POULVAC PABAC IV

Main information

  • Trade name:
  • POULVAC PABAC IV
  • Pharmaceutical form:
  • Emulsion for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • POULVAC PABAC IV
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Pasteurella vaccine
  • Therapeutic area:
  • Chicken Females, Other Birds, Turkeys

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0182/001
  • Authorization date:
  • 24-07-2011
  • EU code:
  • FR/V/0182/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

POULVACPABACIV[POULVACiP(Spainonly)]emulsionforinjectioninchickens,

ducks,andturkeys

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perdoseof0.5ml

Activesubstances:

Pasteurellamultocida,strainX-73(serovar1 *

),inactivated min.70%survival(chickens) **

Pasteurellamultocida,strainP-1059(serovar3 * ),inactivatedmin.70%survival(turkeys) **

Pasteurellamultocida,strainP-1662(serovar4 * ),inactivatedmin.70%survival(turkeys) **

Pasteurellamultocida,strainCU(serovar3x4 * ),inactivated min.70%survival(turkeys) **

accordingtoHeddlestonclassification

invaccinatedbirds,followingvirulentchallenge,accordingtoPh.Eur.1945requirements

Adjuvant:

Lightliquidparaffin 0.325ml

Sorbitansesquioleate 0.025ml

Polysorbate80 0.004ml

Excipients:

Formaldehyde traces

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Emulsionforinjection

Whitecreamyemulsion,withnoextraneousparticles.

Aseparationoftheemulsioncanoccurovertime,leadingtoabiphasicappearancewherethe

upperlayerappearsasawhitetoanoff-whitemilkysuspensionandthebottomlayerappearsas

agreytotanaqueousphase.

4. CLINICALPARTICULARS

4.1 TargetSpecies

Chickens(futurelayingandfuturebreedinghens),DucksandTurkeys.

4.2 Indicationsforuse,specifyingthetargetspecies

Inchickens(futurelayingandfuturebreedinghens)andducks:

-activeimmunizationinordertoreducemortalitycausedbyPasteurellamultocida

serovar1(Heddlestonclassification).

Onsetofimmunityagainstserovar1isof2weeksfromadministrationofthesecond

dose.

Durationofimmunityisof16weekspostbasicvaccination(futurelayingandfuture

breedinghens)or9weekspostbasicvaccination(ducks).

Inturkeys:

-activeimmunizationinordertoreducemortalitycausedbyPasteurellamultocida

serovar3,4and3x4(Heddlestonclassification).

Onsetofimmunityagainstserovars3,4and3x4isof2weeksfromadministrationof

theseconddose.

Durationofimmunityisof6weekspostbasicvaccination.

4.3 Contra-indications

Donotvaccinateunhealthybirds.

Donotuseinbirdsinlay.

4.4 Specialwarningsforeachtargetspecies

Nospecificstudieshavebeenconductedinchickensandduckstodemonstrateefficacy

ofthevaccineagainstPasteurellamultocidaserovarsothersthan1.

Nospecificstudieshavebeenconductedinturkeystodemonstrateefficacyofthe

vaccineagainstPasteurellamultocidaserovarsothersthan3,4and3x4.

Noinformationisavailableonthepossibleinterferencesfromthepresenceofmaternal

antibodiesontheresponsetovaccinationwithPoulvacPabacIV.Itisthereforenot

recommendedtousethisvaccineinbirdswithmaternalantibodies.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

TOTHEUSER:

Thisproductcontainsmineraloil.Accidentalinjection/selfinjectionmayresultin

severepainandswelling,particularlyifinjectedintoajointorfinger,andinrarecases

couldresultinthelossoftheaffectedfingerifpromptmedicalattentionisnotgiven.

Ifyouareaccidentallyinjectedwiththisproduct,seekpromptmedicaladviceevenif

onlyaverysmallamountisinjectedandtakethepackageleafletwithyou.Ifpain

persistsformorethan12hoursaftermedicalexamination,seekmedicaladviceagain.

TOTHEPHYSICIAN:

Thisproductcontainsmineraloil.Evenifsmallamountshavebeeninjected,accidental

injectionwiththisproductthatcontainsoilcancauseintenseswelling,whichmay,for

example,resultinischaemicnecrosisandeventhelossofadigit.Expert,PROMPT,

surgicalattentionisrequiredandmaynecessitateearlyincisionandirrigationofthe

injectedarea,especiallywherethereisinvolvementoffingerpulportendon.

