PORCILIS

Main information

  • Trade name:
  • PORCILIS M HYO
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PORCILIS M HYO
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Mycoplasma vaccine
  • Therapeutic area:
  • Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0158/001
  • Authorization date:
  • 18-11-2010
  • EU code:
  • FR/V/0158/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PorcilisMHyo,suspensionforinjection;

IT:PorsilisMHyo

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

perdoseof2ml

Activesubstance

InactivatedwholecellconcentrateofMycoplasmahyopneumoniaestrain11:

7.0log

Ab

titre*

Adjuvant:150mgdl- 

-tocopherylacetate

*Meanantibodytitre(Ab)obtainedafterinoculationofmicewitha1/20pigdose.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforinjection;whiteornearlywhite

4. CLINICALPARTICULARS

4.1 Targetspecies

Pig(finishingpigs)

4.2 Indicationsforuse,specifyingthetargetspecies

Forfinishingpigs:

Fortheactiveimmunisationofpigstoreducepulmonarylesionsduetoinfectionby

Mycoplasmahyopneumoniae.

Onsetofimmunity:2weeksafterthesecondinjection

Durationofimmunity:atleast20weeksafterthesecondinjection.

4.3 Contraindications

None

4.4 Specialwarnings

None

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Vaccinateonlyhealthyanimals.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackage

leafletorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Ameantransienttemperatureincreaseinbodytemperatureofabout0.3

C,inindividual

pigsupto2.0

C,mayoccuronthefirst1to2daysaftervaccination.Theanimalsreturn

tonormalthenextday.Atransientswelling/redness(max.diameter5cm)mayoccurat

theinjectionsitediminishingoveraperiodofmaximally14days.

Inisolatedcaseshypersensitivityreactionsmayoccur.

4.7 Useduringpregnancy,lactationorlay

Notapplicable

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Safetyandefficacydataareavailableinpigsfrom4weeksofageonwards,which

demonstratethatthisvaccinecanbemixedwithPorcilisPRRS.

TheproductliteratureofPorcilisPRRSshouldalsobeconsultedbeforeadministrationof

themixedproduct.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithany

otherveterinarymedicinalproductexcepttheproductmentionedabove.Adecisiontouse

thisvaccinebeforeorafteranyotherveterinarymedicinalproductthereforeneedstobe

madeonacasebycasebasis.Noinformationisavailableonthesafetyandefficacyofthe

useofPorcilisMHyomixedwithPorcilisPRRSinbreedinganimalsorduringpregnancy.

4.9 Amountstobeadministeredandadministrationroute

Intramuscularinjectioninpigsof2mlperanimalintheneckintheareabehindtheear.

Vaccinationscheme:

Vaccinatepigstwicewithathreeweekinterval.Thefirstinjectioncanbegivenfroman

ageof1weekonwards.

ForsimultaneoususewithPorcilisPRRSinfinishingpigsfrom4weeksofage(3weeks

afterpriming)thevaccinemaybeusedforreconstitutionshortlybeforevaccination.

Therebythefollowinginstructionsshouldbeused:

PorcilisPRRS PorcilisMHyo

10doses + 20ml

25doses + 50ml

50doses + 100ml

100doses + 200ml

Asingledose(2ml)ofPorcilisMHyomixedwithPorcilisPRRSisgivenintramuscularly

intheneck.

Beforeusingthevaccineallowittoreachroomtemperature(15-25

C)andshakewell

beforeuse.

Usesterilesyringesandneedles.

Avoidintroductionofcontamination.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadversereactionsotherthanalreadymentionedundersection“Adversereactions”have

beenobservedafteradministrationofadoubledose.

4.11Withdrawalperiod(s)

Zerodays

5. IMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Inactivatedbacterialvaccine

ATCvetcode:QI09AB13

PorcilisMHyoisaninactivatedbacterialvaccinecontainingwholecellconcentrateof

Mycoplasmahyopneumoniaestrain11.Thisantigenisincorporatedinanadjuvantbasedon

dl-α-tocopherylacetateinordertogiveaprolongedstimulationofimmunity.Theproduct

stimulatesthedevelopmentofactiveimmunityinpigsagainstMycoplasmahyopneumoniae.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

dlα-tocopherylacetate

Polysorbate80

Simethicone

Sodiumchloride

Sodiumdihydrogenphosphate

Disodiumhydrogenphosphate

Waterforinjection

6.2 Incompatibilities

DonotmixwithanyotherveterinarymedicinalproductexceptwithPorcilisPRRS.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:3hours.

ShelflifeaftermixingwithPorcilisPRRS:1hour(atroomtemperature)

6.4 Specialprecautionsforstorage

Storeinarefrigerator(2

C–8

C).Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Cardboardboxeswitheither1PETvialof20,50,100,200or250ml,5PETvialsof20,50,

100,200or250mlor10PETvialsof20,50,100,200or250ml.Vialsareclosedwitha

halogenobutylrubberstopperandacodedaluminiumcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V. Representedbythenationalcompanies

WimdeKörverstraat35 intheMemberStates

NL-5831ANBoxmeer

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

FR:28June2004

10. DATEOFREVISIONOFTHETEXT

November2010

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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Mirvaso (Galderma International)

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Rapiscan (GE Healthcare AS)

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Pelmeg (Cinfa Biotech S.L.)

Pelmeg (Cinfa Biotech S.L.)

Pelmeg (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)7894 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4700

Europe -DG Health and Food Safety

22-11-2018

Ozurdex (Allergan Pharmaceuticals Ireland)

Ozurdex (Allergan Pharmaceuticals Ireland)

Ozurdex (Active substance: dexamethasone) - PSUSA - Modification - Commission Decision (2018)7886 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1140/PSUSA/985/201801

Europe -DG Health and Food Safety

22-11-2018

Brintellix (H. Lundbeck A/S)

Brintellix (H. Lundbeck A/S)

Brintellix (Active substance: vortioxetine) - Centralised - Renewal - Commission Decision (2018)7896 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2717/R/19

Europe -DG Health and Food Safety

22-11-2018

Levetiracetam Hospira (Hospira UK Limited)

Levetiracetam Hospira (Hospira UK Limited)

Levetiracetam Hospira (Active substance: levetiracetam) - Centralised - Renewal - Commission Decision (2018)7895 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2783/R/18

Europe -DG Health and Food Safety

22-11-2018

NovoSeven (Novo Nordisk A/S)

NovoSeven (Novo Nordisk A/S)

NovoSeven (Active substance: Eptacog alfa (activated)) - Centralised - 2-Monthly update - Commission Decision (2018)7877 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000074/II/0104

Europe -DG Health and Food Safety

22-11-2018

Selincro (H. Lundbeck A/S)

Selincro (H. Lundbeck A/S)

Selincro (Active substance: nalmefene) - PSUSA - Modification - Commission Decision (2018)7889 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10120/201802

Europe -DG Health and Food Safety

22-11-2018

Neuraceq (Life Radiopharma Berlin GmbH)

Neuraceq (Life Radiopharma Berlin GmbH)

Neuraceq (Active substance: florbetaben (18F)) - Centralised - Renewal - Commission Decision (2018)7882 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2553/R/25

Europe -DG Health and Food Safety

22-11-2018

Vabomere (Rempex London Limited)

Vabomere (Rempex London Limited)

Vabomere (Active substance: meropenem/vaborbactam) - Centralised - Authorisation - Commission Decision (2018)7888 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4669/00

Europe -DG Health and Food Safety