BRONCHI-SHIELD

Main information

  • Trade name:
  • BRONCHI-SHIELD
  • Pharmaceutical form:
  • Powder and solvent for solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRONCHI-SHIELD
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Bordetella vaccine
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0153/001
  • Authorization date:
  • 23-08-2011
  • EU code:
  • FR/V/0153/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

BRONCHI-SHIELD,lyophilisateandsolventforsuspensionfornasaldropsfordogs.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1dose(1ml)ofvaccinecontains:

1.Lyophilizedfraction:

Activesubstance:

Bordetellabronchiseptica,live,strain92B 2.1x10 6 to5.5x10 8 CFU(*)

(*)CFU:colonyformingunit

Excipients:

Forafulllistofexcipients,seesection6.1.

2.Solvent:

Waterforinjections 1ml

3.PHARMACEUTICALFORM

Lyophilisateandsolventforsuspensionfornasaldrops.

Uniformcreamcolourcake.

4.CLINICALPARTICULARS

4.1TargetSpecies

Dogs.

4.2Indicationsforuse,specifyingthetargetspecies

Indogs:

-Foractiveimmunizationofdogsof8weeksofageoroldertoreducecoughingcausedbyBordetella

bronchiseptica.

Durationofimmunity:1year.

Onsetofimmunity:from5daysaftervaccination.

4.3Contraindications

Donotvaccinatesick/unhealthyanimals.

Donotvaccinateanimalsundergoingantibacterialorimmunosuppressivetreatment.

Seesection4.6.

4.4Specialwarningsforeachtargetspecies

Theproductcontainslivebacteriaandmustbeadministeredbytheintranasalrouteonly.Parenteral

administrationcangenerateabscessesandcellulitis.

Ifanyantibioticisusedwithin2weeksaftervaccination,vaccinationshouldberepeatedaftercompletionofthe

antibiotictreatment.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

VaccinateddogsmayexcretethevaccinestrainofBordetellabronchisepticaupto7weeksfollowing

vaccination.Duringthistime,immunodepressedpersonsareadvisedtoavoidcontactwithvaccinateddogs.

Similarprecautionsarealsoapplicabletounvaccinatedin-contactorimmunodepressedanimals.

Thevaccinehasbeenshownsafeinpigs.Catsandunvaccinateddogsincontactwithvaccinateddogsmayreact

tothevaccinestrain,presentingmoderateclinicalsignssuchassneezing,nasalandoculardischarge.Other

animals,suchasrabbitsandsmallrodents,havenotbeentested.

Specialprecautionsshouldbetakentoavoidspreadingofthevaccinestrainintheclinic.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Disinfecthandsandequipmentafteruse.

Incaseofaccidentalself-injectionduringreconstitutionoftheproductorinhalationoftheaerosolizedproductat

thetimeofapplicationinthedognostrils,seekmedicaladviceimmediatelyandshowthepackageleafletorthe

labeltothephysician.

Personsadministeringtheproducttothedogshouldbeawarethatrepeatedexposuretotheproductbyinhalation

ofaerosolizedproductmayleadtorarehypersensitivityreactions.

AlthoughtheriskthatimmunocompromisedhumansbecomeinfectedwithBordetellabronchisepticais

extremelylow,suchindividualsshouldbeawarethatdogscanshedtheorganismforupto7weeksafter

vaccination.Immunocompromisedpersonsareadvisedtoavoidcontactwiththevaccineandvaccinateddogs

duringthesheddingperiod.

4.6Adversereactions(frequencyandseriousness)

Occasionally,transientcoughing(1or2days)mayoccurduringthefirstdaysfollowingvaccination.

Inrareoccasions,transientnasaloroculardischargemaybeobserved.

Inanimals,whichshowmoreseveresigns,appropriateantibiotictreatmentmaybeindicated.However,

veterinariansshouldbeawarethatantibiotictreatmentgivenlessthan14daysaftervaccinationmayimpair

vaccineefficacy.

Hypersensitivityreactionsmayoccur.Incaseofanaphylacticreaction,administeradrenaline.