Otherprecautions

None

4.6 Adversereactions(frequencyandseriousness)

Inchickens:localreactionsintheformofpalpableswellingsmaybeobservedatthe

injectionsiteinallbirds.

Theseswellingscanbelarge(over3cm)and,insomebirds(atleast5%),thelocal

reactionsmaypersistformorethan4weeksaftervaccinationandtheendpointofthese

reactionsisnotknown.

Inturkeys:localreactionsintheformofpalpableswellingsmaybeobservedatthe

injectionsiteinallbirds.

Theseswellingscanbelarge(over4.5cm)and,insomebirds(atleast10%),thelocal

reactionsmaypersistformorethan4weeksaftervaccinationandtheendpointofthese

reactionsisnotknown.

Inducks:localreactionsintheformofpalpableswellingsmaybeobservedatthe

injectionsiteinallbirds.

Theseswellingscanbelarge(over6cm)and,insomebirds(atleast28%),thelocal

reactionsmaypersistformorethan4weeksaftervaccinationandtheendpointofthese

reactionsisnotknown.

Atransientreductioninweightgaincanbeobservedinchickens,ducksandturkeysfor

upto4weeksfollowingvaccination.

Thesereactionsdonotrequireanyparticulartreatment.

4.7 Useduringpregnancy,lactationorlaying

Donotuseinbirdsinlay.

4.8 Interactionswithothervaccinesandmedicinalproductswhenadministeredin

combinationwiththeproduct

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenused

withanyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebefore

orafteranyotherveterinarymedicinalproductthereforeneedstobemadeonacase

bycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Administration

Onedoseof0.5mlbysubcutaneousrouteonly(atthebaseoftheneck).

Beforeadministration,allowthevaccinetowarmtoroomtemperatureandshake

well.

Aseparationoftheemulsioncanoccurovertime,leadingtoabiphasicappearance.

Theupperlayerrepresentsthemajorityofthefinishedproductandappearsasa

whitetoanoff-whitemilkysuspension.Thebottomphaseisgreytotanand

appearsmoreaqueous.

Gentleshakingofthebottlewillallowtheproducttoreturntoahomogeneous

appearance.Thisminorseparationhasnoeffectonthesafetyorefficacyofthe

product.

Administerunderasepticconditions.

Vaccinationschedule

Chickens(futurelayingandfuturebreedinghens):

Firstinjectionat6weeks.

Booster:4weekslater.

Ducks:

Firstinjectionat3weeks.

Booster:3weekslater.

Turkeys:

Firstinjectionat6weeks.

Booster:4weekslater.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Adverseeffectsobservedaresimilartothosementionedinparagraph4.6after

administrationofadoubledose.However,persistentlargesizelocalreactionsare

obtainedinahigherproportionofbirdsafteradministrationofadoubledose.

4.11 Withdrawalperiod(s)

Zerodays

5. IMMUNOLOGICALPROPERTIES

Thevaccineinducesactiveimmunityagainstserovars1,3,4and3x4ofPasteurellamultocida.

ATCVetcode:QI01AB02

Inactivatedbacterialvaccines

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lightliquidparaffin

Sorbitansesquioleate

Polysorbate80

Formaldehyde

Sodiumchloride

Waterforinjections

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Usetheentirecontentofthebottleimmediatelyafterbroaching.

Theuseofaclosedmulti-doseinjectionsystemisrecommendedforadministrationof

theproducttominimisetheriskofcontamination.Anyunusedproductmustbe

discardedwithin3hoursofbroaching.

6.4 Specialprecautionsforstorage

Storeandtransportrefrigerated(2°C-8°C).Donotfreeze.Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Natureoftheprimarycontainers:

Highdensitypolyethylenebottle.

Chlorobutylstopper

Aluminiumcap.

Packaging:

Cartonboxof1bottleof1000doses.

Cartonboxof10bottlesof1000doses.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewiththe

localrequirements.

7. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

[MAHolder]

8. MARKETINGAUTHORISATIONNUMBER(S)

[MAnumber]

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

[date]

10. DATEOFREVISIONOFTHETEXT

[date]

