Vanguard Lepto ci

Main information

  • Trade name:
  • Vanguard Lepto ci
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Vanguard Lepto ci
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Leptospira
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0345/001
  • Authorization date:
  • 02-10-2012
  • EU code:
  • UK/V/0345/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:February2012

AN:00662/2011

Page1of4

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VanguardLeptoci

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Quantityper1mldose

Activesubstances:

InactivatedLeptospiracanicola,atleast40hamsterprotectivedoses.

InactivatedLeptospiraicterohaemorrhagiae,atleast40hamsterprotective

doses.

SeeSection6.1forfulllistofexcipients.

3. PHARMACEUTICALFORM

Solutionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsfrom7weeksofage.

4.2 Indicationsforuse,specifyingthetargetspecies

ActiveimmunisationofdogstoreduceclinicalsignscausedbyLeptospira

canicolaandLeptospiraicterohaemorrhagiae.

Onsetofimmunityoccursbyapproximatelytwoweeksafterthelastdoseof

theBasicVaccinationScheme.

4.3 Contraindications

Donotuseinunhealthyanimals.

4.4Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

None.

Revised:February2012

AN:00662/2011

Page2of4

ii.Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Incaseofaccidentalself-injection,washtheareaimmediatelywith

water.Ifsymptomsdevelop,seekmedicalattentionshowingacopyof

theproductliterature.

4.6 Adversereactions(frequencyandseriousness)

Vaccinateddogsmayhaveatransientswelling(upto3cm)4-6hoursafter

vaccinationwhichresolvesafterapproximately7days.

AfterconcurrentormixedadministrationofVanguardLeptociand

VanguardR,vaccinateddogsmayhaveatransientswelling(upto6cm)

andatransientswellingofthesub-mandibularand/orpre-scapularlymph

nodesattheinjectionsite4hoursaftervaccinationwhichresolvewithin24

hours

Ifasystemicanaphylacticreactionoccurs(egvomiting),administer

adrenalineoranequivalent.

4.7 Useduringpregnancy,lactationorlay

Donotuseduringpregnancy .

4.8 Interactionwithothermedicinalproductsandotherformsof

interaction

Noinformationisavailableonthesafetyandefficacyfromtheconcurrent

useofthisvaccinewithanyotherexceptvaccinesfromtheVanguardrange

containingcaninedistempervirus,canineparvovirus,canineadenovirusor

canineparainfluenzavirusorVanguardR(whereauthorised).

Safetyandefficacydataareavailablewhichdemonstratethatthisvaccine

canbeadministeredonthesamedayasVanguardR(whereauthorised)

eithersimultaneously(mixedtogether)oratdifferentinjectionsites.

Adecisiontousethisvaccinebeforeorafteranyotherveterinarymedicinal

productneedstobedecidedonacasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Dosageandrouteofadministration:

Shakewellandimmediatelyinjecttheentirecontentsofthevial(1ml)

subcutaneously.Donotusechemicallysterilisedsyringesorneedles,as

thesewillinterferewiththeeffectivenessofthevaccine.

UsewithVanguardR

Tomixbothproducts,onevialofVanguardLeptocishouldbemixedwith1

mLofVanguardReitherintheVanguardRvialorthesyringe.VanguardR

willbewellshakenbeforeuse.Themixedvaccineswillbegentlyshaken

andthenadministeredimmediately.

Revised:February2012

AN:00662/2011

Page3of4

BasicVaccinationScheme:

Puppiesyoungerthan10weeksofage

TwodosesofVanguardLeptociatleast14daysapart.Thefirstdosecan

begivenasyoungas7weeksofage.Theseconddoseshouldnotbe

givenuntilatleast10weeksofage.

Puppies10weeksofageandolder

TwodosesofVanguardLeptociatleast14daysapart.

Re-vaccinationScheme:

AsingledoseofVanguardLeptocitobegivenannuallythereafter.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Occasionaltransientswellingsmayoccurattheinjectionsiteafter

vaccinationwithanoverdose.

Notreatmentisnecessaryinmostcasesofoverdose.However,ifa

systemicanaphylacticreactionoccurs(egvomiting),administeradrenaline

oranequivalent.

4.11Withdrawalperiod(s)

Notapplicable.

5. IMMUNOLOGICALPROPERTIES

Thevaccineisintendedfortheactiveimmunisationofhealthypuppiesand

dogsagainstdiseasescausedLeptospiracanicolaandLeptospira

icterohaemorrhagiae.

ATC V ETCODE : QI07AB01

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Phosphatebufferedsaline.

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproductotherthanthoseof

theVanguardrangecontainingcaninedistempervirus,canineparvovirus,

canineadenovirusorcanineparainfluenzavirusorVanguardR(where

authorised).

Revised:February2012

AN:00662/2011

Page4of4

6.3 Shelflife

4years.

6.4 Specialprecautionsforstorage

Storeandtransportat2°C –8°C.Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Thevaccineisfilledin1dosevialsglassTypeI(PhEur),closedwitha

chlorobutylrubberstopperandavarnishedaluminiumcap.

Packcontains1,10,25or100vialsof1mlVanguard ™Leptoci.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Disposeofwastematerialbyboiling,incinerationorimmersioninan

appropriatedisinfectantinaccordancewithnationalrequirements.

Anyunusedveterinarymedicinalproductsshouldbedisposedofin

accordancewithlocalrequirements

7. MARKETINGAUTHORISATIONHOLDER

PfizerLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

8. MARKETINGAUTHORISATIONNUMBER

Vm

00057/4168

9. DATEOFFIRSTAUTHORISATION

Date:25October2005

10. DATEOFREVISIONOFTHETEXT

Date:February2012

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