canine vaccines reup

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SProduct Guide - Pfizer Family of Vaccines

INS IST ON PF IZER VACCINES ®

C a n i n e V a c c i n e s Yo u C a n C o u n t O n .

* Not covered by the Immunization Support Guarantee: Porphyromonas Denticanis-Gulae-Salivosa Bacterin Defensor 1 Defensor 3 Defensor 3 (California)† Notice: This product license is conditional. Efficacy and/or potency of this product have not been fully demonstrated, consultation with a veterinarian is recommended.

Canine VaccinesVaccine Antigen Diluent Package

Vanguard®Plus5L4CV Distemper-MLV,AdenovirusType2-MLV,Parainfluenza-MLV,Parvovirus-MLV, Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona Bacterin Coronavirus-Killed 25X1-dose

Vanguard®Plus5L4 Distemper-MLV,AdenovirusType2-MLV,Parainfluenza-MLV,Parvovirus-MLV, Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona Bacterin Sterile Gel Diluent 25X1-dose

Vanguard®L4 Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona Bacterin Sterile Gel Diluent 25X1-dose

Vanguard® Plus 5 Distemper-MLV,AdenovirusType2-MLV,Parainfluenza-MLV,Parvovirus-MLV Sterile Diluent 25X1-dose

Vanguard® Plus CPV Parvovirus-MLV None 50X1-dose5X10-dose

Vanguard® Plus 5/CV Distemper-MLV,AdenovirusType2-MLV,Parainfluenza-MLV,Parvovirus-MLV Coronavirus-Killed 25X1-dose

Vanguard®DAMP Distemper-MLV,AdenovirusType2-MLV,Measles-MLV,Parainfluenza-MLV Sterile Diluent 25X1-dose

Vanguard®DAP Distemper-MLV,AdenovirusType2-MLV,Parainfluenza-MLV Sterile Diluent 25X1-dose

Vanguard® CV Coronavirus-Killed None 50x1-dose

Bronchicine®CAe Bordetella bronchiseptica —Bacterincellularantigenextract None 5X10-dose 50X1-dose

Vanguard®-B Bordetella bronchiseptica —Avirulentliveculture Sterile Diluent 25X1-dose

Porphyromonas Denticanis- Gulae-Salivosa Bacterin*† Porphyromonas denticanis, P. gulae, P. salivosa Bacterin None 25X1-dose

Defensor® 1* Rabies-Killed None 50X1-dose5X10-dose

Defensor® 3* Rabies-Killed None 50X1-dose 5X10-dose

Defensor® 3 (California)* Rabies-Killed None 50X1-dose5X10-dose

Confidence Based in Science. Peace of Mind with Unequaled Support. Pfizer canine vaccines are backed by rigorous testing and most are backed by our immunization support guarantee, so you can vaccinate with the utmost confidence.

Quality Vaccines. Pfizer canine vaccines are thoroughly tested and paired in the combinations you need most.

WhatYouNeed,AllinOnePlace. The breadth of the Pfizer line ensures that you can get everything you need to help protect your patients from one easy source.

Documented by Peer-Reviewed Data and Published in the Journal of the American Veterinary Medical Association 1

Unbiased Results: Serologic assays performed by prestigious outside laboratory (Cornell) blinded to the vaccination history of each animal Demonstrated Performance: Vanguard produced a consistent serologic response, often lasting up to and beyond 48 months for all 5 key antigens evaluated Vanguard: The canine vaccines with peer-reviewed, published and labeled serology data

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1. MouzinDE,LorenzenMJ,HaworthJD,etal.Durationofserologicresponsetofiveviralantigensindogs.J Am Vet Med Assoc2004;224:55-60.

C A N I N E

P f i z e r V a n g u a r d L e p t o s p i r o s i s V a c c i n e sVanguardPlus5L4CV,VanguardPlus5L4,VanguardL4

VACCINEANTIGENS Vanguard®Plus5L4CV Vanguard®Plus5L4 Vanguard®L4

Canine Parvovirus • •

Canine Distemper • •

CanineParainfluenza • •

CanineAdenovirusType2 • •

Canine Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona Bacterin

• • •

Canine Coronavirus •

Advantages •Safetydocumentedbylarge-scalemulticenterstudy. •Durationofserologicresponsesupportedbypeer-reviewedandpublisheddata.1

•TheLeptospirosisfractionismicrofiltered5timesforantigenpurityandsmoothness. •TheVanguard® Plus 5 vaccines feature a high-titer/low-passage canine parvovirus fraction,

which is highly immunogenic and capable of stimulating active immunity in the presence of maternal antibodies.

