NOBIVAC FORCAT

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobivacForcat

(AT/DE:NobivacRCP-Chlam)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perdoseof1ml:

Lyophilisate:

Activesubstances:

liveattenuatedfelinecalicivirus,strainF9:

4.6log

PFU 1

;

liveattenuatedfelineherpesvirustype1,strainG2620A:

5.2log

PFU 1

;

liveattenuatedfelinepanleucopeniavirus,strainMW-1:

4.3log

CCID

;

liveattenuatedChlamydophilafelis,strainBaker:

2.3log

CCID

.

PFU:Plaque-FormingUnits

CCID

:CellCultureInfectiveDosis50%

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Lyophilisateandsolventforsuspensionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cats

4.2 Indicationsforuse,specifyingthetargetspecies

Activeimmunisationofcats:

toreducetheclinicalsignscausedbyinfectionwithfelinecalicivirusandfelineherpesvirustype1,

toreducetheseverityoftheclinicalsignscausedbyinfectionwithChlamydophilafelis,

topreventtheclinicalsigns,leucopeniaandvirusexcretioncausedbyinfectionwithfeline

panleucopeniavirus.

Onsetofimmunity:forFCVandFHV:4weeks;forFPLVandC.felis:3weeks.

DurationofimmunityforFCV,FHV,C.felis:1year,forFPLV:3years.

4.3 Contraindications

Seesection4.7

4.4 Specialwarnings

BecauseantimicrobialsmayinactivatetheliveC.felisvaccinestrain,systemicantimicrobialtherapy

shouldbeavoidedduringvaccinationandforatwoweekperiodafterwards.

Maternalantibodies,whichmaypersistuptotheageof9-12weeks,canhaveanegativeinfluenceon

theefficacyofvaccination.Inthepresenceofmaternalantibodies,vaccinationmaynotcompletely

preventtheclinicalsigns,leucopeniaandvirusexcretionfollowinganFPLVinfection,andmayreduce

theprotectionagainstaC.felisinfection.Insuchcaseswhereahighlevelofmaternallyderived

antibodiesisexpected,thevaccinationscheduleshouldbeplannedaccordingly.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Vaccinateonlyhealthyanimals.

TheC.felisvaccinestrainmaybeexcretedbyvaccinatedcatsformorethan21daysandmaybe

transmittedtonon-vaccinatedanimalswithoutinducingclinicalsigns.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Itisadvisedthatimmunodeficientpersonsorpersonstakingimmunosuppressivedrugsdonothandle

thisvaccine.OwnersshouldbemadeawarethatsomevaccinatedcatsmayexcreteC.felis.

Incaseofaccidentalselfinjection,seekmedicaladviceimmediatelyandshowthepackageleafletor

thelabeltothephysician,referringtothelivechlamydialcomponent.

4.6 Adversereactions(frequencyandseriousness)

Aslightpainfulswellingmaybeobservedattheinjectionsitefor1-2days.Aslighttransientrisein

bodytemperature(upto40°C)mayoccurfor1-2days.Insomecasessneezing,coughing,nasal

discharge,andaslightdullnessorreducedappetitemaybeobservedforupto2dayspostvaccination.

4.7 Useduringpregnancyandlactation

Donotuseduringpregnancyorlactation,astheproducthasnotbeentestedinpregnantorlactating

queens.LiveFPLviruscancausereproductiveproblemsinpregnantqueensandbirthdefectsinthe

progeny.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafteranyotherveterinary

medicinalproductthereforeneedstobemadeonacasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Use1mlsolventtoreconstitutethelyophilisate(=1singledose).

Administer1mlofthevaccineperanimalbysubcutaneousinjection.

Usesterileinjectionequipment,freefromtracesofdisinfectants.

Vaccinationschedule:

Basicvaccination:

Twosingledoseinoculations,3-4weeksapart.

