04-05-2012
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.