NOBIVAC FORCAT

Main information

  • Trade name:
  • NOBIVAC FORCAT
  • Pharmaceutical form:
  • Powder and solvent for suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NOBIVAC FORCAT
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Feline panleucopenia virus / parvovirus vaccine + Feline rhinotracheitis virus vaccine + Feline calicivirus vaccine + Chlamydia
  • Therapeutic area:
  • Cats Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0114/001
  • Authorization date:
  • 30-03-2011
  • EU code:
  • NL/V/0114/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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.

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

22-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/mNsFqKTfFk

FDA - U.S. Food and Drug Administration