AVINEW

Main information

  • Trade name:
  • AVINEW
  • Pharmaceutical form:
  • Lyophilisate
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AVINEW
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Newcastle disease virus / paramyxovirus vaccine
  • Therapeutic area:
  • Chicken

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0123/001
  • Authorization date:
  • 01-11-2009
  • EU code:
  • FR/V/0123/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AVINEW

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachdoseofreconstitutedvaccinecontains:

Activesubstance:

LiveNewcastlediseasevirus,VG/GAstrain,atleast 5.5log

EID

EID50:EggInfectiveDose50percent.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Lyophilisateforsuspension fororalandocularadministrationandforspraying.

Pale,homogeneouslyophilisate.

4. CLINICALPARTICULARS

4.1 Targetspecies

Chickens(broiler,futurelayerandfuturebreederpullets).

4.2 Indicationsforuse,specifyingthetargetspecies

Inbroilerchickensfromtheageofoneday:

ActiveimmunisationagainstNewcastlediseasetoreducemortalityandclinicalsignsassociatedwith

thedisease.

Onsetofimmunity:14daysafterprimaryvaccination.

Durationofimmunityinducedbythevaccinationschemedescribedunder4.9:protectionuntiltheage

of6weeks.

Infuturelayerandfuturebreederpulletsfromtheageof4weeks:

PrimingforactiveimmunisationagainsteggdropcausedbyNewcastlediseasebeforevaccinationwith

aninactivatedvaccine(strainUlster2C)priortothebeginningoflay.

Fordurationofimmunityoffullschedule,seeSPCoftheinactivatedboostervaccine.

4.3 Contraindications

None.

4.4 Specialwarnings

Vaccineviruscanspreadtounvaccinatedbirds.Infectionofunvaccinatedbirdswiththevaccinevirus

fromvaccinatedbirdsdoesnotinduceanysignofdisease.Moreover,areversiontovirulencetrial

carriedoutinthelaboratoryhasshownthatthevaccinevirusdoesnotacquireanypathogenic

characteristicafter10passagesinchickens.Therefore,spreadtounvaccinatedbirds,inthepresent

stateofknowledge,canbeconsideredassafe.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Vaccinatehealthybirdsonly.

Applytheusualasepticprocedures.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Careshouldbetakenwhenhandlingthevaccinepreparation.

BecauseNewcastlediseaseviruscancauseatransitoryconjunctivitisinman,itisrecommendedto

wearrespiratoryandeyeprotectionincompliancewithcurrentEuropeanstandards.

Formoreinformation,contactthemanufacturer.

Handsshouldbewashedanddisinfectedaftervaccinating.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

Infuturelayerandfuturebreederpullets,refertotheSPCoftheinactivatedboostervaccine.

4.7 Useduringpregnancy,lactationorlay

Vaccinationofchickensinlayisnotrecommended.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyfromtheconcurrentuseofthisvaccinewithany

other.Itis,therefore,recommendedthatnoothervaccinesshouldbeadministeredwithin14days

beforeoraftervaccinationwithAvinew.

4.9 Amountstobeadministeredandadministrationroute

Inbroilerchickens:

Primaryvaccinationbyocularroute(eyedropapplication)oroculo-nasalroute(coarsespray

application):fromtheageofoneday.

Boostervaccinationsbyoralroute(drinkingwaterapplication):attheageof2to3weeks.

Theminimalintervalbetweenthetwovaccinationsshouldbeof2weeks.

Infuturelayerandfuturebreederpullets:

Twoadministrationsbyocularroute(eyedropapplication),oculo-nasalroute(coarsesprayapplication)

ororalroute(drinkingwaterapplication):attheageof4weeksand8weeks.

Vaccinationwiththeproductshouldbefollowedbyvaccinationwithaninactivatedvaccine(strain

Ulster2C)priortothebeginningoflaytoprovidesufficientefficacy.

Methodofadministration:

Toreconstituteandpreparethevaccine,usecleancoldwater.Forthepreparationandadministration

ofthevaccine,usesterilematerialfreefromdisinfectantand/orantiseptic.Shakethereconstituted

vaccinesolutionbeforeuse.

- Individualvaccination:ocularroute

For1,000birds,reconstitutethelyophilisatepelletcorrespondingto1,000dosesinto3to5mlofboiled

andcooled nonchlorinateddrinkingwaterandsubsequentlydiluteitinto50mlofboiledandcoolednon

chlorinateddrinkingwater.

