Suvaxyn

Main information

  • Trade name:
  • Suvaxyn M. Hyo - Parasuis
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Suvaxyn M. Hyo - Parasuis
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Inactivated bacterial vaccines and antisera
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0279/001
  • Authorization date:
  • 23-02-2012
  • EU code:
  • UK/V/0279/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:November2012

AN:02051/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SuvaxynM.hyo –Parasuis,suspensionforinjectionforpigs.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances per2mldose

InactivatedMycoplasmahyopneumoniae,strainP-5722-3 RP * 1 –1.9

InactivatedHaemophilusparasuisserotype4,strain2170B RP * 1 –8.1

InactivatedHaemophilusparasuisserotype5,strainIA84-29755RP * 1 –3.4

*Relativepotencyascomparedtoareferenceinanin-vitroELISAassay

Adjuvant:

Carbopol941 4.0mg

Excipients:

Thiomersal 0.2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforinjection.

Semi-transparent,homogeneous,paleredsolution

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs(fatteners).

4.2 Indicationsforuse,specifyingthetargetspecies

Fortheactiveimmunisationofpigstoreducelunglesionscausedby

Mycoplasmahyopneumoniaeandtoreducelesionsandclinicalsignscaused

byHaemophilusparasuisserotypes4and5.

OnsetofimmunityagainstMycoplasmahyopneumoniaehasbeen

demonstratedoneweekaftersecondvaccination.

OnsetofimmunityagainstHaemophilusparasuisserotype4and5hasbeen

demonstrated3.5weeksaftersecondvaccination.

Durationofimmunitystudiesindicatethatthevaccineprotectsfor6monthsafter

thesecondvaccinationagainstMycoplasmahyopneumoniaeand

Haemophilusparasuisserotypes4and5.

Revised:November2012

AN:02051/2011

4.3 Contraindications

None.

4.4 Specialwarningsforeachtargetspecies

TheefficacyoftheH.parasuiscomponentsofthevaccinemaybereduceddue

tomaternalantibody(MDA)interference.

FieldstudieshaveshownthatmaternalantibodytitrestoH.parasuishave

droppedsignificantlyinmostcasesby3weeksofage.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Onlyhealthyanimalsshouldbevaccinated.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Inthecaseofaccidentalself-injection,seekmedicaladviceandshowthe

packageinsertorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Vaccinatedanimalsmaycommonlyexperienceamildinjectionsitereaction(up

to3.7cmindiameter)whichresolveswithin5days.Inrareoccasions,injection

sitereactionsofmorethan5cmindiametermaybeobserved.

Vaccinatedanimalsmaycommonlyhaveamild,transitoryhyperthermiawhich

returnstonormalwithin24hours.Inrareoccasionshyperthermiacanbe

observedforalongerperiodoftime.

Inveryrarecases,anaphylacticreactionsmaybeobservedaftervaccination.

4.7 Useduringpregnancy,lactationorlay

Donotuseduringpregnancyorlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenused

withanyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebefore

orafteranyotherveterinarymedicinalproductthereforeneedstobedecidedon

acasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Thevaccineshouldbeshakenwellbeforeuse.

Administera2.0mldosebyintramuscularinjectionintheneck.Second

vaccinationshouldbeadministeredpreferablyatthealternatesideoftheneck.

Revised:November2012

AN:02051/2011

VaccinationSchedule:

Pigscanbevaccinatedfromtheageof7daysandolder.Asecondvaccination

shouldbegiven14-21dayslater.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Afteradministrationwithadoubledose,reactionsinpigsaresimilartothose

seenafteradministrationofasingledosebutmaypersistforlonger(upto11

days),andinjectionsitereactionsmaybelarger(inrareoccasionsover5cmin

diameter).

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

AninactivatedliquidvaccinetostimulateactiveimmunityagainstMycoplasma

hyopneumoniaeandHaemophilusparasuisserotypes4and5.

ATCVetcode:QI09AB17

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Thiomersal

Amaranth

Ethylenediaminetetraaceticacid

Sodiumchloride

Sodiumphosphatedibasic

Waterforinjections.

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelflifeafterfirstopeningtheimmediatepackaging:useimmediately.

6.4 Specialprecautionsforstorage

Storeandtransportrefrigeratedat2°C –8°C.

Storeprotectedfromlightintheoriginalcontainer.

Donotfreeze.

Revised:November2012

AN:02051/2011

6.5 Natureandcompositionofimmediatepackaging

Highdensitypolyethylenevials:

25mlvialcontaining10doses.

60mlvialcontaining25doses.

120mlvialcontaining50doses.

250mlvialcontaining125doses.

Packaging:Cardboardboxwith1or10highdensitypolyethylenevialsof25,60,

120or250mlwithachlorobutylrubberstopperandaluminiumcap.

Lowdensitypolyethylenesachet:

100mlsachetcontaining50doses.

Packaging:Cardboardboxwith1or10lowdensitypolyethylenesachetsof100

mlwithabromobutylrubberstopperandaluminiumcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLimited

RamsgateRoad

Sandwich

Kent

CT139NJ

8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4409

9. DATEOFFIRSTAUTHORISATION

March2006.

10. DATEOFREVISIONOFTHETEXT

November2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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