4.7Useduringpregnancy,lactationorlay

Donotuseduringpregnancyandlactationduetothelackofsupportivestudiesandpossiblespreadofthe

vaccinestrain.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotuseimmunodepressingagentswithin1monthofvaccinationwiththeproduct.

Donotadministerantibioticsduring14daysfollowingvaccination.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyotherveterinary

medicinalproduct.Adecisiontousethisvaccinebeforeorafteranyotherveterinarymedicinalproduct

thereforeneedstobemadeonacasebycasebasis.

4.9Amountstobeadministeredandadministrationroute

Thevaccineistobeadministeredbynasaldropstodogsoftheageof8weeksandolder.

Asepticallyreconstitutethelyophilisatewiththesolvent.

Shaketheproductwellafterreconstitution.Withdrawtheliquidwiththesyringe,removetheneedleandreplace

withtheapplicator.Thevaccineshouldbeusedimmediately.

Theheadofthedogshouldbeheldwiththenosepointingupwardsanditsmouthclosed,sothatitisforcedto

breaththroughitsnostrils.Administertheproductinthenostrilsdropbydrop.

Primaryvaccination:

Vaccinationwith1doseof1mlperdogfromtheageof8weeks.

Administer0.5mlofthevaccineineachnostril.Forlargeranimals(>15kg),1mlmaybeadministeredina

singlenostril.

Onedoseatleastfivedaysbeforetheperiodofanticipatedrisk,e.g.temporarykennelling.

Seealsosection4.5“Specialprecautionsforuse”.

Booster:

Annualboosterofonedose.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inadditiontotheadversereactionsmentionedinsection4.6,ten-foldoverdosevaccinatedpuppiesmaysneeze

oneormoretimesfollowingvaccination.

Emergencyprocedures:seesection4.6.

4.11Withdrawalperiod(s)

Notapplicable.

5.IMMUNOLOGICALPROPERTIES

LivevaccinestimulatingactiveimmunityagainstBordetellabronchiseptica.

Pharmacotherapeuticgroup:Livebacterialvaccines

ATC-vetcode:QI07AE01

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

1.Lyophilisedfraction:

Bacto-peptone

Sucrose

Dipotassiumphosphate

Potassiumdihydrogenphosphate

Potassiumhydroxide

Gelatine250A

EagleHEPESmedium

HydrochloricacidforpHadjustment

SodiumhydroxideforpHadjustment

2.Solvent:

Waterforinjections

6.2Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct,exceptthesolventsuppliedforusewiththeproduct.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterreconstitutionaccordingtodirections:8hours.

6.4Specialprecautionsforstorage

Storeandtransportrefrigerated(+2°C–+8

C)andprotectfromlight.

Donotfreeze.

6.5Natureandcompositionofimmediatepackaging

Lyophilisedfraction:

Vial:TypeIglassvial

Closure:Bromobutylrubberstoppersealedwithaluminumcap

Solvent:

Vial:TypeIglassvial

Closure:Bromobutylstoppersealedwithaluminumcap

Packsizes:

Boxcontaining5vialsof1doseoflyophilisateand5vialsof1doseofsolventand5cannulaeforapplication

Boxcontaining10vialsof1doseoflyophilisateand10vialsof1doseofsolventand10cannulaefor

application

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerialsderivedfromthe

useofsuchproducts

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriatedisinfectantapprovedforuse

bythecompetentauthorities.

7.MARKETINGAUTHORIZATIONHOLDER

FortDodgeSantéAnimale

24,avenueMarcelDassault

37204Tourscedex3

France

8.MARKETINGAUTHORIZATIONNUMBER(S)

{MANumber}

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

22September2003

10.DATEOFREVISIONOFTHETEXT

June2010.

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Subjecttoprescription.

Theimport,sale,supplyand/oruseofBronchi-ShieldisormaybeprohibitedincertainMemberStatesonthewhole

orpartoftheirterritorypursuanttonationalanimalhealthpolicy.Anypersonintendingtoimport,sell,supply

and/oruseBronchi-ShieldmustconsulttherelevantMemberState’scompetentauthorityonthecurrentvaccination

policiespriortotheimport,sale,supplyand/oruse.

26-5-2018

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FDA - U.S. Food and Drug Administration

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