ANNEXII

A. <MANUFACTURER(S)OFTHEBIOLOGICALACTIVESUBSTANCE(S)AND>

MANUFACTURINGAUTHORISATIONHOLDER(S)RESPONSIBLEFORBATCH

RELEASE

B. CONDITIONSORRESTRICTIONSOFTHEMARKETINGAUTHORISATION

REGARDINGSUPPLYORUSE

C. CONDITIONSORRESTRICTIONSOFTHEMARKETINGAUTHORISATIONWITH

REGARDTOSAFEANDEFFECTIVEUSE

D. STATEMENTOFTHEMRLs

E. SPECIFICOBLIGATIONSTOBEFULFILLEDBYTHEMARKETING

AUTHORISATIONHOLDER>

A. MANUFACTURER(S)OFTHEBIOLOGICALACTIVESUBSTANCE(S)AND>

MANUFACTURINGAUTHORISATIONHOLDER(S)RESPONSIBLEFORBATCH

RELEASE

<Nameandaddressofthemanufacturer(s)ofthebiologicalactivesubstance(s)

PfizerAnimalHealth

2000RockfordRoad,

CharlesCity,

Iowa50616

USA

Nameandaddressofthemanufacturer(s)responsibleforbatchrelease

PfizerOlot,S.L.U.

Ctra.Camprodons/n“LaRiba“

17813ValldeBianya

Girona

Spain

B. CONDITIONSORRESTRICTIONSOFTHEMARKETINGAUTHORISATION

REGARDINGSUPPLYORUSE

C. CONDITIONSORRESTRICTIONSOFTHEMARKETINGAUTHORISATIONWITH

REGARDTOTHESAFEANDEFFECTIVEUSEOFTHEPRODUCT

Notapplicable.

D. STATEMENTOFTHEMRLs

Notapplicable.

E. SPECIFICOBLIGATIONSTOBEFULFILLEDBYTHEMARKETING

AUTHORISATIONHOLDER

Notapplicable.

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

10x1000doses

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

POULVACPABACIVemulsionforinjectioninchickens,ducks,andturkeys

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

InactivatedPasteurellamultocidastrainX-73(serovar1),strainP-1059(serovar3),strainP-1662

(serovar4)andstrainCU(serovar3x4):min.70%survival.

Lightliquidparaffin,Sorbitansesquioleate,Polysorbate80,Formaldehyde(traces)

Excipientqs1doseof0.5ml

3. PHARMACEUTICALFORM

Emulsionforinjection.

4. PACKAGESIZE

Boxof10bottlesof1000doses(500ml).

5. TARGETSPECIES

Chickens(futurelayingandfuturebreedinghens),ducks,turkeys.

6. INDICATION(S)

Inchickens(futurelayingandfuturebreedinghens),ducksandturkeys:activeimmunizationinorder

toreducemortalitycausedbyPasteurellamultocida.

7. METHODANDROUTE(S)OFADMINISTRATION

Subcutaneous(atthebaseoftheneck).

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays.

9. SPECIALWARNING(S),IFNECESSARY

Accidentalinjectionisdangerous-readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP:

Useimmediatelyafterbroaching

11. SPECIALSTORAGECONDITIONS

Storeandtransportrefrigerated(2°C-8°C).

Protectfromlight.

Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:readpackageleaflet.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

PfizerAnimalHealth

….

16. MARKETINGAUTHORISATIONNUMBER(S)

………………….

17. MANUFACTURER’SBATCHNUMBER

Batch:

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

1x1000doses

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

POULVACPABACIVemulsionforinjectioninchickens,ducks,andturkeys

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

InactivatedPasteurellamultocidastrainX-73(serovar1),strainP-1059(serovar3),strainP-1662

(serovar4)andstrainCU(serovar3x4):min.70%survival.

Lightliquidparaffin,Sorbitansesquioleate,Polysorbate80,Formaldehyde(traces).

Excipientqs1doseof0.5ml

3. PHARMACEUTICALFORM

Emulsionforinjection.

4. PACKAGESIZE

Boxof1bottleof1000doses(500ml).

5. TARGETSPECIES

Chickens(futurelayingandfuturebreedinghens),ducks,turkeys.

6. INDICATION(S)

Inchickens(futurelayingandfuturebreedinghens),ducksandturkeys:activeimmunizationinorder

toreducemortalitycausedbyPasteurellamultocida.

7. METHODANDROUTE(S)OFADMINISTRATION

Subcutaneous(atthebaseoftheneck).

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays.

9. SPECIALWARNING(S),IFNECESSARY

Accidentalinjectionisdangerous-readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP:

Useimmediatelyafterbroaching

11. SPECIALSTORAGECONDITIONS

Storeandtransportrefrigerated(2°C-8°C).

Protectfromlight.

Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:readpackageleaflet.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

PfizerAnimalHealth

….

16. MARKETINGAUTHORISATIONNUMBER(S)

………………….

