Duramune DAP+L

Main information

  • Trade name:
  • Duramune DAP+L
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Duramune DAP+L
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • live Canine distemper virus vaccine + live Canine adenovirus vaccine + live Canine parvovirus vaccine + inactivated Leptospira v
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0007/001
  • Authorization date:
  • 29-09-2011
  • EU code:
  • UK/V/0007/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:November2012

AN:00961/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEIMMUNOLOGICALVETERINARYMEDICINAL

PRODUCT

DuramuneDAP+L

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Qualitativecomposition

Combinedcaninedistempervirusvaccine(live),lyophilisate;canine

adenovirusvaccine(live),lyophilisate;canineparvovirosisvaccine

(live),lyophilisateandcanineleptospirosisvaccine(inactivated).

Quantitativecomposition

1.Lyophilisatefraction:

ActiveSubstances Per1mldose

CanineDistempervirus,strainOnderstepoort 10 2.5 to10 4.8 TCID

*

CanineAdenovirustype2,strainV197 10 4.8

to10 7.0

TCID

*

CanineParvovirus,strainSAH 10 4.7 to10 6.5 TCID

*

*TCID50=tissueculture50%infectivedose

Excipients

Nonegivingrisetosafetyconcerns.

Forafulllistofexcipients,seesection6.1.

2.Liquidsolventfraction:

ActiveSubstances Per1mldose

InactivatedLeptospirainterrogansbacteria

(outermembranecoat)

Serogroupcanicola,Serovarcanicola Potencyaccordingto

Ph.Eur.*

Serogroupicterohaemorrhagiae,serovar

icterohaemorrhagiae Potencyaccordingto

Ph.Eur.*

Adjuvants

Ethylene/Maleicanhydride(EMA) 0.01ml

NeocrylA640 0.03ml

Excipients

Forafulllistofexcipients,seesection6.1.

*hamster80%protectivedoseaccordingtoPh.Eur.

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3. PHARMACEUTICALFORM

Lyophilisateandsolventforsuspensionforinjection.

Lyophilisate:Cream-yellowcolourpowder

Solvent:OpaqueWhiteliquid

Reconstitutedvaccine:orangeoryellowishcolourwithlight

opalescence

4. CLINICALPARTICULARS

4.1 TargetSpecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Fortheactiveimmunisationofdogstopreventmortalityanddisease

causedbycaninedistempervirusandcanineparvovirus;toprevent

mortalityandreduceclinicalsignsduetoinfectiouscaninehepatitis

andLeptospirainterrogans,serogroupsicterohaemorrhagiaeand

canicola;andtoreduceclinicalsignsandinfectioncausedbycanine

adenovirus2.

Theonsetofimmunityisfromtwoweeksafterthesecondvaccination.

Thedurationofimmunityisthreeyearsforthecaninedistempervirus,

canineadenovirus,andcanineparvovirusfractions.Thedurationof

immunityisoneyearfortheleptospirafractions.

4.3 Contraindications

Seesection4.7.

4.4 Specialwarnings

Thelivevaccinestrainsofcanineadenovirustype2(strainV197)and

canineparvovirus(strainSAH)mayspreadtounvaccinatedanimals,

butdonotcausedisease.

Animals that have received immunosuppressive drugs (e.g.

glucocorticoids)shouldnotbevaccinateduntilanintervalofatleast

4weekshaselapsed.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

TheefficacyoftheCDV,CPVandCAVcomponentsofthevaccine

maybereducedduetomaternalantibodyinterference.However,the

vaccinehasbeenproventobeofbenefitagainstvirulentchallengein

thepresenceofmaternalantibodylevelstoCDV,CAVandCPVthat

Revised:November2012

AN:00961/2011

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arelikelytobeencounteredunderfieldconditions.Insituationswhere

higherMDAlevelsareexpectedthevaccinationprotocolshouldbe

plannedaccordingly.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Incaseofaccidentalselfinjection,seekmedicaladviceimmediately

andshowthepackageleafletorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Followingthefirstvaccination,itisverycommonforpuppiestodevelop

asmallvisibleswelling(<2cm)lastingforgenerallyonlytwodays.

Followingthesecondvaccination,itisverycommonforasmallvisible

swelling(upto5cm)tobeseenattheinjectionsite,whichmaylastfor

uptofivedays.Theswellingmaybepainfulfor1to2days.

Inmostcases,thesesmallandtransientinjectionsitereactionsresolve

withnoneedfortreatment.

Inveryrarecases,typeIhypersensitivityreactions(facialoedema,

urticaria,anaphylacticreaction),vomitinganddiarrhoeamaybe

observedaftervaccination.Intheeventofanallergicoranaphylactic

reaction,immediateappropriatesymptomatictreatmentshouldbe

given.