•Helpsprovideprotectionagainstthe4mostcommonstrainsofLeptospirosis:L. canicola, L. grippotyphosa, L. icterohaemorrhagiae, and L. pomona.

Safety and Efficacy Shownsafefordogsasyoungas6weeksofageinlaboratorytestsandinclinicaltrialsunderfieldconditions.

Evidence-based performance of the viral antigens based on retrospective serological studies.1

1.MouzinDE,LorenzenMJ,HaworthJDetal.Durationofserologicresponsetofiveviralantigensindogs. J Am Vet Med Assoc2004;224:55-60.

P f i z e r V a n g u a r d L e p t o s p i r o s i s V a c c i n e s (continued)

DosageandAdministration General Directions: Vaccinationofhealthydogs6weeksofageorolderisrecommended.Asepticallyrehydratethefreeze-driedvaccine fraction,shakewell,andadminister1mLsubcutaneouslyorintramuscularly. Primary Vaccination: Healthydogsshouldreceive2dosesadministered3-4weeksapart,followedbyasingledoseofVanguardCV threeweekslaterwhenusingVanguardPlus5L4CV. Revaccination: Annualrevaccinationwithasingledoseisrecommended. Recommendations: TheAmericanAnimalHospitalAssociation(AAHA)2006Vaccine GuidelinesstatethatvaccinationforLeptospira

shouldberestrictedtouseinareaswhereareasonableriskofexposurehasbeenestablished.1 The Pfizer Guarantee: Pfizer’sImmunizationSupportGuaranteeprovidesONEyearofcoverageforallreasonablediagnosticandtreatment costsupto$5000ifapetvaccinatedwithoneofthePfizerLeptospiraantigenscontractsthecorrespondingdisease.

Precautions Storeat2°Cto7°C.Prolongedexposuretohighertemperaturesand/ordirectsunlightmayadverselyaffectpotency.Donotfreeze.Useentire

contents when first opened. Sterilized syringes and needles should be used to administer this vaccine. Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine. Burn containers and all unused contents. Contains gentamicin as preservative. Vaccination of pregnantbitchesshouldbeavoided.Incaseofanaphylaxis,administerepinephrineorequivalent.

Product Information Customer-friendly packaging includes peel-off labels to make record-keeping faster and more accurate,

a color-coded organizing system and an easy-open safety band.

Product Codes: VanguardPlus5L4CV-5179 VanguardPlus5L4-5180 VanguardL4-5181

Pfizer Immunization Support Guarantee PfizercorevaccinesmaybeusedinextendeddurationprotocolsasrecommendedbytheAmericanAnimalHospitalAssociationandtheAmerican

AssociationofFelinePractitioners.Inadditiontoprovidingimmunizationsupportforthefullthreeyears,VanguardandFelocellarecoveredbyanextrayearofsupportbecausetheyprovidelong-termserologicperformancedemonstratedbyfouryearsofserologydata.Noothervaccinesofferthat level of support.

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1.AmericanAnimalHospitalAssociation,2006AAHACanineVaccineGuidelines,Revised.

P f i z e r V a n g u a r d P l u s V a c c i n e sVanguard Plus 5, Vanguard Plus CPV, Vanguard Plus 5/CV

VACCINEANTIGENS Vanguard® Plus 5 Vanguard® Plus CPV Vanguard® Plus 5/CV

Canine Parvovirus • • •





Advantages •ThePLUSinVanguard Plus vaccines refers to the high-titer/low-passage canine parvovirus (CPV) fraction, which is highly immunogenic

and capable of stimulating active immunity in the presence of maternal antibodies. •TheparvovirusstrainintheVanguardPlusvaccinelinehasbeenshowntohelpprotectagainstchallengewithCPV-2c.1

•AAHA2006VaccinationGuidelinesstatethatproductswithCPV-2,regardlessofgenotype(ie,CPV-2,2aor2b),provideexcellent protection against field isolates.2 •TheCAV-2straininVanguard Plusvaccinescross-immunizesagainstCAV-1tohelpprotectdogsagainstICHwithoutproducing post-vaccinationsideeffects,includinguveitisandcornealopacity,sometimesattributedtoCAV-1vaccines.

