AQUAVAC VIBRIO IMMERSION AND INJECTION

Main information

  • Trade name:
  • AQUAVAC VIBRIO koncentrat za kopel in suspenzija za injiciranje
  • Pharmaceutical form:
  • Lyophilisate and Solvent
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AQUAVAC VIBRIO koncentrat za kopel in suspenzija za injiciranje
    Slovenia
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0164/001
  • Authorization date:
  • 18-01-2012
  • EU code:
  • FR/V/0164/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AquaVacVibrio Immersionand Injection

DK:AquaVacVibrio (vet)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances:

Inactivated cellsofListonella(Vibrio)anguillarumstrain78-SKID:RPS

(*)> 75%

Inactivated cellsofVibrioordalii 1 strainMSC275:RPS

(*)> 75%

(*) RPS

60 :relativepercentagesurvivalinvaccinates,attimeof60%ofmortalityincontrols,after

vaccinationbyinjectionandsubsequentchallenge

Excipient

Formaldehyde < 0.5 mg/ml

Forafulllistofexcipients, seesection6.1.

3. PHARMACEUTICALFORM

Concentratefordip suspensionand Suspensionforintraperitonealinjection.

Suspensioninbrownaqueousliquid.

4 CLINICALPARTICULARS

4.1 TargetSpecies

Rainbowtrout(Oncorhynchusmykiss)

4.2 IndicationsforUse, Specifying theTargetSpecies

ForRainbowTrout, 2goroverbyimmersionand 6goroverbyinjection.

Activeimmunisationto reducemortalitycaused byvibriosisduetoListonella(Vibrio)

anguillarumandVibrio ordalii.

Theonsetofimmunityisatleast336 degreedays. Adurationofimmunityof1200 degree

dayshasbeenshown.

4.3 Contraindications

Do notvaccinatefishduringtheincubationperiod ofvibriosis.

Do notvaccinateifthewatertemperatureisbelow10°C.

4.4 Specialwarningsfor<eachtargetspecies>

Theminimumweightsforfishbeforevaccinationmustberespected.

4.5 Specialprecautionsforuse

VibrioordaliiisasubsetofListonella(Vibrio)anguillarumO2

Specialprecautionsforuseinanimals

Onlyvaccinatehealthyfish.

Do notrepeatvaccinatefishwithAquaVacVibrio immersionand injectionvaccine.

Avoidstressatthetimeofthehandlingoffish, aswellastemperaturevariations, inparticular

betweenthevaccinesuspensionand thewateroftheholdingarea.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthe

leaflet/labelto thephysician.

4.6 Adversereactions(frequency andseriousness)

Noneknown.

4.7 Useduring pregnancy, lactationorlay

Intheabsenceofspecificsafetydata, thevaccineshould notbeadministered to broodstock

orfishintended asbroodstock.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thevaccinecanbeused asprimaryvaccinationbyimmersionroute, followed bya

revaccinationwithAquaVacVibrio Oral. Thisschemehasbeenvalidated forfishofatleast

12gatpriming.

No informationisavailableonthesafetyand efficacyfromtheconcurrentuseofthisvaccine

withanyotherveterinarymedicinalproduct. Adecisionto usethisvaccinebeforeorafter

anyotherveterinarymedicinalproductthereforeneedsto bemadeonacasebycasebasis.

4.9 Amountsto beadministeredandadministrationroute

Shakethebottlebeforeuse.

Administrationbyimmersion(weightatleast2 g)

Diluteallofthebottle(1 litre)in9 litresofhatcherywater, cleanand suitablyoxygenated.

Placethefishinto batchesand immersefor30 secondsinthediluted vaccine.

Alitreofvaccine(making10 litresofdiluted vaccine)allowsthevaccinationofamaximum

of100 kgoffish.

Administrationbyinjection(weightatleast6 g)

Thevaccinemustbeadministered usingamulti-doseinjectionapplicatorincorporatinga

mechanismto preventflush-back. Thisappliesequallyto hand-held and automaticsystems.

Theproductisadministered byintra-peritonealinjectionintheventralarea, justanteriorto

thepelvicfins. Thedoseis0.1 mlperfish.

Thefishshould beanaesthetised priorto vaccination, usingananaestheticlicensed foruseon

fish.

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

No adverseeffectshavebeennoted followingadoubledoseofthevaccineintrout.

4.11 WithdrawalPeriod(s)

Zero degreedays

5 IMMUNOLOGICALPROPERTIES

ATCVetcodeQI10BB01

ThevaccineinducesactiveimmunityagainstvibriosisduetoListonella(Vibrio)

anguillarumandVibrio ordalii.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Formaldehyde

Sodiumchloride

6.2 Incompatibilities

Do notmixwithanyothervaccineorimmunologicalproduct.

6.3 Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackaged forsale:2 years

Shelflifeafterfirstopeningtheimmediatepackaging:

Vaccinationbyimmersion:useimmediately

Vaccinationbyinjection:usethefullcontentswithin5hoursofthetimewhenthebottlecap

isbroached.

6.4 SpecialPrecautionsforStorage

Storeand transportrefrigerated (2°Cto 8°C).

Protectfromlight.

Do notfreeze.

6.5 Natureandcompositionofimmediatepackaging

Natureofimmediatepackaging:

Highdensitypolyethylenebottlewithbromobutylstopperand aluminiumseal.

1000 mlbottle(10000 dosesbyinjection,100kgoffishbyimmersionvaccination).

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsor

wastematerialsderivedfromtheuseofsuchproducts, ifany

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshould bedisposed ofinaccordancewithlocalrequirements.

7 MARKETINGAUTHORISATIONHOLDER

IntervetInternationalBV

WimdeKörverstraat35

5831AN Boxmeer

TheNetherlands

Represented bythenationalcompaniesintheconcerned memberstates.

8 MARKETINGAUTHORISATIONNUMBER(S)

9 DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION.

12-01-2005 /05-07-2011

10 DATEOFREVISIONOFTHETEXT

May2011

PROHIBITIONOFSALE, SUPPLYAND/ORUSE

Notapplicable.