17. MANUFACTURER’SBATCHNUMBER

Batch:

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

1000doses

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

POULVACPABACIVemulsionforinjectioninchickens,ducks,andturkeys

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

InactivatedPasteurellamultocidastrainX-73(serovar1),strainP-1059(serovar3),strainP-1662

(serovar4)andstrainCU(serovar3x4):min.70%survival.

Lightliquidparaffin,Sorbitansesquioleate,Polysorbate80,Formaldehyde(traces).

Excipientqs1doseof0.5ml

3. PHARMACEUTICALFORM

Emulsionforinjection.

4. PACKAGESIZE

1000doses(500ml).

5. TARGETSPECIES

Chickens(futurelayingandfuturebreedinghens),ducks,turkeys.

6. INDICATION(S)

Inchickens(futurelayingandfuturebreedinghens),ducksandturkeys:activeimmunizationinorder

toreducemortalitycausedbyPasteurellamultocida.

7. METHODANDROUTE(S)OFADMINISTRATION

Subcutaneous(atthebaseoftheneck).

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays.

9. SPECIALWARNING(S),IFNECESSARY

Accidentalinjectionisdangerous-readpackageleafletbeforeuse.

10. EXPIRYDATE

EXP:

Useimmediatelyafterbroaching

11. SPECIALSTORAGECONDITIONS

Storeandtransportrefrigerated(2°C-8°C).

Protectfromlight.

Donotfreeze

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:readpackageleaflet.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

PfizerAnimalHealth

….

16. MARKETINGAUTHORISATIONNUMBER(S)

………………….

17. MANUFACTURER’SBATCHNUMBER

Batch:

B. PACKAGELEAFLET

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Manufacturingauthorisationholder:

PfizerAnimalHealth

Manufacturerforthebatchrelease:

PfizerOlot,S.L.U.

Ctra.Camprodons/n“LaRiba“

17813ValldeBianya

Girona

Spain

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

POULVACPABACIV

Emulsionforinjectioninchickens,ducks,andturkeys

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENTS

Whitecreamyemulsionwithnoextraneousparticles.

Perdoseof0.5ml:

Pasteurellamultocida,strainX-73(serovar1 * ),inactivated min.70%survival(chickens) **

Pasteurellamultocida,strainP-1059(serovar3 * ),inactivated min.70%survival(turkeys) **

Pasteurellamultocida,strainP-1662(serovar4 * ),inactivated min.70%survival(turkeys) **

Pasteurellamultocida,strainCU(serovar3x4 * ),inactivated min.70%survival(turkeys) **

accordingtoHeddlestonclassification

invaccinatedbirds,followingvirulentchallenge,accordingtoPh.Eur.1945requirements

Lightliquidparaffin 0.325ml

Sorbitansesquioleate 0.025ml

Polysorbate80 0.004ml

Formaldehyde traces

Excipient qs1dose(0.5ml)

4. INDICATIONS

Inchickens(futurelayingandfuturebreedinghens)andducks:

-activeimmunizationinordertoreducemortalitycausedbyPasteurellamultocidaserovar1

(Heddlestonclassification).

Onsetofimmunityagainstserovar1isof2weeksfromadministrationoftheseconddose.

Durationofimmunityisof16weekspostbasicvaccination(futurelayingandfuturebreedinghens)or

9weekspostbasicvaccination(ducks).

Inturkeys:

-activeimmunizationinordertoreducemortalitycausedbyPasteurellamultocidaserovar3,4and

3x4(Heddlestonclassification).

Onsetofimmunityagainstserovars3,4and3x4isof2weeksfromadministrationoftheseconddose.

Durationofimmunityisof6weekspostbasicvaccination.

5. CONTRA-INDICATIONS

Donotvaccinateunhealthybirds.

Donotuseinbirdsinlay.

6. ADVERSEREACTIONS

Inchickens:localreactionsintheformofpalpableswellingsmaybeobservedattheinjectionsiteinall

birds.

Theseswellingscanbelarge(over3cm)and,insomebirds(atleast5%),thelocalreactionsmay

persistformorethan4weeksaftervaccinationandtheendpointofthesereactionsisnotknown.

Inturkeys:localreactionsintheformofpalpableswellingsmaybeobservedattheinjectionsiteinall

birds.

Theseswellingscanbelarge(over4.5cm)and,insomebirds(atleast10%),thelocalreactionsmay

persistformorethan4weeksaftervaccinationandtheendpointofthesereactionsisnotknown.

Inducks:localreactionsintheformofpalpableswellingsmaybeobservedattheinjectionsiteinall

birds.