Thefirstinoculationcanbegivenfromtheageof8-9weeksandthesecondinoculationfromtheage

of12weeks.(Seealsosection4.4)

Revaccination:

Asingledose(1ml)accordingtothefollowingschedule:

Revaccinationagainstfelinecalicivirus,felineherpesvirustype1andChlamydophilafelismustbe

giveneveryyear(withNobivacForcatorothervaccinescontainingtheF9,G2620orBakerstrains,

whereavailable).

Revaccinationagainstfelinepanleucopeniaviruscanbegiveneverythreeyears(withstrainMW-1as

inNobivacForcat,whereavailable).

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Atten-foldoverdose,aslightpainfulswellingmaybeobservedattheinjectionsitefor4-10days.

Aslighttransientriseintemperature(upto40.8°C)mayoccurfor1-2days.

Insomecasesgeneraldiscomfort,coughing,sneezing,transientlethargyandreducedappetitemaybe

observedforafewdayspostvaccination.

4.11Withdrawalperiod(s)

Notapplicable.

5. IMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Livebacterialandviralvaccineforcats

ATCvetcode:QI06AF01

Tostimulateactiveimmunityagainstfelinecalicivirus(FCV),felineherpesvirustype1(FHV,feline

rhinotracheitisvirus),felinepanleucopeniavirus(FPL)andChlamydophilafelis(formerlycalledfeline

Chlamydiapsittaci)incats.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lyophilisate

Gelatin

Sucrose

Disodiumphosphatedihydrate

Solvent

Disodiumphosphatedihydrate

Potassiumdihydrogenphosphate

Waterforinjections

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct,exceptdiluentsuppliedforusewiththe

product.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

-Lyophilisate:33months.

-Solvent:5years

Shelflifeafterreconstitutionaccordingtodirections:30minutes.

6.4.Specialprecautionsforstorage

Lyophilisate:Storeinarefrigerator(2°C-8°C).Donotfreeze.Protectfromlight.

Solvent:Storebelow25°Cifstoredseparatelyfromthelyophilisate.Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Lyophilisate:1dosevialofglasstypeI(Ph.Eur.)closedwithahalogenobutylrubberstopperand

sealedwithacodedaluminiumcap.

Solvent:1dosevialofglasstypeI(Ph.Eur.)closedwithahalogenobutylrubberstopperandsealed

withacodedaluminiumcap.

Packsizes:

Solventmaybepackedtogetherwiththelyophilisateorseparately:

Cartonboxwith5dosesoflyophilisateandsolvent

Cartonboxwith10dosesoflyophilisateandsolvent

Cartonboxwith25dosesoflyophilisateandsolvent

Cartonboxwith50dosesoflyophilisateandsolvent

Cartonboxwith5dosesoflyophilisateandcartonboxwith5dosesofsolvent

Cartonboxwith10dosesoflyophilisateandcartonboxwith10dosesofsolvent

Cartonboxwith25dosesoflyophilisateandcartonboxwith25dosesofsolvent

Cartonboxwith50dosesoflyophilisateandcartonboxwith50dosesofsolvent

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Disposeofwastematerialbyboiling,incineration,orimmersioninanappropriatedisinfectantapproved

forusebythecompetentauthorities.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

WimdeKörverstraat35

NL-5831ANBoxmeer

representedbythenationalcompaniesintheconcernedmemberstates.

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

28November2002/22December2010

10 DATEOFREVISIONOFTHETEXT

March2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

[5x,10x,25x,50x1dose]

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobivacForcat

(AT/DE:NobivacRCP-Chlam)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

perdose:

4.6log

pfuFCV(F9)

5.2log

pfuFHV-1(G2620A)

4.3log

CCID

FPLV(MW-1)

2.3log

CCID

C.felis(Baker)

3. PHARMACEUTICALFORM

Lyophilisateandsolventforsuspensionforinjection

4. PACKAGESIZE

5x1dose

10x1dose

25x1dose

50x1dose

5. TARGETSPECIES

Cats

6. INDICATION(S)

Livevaccineagainstfelinepanleucopeniavirus,calicivirus,herpesvirustype1andChlamydophila

felis.

