AQUAVAC VIBRIO ORAL

Main information

  • Trade name:
  • AQUAVAC VIBRIO ORAL
  • Pharmaceutical form:
  • Oral emulsion
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AQUAVAC VIBRIO ORAL
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Vibrio vaccine
  • Therapeutic area:
  • Fish

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0165/001
  • Authorization date:
  • 18-01-2012
  • EU code:
  • FR/V/0165/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEIMMUNOLOGICALVETERINARYMEDICINAL

PRODUCT

AQUAVACVIBRIOORAL

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances Quantity

InactivatedcellsofListonella(Vibrio)anguillarumstrain78-SKIDRPS

(*)> 60%

afteradministration

InactivatedcellsofVibrio)ordalii 1

strainMSC275 RPS

(*)> 60%

afteradministration

(*) RPS

60 :relativepercentagesurvivalinvaccinates,attimeof60%ofmortalityincontrols,after

oralvaccinationandsubsequentchallenge

Excipient

Formaldehyde < 0.5 mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralemulsion

Paleyellowemulsion

4. CLINICALPARTICULARS:

4.1 Targetspecies

RainbowTrout(Oncorhynchusmykiss)

4.2 Indicationsforuse,specifyingthetargetspecies

ForRainbowTrout,12gorover:

Fortheactiveimmunisationoffishtoreducemortalityduetovibriosiscausedby

Listonella(Vibrio)anguillarumandVibrioordalii.

Onsetofimmunity:336degree-daysincaseofuseofAquavacVibrioOralasa

primaryvaccine.Adurationofimmunityhasnotbeendemonstratedbeyondthis.

ForfishvaccinatedbyimmersionwithAquavacVibrioImmersionandInjectionand

revaccinatedwithAquavacVibrioOral,protectionwasseenafter336 degreedays.

4.3 Contraindications

Donotvaccinatefishduringtheincubationperiodofvibriosis.

Donotvaccinateifthewatertemperatureisbelow10°C.

4.4 Specialwarningsforeachtargetspecies

Theminimumweightsforfishbeforevaccinationmustberespected.

4.5 Specialprecautionsforuse

VibrioordaliiisasubsetofListonella(Vibrio)anguillarumO2

Specialprecautionsforuseinanimals

Onlyvaccinatehealthyfish

Avoidstressatthetimeofthehandlingoffish,aswellastemperaturevariations.

DonotrepeatvaccinatefishwithAquaVacVibrioOralvaccine.

Thevaccine-treatedfeedshouldnotbeusediffungalcontaminationisnoticed.

Specialprecautionsto betakenby thepersonsadministeringtheveterinary

medicinalproductto animals.

Wearprotectivegloveswhenhandlingthevaccineandthevaccine-treatedfeed.

4.6 Adversereactions(frequencyandseriousness)

Nonereported

4.7 Useduringpregnancy,lactationorlay

Intheabsenceofspecificsafetydata,thevaccineshouldnotbeadministeredto

broodstockorfishintendedasbroodstock .

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thevaccinecanbeusedasarevaccinationscheme,followingaprimaryvaccination

byimmersionroutewithAquaVacVibrioImmersionandInjection.Thisschemehas

beenvalidatedforfishofatleast12gatpriming.

No informationisavailableonthesafetyandefficacyfromtheconcurrentuseofthis

vaccinewithanyotherveterinarymedicinalproduct.Adecisiontousethisvaccine

beforeorafteranyotherveterinarymedicinalproductthereforeneedsto bemadeona

casebycasebasis.

4.9. Amountstobeadministeredandadministrationroute

Thevaccineisadministeredorally,mixedwithfoodpellets,usingthefollowing

protocol:

Primaryvaccination

Day1-5 :0.02 mlperfishperday

Day6-10 :No vaccinefeed

Day11-15 :0.02 mlperfishperday

Total :0.2 mlperfishover10 days

RevaccinationafterprimaryvaccinationwithAquaVacVibrioImmersionand

Injection:fieldexperiencehasindicatedthatimmunitytotheinitialimmersion

vaccinationisatleast3 months.Whenimmunitywanes,therevaccinationschemeis

recommended.

Day1-5 :0.01 mlperfishperday

Day6-10 :No vaccinefeed

Day11-15 :0.01 mlperfishperday

Total :0.1 mlperfishover10 days

Preparationofvaccinetreatedfeed

Placethevaccineatambienttemperature(20°C)for1 hourbeforeuseso itismore

liquid.If2 distinctphasesappear,mixthebottlewelluntilahomogeneousmixtureis

obtained.Turnthefeedpelletsslowlyanddirectlypourthevaccineontothefeed.Ifa

sprayerisused,itshouldbesetto deliveracoarsespraywithoutproducingaerosol

particles,andthespraycontainermustbecompletelyemptiedduringthemixing

operation.Mixwellforatleast2 minutesafterallthevaccinehasbeenadded.Leave

thevaccinefeedfor1 hourbeforeusingto allowthevaccineto penetrateintothe

pelletswell.Thevaccinecanbemixedwithallorpartofthedailyfeedration.

4.10 Overdose(symptoms,emergency procedures,antidotes)(ifnecessary)

No adverseeffectshavebeennotedfollowingadoubledoseofthevaccineintrout.

4.11 Withdrawalperiod(s)

Zerodegreedays.

5 IMMUNOLOGICALPROPERTIES

ATCVetcodeQI10BB01

ThevaccineinducesactiveimmunityagainstvibriosisduetoListonella(Vibrio)

anguillarumandVibrioordalii.

6 PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Formaldehyde

Sodiumchloride

Fishoil

Lecithin

6.2 Incompatibilities

Donotmixwithanyothervaccineorimmunologicalproduct.

6.3 Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3 years

Shelf-lifeofvaccine-treatedfeed:10 days

6.4 Specialprecautionsforstorage

Storeandtransportrefrigerated(2°Cto 8°C).Protectfromlight.Do notfreeze.

Ifthevaccinetreatedfeedisstored,itshouldbestoredinthedark andtemperatures

shouldnotexceed16°C. Ifthistemperatureisexceeded,thevaccinetreatedfeedmay

bealtered.

6.5 Natureandcompositionofimmediatepackaging

Natureofimmediatepackaging:

Highdensitypolyethylenebottlewithbromobutylstopperandaluminiumseal.

1000 mlbottle(10000 dosesasrevaccinationscheme,5000 dosesasprimary

vaccination).

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromuseofsuchproducts,ifany

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7 MARKETINGAUTHORISATIONHOLDER

IntervetInternationalBV

WimdeKörverstraat35

5831AN Boxmeer

TheNetherlands

Representedbythenationalcompaniesintheconcernedmemberstates.

8 MARKETINGAUTHORISATIONNUMBER

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

12-01-2005 /05-07-2011

10. DATEOFREVISIONOFTEXT

May2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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