Poulvac Marek CVI + HVT

Main information

  • Trade name:
  • Poulvac Marek CVI + HVT
  • Pharmaceutical form:
  • Lyophilisate and Solvent
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Poulvac Marek CVI + HVT
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • mareks disease
  • Therapeutic area:
  • Chicken Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0102/001
  • Authorization date:
  • 26-08-2011
  • EU code:
  • NL/V/0102/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ANNEXII

A. MANUFACTURER(S)OFTHEBIOLOGICALACTIVESUBSTANCE(S)

ANDMANUFACTURINGAUTHORISATIONHOLDER(S)RESPONSIBLE

FORBATCHRELEASE

B. CONDITIONSORRESTRICTIONSOFTHEMARKETING

AUTHORISATIONREGARDINGSUPPLYORUSE

C. CONDITIONSORRESTRICTIONSOFTHEMARKETING

AUTHORISATIONWITHREGARDTOSAFEANDEFFECTIVEUSE

D. STATEMENTOFTHEMRLs

E. SPECIFICOBLIGATIONSTOBEFULFILLEDBYTHEMARKETING

AUTHORISATIONHOLDER

A. MANUFACTURER(S)OFTHEBIOLOGICALACTIVESUBSTANCE(S)AND

MANUFACTURINGAUTHORISATIONHOLDER(S)RESPONSIBLEFORBATCH

RELEASE

Nameandaddressofthemanufacturer(s)ofthebiologicalactivesubstance(s)

PfizerGlobalManufacturingWeesp

C.J.vanHoutenlaan36

1381CPWeesp

TheNetherlands

or

PfizerAnimalHealth

2000RockfordRoad

CharlesCity

Iowa50616

USA

Nameandaddressofthemanufacturer(s)responsibleforbatchrelease

PfizerGlobalManufacturingWeesp

C.J.vanHoutenlaan36

1381CPWeesp

TheNetherlands

or

PfizerOlot,S.L.U.

CarreteraCamprodons/n-LaRiba

17813-ValldeBianya

Girona

Spain

B. CONDITIONSORRESTRICTIONSOFTHEMARKETINGAUTHORISATION

REGARDINGSUPPLYORUSE

Tobesuppliedonlyonveterinaryprescription.

C. CONDITIONSORRESTRICTIONSOFTHEMARKETINGAUTHORISATION

WITHREGARDTOTHESAFEANDEFFECTIVEUSEOFTHEPRODUCT

Notapplicable.

D. STATEMENTOFTHEMRLs

Notapplicable.

E. SPECIFICOBLIGATIONSTOBEFULFILLEDBYTHEMARKETING

AUTHORISATIONHOLDER

Notapplicable.

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

PoulvacMarekSterileDiluent

200ml,400mlor1000ml

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PoulvacMarekDiluent

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

3. PHARMACEUTICALFORM

4. PACKAGESIZE

200ml,400ml,1000ml

5. TARGETSPECIES

Chicken.

6. INDICATION(S)

ForusewiththefollowingMarek’sDiseasevaccinesforchickens:

PoulvacMarekCVI

PoulvacMarekHVT

PoulvacMarekHVTCA

PoulvacMarekCVI+HVT

7. METHODANDROUTE(S)OFADMINISTRATION

Thecontentsofthispackmaybeusedtoreconstitute----dosesofvaccine,inwhichcasethedoseper

birdofreconstitutedvaccineshouldbe----ml.

I.M.S.C.

8. WITHDRAWALPERIOD

Zerodays.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year}

Useentirecontentswhenfirstopened.

11. SPECIALSTORAGECONDITIONS

StoreatRoomTemperature(15to25°C)

Avoidexposuretoheatand/ordirectsunlight.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Burnthecontainerandanyunusedcontent.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

[MAHHolder]

16. MARKETINGAUTHORISATIONNUMBER(S)

[MAHnumber]

17. MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

1000&2000doseampoules

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PoulvacMarekCVI+HVT

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

10 2.9 CCID

/DS+≥1000PFU/DS

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

4. ROUTE(S)OFADMINISTRATION

PROINJECTI.M.ORS.C

5. WITHDRAWALPERIOD

6. BATCHNUMBER

Lot{number}

7. EXPIRYDATE

EXP{month/year}

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B.PACKAGELEAFLET

PACKAGELEAFLET

PoulvacMarekCVI+HVT

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

[MAHHolder]

Manufacturerforthebatchrelease:

PfizerGlobalManufacturingWeesp

C.J.vanHoutenlaan36

1381CPWeesp

TheNetherlands

or

PfizerOlot,S.L.U.

CarreteraCamprodons/n-LaRiba

17813-ValldeBianya

Girona

Spain

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PoulvacMarekCVI+HVT

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

1doseof0.2mlcontains:

Activesubstances:

LiveMarek’sdiseasevirus,strainCVI988,cellassociated:notlessthan10 2.9

CCID

,notmorethan

10 3.5 CCID

*.

LiveMarekHVTstrainF#126,cellassociated:notlessthan1000PFU,notmorethan6000PFU**

*CCID

=cellculture50%infectivedose

**PFU=plaqueformingunits

4. INDICATION(S)

Activeimmunisationofhealthyday-oldchicksagainstMarek’sDiseasetoreducemortality,clinical

signsandlesionsofthedisease.

