculonasalroute

Reconstitutethefreeze-driedvaccineinclean,disinfectant-andantiseptic-freewatertowhich2%liquid

skimmedmilkisaddedandadministerbymeansofastandardiseddropper.Theamountoffluidrequiredfor

eye-ornose-dropadministrationdependsonthenumberofdosesandthedropletsize,butapproximately35

mlper1000dosesisused.Applyonedropinanareoreye.Checkthatthedropisentirelyabsorbedbefore

releasingthebird.

Sprayvaccination

Thevaccinemustbereconstitutedwithclean,disinfectant-andantiseptic-freewatertowhich2%ofliquid

skimmedmilkisadded.Theappropriatenumberofvialsmustbeopenedunderwater.Thevolumeofvaccine

suspensionmustbesufficienttoensureahomogeneousvaccinationofthebirds.

Dependingontheageofthechickenstobevaccinatedandtherearingsystem,take250to500mlofwater

per1000doses.Thevaccinesuspensionistobesprayedevenlyovertheappropriatenumberofanimalsata

distanceof30-40cmwitharegularsprayingapparatus,preferablywhentheanimalssittogetherunderadim

light.Thesprayapparatusmustbefreefromsediments,corrosionandtracesofdisinfectantsandideally

shouldbeusedforvaccinationpurposesonly.

Ifapplicable,reduceventilationtopreventlossofspray.

Forfuturelayersandbreederspleaseseesection4.2.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Administrationoftenfoldthemaximumdosebytherecommendedrouteshasnotresultedinanyothereffect

onthetargetspeciesthanthosedescribedunder4.6.

4.11Withdrawalperiod

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Thevaccinecontainstheliveattenuatedstrain11/94ofavianrhinotracheitisvirus,sub-typeB.Upon

administration,thevaccineinducesactiveimmunityinchickensagainstavianrhinotracheitisvirus.

ThegrowthcharacteristicofthevaccinestraininChickenEmbryoFibroblastsallowsdifferentiationfrom

fieldvirus.Indicativeresultscanbeobtainedbyspecialisedlaboratories.

ATCVetcode:QI01AD01.AvianRhinotracheitisvirusvaccine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Pancreaticdigestofcasein,Sorbitol,Gelatine,Disodiumphosphatedihydrate,Waterforinjections

6.2 Incompatibilities

Donotmixwithanyothermedicinalproduct.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterreconstitutionaccordingtodirections:2hours.

6.4 Specialprecautionsforstorage

Storeinarefrigerator(+2°Cto+8°C).

Donotfreeze

Keepthevialintheoutercartoninordertoprotectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Cardboardboxcontaining1,2,5,10,20or50glass(TypeI)vialsof250,500,1000,2500,5,000,10,000or

25,000dosesclosedwithahalogenobutylrubberstopperandsealedwithanaluminiumcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriatedisinfectantinaccordance

withnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalBV.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

asrepresentedbythenationalcompanies

8. MARKETINGAUTHORISATIONNUMBER

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

FR:17June2004/23March2010

10. DATEOFREVISIONOFTHETEXT

February2009

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.