Spirovac

Main information

  • Trade name:
  • Spirovac
  • Pharmaceutical form:
  • Injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Spirovac
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Leptospira vaccine
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0284/001
  • Authorization date:
  • 21-07-2011
  • EU code:
  • UK/V/0284/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:October2011

AN:00139/2010

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Spirovac

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachdose(2ml)ofSpirovaccontainsthefollowing:

Activesubstances:

InactivatedLeptospiraborgpeterseniiserovarHardjo ≥2RP*

*RP=ELISARelativePotency.

Adjuvant

Aluminiumhydroxide 3.0to3.6mgofaluminium

Excipients

Formaldehyde <1mg

Thiomersal max0.01%(w/v)

SeeSection6.1forfulllistofexcipients.

3. PHARMACEUTICALFORM

Suspensionforinjection.Slightlycolouredturbidliquidwhichmightcontaina

loosesediment.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattlefrom4weeksofage.

4.2 Indicationsforuse,specifyingthetargetspecies

Foractiveimmunisation

-ofcattletopreventkidneycolonisationandsheddingofLeptospira

borgpeterseniiserovarHardjoinurine;a3weeksonsetofimmunityand12

monthsdurationofprotectionhavebeendemonstratedbychallengewith

LeptospiraborgpeterseniiserovarHardjo.

-ofcattlepersistentlyinfectedwithLeptospiraborgpeterseniiserovarHardjo:

toreduceurinarysheddingofLeptospiraborgpeterseniiserovarHardjo

withoutclearanceofrenalcolonisation;thiseffectappears4weekspost

vaccinationanditsdurationisunknown.Theepidemiologicalsignificanceof

thereducedsheddinghasnotbeendemonstrated.

Thevaccinationmaynotpreventabortionincowsinwhichplacentalinfection

hasalreadyoccurred.

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4.3 Contraindications

None.

4.4 Specialwarningsforeachtargetspecies

Vaccinatedcattlemaybepositiveindiagnostictestsforleptospirosisand

thereforeunacceptableforexporttosomecountries.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

None.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

None.

4.6Adversereactions(frequencyandseriousness)

Adiffuseandoedematousswellingupto10cmindiameter,sometimes

sensitivetopalpation,couldoccurinupto40%ofanimalsandcanlastforup

to66daysaftercompletionofvaccination.Thereactiontosubsequent

vaccinationsandthereactioninpregnantanimals(see4.7)aremoremarked.

Theinjectionsitereactionmaybesensitivetopalpationtheweekfollowing

vaccinationandmaypersistasahardnoduleforseveralweeks.

Concurrentvaccinationwith(theinactivatedmonovalent)PregsureBVD

vaccine(fromthesamemanufacturer)andSpirovacmayincreasetheseverity

anddurationofthelocalreactiontoSpirovac.

4.7Useduringpregnancy,lactationorlay

Canbeusedduringpregnancyandlactation.Theswellingismoremarkedin

pregnantanimals.Adiffuseswellingofupto22cmindiametercanoccur

followingsecondinjection.Thiseffectismoremarkedforpregnantanimalsin

theirthirdtrimesterofpregnancy.

SafetyofconcurrentuseofSpirovacand(theinactivatedmonovalent)

PregsureBVDvaccine(fromthesamemanufacturer)hasonlybeen

demonstratedinafieldstudy.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Safetyandefficacydataareavailablewhichdemonstratethatthisvaccinecan

beadministeredonthesamedaybutnotmixedwith(theinactivated

monovalent)PregsureBVDvaccine(fromthesamemanufacturer)(see

section4.6.);noimpairmentoftheserologicalresponsetotheLeptospiraand

BVDcomponentswasobserved,butefficacywasnotestablishedby

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challengeforthese2componentsandcellmediatedimmunitytoLeptospira

wasnotinvestigated.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhen

usedwithanyotherveterinarymedicinalproductexcepttheproduct

mentionedabove.Adecisiontousethisvaccinebeforeorafteranyother

veterinarymedicinalproductthereforeneedstobemadeonacasebycase

basis.

4.9 Amountstobeadministeredandadministrationroute

Dose:2ml

Administration:

Bysubcutaneousinjection,preferablyintheneck.Shakethecontainerwell

beforewithdrawingthedose.

Basicvaccinationscheme:

2dosesofvaccineseparatedbya4to6weekinterval.

Revaccinationscheme:

Asingle2mldoseonanannualbasis.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadversedrugreactions,otherthanthoselistedinSection4.6,occurred

afteradministrationoftwicethenormaldose.Aspartofthenaturalresponse

followingvaccination,andfollowinganoverdoseoftwicethemaximumdose

ofthevaccine,areactivelymphadenopathyinthelocallymphnodeaswellas

productionofasubcutaneous,granulomatous,inflammatoryreactioncouldbe

visibleundertheskinforatleast2months.Thetotaldurationofthisreaction

intheunderlyingtissuesisnotknown.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

TostimulateanactiveimmunityagainstLeptospiraborgpeterseniiserovar

Hardjo.

Vaccinationinduceshumoralantibodyresponseandcell-mediatedimmunity

asmeasuredbyserologyandgamma-interferonproduction.Amarked,

statisticallysignificantdifferenceisalsoseenintheanamnesticresponse

followingasingleboostervaccinationorinfection(challenge)12monthsafter

primaryvaccination.

Astrongserologicalcross-reactivitypostvaccinationhasbeendemonstrated

againstLeptospirainterrogansserovarHardjo,acloselyrelatedspeciesinthe

Revised:October2011

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sameserovar.Thiswassustainedforatleast12monthsfollowingprimary

vaccination,andisalsoseenintheanamnesticresponsefollowingasingle

boostervaccination.Acattlechallengemodelisnotavailabletodocument

protection.

ATC V ETCODE : QI02AB03(Immunologicalsforbovidae,inactivatedbacterial

vaccines,Leptospira)

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Aluminiumhydroxide

Thiomersal

Formaldehyde

SodiumChloride

Waterforinjections

6.2Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelflifeafterfirstopeningtheimmediatepackaging:10hours.

6.4.Specialprecautionsforstorage

Storeandtransportrefrigerated(2°C-8°C).Donotfreeze.Protectfromlight.

6.5Natureandcompositionofimmediatepackaging

Container: 25doses(50ml)HDPEvialor

5doses(10ml)or25doses(50ml)GlasstypeIvials.

Closure: Chlorobutylstopperwithaluminiumoverseal.

OuterPackaging:Cardboardcartonwithpackageinsertleaflet.

Packsizes: 5or25doses(10or50ml).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

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7. MARKETINGAUTHORISATIONHOLDER

PfizerLimited

RamsgateRoad

Sandwich

Kent

CT139NJ

8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4240

9. DATEOFFIRSTAUTHORISATION

27 th

October2005

10. DATEOFREVISIONOFTHETEXT

October2011

There are no safety alerts related to this product.

25-10-2018

Canigen L4 (Intervet International B.V.)

Canigen L4 (Intervet International B.V.)

Canigen L4 (Active substance: Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas) - Centralised - Yearly update - Commission Decision (2018)7138 of Thu, 25 Oct 2018

Europe -DG Health and Food Safety