PARVOKAN

Main information

  • Trade name:
  • PARVOKAN
  • Pharmaceutical form:
  • Live freeze-dried pellet for suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PARVOKAN
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • live goose parvovirus + inactivated duck parvovirus
  • Therapeutic area:
  • Other Birds

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0144/001
  • Authorization date:
  • 24-02-2012
  • EU code:
  • FR/V/0144/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PARVOKAN

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each0.2-mldosecontains:

Activesubstances:

Suspension:

Inactivated Muscovyduck parvovirus, GMstrain, atleast......................................................1.5 log10 SN.U

Freeze-dried pellet:

Liveattenuated Derzsy’sDiseasevirus, Hstrain, atleast.....................................................2.5 log10 CCID50

1 SN.U:q.s. to obtain amean seroneutralizingantibodytitreof 1 in thevaccinated animal

Adjuvant(s):

Suspension:

(asaluminiumhydroxide).............................................................................................................0.42 mg

Excipient(s):

Suspension:

Thiomersal, atmost...............................................................................................................................20 µg

Forafulllistofexcipients, seesection6.1.

3. PHARMACEUTICALFORM

Freeze-dried pelletand suspensionforsuspensionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Muscovyducks.

4.2 Indicationsforuse, specifying thetargetspecies

InMuscovyducklings:

ActiveimmunisationagainstMuscovyduck parvovirosisand Derzsy’sDisease.

Theonsetofimmunityforbothcomponentswasdemonstrated fromtheageof14days,andlastsalltheperiodof

maximalsusceptibilityofducklings(i.e. 4 weeksofage).

4.3 Contraindications

Noneknown.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

-Vaccinatehealthyanimalsonly.

-Applytheusualasepticprocedures.

-Onlydisinfectant-freeand/orantiseptic-freeequipmentshould beused fortheinjectionofvaccinesolution.

Specialprecautionsto betakenby thepersonadministering theveterinary medicinalproductto

animals

Incaseofaccidentalinjectiontohuman,seekmedicaladviceimmediatelyandshowthepackageleafletorthelabel

to thephysician.

4.6 Adversereactions(frequency andseriousness)

Atransientinflammatoryreactionmayoccurattheinjectionsite.

4.7 Useduring pregnancy, lactationorlay

Intheabsenceofdata, thevaccinationoffemalebreederducksisnotrecommended.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

No informationisavailableonthesafetyand efficacyfromtheconcurrentuseofthisvaccinewithanyother. Itis

thereforerecommended thatno othervaccinesshould beadministered within14 daysbeforeoraftervaccination

withtheproduct.

4.9 Amountsto beadministeredandadministrationroute

Posology

Subcutaneousroute:

-1stinjection:one0.2 mldoseat1 dayofage.

-2nd injection:one0.2 mldose14 to 21 dayslater.

Methodofreconstitution

-Shakewellthebottleofsuspensionuntilresuspensionofthedeposit.

-Pushtheneedleofa5-mlsyringethroughthebottleclosureofthesuspension.

-Suck up around 2 mlofproduct.

-Pushtheneedleofthefilled syringethroughtheclosureofthefreeze-dried pelletbottle.

-Injectthevolumeofsuspension.

-Shakewellthebottleoffreeze-dried pelletuntilcompletedissolutionofthefreeze-dried pellet.

-Suck up thereconstituted vaccinewiththesyringeand injectitinto thebottleofsuspension.

-Shakewellthebottleofreconstituted suspensionbeforeuse.

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

Nootherundesirableeffectthanthosementionedinsection“Adversereactions”wasobservedaftertheinjectionof

anoverdoseofvaccine.

4.11 Withdrawalperiod(s)

Zero days.

5. IMMUNOLOGICALPROPERTIES

ThevaccineinducesaspecificprotectionagainstMuscovyduckparvovirosisandDerzsy’sDiseaseinthevaccinated

animal.

ATCvetcode:QI01BH01.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Thiomersal

Aluminiumhydroxide

Disodiumphosphatedihydrate

Citricacid monohydrate

Meatand caseinpeptone

Waterforinjection

Sodiumchloride

Monopotassiumphosphate

Disodiumphosphatemonohydrate

6.2 Incompatibilities

Do notmixwithothervaccines.

6.3 Shelflife

15 months.

Afterreconstitution:2 hours.

6.4. Specialprecautionsforstorage

Storebetween2°Cand 8°C, protected fromlight.

6.5 Natureandcompositionofimmediatepackaging

Natureofcontainers

Suspension: Polypropylenebottle

Nitrilelastomerclosure

Freeze-dried pellet:Type-Iglassbottle

Butylelastomerclosure

Presentations

Boxofone500-dosebottleofsuspensionand one500-dosebottleoffreeze-dried pellet.

Boxofone1,500-dosebottleofsuspensionand three500-dosebottlesoffreeze-dried pellet.

Boxoften500-dosebottlesofsuspensionand ten500-dosebottlesoffreeze-dried pellet.

Boxoften1,500-dosebottlesofsuspensionand thirty500-dosebottlesoffreeze-dried pellet.

Notallpack sizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinary medicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Destroyunused vaccinecontentsand disinfectemptybottlesbeforediscardingthemaccordingtotheregulationin

force.

7. MARKETINGAUTHORISATIONHOLDER

FRANCE

MERIAL

29, avenueTonyGarnier

69007 LYON, FRANCE

GERMANY

MERIALGmbH

AmSöldnermoos6,

85399 HALLBERGMOOS,GERMANY

8. MARKETINGAUTHORISATIONNUMBER(S)

[To becompleted in accordancewith nationalrequirementsafterconclusion oftheMRphase].

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Firstauthorisation:1 st March2004

Renewal:expected for1 st March2009

10. DATEOFREVISIONOFTHETEXT

[To becompleted in accordancewith nationalrequirementsafterconclusion oftheMRphase].

PROHIBITIONOFSALE, SUPPLYAND/ORUSE

Notapplicable.

There are no safety alerts related to this product.

4-7-2018

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Active substance: Inactivated porcine parvovirus, strain NADL-2 / Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018) 4354 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

19-6-2018

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8

Europe -DG Health and Food Safety