Nobivac KC

Main information

  • Trade name:
  • Nobivac KC
  • Pharmaceutical form:
  • Nasal drops, solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Nobivac KC
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0142/001
  • Authorization date:
  • 17-06-2010
  • EU code:
  • UK/V/0142/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

AN:01119/2013

Revised:July2013

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobivacKC(inAT,BE,DE,DK,LUandNO:NobivacBbPi)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perdoseof0.4mlvaccinereconstitutedwithdiluent(waterfor

injections):

Activesubstances:

and

ofliveBordetellabronchisepticabacteriastrain

B-C2

3.0

and

TCID

oflivecanineparainfluenzavirusstrain

Cornell

colonyformingunits

TissueCultureInfectiveDose50%

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Lyophilisateandsolventforsuspensionfornasaladministration

Lyophilisate:Off-whiteorcream-colouredpellet

Solvent:clearcolourlesssolution

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

ActiveimmunisationofdogsagainstBordetellabronchisepticaand

canineparainfluenzavirusforperiodsofincreasedrisktoreduce

clinicalsignsinducedbyB.bronchisepticaandcanineparainfluenza

virusandtoreducesheddingofcanineparainfluenzavirus.

Onsetofimmunity:

forBordetellabronchiseptica:72hoursaftervaccination;

forcanineparainfluenzavirus:threeweeksaftervaccination.

Durationofimmunity:

1year

AN:01119/2013

Revised:July2013

Page2of5

4.3Contraindications

None

4.4Specialwarnings

Onlyhealthydogsshouldbevaccinated.

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

VaccinatedanimalscanspreadtheBordetellabronchisepticavaccine

strainforsixweeksandthecanineparainfluenzavaccinestrainfora

fewdaysaftervaccination.

Immunosuppressivemedicationmayimpairthedevelopmentof

activeimmunityandmayincreasethechanceofadverseeffects

causedbythelivevaccinestrains.

Cats,pigsandunvaccinateddogsmayreacttothevaccinestrains

withmildandtransientrespiratorysigns.Otheranimals,likerabbits

andsmallrodentshavenotbeentested.

ii) Specialprecautionstobetakenbytheperson

administeringtheveterinarymedicinalproductto

animals

Immunocompromisedindividualsshouldavoidanycontactwiththe

vaccineandvaccinateddogsuptosixweeksaftervaccination.

Disinfecthandsandequipmentafteruse.

4.6Adversereactions(frequencyandseriousness)

Milddischargesfromtheeyesandnosecanoccurfromtheday

aftervaccination,sometimesaccompaniedbywheezing,sneezing

and/orcoughing,particularlyinveryyoungsusceptiblepuppies.

Signsaregenerallytransient,butinoccasionalcasesmaypersist

foruptofourweeks.Inanimals,whichshowmoreseveresigns,

appropriateantibiotictreatmentmaybeindicated.

4.7Useduringpregnancy,lactationorlay

Canbeusedduringpregnancy

4.8Interactionwithothermedicinalproductsandotherformsof

interaction

Donotadministerinconjunctionwithotherintranasaltreatmentsor

duringantibiotictreatment.

Safetyandefficacydataareavailablewhichdemonstratethatthis

vaccinecanbeadministeredonthesameday,butnotmixed,with

thelivevaccinesoftheNobivacseriesagainstcaninedistemper,

caninecontagioushepatitiscausedbycanineadenovirustype1,

canineparvovirusdiseaseandrespiratorydiseasecausedbycanine

adenovirustype2,whereauthorised,andinactivatedvaccinesof

theNobivacseriesagainstcanineleptospirosiscausedbyallor

someofthefollowingserovars:L.interrogansserogroupCanicola

AN:01119/2013

Revised:July2013

Page3of5

serovarCanicola,L.interrogansserogroupIcterohaemorrhagiae

serovarCopenhageni,L.interrogansserogroupAustralisserovar

Bratislava,andL.kirschneriserogroupGrippotyphosaserovar

Bananal/Liangguang.

Noinformationisavailableonthesafetyandefficacyofthisvaccine

whenusedwithanyotherveterinarymedicinalproductexceptthe

productsmentionedabove.Adecisiontousethisvaccinebeforeor

afteranyotherveterinarymedicinalproductthereforeneedstobe

madeonacasebycasebasis.

Incaseantibioticsareadministeredwithinoneweekafter

vaccination,thevaccinationshouldberepeatedaftertheantibiotic

treatmentisfinished.

4.9Amountstobeadministeredandadministrationroute

Allowthesterilediluentprovidedtoreachroomtemperature(15-

C).Asepticallyreconstitutethefreeze-driedvaccinewiththe

diluent.Shakewellafteradditionofthediluent.Removetheneedle,

connecttheapplicatortipandadminister0.4mlintoonenostril.

