Covexin 10

Main information

Documents

Localization

  • Available in:
  • Covexin 10
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Cattle, Sheep

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0201/001
  • Authorization date:
  • 11-03-2011
  • EU code:
  • UK/V/0201/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:June2013

AN:00069/2013

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Covexin10SuspensionforInjectionforSheepandCattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveIngredients Potencyvalue/mL

C.perfringenstypeAtoxoid

0.5U #

C.perfringenstypeB&C( β)

toxoid

18.2IU*

C.perfringenstypeD( ε)toxoid

5.3IU*

C.chauvoeiwholeculture meetsPhEur.**

C.novyitoxoid

3.8IU*

C.septicumtoxoid

4.6IU*

C.tetanitoxoid

4.9IU*

C.sordelliitoxoid

4.4U 1

C.haemolyticumToxoid

17.4U #

Adjuvant

Alum 3.03 –4.09mg/mLAluminium

Preservative

Thiomersal 0.05 –0.18mg/mL

Excipientto1ml

Formaldehyde

0.5mg/mL

*ELISAAccordingtoPh.Eur

**ChallengetestaccordingtoPh.Eur.

1

InHouseELISA

Invitrotoxinneutralisationtestbasedonhaemolysisofsheeperythrocytes.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforinjection

Lightbrownaqueoussuspensionthatsettlesonstorage

4.CLINICALPARTICULARS

4.1Targetspecies

Sheepandcattle

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4.2Indicationsforuse,specifyingthetargetspecies

Fortheactiveimmunisationofsheepandcattleagainstdiseasesassociatedwith

infectionscausedbyClostridiumperfringenstypeA,C.perfringenstypeB,C.

perfringenstypeC,C.perfringenstypeD,Clostridiumchauvoei,Clostridiumnovyi

typeB,Clostridiumsepticum,ClostridiumsordelliiandClostridiumhaemolyticumand

againsttetanuscausedbyClostridiumtetani.

Forthepassiveimmunisationoflambsandcalvesagainstinfectionscausedbythe

abovementionedclostridialspecies(exceptC.haemolyticuminsheep).

Theonsetofimmunityistwoweeksaftertheprimarycourse.

Durationofactiveimmunity

Ananamnestichumoralimmuneresponse(immunologicalmemory)toall

componentswasdemonstrated12monthsfollowingtheprimarycourseof

vaccination.

Asdemonstratedbyserology/persistentantibodytitreonly:

Sheep:12monthsagainstC.perfringenstypeA,B,CandD,C.novyitypeB,C.

sordellii,C.tetani

<6monthsagainstC.septicum,C.haemolyticum,C.chauvoei

Cattle:12monthsagainstC.tetaniandC.perfringenstypeD

<12monthsagainstC.perfringenstypeA,BandC

<6monthsagainstC.novyitypeB,C.septicum,C.sordellii,C.haemolyticum,C.

chauvoei

Durationofpassiveimmunityasdemonstratedbyserology/persistentantibodytitre

onlyis

Forlambs:

Atleast2weeksforC.septicumandC.chauvoei,atleast8weeksforC.perfringens

typeBandC.perfringenstypeCandatleasttwelveweeksforC.perfringenstypeA,

C.perfringenstypeD,C.novyitypeB,C.tetaniandC.sordellii.Nopassive

immunitywasobservedforC.haemolyticum.

Forcalves:

Atleast2weeksforC.sordellii,andC.haemolyticum,atleast8weeksforC.

septicumandC.chauvoeiandatleasttwelveweeksforC.perfringenstypeA,C.

perfringenstypeB,C.perfringenstypeC,C.perfringenstypeD,C.novyitypeB,and

C.tetani.

4.3Contraindications

None

4.4Specialwarnings

Theeffectivenessofthevaccineinprovidingpassiveimmunitytoyounglambsand

calvesdependsontheseanimalsingestingadequateamountsofcolostrumonthe

firstdayoflife.

Clinicaltrialshavedemonstratedthatthepresenceofmaternalantibodies,

particularlyagainstC.tetani,C.novyitypeB,C.perfringenstypeA(calvesonly),C.

chauvoei(lambsonly)andC.perfringenstypeDmayreducetheantibodyresponse

tovaccinationinyounglambsandcalves.Therefore,toensureanoptimal

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responseinyounganimalswithhighlevelsofMDA,theprimaryvaccinationshould

bedelayeduntilthelevelswane(whichisafterabout8-12weeksofage,seesection

4.2).

4.5Specialprecautionsforuse

i Specialprecautionsforuseinanimals

Intheeventofananaphylacticreactionappropriatetreatmentsuch

asadrenalineshouldbeadministeredwithoutdelay.