Safety and Efficacy Field trials of Vanguard Plusvaccinesshowedthemtobesafeindogsasyoungas6weeksofageundernormalusageconditions.

DosageandAdministration Vanguard Plus 5 and Vanguard Plus CPV General Directions: Vaccinationofhealthydogsisrecommended.Asepticallyrehydratethefreeze-driedvaccinewiththesterilediluent

provided,shakewell,andadminister1mLsubcutaneouslyorintramuscularly. Primary Vaccination:Healthydogs6weeksofageoroldershouldreceive3doses,eachadministered3weeksapart. Revaccination:Annualrevaccinationwithasingledoseisrecommended,although,asrecommendedbytheAmericanVeterinaryMedical

AssociationanditsCouncilonBiologicandTherapeuticAgents,theattendingveterinarianshoulddeterminethefrequencyofrevaccinationbased ontheanimal’slifestyleandriskofexposure.3

The Pfizer Support Guarantee: Pfizer’s Immunization Support Guarantee provides coverage for all reasonable diagnostic and treatment costs up to $5000 if a pet vaccinated with one of the antigens in our Pfizer Vanguard Plus Vaccines contracts the corresponding disease.

Vanguard Plus 5/CV General Directions: Vaccinationofhealthydogsisrecommended.Asepticallyrehydratethefreeze-driedvaccine(VanguardPlus5)withthe

accompanyingvialofliquidvaccine(VanguardCV),shakewell,andadminister1mLsubcutaneouslyorintramuscularly. Primary Vaccination: Healthydogs6weeksofageoroldershouldreceive3doses,eachadministered3weeksapart.

Revaccination:Annualrevaccinationwithasingledoseisrecommended,although,asrecommendedbytheAmericanVeterinaryMedical AssociationanditsCouncilonBiologicandTherapeuticAgents,theattendingveterinarianshoulddeterminethefrequencyofrevaccinationbased ontheanimal’slifestyleandriskofexposure.3

1.Dataonfile,StudyReportNo.9161R-10-06-209,PfizerInc.2.AmericanAnimalHospitalAssociation,2006AAHACanineVaccineGuidelines,Revised.3. AmericanVeterinaryMedicalAssociation,PositionStatementsonBiologics,June2001.

P f i z e r V a n g u a r d P l u s V a c c i n e s (continued)

Seroconversion to canine parvovirus (CPV) in maternally immune puppies vaccinated with Vanguard PlusMean pre-vaccination Mean post-vaccination SN titers†

Test Group No. SN titer (range)† 1st dose 2nddose 3rd doseAllvaccinates 25 24(<2-256) 108 605 11761st dose responders 13 6(<2-64) 460 1745 14102nddoseresponders 9 87(16-256) 20 376 16253rd dose responders 3 128(128) 32 25 203Nonvaccinated controls 25 64(4-1024) 9 3 <2† Reciprocal of serum neutralization titer

The ability of the CPV component in Vanguard Plus vaccines to overcome serum neutralization (SN) titers associated with maternal antibodies wasdemonstratedinatestof25vaccinatedpuppies.Puppieswerevaccinatedat6,9and12weeksofage.Asshowninthetable,13of25vaccinatedpuppiesseroconverted(ierespondedwitha4-foldorgreaterincreaseinSNtiter)afterreceiving1dose.Nineotherpuppiesseroconvertedafterthe2nddose,andall25vaccinates,somewithpre-vaccinationtitersashighas1:256,respondedafter3doses.


contents when first opened. Sterilized syringes and needles should be used to administer this vaccine. Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine. Burn containers and all unused contents. Contains gentamicin as preservative. Vaccination of pregnant bitchesshouldbeavoided.Aswithmanyvaccines,anaphylaxismayoccurafteruse.Initialantidoteofepinephrineisrecommendedandshouldbefollowedwithappropriatesupportivetherapy.Thisproducthasbeenshowntobeefficaciousinhealthyanimals.Aprotectiveimmuneresponsemay not be elicited if animals are incubating an infectious disease, are malnourished or parasitized, are stressed due to shipment or environmental conditions, are otherwise immunocompromised, or the vaccine is not administered in accordance with label directions.

Product Information Customer-friendly packaging includes peel-off labels to make record-keeping faster and more accurate, a color-coded organizing system

and an easy-open safety band.

