INGELVAC PRRS KV

Main information

  • Trade name:
  • INGELVAC PRRS KV
  • Pharmaceutical form:
  • Emulsion for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • INGELVAC PRRS KV
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Porcine reproductive and respiratory syndrome (PRRS) virus
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0116/001
  • Authorization date:
  • 01-06-2012
  • EU code:
  • FR/V/0116/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ingelvac®PRRSKVemulsionforinjectionforpigs(sowsandgilts)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

InactivatedPorcineReproductiveandRespiratorySyndrome(PRRS)virus,P120strain:

2.5log10

IF*Units.

*IFUnits:ImmunoFluorescenceantibodytitreobtainedaftertwoinjectionsinpigsunderspecific

laboratoryconditions.

Adjuvant:

O/woilyexcipient(containinghydrogenatedpolyisobuteneasadjuvant): q.s.1doseof2ml.

Excipients:

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Emulsionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs(sowsandgilts).

4.2 Indicationsforuse,specifyingthetargetspecies

ReductionofthereproductivedisorderscausedbyPorcineReproductiveandRespiratorySyndrome

virus(Europeanstrain)inacontaminatedenvironment:vaccinationreducesthenumberofearly

farrowingandthenumberofstill-births.

4.3 Contraindications

None.

4.4 Specialwarningsforeachtargetspecies

InPRRSinfectedherds,viralinfectionisheterogeneousandvariesovertime.Insuchcontext,the

implementationofavaccinationprogramisatooltoimprovethereproductiveparametersandmay

contributetothediseasecontrolinconjunctionwithsanitarymeasures.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Vaccinateonlyhealthyanimals.

Applyusualproceduresforthehandlingofanimals.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Totheuser:

Thisproductcontainsmineraloil.Accidentalinjection/selfinjectionmayresultinseverepainand

swelling,particularlyifinjectedintoajointorfinger,andinrarecasescouldresultinthelossofthe

affectedfingerifpromptmedicalattentionisnotgiven.

Ifyouareaccidentallyinjectedwiththisproduct,seekpromptmedicaladviceevenifonlyavery

smallamountisinjectedandtakethepackageinsertwithyou.Ifpainpersistsformorethan12hours

aftermedicalexamination,seekmedicaladviceagain.

Tothephysician:

Thisproductcontainsmineraloil.Evenifsmallamountshavebeeninjected,accidentalinjectionwith

thisproductcancauseintenseswelling,whichmay,forexample,resultinischaemicnecrosisandeven

thelossofadigit.Expert,PROMPT,surgicalattentionisrequiredandmaynecessitateearlyincision

andirrigationoftheinjectedarea,especiallywherethereisinvolvementoffingerpulportendon.

4.6 Adversereactions(frequencyandseriousness)

Vaccinationmayinduceatransientoedema(atmost3cm)lastinggenerallylessthanoneweekand

smalllocalreaction(granulomas),withoutanyeffectonthehealthandthereproductiveperformance

oftheanimal.Largerreactions(upto7cmdiameter)havebeenobservedoccasionallyafterfrequently

repeatedrevaccinations.Vaccinationmayrarelycausehypersensitivityreactions.Insuchcases,an

appropriatesymptomatictreatmentshouldbecarriedout.

4.7 Useduringpregnancy,lactationandlay

Canbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Dataareavailablewhichdemonstratethatthisvaccinecanbeadministratedonasamedayina

separatesite,withinactivatedvaccinesagainstparvovirosis,influenzaandAujeszky’sdiseaseasno

adverseeffectontheserologicalresponsehasbeenobserved

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproductexcepttheproductsmentionedabove.Adecisiontousethisvaccine

beforeorafteranyotherveterinarymedicinalproductthereforeneedstobemadeonacasebycase

basis.

4.9 Amountstobeadministeredandadministrationroute

Applyusualasepticprocedures.

Onedoseof2mlisadministeredbydeepintramuscularroute,intheneckmusclesbehindtheear,

accordingtothefollowingvaccinationscheme:

Primaryvaccination:

Gilts: 2injections3–4weeksapart,atleast3weeksbeforemating.

Sows: 2injections3–4weeksapart(vaccinationofallthesowsoftheherdwithinashort

periodisrecommended).

Revaccination:

Oneinjectionat60-70daysofeachgestation,asofthefirstgestationfollowingtheprimary

vaccination.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Afteradministrationofadoubledose,noadversereactionsotherthanthosedescribedinsection4.6

wereobserved.

4.11Withdrawalperiod

Zerodays.

5. IMMUNOLOGICALPROPERTIES

ATCVetcode:QI09AA05.

ThevaccinecontainsinactivatedPRRSvirusinanoilyadjuvant.Itisintendedtostimulateimmunity

againstPRRSvirus.Theefficacywasdemonstratedunderfieldconditionsduringfieldtrials.Whereas

noeffectorimmunomechanismonprotectionhasbeenshown,theuptakeofthevaccinehasbeen

demonstratedbytheproductionofspecificanti-PRRSIFAantibodiesinvaccinatedanimals.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Hydrogenatedpolyisobutene

Polyoxyethylenefattyacids

Etheroffattyalcoholsandofpolyols

Benzylalcohol

Triethanolamine

Potassiumchloride

Sodiumchloride

Potassiumdihydrogenphosphate

Disodiumphosphatedihydrate

Magnesiumchloride

Calciumchloride

Waterforinjections

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelf-lifeafterfirstopeningthevial: Useimmediatelyafteropening.

6.4 Specialprecautionsforstorage

Storeinarefrigerator(2°Cto8°C).

Donotfreeze.

Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Natureofprimarypackagingelements:

- TypeIglassbottle

- Nitrilelastomerclosure

- Aluminiumcap

Packagingintendedforsale:

- Boxof1bottleof5doses

- Boxof10bottlesof5doses

- Boxof1bottleof10doses

- Boxof10bottlesof10doses

- Boxof1bottleof25doses

- Boxof10bottlesof25doses

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Tobecompletedbylocalaffiliate

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletedbylocalaffiliate

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: Tobecompletedbylocalaffiliate

Dateoflastrenewal: Tobecompletedbylocalaffiliate

10. DATEOFREVISIONOFTHETEXT

Tobecompletedbylocalaffiliate

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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

29-6-2018

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Active substance: Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)4166 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/3796/II/7

Europe -DG Health and Food Safety

9-2-2018

Suvaxyn Circo (Zoetis Belgium S.A.)

Suvaxyn Circo (Zoetis Belgium S.A.)

Suvaxyn Circo (Active substance: Porcine circovirus vaccine (inactivated, recombinant)) - New authorisation - Commission Decision (2018)861 of Fri, 09 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4242

Europe -DG Health and Food Safety