Heptavac P Plus

Main information

  • Trade name:
  • Heptavac P Plus
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Heptavac P Plus
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Clostridium vaccine + Pasteurella vaccine
  • Therapeutic area:
  • Sheep Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0121/001
  • Authorization date:
  • 14-07-2010
  • EU code:
  • UK/V/0121/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:July2010

AN:01235/2009

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

HeptavacPPlus(IT:HeptavacP)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances:

perml:

Clostridiumperfringens betatoxoidinducing≥10IU

Clostridiumperfringens epsilontoxoidinducing≥5IU

Clostridiumsepticum toxoidinducing≥2.5IU

Clostridiumtetani toxoidinducing≥2.5IU

Clostridiumnovyi toxoidinducing≥3.5IU

Clostridiumchauvoei cellsandequivalenttoxoidinducing≥0.5guineapigPD

Formalinkilledcellsoftheepidemiologicallymostimportantserotypesof

MannheimiahaemolyticaandPasteurellatrehalosigrownunderironrestricted

conditions:5x10 8 cellsperstrain

Adjuvant:

Aluminiumhydroxidegel400mg

Excipient:

Thiomersal0.13mg(preservative)

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Sheep.

4.2 Indicationsforuse,specifyingthetargetspecies

Fortheactiveimmunisationofsheepasanaidinthecontroloflambdysentery,

pulpykidney,struck,tetanus,braxy,blackleg,blackdisease,clostridialmetritis

causedbyClostridiumperfringenstypesB,CandD,Cl.septicum,Cl.novyi,

Cl.chauvoeiandCl.tetani.Thevaccinemaybeusedasanaidinthecontrolof

Revised:July2010

AN:01235/2009

Page2of6

pneumonicpasteurellosisinsheepofallagesfromaminimumageof3weeks

andinthecontrolofsystemicpasteurellosisinweanedfatteningandbreeding

sheep.

Thevaccinemaybeusedinpregnantewesasanaidinthecontroloflamb

dysentery,pulpykidney,tetanusandpasteurellosisintheirlambsprovidedthat

thelambsreceivesufficientimmunecolostrumduringthefirst1-2daysoflife.

4.3 Contraindications

None.

4.4 Specialwarningsforeachtargetspecies

HeptavacPPlusshouldnotbeusedinlambslessthan3weeksofage.The

nutritionalandmetabolicstatusofpregnantewesisextremelyimportantatthe

timeofvaccination.Ifindoubt,adviceshouldbesoughtfromaveterinary

surgeon.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Inanygroupofanimals,asmallnumberofindividualsmayfailtorespond

tovaccinationasaresultofimmunologicalincompetence.Satisfactory

immuneresponseswillonlybeattainedinhealthyanimals,thusitis

importanttoavoidvaccinationofanimalswhichhaveintercurrentinfection

ormetabolicdisorder.Aswithmostkilledvaccines,significantlevelsof

immunitycannotbeexpecteduntiltwoweeksaftertheseconddoseof

vaccineintheprimaryvaccinationcourse.

Whenhandlingsheep,stressshouldbeavoided,particularlyduringthe

laterstagesofpregnancywhenthereisariskofinducingabortionand

metabolicdisorders.

Becausesheepareverysensitivetocontaminationoftheinjectionsite

(whichmayresultinnon-productrelatedtissuereactionsandevenin

abscesses),itisadvisedtofollowstrictasepticinjectiontechniques.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Inthecaseofaccidentalself-injectionseekmedicaladviceimmediately

andshowthepackageleafletorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Occasionallyhypersensitivityreactionsmayoccur.Intheeventofananaphylactic

Revised:July2010

AN:01235/2009

Page3of6

reactionappropriatetreatmentshouldbeadministeredwithoutdelay.

Vaccinationmayresultinsmalltransientinjectionsitereactions,usually

characterisedbyswelling,possiblylastingforupto3-4monthsaftervaccination.

4.7 Useduringpregnancy,lactationorlay

Ewesmaybevaccinatedduringpregnancyasanaidinthecontroloflamb

dysentery,pulpykidney,tetanusandpasteurellosisintheirlambsprovidedthat

thelambsreceivesufficientimmunecolostrumduringthefirst1-2daysoflife.