Product Codes: Vanguard Plus 5 - 5303 Vanguard Plus CPV - 5300 Vanguard Plus CPV (10 dose) - 5301 Vanguard Plus 5/CV - 5305

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P f i z e r P r o t o c o l - S p e c i f i c C a n i n e V a c c i n e s

VanguardDAMP,VanguardDAP,VanguardCV

VACCINEANTIGENS Vanguard®DAMP Vanguard®DAP Vanguard® CV




Measles •


Protocol-specific vaccines are administered more selectively than recommended core vaccines based on individualized medical decisions that take into account a risk/benefit ratio based on the dog’s geographic location, lifestyle and medical history.

Advantages •Vanguard®DAMPfeaturesameaslesvirusthathelpsstimulateactivecross-immunityagainstcaninedistemper(CD)virusinpuppiesas youngas6weeksofageregardlessoflevelsofmaternalantibodiesthatinterferewithactiveCDvirusimmunization. •TheCAV-2featuredinbothVanguardDAMPandVanguardDAPcross-immunizesagainstcanineadenovirus-1(CAV-1)tohelpprotect

dogsagainstinfectiouscaninehepatitis(ICH)withoutproducingpost-vaccinationsideeffects,includinguveitisandcornealopacity,sometimesassociatedwithCAV-1vaccines.

•Highlyspecializedvaccinesthatallowfortailoredprotocols.

Safety and Efficacy Vanguard DAMP DogsvaccinatedwithVanguardDAMPwereimmunizedagainstCD,ICH,canineadenovirus-2(CAV-2)respiratorydisease,andcanine

parainfluenza(CPI),demonstratingthatnosignificantimmunologicinterferenceexistedamongthevaccinefractions.Noadversereactions toDAMPvaccinationwereobservedinanyofthetestdogs.

AcombinedCDandmeaslesvirusvaccineincreasestheprobabilityofprotectingpuppiesagainstCDduringtheperiodwhentheycommonlycarrymaternalantibodies.Onestudyshowedthat45/67experimentaldogsat6weeksofagehadmaternalantibodylevelssufficientto interferewithactiveimmunization.Whenvaccinatedwithacombinationdistemper-measlesvaccineat6weeksofage,63/67puppies(94%)wereprotected,42ofthembythemeaslesvirusfraction.1

1.BrownAL,VitamvasJA,MerryDL,etal.Immuneresponseofpupstomodifiedlivevirus-canine-distemper-measlesvaccine.Am J Vet Res1972;33:1447-1456.

P f i z e r P r o t o c o l - S p e c i f i c C a n i n e V a c c i n e s (continued)

Vanguard DAMP (continued)Use of measles vaccine in adult bitches may produce high levels of measles antibodiesthatcaninterferewithsuccessfulprotectionofpuppiesinthenextgeneration.Thus,VanguardDAMPisrecommendedforuseinpuppies6-12weeksofage.Heterotypicimmunityshouldnotbereliedonforprotectionafter16weeksofage.

IthasbeendemonstratedthatCAV-2vaccinecross-protectsagainstICHcausedbyCAV-1.TheCAV-2straininVanguardvaccinesisusedasareplacementforCAV-1becauseithasadvantages.SomeCAV-1vaccinesmay produce undesirable reactions, including persistent kidney infections, uveitis, and corneal opacity (“blue eye”), which have not been reported aftervaccinationwithCAV-2.1Inaddition,theCAV-2strainusedinVanguard vaccines has been specially selected for freedom from oncogenic properties characteristic of adenoviruses.

StudiesdemonstratedthattheCAV-2fractioninVanguardDAMPnotonlyprotectsagainstICH,butagainstCAV-2respiratorydiseaseaswell.2

Vanguard DAPEfficacy was demonstrated in challenge of immunity studies where vaccinated dogs were protected against virulent CD virus. Following challengewithavirulentCDvirus,95%ofthevaccinateddogsremainedhealthy.Incontrast,allnonvaccinatedcontroldogsdeveloped clinicalsignsofCD,and80%died.

Safety was confirmed in laboratory and field trials involving more than 15,000 dogs. No significant post-vaccination reactions attributable to the vaccine were reported.

Vanguard CVSafetyofVanguardCVwasassessedinafieldtrialinwhich5,999doseswereadministered.

Post-vaccinationreactionswereobservedinonly0.78%ofdogs.