7. METHODANDROUTE(S)OFADMINISTRATION

Subcutaneousinjection

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year}

Usewithin30minutesafterreconstitution.

11. SPECIALSTORAGECONDITIONS

Storeinarefrigerator.

Donotfreeze

Protectfromlight.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

NL-5831ANBoxmeer

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot{number}

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

[1dose]

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobivacForcat

(AT/DE:NobivacRCP-Chlam)

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

perdose:

4.6log

pfuFCV

5.2log

pfuFHV-1

4.3log

CCID

FPLV

2.3log

CCID

C.felis

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

1dose

4. ROUTE(S)OFADMINISTRATION

s.c.

5. WITHDRAWALPERIOD

Notapplicable

6. BATCHNUMBER

Lot{number}

7. EXPIRYDATE

EXP{month/year}

Usewithin30minutesafterreconstitution.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

PARTICULARSTOAPPEARONIMMEDIATEPACKAGING(LABEL)OFTHE

SOLVENT

[1dose]

NobivacSolvent

–sterilebufferedsolution

Speciesexpressedinwrittenwordsandbymeansofapictogram

1dose

EXP{month/year}

Lot{number}

Intervetlogo

B.PACKAGELEAFLET

PACKAGELEAFLET

NobivacForcat

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

IntervetInternationalBV

WimdeKörverstraat35

NL-5831ANBoxmeer

representedbythenationalcompaniesintheconcernedmemberstates

Manufacturerforthebatchrelease:

IntervetInternationalBV

WimdeKörverstraat35

NL-5831ANBoxmeer

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NobivacForcat

(AT/DE:NobivacRCP-Chlam)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Perdoseof1mlreconstitutedvaccine:

-Liveattenuatedfelinecalicivirus,strainF9:

4.6log

10 pfu 1

-Liveattenuatedfelineherpesvirustype1,strainG2620A:

5.2log

pfu 1

-Liveattenuatedfelinepanleucopeniavirus,strainMW-1:

4.3log

CCID

2

-LiveattenuatedChlamydophilafelis,strainBaker:

2.3log

CCID

pfu:plaqueformingunits

CCID

:Cellcultureinfectivedose50%

4. INDICATION(S)

Activeimmunisationofcats:

toreducetheclinicalsignscausedbyinfectionwithfelinecalicivirusandfelineherpesvirustype1

(felinerhinotracheitisvirus)

toreducetheseverityoftheclinicalsignscausedbyinfectionwithChlamydophilafelis(feline

Chlamydiapsittaci);

topreventtheclinicalsigns,leucopeniaandvirusexcretioncausedbyinfectionwithfeline

panleucopeniavirus.

Onsetofimmunity:forFCVandFHV:4weeks;forFPLVandC.felis:3weeks.

DurationofimmunityforFCV,FHV,C.felis:1year,forFPLV:3years.

5. CONTRAINDICATIONS

Donotuseduringpregnancyorlactation,astheproducthasnotbeentestedinpregnantorlactating

queens.LiveFPLviruscancausereproductiveproblemsinpregnantqueensandbirthdefectsinthe

progeny.

6. ADVERSEREACTIONS

Aslightpainfulswellingmaybeobservedattheinjectionsitefor1-2days.Aslighttransientrisein

bodytemperature(upto40°C)mayoccurfor1-2days.Insomecasessneezing,coughing,nasal

dischargeandaslightdullnessorreducedappetitemaybeobservedforupto2dayspostvaccination.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cats

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Use1mlsolventtoreconstitutethelyophilisate(=1singledose).

Administer1mlofthevaccineperanimalbysubcutaneousinjection.

Vaccinationschedule:

Basicvaccination:

Twosingledoseinoculations,3-4weeksapart.