Usecalibrateddropper,soastodistribute50µl-drops.

Placeonedropofthevaccinesolutionontheeyeofeachbird,allowthedroptospreadandreleasethe

bird.

- Massvaccination:oralroute

For1,000birds,reconstitutethelyophilisatepelletcorrespondingto1,000dosesinto3to5mlofnon

chlorinateddrinkingwaterandsubsequentlydiluteitintothevolumeofnonchlorinateddrinkingwater

tobeconsumedwithinonetotwohours.

Whenusingmainswater,treatallwatertocomeintocontactwiththevaccinewithskimmedmilk

powderatarateof2.5gperlitreinordertoneutralisetracesofchlorine.

Distributethevaccinesolutionatthetimeofusetobirds.Birdsshouldbedeprivedofwaterfortwo

hourspriortovaccination.

- Massvaccination:respiratoryroute

For1,000birds,reconstitutethelyophilisatepelletcorrespondingto1,000dosesinto3to5mlofnon

chlorinateddrinkingwaterandsubsequentlydiluteitintothevolumeofnonchlorinateddrinkingwater

accordingtothetypeofsprayerused(pressure-sprayerorsprayerwithrotarycone).

Spraythevaccinesolutionabovethebirdsusingaspraycapableofproducingmicro-droplets(mean

diameter80-100µm).

Forpropervaccinedistribution,makesurethatbirdsarecloselyconfinedtogetherduringspraying.The

ventilationsystemofthepoultryhouseshouldbeinoperativeduringthesprayadministration.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noside-effecthasbeenobservedfollowingadministrationof10timestherecommendeddoseof

vaccine.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

ThevaccinecontainsliveNewcastlediseasevirus,VG/GAstrain.TheVG/GAstrainislentogenicand

naturallyapathogenicforchickens.ThevaccineinducesactiveimmunisationagainstNewcastle

disease,asdemonstratedbychallengetestinbroilerchickens.

ATCvetcode:QI01AD06.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Proteinhydrolysate

Mannitol

Polyvidone

Sucrose

Potassiumglutamate

Potassiumphosphate

Bovinealbumin

Water

6.2 Incompatibilities

Thepresenceofdisinfectantand/orantisepticinwaterandmaterialusedforthepreparationofvaccine

solutionisnotcompatiblewithaneffectivevaccination.

Donotmixwithotherproducts.

6.3 Shelflife

16months.

Afterreconstitution:2hours.

6.4 Specialprecautionsforstorage

Storebetween2°Cand8°C,protectedfromlight.

6.5 Natureandcompositionofimmediatepackaging

- Type-Iglassbottle

Butylelastomerclosure

Aluminiumcap

- Boxofone1,000-dosebottle

Boxofone2,000-dosebottle

Boxoften1,000-dosebottles

Boxoften2,000-dosebottles

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Disinfectemptybottlesorbottlescontainingunusedproductbeforediscarding.

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriatedisinfectantin

accordancewithnationalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

GERMANY

MERIALGmbH

AmSöldnermoos6,85399HALLBERGMOOS

Germany

(49)81195930

(49)8119593101

FRANCE,FINLAND,GREECEandAUSTRIA

MERIAL

29,avenueTonyGarnier,69007LYON

France

(33)472723000

(33)472723069

BELGIUMandLUXEMBURG

MERIALBELGIUM

BdSylvainDupuis243,1070BRUXELLES

Belgium

(32)25294900

(32)25294911

THENETHERLANDS

MERIALBV

Bovenkerkerweg6-8,Postbus338,1185XEAMSTELVEEN

TheNetherlands

(31)205473933

(31)206402201

IRELANDandUNITED-KINGDOM

MERIALANIMALHEALTHLTD

POBox327,SandringhamHouse,HarlowBusinessPark,HARLOWEssexCM195TG

United-Kingdom

(44)1279775858

(44)1279775888

PORTUGAL

MERIALPORTUGUESALDA

Av.MariaLamas,Lote19–BL.Apiso2,SerraDasMinas,2635-432RIODEMOURO

Portugal

(351)219169340

(351)219164250

SPAIN

MERIALLABORATORIOSSA

c/Tarragona,161-planta3a,08014BARCELONA

Spain

(34)932928383

(34)932928389

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

June2007

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Conditionofsupply: subjecttomedicalprescription

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