Onsetofimmunity:9dayspostvaccination.

5. CONTRAINDICATIONS

Donotvaccinateunhealthychickens.

AvoidearlyexposureofchickstoMarek’sdiseasetoallowfordevelopmentofprotection.

6. ADVERSEREACTIONS

None.

7. TARGETSPECIES

Chicken.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Posology:

Onedoseofvaccinesuspendedin0.2mlofaccessorydiluent.

Dilutionofvaccine:

Reconstituteeach1,000doseswith200mlofdiluent.Each2,000dosesofvaccineshouldbedilutedin

400mlofdiluent.Dilutionshouldbedoneunderasepticconditions.Anampoulemayoccasionally

explodeafterithasbeentakenoutoftheliquidnitrogencontainer,safetymeasuresmustbetaken(see

4.5).Taketheampouleofvaccineoutoftheliquidnitrogencontainerintoabowlcontainingcleantepid

water(temperaturebetween12ºCand22ºC).Thawthevaccinebycarefullyturningtheampoule.

Thenremovefromthewateranddrytheampoule.Thethawedvaccineconcentratemustbeused

immediately.

Breaktheampouleandwithdrawthetotalcontentscarefullyintoa10mlsteriledisposablesyringe,

usingan18Gx1andahalfinch(1.2mmx40mm)orlargergaugeneedle.Slowlydrawabout8mlof

diluentintothesyringe.Turnthesyringe5-10timestomixthecontentwell.Slowlytransferasmall

volumeofthemixtureintotheemptyvaccineampouleinordertoremovethelastremnantsofthe

vaccineandwithdrawthissmallamountbackintothesyringe.Carefullytransfertheentirecontentsof

thesyringeintothediluentcontainer.Rotatethebottleabout10timestomixthecontentswell.The

vaccineisnowreadyforusewithin2hours.

Routeofadministration:

Intramuscularlyinoneofthelegmusclesorsubcutaneouslyintheneck.

9. ADVICEONCORRECTADMINISTRATION

Nomorethanonesingledoseofvaccineshouldbeadministeredtoonedayoldchicksonly.

10. WITHDRAWALPERIOD

Zerodays.

11. SPECIALSTORAGEPRECAUTIONS

Thevaccineshouldbestoredat-196°Cinacontainerwithliquidnitrogen.Storethediluentatroom

temperature(15°Cto25°C).Avoidexposuretoheatand/ordirectsunlight.Oncethawed,thevaccine

cannotberefrozen.Keepoutofreachandsightofchildren.

Followingsuspending,thevaccineshouldbeusedwithin2hours.

12. SPECIALWARNING(S)

Thevaccineviruseshavethepotentialtospread.Allchickensonasiteshouldbevaccinated.After10

passagesthevaccineshowedanincreaseinvirulenceinthehighlysusceptiblepurebredRhodeIsland

Redbirds.

Specialprecautionsforuseinanimals

Donotuseonchickensinlay.

Exposuretoheatanddirectsunlightmustbeavoided.

Contactwithdisinfectantsmakesthevaccineineffective.

Usecleanmaterialsforvaccination.

Avoidvaccinationofstressedanimals.

Avoidinjectionintoornearjointsandtendons.

Donotvaccinateinaninfectedenvironment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Toavoidallpossiblerisksofworkingwithliquidnitrogenand/orexplosionofglassampoules,the

followingprecautionsmustbetaken:

Useofgloves.

Useoffacialprotectionorsafetygoggles.

Useofskin-coveringclothes.

Incaseofaccidentalself-injectionseekmedicaladviceimmediatelyandshowthepackageinsertor

labeltothephysician

Operatorwarnings:liquidnitrogencausesseriousfreezeburnsandthawingampoulesmayoccasionally

explodeafterremovalfromtheliquidnitrogen.Operatorsmustprotecttheirfacewithavisoror

gogglesandhandswithgloves,whenhandlingliquidnitrogencontainersandwhenthawingampoules.

Ifliquidnitrogenisspilledandcomesintocontactwithskincausingfrostbiteinjuries,immediatelywarm

theaffectedareabyimmersioninwaterat29±1°Corbytheuseofbodyheat.Considerablepainwill

beexperiencedduringwarmingbutthisisnormal.Donotrubtheaffectedarea.Seekmedicaladviceif

fullfunctionandfeelingarenotrapidlyrestored.

Afterhandlingthevaccine,operatorsshouldwashanddisinfecttheirhandswithanapproved

disinfectant.

Seekmedicaladviceintheeventofaliquidnitrogenburn.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafteranyotherveterinary

medicinalproductthereforeneedstobemadeonacasebycasebasis.

Noavailabledataonoverdosesymptoms.

DonotmixwithanyotherproductexceptPoulvacMarekDiluent.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriatedisinfectantapproved

forusebythecompetentauthorities.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

30March2012

15. OTHERINFORMATION

ATCVetCode:QI01AD03

Packaging:

PoulvacMarekCVI+HVT

Glassampoulesof2ml(1000or2000doses)

PoulvacMarekDiluent

Glassbottlecontaining200or400ml.

PVCplasticbagscontaining200,400or1000ml.

Notallpacksizesmaybemarketed.

LEGALCATEGORY

Tobesuppliedonlyonveterinaryprescription

MARKETINGAUTHORISATIONNUMBER

[MAHNumber]

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