Thefirstinoculationatcanbegivenfromtheageof8-9weeksandthesecondinoculationfromthe

ageof12weeks.

Revaccination:

Asingledose(1ml)accordingtothefollowingschedule:

Revaccinationagainstfelinecalicivirus,felineherpesvirustype1andChlamydophilafelismustbe

giveneveryyear(withNobivacForcatorothervaccinescontainingtheF9,G2620orBakerstrains,

whereavailable).

Revaccinationagainstfelinepanleucopeniaviruscanbegiveneverythreeyears(withstrainMW-1as

inNobivacForcat).

9. ADVICEONCORRECTADMINISTRATION

Usesterileinjectionequipment,freeformtracesofdisinfectants.

10. WITHDRAWALPERIOD

Notapplicable

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Lyophilisate:Storeinarefrigerator(2

C-8

C).Donotfreeze.Protectfromlight

Solvent:Storebelow25°Cifstoredseparatelyfromthelyophilisate.Donotfreeze.

Reconstitutedproduct:usewithin30minutes.

Donotuseaftertheexpirydatewhichisstatedonthelabel.

12. SPECIALWARNING(S)

BecauseantimicrobialsmayinactivatetheliveC.felisvaccinestrain,systemicantimicrobialtherapy

shouldbeavoidedduringvaccinationandforatwoweekperiodafterwards.

Maternalantibodies,whichmaypersistuptotheageof9-12weeks,canhaveanegativeinfluenceon

theefficacyofvaccination.Inthepresenceofmaternalantibodies,vaccinationmaynotcompletely

preventtheclinicalsigns,leucopeniaandvirusexcretionfollowinganFPLVinfection,andmayreduce

theprotectionagainstaC.felisinfection.Insuchcaseswhereahighlevelofmaternallyderived

antibodiesisexpected,thevaccinationscheduleshouldbeplannedaccordingly.

Vaccinateonlyhealthyanimals.

TheC.felisvaccinestrainmaybeexcretedbyvaccinatedcatsformorethan21daysandmaybe

transmittedtonon-vaccinatedanimalswithoutinducingclinicalsigns.

Itisadvisedthatimmunodeficientpersonsorpersonstakingimmunosuppressivedrugsdonothandle

thisvaccine.OwnersshouldbemadeawarethatsomevaccinatedcatsmayexcreteC.felis.

Incaseofaccidentalselfinjection,seekmedicaladviceimmediatelyandshowthepackageleafletor

thelabeltothephysician,referringtothelivechlamydialcomponent.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafteranyotherveterinary

medicinalproductthereforeneedstobemadeonacasebycasebasis.

Atten-foldoverdose,aslightpainfulswellingmaybeobservedattheinjectionsitefor4-10days.

Aslighttransientriseintemperature(upto40.8°C)mayoccurfor1-2days.

Insomecasesgeneraldiscomfort,coughing,sneezing,transientlethargyandreducedappetitemaybe

observedforafewdayspostvaccination.

Donotmixwithanyotherveterinarymedicinalproduct,exceptdiluentsuppliedforusewiththe

product.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriatedisinfectantapprovedfor

usebythecompetentauthorities.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Solventmaybepackedtogetherwiththelyophilisateorseparately:

Cartonboxwith5dosesoflyophilisateandsolvent

Cartonboxwith10dosesoflyophilisateandsolvent

Cartonboxwith25dosesoflyophilisateandsolvent

Cartonboxwith50dosesoflyophilisateandsolvent

Cartonboxwith5dosesoflyophilisateandcartonboxwith5dosesofsolvent

Cartonboxwith10dosesoflyophilisateandcartonboxwith10dosesofsolvent

Cartonboxwith25dosesoflyophilisateandcartonboxwith25dosesofsolvent

Cartonboxwith50dosesoflyophilisateandcartonboxwith50dosesofsolvent

Notallpacksizesmaybemarketed.