Donotvaccinatesickorimmunodeficientanimals.

iiSpecialprecautionstobetakenbythepersonadministering

theveterinarymedicinalproducttoanimals

Incaseofaccidentalself-injection,seekmedicaladviceimmediately

andshowthepackageleafletorthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

75-100%ofanimalsvaccinatedwithCovexin10mayexperiencereactionsto

vaccination.Thesereactionsareusuallylocalisedswellingorindurationatthe

injectionsitebutmayalsoincludemildhyperthermia,abscessorotherreactioninthe

underlyingtissuesattheinjectionsite.

Swellingattheinjectionsiteoccursinthemajorityofanimals.Thismayreachuptoa

meanvalueof6cminsheepand15cmdiameterincattle;occasionallyreactionsof

upto25cmdiametermaybeseenincattle.Mostlocalreactionsresolvewithin3-6

weeksinsheepandinlessthan10weeksincattle,butmaypersistlongerina

minorityofanimals.Anabscessmaydevelopinsomeanimals.Vaccinationmaygive

risetoreactionsintheunderlyingtissuesattheinjectionsite.

Skindiscolourationattheinjectionsite(whichreturnstonormalasthelocaleaction

resolved)mayoccur.Localisedpainattheinjectionsitefor1-2dayspostfirst

vaccinationmayoccur.

Thelocalreactionsdonotaffectthegeneralhealth,demeanour,feedingorweight

gainoftheanimals.

4.7Useduringpregnancy,lactationorlay

Pregnancy:

Nosideeffectsotherthanthosedescribedunder4.6wereseenwhenthevaccine

wasusedinsheepandcattlebetween8and2weekspriortoparturition.Inthe

absenceofspecificdata,norecommendationcanbemadeforuseofthevaccine

duringthefirstorsecondthirdofpregnancy.

Avoidstressinpregnantewesandcows.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwith

anyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafter

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anyotherveterinarymedicinalproductthereforeneedstobemadeonacaseby

casebasis.

4.9Amountstobeadministeredandadministrationroute

Sheep –from2weeksofage

Dose-1ml

Cattle –from2weeksofage

Dose –2ml

Administration:Bysubcutaneousinjectionatasuitablesite.Therecommendedsite

isthelooseskinonthesideoftheneck.

Thebottleshouldbewellshakenbeforeanyvaccineiswithdrawn.

Syringesandneedlesshouldbesterilebeforeuseandtheinjectionshouldbemade

throughanareaofclean,dryskintakingprecautionsagainstcontamination.

Primaryvaccination:Twodosesshouldbeadministered,4-6weeksapart(see

section4.2and4.4).

Boostervaccination:Asingledoseshouldbeadministeredat6to12monthintervals

(seealsopoint4.2).

Useinpregnancy

Toprovidepassiveprotectionoftheoffspring,viathecolostrum,asinglebooster

doseshouldbeadministeredbetween8and2weeksbeforeparturition,providedthat

animalshavereceivedafullprimaryvaccinationcoursebeforepregnancy.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incalvesandlambs,localreactionsmayincreaseslightlyiftwicetherecommended

doseisadministered(refertosection4.6)

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

ImmunologicalforBovidae:QI02AB01

ImmunologicalforOvidae:QI04AB01

TostimulateactiveimmunityinsheepandcattleagainstC.chauvoeiandthetoxins

ofClostridiumperfringenstypeA,C.perfringenstypeB,C.perfringenstypeC,C.

perfringenstypeD,C.novyi,C.septicum,C.tetani,C.sordellii,andC.haemolyticum

containedinthevaccine.

Toprovidepassiveimmunityviathecolostrumagainsttheaboveclostridialinfections

inyounglambsandcalves

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6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Alum

Thiomersal

Formaldehyde

SodiumChloride(0.85%solution)

6.2Incompatibilities

Donotmixwithanyothervaccine/immunologicalproduct.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:30months

Shelflifeafterfirstopeningtheimmediatepackaging:8hours

6.4.Specialprecautionsforstorage

Storeandtransportbetween+2°Cand+8°C.Protectfromlight.Donotfreeze.

6.5Natureandcompositionofimmediatepackaging

Cardboardboxwith1of50mlor100mlflexiblehighdensitypolyethylenebottleand

closedwithapharmaceuticalgraderubberbungheldinplacewithanaluminium

seal.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

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8.MARKETINGAUTHORISATIONNUMBER

Vm 00057/4282

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Date:10March2003

10.DATEOFREVISIONOFTHETEXT

Date:June2013

APPROVED 4/07/13