Vaccinationscheme:

Dogsshouldbeatleast3weeksofage.WhenNobivacKCis

concurrentlyadministered(i.e.notmixed)withanothervaccineofthe

Nobivacseriesasindicatedundersection4.8,dogsshouldnotbe

youngerthantheminimumagerecommendedfortheotherNobivac

vaccine.

Unvaccinateddogsshouldreceiveonedoseatleast3weekspriorto

theperiodofanticipatedrisk,e.g.temporarykennelling,inorderto

getprotectionforbothvaccineagents.Inordertogetprotectionfor

Bordetellabronchisepticaunvaccinateddogsshouldreceiveone

doseatleast72hourspriortotheperiodofanticipatedrisk(seealso

section4.5Specialprecautionsforuse).

Revaccinateannually.

4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Particularlyinveryyoungpuppies,signsofupperrespiratorytract

diseasemayoccurafteranoverdose,includingocularandnasal

discharges,pharyngitis,sneezingandcoughing.Thesignsmaystart

thedayaftervaccinationandhavebeenseenforupto4weeksafter

vaccination.

4.11Withdrawalperiod

Notapplicable

5. IMMUNOLOGICALPROPERTIES

AN:01119/2013

Revised:July2013

Page4of5

TheproductcontainsliveBordetellabronchisepticastrainB-C2and

livecanineparainfluenzavirusstrainCornell.Afterintranasal

vaccination,theproductstimulatesthedevelopmentofactive

immunityagainstBordetellabronchisepticaandcanineparainfluenza

virus.

Nodataontheinfluenceofmaternalantibodiesontheeffectof

vaccinationwithNobivacKCareavailable.Fromliterature,itis

consideredthatthistypeofintranasalvaccineisabletoinducean

immuneresponsewithoutinterferencewithmaternallyderived

antibodies.

DataareavailabletoshowareductioninsheddingofBordetella

bronchisepticafrom3monthsto1yearaftervaccination.

ATCvetcode:QI07AF

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gelatin-basedstabiliser.

Sodiumchloride.

Phosphatebuffer.

Waterforinjections.

6.2Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct,except

diluentrecommendedforusewiththeproduct.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

27months.

Shelf-lifeafterreconstitutionaccordingtodirections:1hour.

6.4.Specialprecautionsforstorage

Storeandtransportrefrigerated(2

C –8

C).

Donotfreeze.

Protectfromlight.

6.5Natureandcompositionofimmediatepackaging

3ml(singledosepresentation)or10ml(5and10dose

presentation)vialofglassTypeI(Ph.Eur.)closedwitha

halogenobutylrubberstopperandsealedwithcodedaluminiumcap

andaccompaniedbyavialofsterilediluentandapplicator.

Thediluentsuppliedforreconstitutionisfilledinthesametype

container(glassTypeIvialandrubberstopper)astheproduct.The

fillingvolumeis:

1dose0.6ml

5dose2.4ml

10dose4.6ml

AN:01119/2013

Revised:July2013

Page5of5

Packsizes:Boxeswith1,5,10,25or50x1,5,or10dosesof

vaccineanddiluentandapplicator.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinary

medicinalproductorwastematerialsderivedfromtheuseof

suchproducts

Disposeofwastematerialbyboiling,incinerationorimmersioninan

appropriatedisinfectantapprovedforusebythecompetent

authorities.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

IntervetUKLtd.

WaltonManor

Walton

MiltonKeynes

Buckinghamshire

MK77AJ

8. MARKETINGAUTHORISATIONNUMBER

Vm: 06376/4026

9. DATEOFFIRSTAUTHORISATION

Date:15November1999

10 DATEOFREVISIONOFTHETEXT

Date:July2013

Approved:02/10/2013

19-4-2018

March 30, 2018: KC Paramedic Indicted for Stealing Fentanyl, Morphine from Ambulances

March 30, 2018: KC Paramedic Indicted for Stealing Fentanyl, Morphine from Ambulances

March 30, 2018: KC Paramedic Indicted for Stealing Fentanyl, Morphine from Ambulances

FDA - U.S. Food and Drug Administration

14-8-2018

Nobivac LeuFel (Virbac)

Nobivac LeuFel (Virbac)

Nobivac LeuFel (Active substance: Feline leukaemia vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)5535 of Tue, 14 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4778/WS/1282/1

Europe -DG Health and Food Safety

25-7-2018

Nobivac L4 (Intervet International B.V.)

Nobivac L4 (Intervet International B.V.)

Nobivac L4 (Active substance: Canine leptospirosis vaccine (inactivated)) - Centralised - Yearly update - Commission Decision (2018)4990 of Wed, 25 Jul 2018

Europe -DG Health and Food Safety