Regardingthehandlingofpregnantsheepseealsosection4.5.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenused

withanyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebefore

orafteranyotherveterinarymedicinalproductthereforeneedstobemadeona

casebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Thevaccineshouldbeadministeredbysubcutaneousinjectioninthelateralside

oftheupperneckobservingasepticprecautions.Allbreedingsheepnot

previouslyvaccinatedwithHeptavacPPlusmustreceivetwoinjections,eachof

2.0ml,separatedbyanintervalof4-6weeks.Thereaftertheymustreceive

boosterinjectionsatintervalsofnotmorethan12months.Inadultbreedingewes

theseyearlyboosterinjectionsshouldbegivenduringthepre-lambingperiod,4-

6weekspre-lambing,asanaidincontrolofdiseaseintheirlambs.

Onfarmswheretheincidenceofpasteurellosisishigh,asupplementarybooster

injectionusingaPasteurellavaccinemayberequired2-3weekspriorto

expectedseasonaloutbreaks.

HeptavacPPlusshouldnotbeusedinlambslessthan3weeksofagedueto

thepossibleimmunologicalincompetenceoftheveryyounglamband

competitionfromanymaternallyderivedcolostralantibodies.Lambsbeing

retainedforfatteningorsubsequentbreedingwillrequireafullcourseof

vaccination.Ataminimumageof3weekstheselambsshouldreceivetwo

injections,eachof2.0ml,separatedbyanintervalof4-6weeks.Itshouldbe

notedthatHeptavacPPlusistherecommendedvaccineforbreedingstock

sinceitprovidesoptimalaidinthecontrolofthepredominantclostridialdiseases

inadultsheepbyactiveimmunisationandinyounglambsbypassive

immunisation.

Thevaccinebottlemustbeshakenwellbeforeuse.Theuseofautomatic

vaccinationequipmentisrecommended.Sincethebottleisnon-collapsible,a

vaccinatorwithaventeddraw-offspikeorsimilardevicemustbeused.The

instructionssuppliedwithsuchequipmentshouldbenotedandcareshouldbe

Revised:July2010

AN:01235/2009

Page4of6

takentoensurethedeliveryofthefulldose,particularlywiththefinalfewdoses

fromthebottle.

Thevaccinemaybeadministeredusingasterileneedleandsyringe,providinga

freshsterileneedleisusedeachtimetherubbercapispunctured,toavoid

contaminationoftheremainingcontents.Syringesandneedlesmustbefrom

gammairradiatedpacksorfreshlysterilisedbyboilingforatleast20minutes.

Noalcoholorotherdisinfectantsshouldbeusedforsterilisation.

EvidenceofefficacyofthePasteurella/MannheimiacomponentofHeptavacP

Pluswasgeneratedinanexperimentalinfectionmodelanditisnotpossibleto

providedurationofimmunityinformationusingthissystem.Therearereportsthat

activeimmunitywilllastforuptooneyearandthatpassiveimmunitywillpersist

forupto4weeksafterbirthinlambsfromewesvaccinatedwithconventional

Pasteurellavaccines.

HeptavacPPlushasbeendevelopedfollowingresearchanddevelopmentwhich

resultedintheapplicationofPlus‘IRP’technologyforthemanufactureofthe

Pasteurella/Mannheimiacomponentsofthisvaccine.TheinclusionoftheseIRP

componentsshouldprovideenhancedefficacyandcrossprotectione.g.

protectionagainstserotypeA12,whichisnotincludedinthevaccine,hasbeen

demonstrated.Studiesontheresponseofsheeptothisvaccineshowthattwo

injectionsseparatedbyanintervalof4-6weeksarerequiredtogainthefull

benefitofthe‘IRP’.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Accidentaloverdosageisunlikelytocauseanyreactionotherthandescribedin

section4.6.Noadverselocalorsystemicreactionswerenotedinoverdose

studies(doubledose)performedinpregnantewesandlambs.

4.11Withdrawalperiod

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Fortheimmunisationofsheepasanaidinthecontrolofclostridialdiseasesand

pasteurellosis.

ATCvetcode:QI04AB05

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Thiomersal,

Tris,

Maleicacid,

Revised:July2010

AN:01235/2009

Page5of6

Sodiumchloride,

Formaldehyde,

Water.

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelflife

Shelf-life:24months.

Onceopened,thevaccinemustbeusedwithin10hours.

6.4. Specialprecautionsforstorage

Storebetween+2

Cand+8

Cinthedark.Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Lowdensitypolyethylenecontainersof50,100,250or500mlwithrubberclosure

andaluminiumcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetUKLtd

WaltonManor

Walton

MiltonKeynes

Buckinghamshire

MK77AJ

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 01708/4468

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Date:17-12-2002/17-12-2007

10. DATEOFREVISIONOFTHETEXT

Revised:July2010

AN:01235/2009

Page6of6

Date:July2010

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.