4.7 Useduringpregnancy,lactationandlay

Donotuseinpregnantorlactatingbitches.

4.8 Interactionswithothermedicinalproductsandotherformsof

interaction

Noinformationisavailableonthesafetyandefficacyofthisvaccine

whenusedwithanyotherveterinarymedicinalproduct.Adecisionto

usethisvaccinebeforeorafteranyotherveterinarymedicinalproduct

thereforeneedstobemadeonacasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Thevaccineistobeadministeredsubcutaneouslytodogsoftheageof

6weeksandolder.

Asepticallyreconstitutethecontentsofthelyophilisatevialusingthe

liquidvaccine.Shakewellbeforeuse.Theentirecontentsofthe

reconstitutedvialshouldbeadministeredasasingledose.

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Puppies6-10weeksofage

Theinitialvaccinationcourseconsistsoftwovaccinations.Thefirst

vaccinationshouldbegivenbetween6-8weeksofageandthesecond

vaccinationshouldbegivenfrom10weeksofage.

Puppiesofatleast10weeksofage

Twovaccinationsshouldbegivenwithanintervalof2-4weeks

betweendoses.

Boostervaccination

Administerasingledosebysubcutaneousinjectiononeyearafter

completionoftheprimaryvaccinationschedule.Subsequentbooster

vaccinationsshouldbeadministeredatintervalsofnotlessthanone

yearandnotmorethanthreeyears.Ifintervalslongerthanoneyear

areimplemented,immunityagainsttheleptospiralantigensshouldbe

assuredbyadministeringasuitableL.icterohaemorrhagiaeand

L.canicolavaccineatintervalsofnotmorethanoneyear.

4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Somepuppiesmayexhibitatransientlethargyby4hourspost

vaccinationbutrecoverbytwodayspostvaccination.Asmallvisible

swelling(<5cm)mayverycommonlybeseenattheinjectionsite,

whichmaylastforupto17days.Transientmildhyperthermialasting

notmorethan24hoursmayverycommonlybeseenindogsgivenan

overdose.

4.11Withdrawalperiod(s)

Notapplicable.

5. IMMUNOLOGICALPROPERTIES

Tostimulateactiveimmunityagainstcaninedistempervirus,canine

adenovirus,canineparvovirus,Leptospirainterrogansserogroup

canicolaandLeptospirainterrogansserogroupicterohaemorrhagiae.

ATCVetCode:QI07AI03

Revised:November2012

AN:00961/2011

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6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

1.Lyophilisatefraction:

Sucrose

Gelatin

Bactopeptone

Potassiumphosphatedibasic

Potassiumphosphatemonobasic

Potassiumhydroxide

Eagle’sEarle’smediumwithHEPES

HydrogenChlorideorSodiumHydroxideforpHcorrection

2.Liquidsolventfraction:

Ethylene/Maleicanhydride(EMA)

NeocrylA640

Sodiumchloride

Sodiumphosphatedibasic

Potassiumphosphatemonobasic

Waterforinjections

HydrogenChlorideorSodiumHydroxideforpHcorrection

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproductexceptthe

solventvaccinesuppliedforusewiththeproduct

6.3 Shelflife

Shelflifeoftheveterinaryproductaspackagedforsale:15months

Shelflifeafterreconstitutionaccordingtodirections:Useimmediately.

6.4 Specialprecautionsforstorage

Storeandtransportrefrigerated(+2°C-+8°C).

Protectfromlight.

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

LyophilisateFraction

Vial: TypeI(Ph.Eur.)glass.3mlcapacity

Closure:TypeI(Ph.Eur.)greyorredbromobutylrubberstoppers

sealedwithaluminiumcrimpcaps

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AN:00961/2011

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LiquidsolventFraction

Vial: High-densitypolypropylene.

Contents: 1mlina3mlinjectionvial.

Closure: Chlorobutylsnap-onrubberstopperswithcentrehole

capssealedwithaluminiumcrimpcaps.

PackSizes

Packswith10,25,50or100x1mldoses.Eachdoseisacombination

ofonevialoflyophilisatevaccineandonevialofliquidvaccine.

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinary

medicinalproductorwastematerialsderivedfromtheuseofsuch

products

Disposeofwastematerialbyboiling,incinerationorimmersioninan

appropriatedisinfectantapprovedforusebythecompetentauthorities.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLimited

RamsgateRoad

Sandwich

Kent

CT139NJ

8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4306

9. DATEOFFIRSTAUTHORISATION

01February2007

10. DATEOFREVISIONOFTHETEXT

November2012

Approved: 30/11/2012

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