Theseswellingscanbelarge(over6cm)and,insomebirds(atleast28%),thelocalreactionsmay

persistformorethan4weeksaftervaccinationandtheendpointofthesereactionsisnotknown.

Atransientreductioninweightgaincanbeobservedinchickens,ducksandturkeysforupto4weeks

followingvaccination.

Thesereactionsdonotrequireanyparticulartreatment.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Chickens(futurelayingandfuturebreedinghens),ducks,turkeys.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Onedoseof0.5mlbysub-cutaneousrouteonly(atthebaseoftheneck).

Chickens(futurelayingandfuturebreedinghens):

Firstinjectionat6weeks.

Booster:4weekslater.

Ducks:

Firstinjectionat3weeks.

Booster:3weekslater.

Turkeys:

Firstinjectionat6weeks.

Booster:4weekslater.

9. ADVICEONCORRECTADMINISTRATION

Beforeadministration,allowthevaccinetowarmtoroomtemperatureandshakewell.

Aseparationoftheemulsioncanoccurovertime,leadingtoabiphasicappearance.Theupperlayer

representsthemajorityofthefinishedproductandappearsasawhitetoanoff-whitemilkysuspension.

Thebottomphaseisgreytotanandappearsmoreaqueous.

Gentleshakingofthebottlewillallowtheproducttoreturntoahomogeneousappearance.Thisminor

separationhasnoeffectonthesafetyorefficacyoftheproduct.

Administerunderasepticconditions.Injectatthebaseoftheneck.

Theuseofaclosedmulti-doseinjectionsystemisrecommendedforadministrationoftheproductto

minimisetheriskofcontamination.Anyunusedproductmustbediscardedwithin3hoursof

broaching.

10. WITHDRAWALPERIOD

Zerodays.

11. SPECIALSTORAGEPRECAUTIONS

Storeandtransportrefrigerated(2°C-8°C).

Donotfreeze.

Protectfromlight.

Useimmediatelyafterbroaching.

Keepoutofthereachandsightofchildren.

Donotuseaftertheexpirydatestatedonthelabel/cartonafterEXP

12. SPECIALWARNING(S)

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafteranyotherveterinary

medicinalproductthereforeneedstobemadeonacasebycasebasis.

Noinformationisavailableonthepossibleinterferencesfromthepresenceofmaternalantibodieson

theresponsetovaccinationwithPoulvacPabacIV.Itisthereforenotrecommendedtousthisvaccine

inbirdswithmaternalantibodies.

Nospecificstudieshavebeenconductedinchickensandduckstodemonstrateefficacyofthevaccine

againstPasteurellamultocidaserovarsothersthan1.

Nospecificstudieshavebeenconductedinturkeystodemonstrateefficacyofthevaccineagainst

Pasteurellamultocidaserovarsothersthan3,4and3x4.

Donotuseinbirdsinlay.

Adverseeffectsobservedaresimilartothosementionedinparagraph6afteradministrationofadouble

dose.However,persistentlargesizelocalreactionsareobtainedinahigherproportionofbirdsafter

administrationofadoubledose.

Donotmixwithanyotherveterinarymedicinalproduct.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

TOTHEUSER:

Thisproductcontainsmineraloil.Accidentalinjection/selfinjectionmayresultinseverepainand

swelling,particularlyifinjectedintoajointorfinger,andinrarecasescouldresultinthelossofthe

affectedfingerifpromptmedicalattentionisnotgiven.

Ifyouareaccidentallyinjectedwiththisproduct,seekpromptmedicaladviceevenifonlyaverysmall

amountisinjectedandtakethepackageleafletwithyou.Ifpainpersistsformorethan12hoursafter

medicalexamination,seekmedicaladviceagain.

TOTHEPHYSICIAN:

Thisproductcontainsmineraloil.Evenifsmallamountshavebeeninjected,accidentalinjectionwith

thisproductthatcontainsoilcancauseintenseswelling,whichmay,forexample,resultinischaemic

necrosisandeventhelossofadigit.Expert,PROMPT,surgicalattentionisrequiredandmay

necessitateearlyincisionandirrigationoftheinjectedarea,especiallywherethereisinvolvementof

fingerpulportendon.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewiththelocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

March2012

15. OTHERINFORMATION

ATCVetcode:QI01AB02

Inactivatedbacterialvaccines

Inactivatedvaccineforchickens,turkeysandduckscontainingserovars1,3,4and3x4ofPasteurella

multocida.

Boxof10polyethylenebottlesof1000doses(500ml).

Boxof1polyethylenebottleof1000doses(500ml).

Notallpacksizesmaybemarketed

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

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