PROGRESSIS

Main information

  • Trade name:
  • PROGRESSIS
  • Pharmaceutical form:
  • Emulsion for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PROGRESSIS
    Spain
  • 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/0115/001
  • Authorization date:
  • 18-02-2010
  • EU code:
  • FR/V/0115/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

February2010

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Progressis.

Emulsionforinjectionforpigs(sowsandgilts)

NameinAustria:“Progressis-EmulsionzurInjektionfürSchweine“

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each2-mldoseofvaccinecontains:

Activesubstance:

InactivatedPorcineReproductiveandRespiratorySyndrome(PRRS)virus,

P120strain.....................................................................................................

2.5log10IF*units.

*IFunits:ImmunoFluorescenceantibodytitreobtainedafter2injectionsinpigsunderspecificlaboratory

conditions.

Adjuvant:

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

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Emulsionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs(sowsandgilts).

4.2 Indicationsforuse,specifyingthetargetspecies

ReductionofthereproductivedisorderscausedbyPorcineReproductiveandRespiratorySyndrome

virus(Europeanstrain)inacontaminatedenvironment:vaccinationreducesthenumberofearly

farrowingsandthenumberofstill-births.

4.3 Contraindications

None

4.4 Specialwarningsforeachtargetspecies

InPRRSinfectedherds,viralinfectionisheterogeneousandvariesovertime.Insuchcontext,the

implementationofavaccinationprogramisatooltoimprovethereproductiveparametersandmay

contributetothediseasecontrolinconjunctionwithsanitarymeasures.

4.5 Specialprecautionsforuse

February2010

Specialprecautionsforuseinanimals

Vaccinateonlyhealthyanimals.

Applyusualproceduresforthehandlingofanimals

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Totheuser:

Thisproductcontainsmineraloil.Accidentalinjection/selfinjectionmayresultinseverepainand

swelling,particularlyifinjectedintoajointorfinger,andinrarecasescouldresultinthelossofthe

affectedfingerifpromptmedicalattentionisnotgiven.

Ifyouareaccidentallyinjectedwiththisproduct,seekpromptmedicaladviceevenifonlyaverysmall

amountisinjectedandtakethepackageleafletwithyou.

Ifpainpersistsformorethan12hoursaftermedicalexamination,seekmedicaladviceagain.

Tothephysician:

Thisproductcontainsmineraloil.Evenifsmallamountshavebeeninjected,accidentalinjectionwith

thisproductcancauseintenseswelling,whichmay,forexample,resultinischaemicnecrosisandeven

thelossofadigit.Expert,PROMPT,surgicalattentionisrequiredandmaynecessitateearlyincision

andirrigationoftheinjectedarea,especiallywherethereisinvolvementoffingerpulportendon.

4.6 Adversereactions(frequencyandseriousness)

Vaccinationmayinduceatransientoedema(atmost3cm)lastinggenerallylessthanoneweekand

smalllocalreaction(granulomas),withoutanyeffectonthehealthandthereproductiveperformanceof

theanimal.Largerreactions(upto7cmdiameter)havebeenobservedoccasionallyafterfrequently

repeatedrevaccinations.Vaccinationmayrarelycausehypersensitivityreactions.Insuchcases,an

appropriatesymptomatictreatmentshouldbecarriedout.

4.7 Useduringpregnancy,lactationorlay

Canbeusedduringpregnancyandlactation

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Dataareavailablewhichdemonstratethatthisvaccinecanbeadministratedonasamedayina

separatesite,withinactivatedvaccinesagainstparvovirosis,influenzaandAujeszky’sdiseaseasno

adverseeffectontheserologicalresponsehasbeenobserved

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproductexcepttheproductsmentionedabove.Adecisiontousethisvaccine

beforeorafteranyotherveterinarymedicinalproductthereforeneedstobemadeonacasebycase

basis.

4.9 Amountstobeadministeredandadministrationroute

Applyusualasepticprocedures.

Onedoseof2mlisadministeredbydeepintramuscularroute,intheneckmusclesbehindtheear,

accordingtothefollowingvaccinationscheme:

February2010

Primaryvaccination:

Gilts:

2injections3-4weeksapart,atleast3weeksbeforemating.

Sows:

2injections3-4weeksapart(vaccinationofallthesowsoftheherdwithinashortperiodis

recommended).

Revaccination:

Oneinjectionat60-70daysofeachgestation,asofthefirstgestationfollowingtheprimary

vaccination.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Afteradministrationofadoubledose,noadversereactionsotherthanthosedescribedinsection4.6

wereobserved.

4.11Withdrawalperiod(s)

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

February2010

Do notmixwithanyotherveterinarymedicinalproduct.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelflifeafterfirstopeningthevial:useimmediatelyafteropening.

6.4.Specialprecautionsforstorage

Storeinarefrigerator(2

C–8

C).

Donotfreeze.

Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Natureofprimarypackagingelements:

- TypeIglassbottle

- Nitrilelastomerclosure

- Aluminiumcap

Packagingintendedforsale:

- Boxof1bottleof5doses

- Boxof10bottlesof5doses

- Boxof1bottleof10doses

- Boxof10bottlesof10doses

- Boxof1bottleof25doses

- Boxof10bottlesof25doses

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Tobecompletedbylocalcontact

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletedbylocalcontact

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: Tobecompletedbylocalcontact

Dateoflastrenewal: Tobecompletedbylocalcontact

February2010

10 DATEOFREVISIONOFTHETEXT

Tobecompletedbylocalcontact

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