Suiseng

Main information

Documents

Localization

  • Available in:
  • Suiseng
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Escherichia + Clostridium
  • Therapeutic area:
  • Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0324/001
  • Authorization date:
  • 16-12-2010
  • EU code:
  • UK/V/0324/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:December2010

AN:01077/2010

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SUISENG

Suspensionforinjectionforswine.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionperdose(2ml):

Activesubstances:

F4abfimbrialadhesinofE.coli ≥65%ER

60 *

F4acfimbrialadhesinofE.Coli ≥78%ER

70

F5fimbrialadhesinofE.coli ≥79%ER

50

F6fimbrialadhesinofE.coli ≥80%ER

LTEnterotoxoidofE.coli ≥55%ER

ToxoidClostridiumperfringens,typeC ≥35%ER

ToxoidClostridiumnovyi ≥50%ER

*%ERx:PercentageofimmunizedrabbitswithaXserologicalEIAresponse

Adjuvants:

Aluminiumhydroxidegel 0.5g

Ginsengextract(equivalenttoginsenosides) 4mg(0.8mg)

Excipient:

Benzylalcohol 30mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

White-yellowishsuspensionforinjection.

4. CLINICALPARTICULARS

4.1Targetspecies

Swine(sowsandgilts)

4.2Indicationsforuse,specifyingthetargetspecies

Piglets:Forthepassiveprotectionofneonatalpigletsbymeansoftheactive

immunisationofbreedingsowsandgiltstoreducemortalityandclinicalsignsof

neonatalenterotoxicosis,suchasdiarrhoeacausedbyenterotoxigenic

Escherichiacoli,whichexpressF4ab(K88ab),F4ac(K88ac),F5(K99)orF6

(987P)adhesins.

Thepersistenceoftheseantibodieshasnotbeenestablished.

Revised:December2010

AN:01077/2010

Page 2 of 5

ForthepassiveimmunisationofneonatalpigletsagainstNecroticEnteritisby

meansoftheactiveimmunisationofbreedingsowsandgiltstoinduce

seroneutralizing antibodiesagainsttheβ-toxinofClostridiumperfringenstypeC.

Thepersistanceofantibodieshasnotbeenestablished

Sowsandgilts:Foractiveimmunisationofbreedingsowsandgiltstoinduce

seroneutralizingantibodiesagainstα-toxinofClostridiumnovyi.Therelevanceof

theseroneutralizingantibodieswasnotexperimentallydetermined.

Antibodieshavebeendetected3weeksaftervaccinaton.Thepersistenceof

theseantibodieshasnotbeenestablished.

4.3Contraindications

None

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Onlyhealthyanimalsshouldbevaccinated.

Hypersensitivityreactionsmayoccurinsensitiveanimals.Intheeventofan

anaphylacticreactionappropriatetreatmentsuchasadrenalineshouldbe

administeredwithoutdelay.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Incaseofaccidentalself-injection,seekmedicaladviceandshowthepackage

leafletorthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

Asmallgranulomamayoccurinthemuscletissueattheinjectionsite.The

administrationofthevaccinecancausetheappearanceofasmall(lessthan3

cm),local,transitoryswelling(for24-48hours).Inafewcases(upto1%ofthe

animals),temporarysmallnodulescanbeobserved,whichdisappearwithin2-3

weeks.Thevaccinationmaycauseaslightincreaseinbodytemperaturefora

transientperiodaftervaccination(4-6hoursafterinjection).Rarely,anincreasein

rectaltemperaturehigherthan1.5ºC,lastinglessthan6hours,mayoccur.

4.7Useduringpregnancy,lactationorlay

Canbeusedduringpregnancyfrom6weeksbeforetheexpectedfarrowingdate.

Revised:December2010

AN:01077/2010

Page 3 of 5

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenused

withanyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebefore

orafteranyotherveterinarymedicinalproductthereforeneedstobemadeona

casebycasebasis.

4.9Amountstobeadministeredandadministrationroute

Intramuscular,intotheneckmuscles.

Swine:2ml/animal.

Thebasicvaccinationschemeconsistsoftwodoses:thefirstdoseat

approximately6weeksbeforefarrowingandaseconddoseatapproximately3

weeksbeforefarrowing.

Itisrecommendedthattheseconddoseshouldbegivenpreferablyonalternate

sides.

Revaccination:oneachsubsequentgestation,administeronedose3weeks

beforetheexpecteddateoffarrowing.

Itisadvisabletoadministerthevaccineatatemperaturebetween+15ºCand

+25ºC.

Shakebeforeuse.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noeffectsotherthanthoseindicatedundersection4.6.havebeenobserved

followingadministrationofadoubledose.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Stimulatesdevelopmentofprotectiveadhesin-specificEscherichiacoli

antibodiesandseroneutralizingantibodiesagainsttheheatlabile(LT)enterotoxin

ofEscherichiacoli,ClostridiumperfringenstypeCandClostridiumnovyi.

ATCvetCode:QI09AB08(Inactivatedbacterialvaccine:Escherichia

coli+Clostridialvaccine).

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Aluminiumhydroxidegel

Ginseng

Benzylalcohol

Simethicone

PBSsolution

Revised:December2010

AN:01077/2010

Page 4 of 5

6.2Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18months

Shelf-lifeafterfirstopeningtheimmediatepackaging:8-10hours.

6.4.Specialprecautionsforstorage

Storeandtransportrefrigerated(2ºCand8ºC).Protectfromlight.Donotfreeze.

6.5Natureandcompositionofimmediatepackaging

20ml,50mland100mlType-Icolourlessglassvials,closedwithtypeIrubber

stoppersandaluminiumcaps.

20ml,50ml,100mland250mlPETplasticvials,closedwithtypeIrubberstoppers

andaluminiumcaps.

Packsizes:

-Cardboardboxwith1glassorPETvialof10doses(20ml).

-Cardboardboxwith1glassorPETvialof25doses(50ml).

-Cardboardboxwith1glassorPETvialof50doses(100ml).

-Cardboardboxwith1PETvialof125doses(250ml).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

LABORATORIOSHIPRA,S.A.

Avda.LaSelva,135

17170-AMER(Girona)SPAIN

Tel.+34972430660

Fax.+34972430661

E-mail:hipra@hipra.com

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm

:17533/4009

Revised:December2010

AN:01077/2010

Page 5 of 5

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

05/11/2009

10.DATEOFREVISIONOFTHETEXT

December2010

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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FDA - U.S. Food and Drug Administration

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