EfficacyofVanguardCVwasdemonstratedinachallengestudyof6-to7-weekoldpuppies.Twentypuppieswerevaccinatedbythesubcutaneousroutewith2dosesgiven21daysapart.Theyand10nonvaccinatedcontrolpuppieswerechallenged3weekslaterwithvirulentCCV.Followingchallenge,vaccinateddogsexperiencedsignificantdifferencesinreductionofclinicalsigns,includingdiarrheaandinviralsheddingvsthecontrolgroup.TherewasasignificantreductionofIFAdetectableCCVantigendetectedintheintestineat19dayspost-challengeinvaccinates compared to the control group. Serological responses of vaccinates were equal to or higher than the control group.

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1.AppelM,BistnerSI,MenegusM,etal.Pathogenicityoflow-virulencestrainsoftwocanineadenovirustypes. Am J Vet Res1973;34:543–550.2. BassEP,GillMA,BeckenhauerWH.Evaluationofacanineadenovirustype2strainasareplacementforinfectiouscaninehepatitisvaccine. J Am Vet Med Assoc 1980;177:234–242.

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VanguardDAMP,VanguardDAP,VanguardCV (continued)

DosageandAdministration Vanguard DAMP General Directions: Vaccinationofhealthydogs6-12weeksofageisrecommended.Asepticallyrehydratethefreeze-driedvaccine

withthesterilediluentprovided,shakewell,andadminister1mLintramuscularly. Primary Vaccination:Administerasingle1mLdosetohealthydogsbetween6and12weeksofage. Revaccination:Dogsshouldberevaccinatedat14-16weeksofagewithacaninedistemper,canineadenovirustype2,andcanine

parainfluenzavaccine.Inmostcases,acompleteimmunizationprogramwillalsoincludevaccinationforcanineparvovirus,Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, and L. pomona.Annualrevaccinationwithasingledoseagainstanyorallofthesepathogensisrecommended,although,asrecommendedbytheAmericanVeterinaryMedicalAssociationanditsCouncilonBiologicandTherapeuticAgents, theattendingveterinarianshoulddeterminethefrequencyofrevaccinationbasedontheanimal’slifestyleandriskofexposure.1

Vanguard DAP — the only DAP vaccine combo in the market General Directions: Vaccinationofhealthydogsisrecommended.Asepticallyrehydratethefreeze-driedvaccinewiththesterilediluent

provided,shakewell,andadminister1mLsubcutaneouslyorintramuscularly. Primary Vaccination:Healthydogsshouldreceive2dosesadministered3-4weeksapart.Ifdogsarevaccinatedbeforetheageof4months,

they should be revaccinated upon reaching 4 months of age. (Maternal antibodies may interfere with development of an adequate immune response in puppies less than 4 months old.)

Revaccination:Annualrevaccinationwithasingledoseisrecommended,although,asrecommendedbytheAmericanVeterinaryMedical AssociationanditsCouncilonBiologicandTherapeuticAgents,theattendingveterinarianshoulddeterminethefrequencyofrevaccinationbased ontheanimal’slifestyleandriskofexposure.1

Vanguard CV General Directions: Vaccinationofhealthydogsisrecommended.Shakewell.Asepticallyadminister1mLsubcutaneouslyorintramuscularly. Primary Vaccination:Healthydogs6weeksofageoroldershouldreceive2dosesadministered2-3weeksapart.Ifdogsarevaccinated

before the age of 4 months, they should be revaccinated with a single dose upon reaching 4 months of age. (Maternal antibodies may interfere with development of an adequate immune response in puppies less than 4 months old.)

Revaccination:Annualrevaccinationwithasingledoseisrecommended.

1.AmericanVeterinaryMedicalAssociation,PositionStatementsonBiologics,June2001.



contents when first opened. Sterilized syringes and needles should be used to administer this vaccine. Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine. Burn containers and all unused contents. Contains gentamicin as preservative. Vaccination of pregnantbitchesshouldbeavoided.Aswithmanyvaccines,anaphylaxismayoccurafteruse.Initialantidoteofepinephrineisrecommended andshouldbefollowedwithappropriatesupportivetherapy.Thisproducthasbeenshowntobeefficaciousinhealthyanimals.Aprotective immune response may not be elicited if animals are incubating an infectious disease, are malnourished or parasitized, are stressed due to shipment or environmental conditions, are otherwise immunocompromised, or the vaccine is not administered in accordance with label directions.

Product Information Customer-friendly packaging includes peel-off labels to make record-keeping faster and more accurate, a color-coded organizing system

and an easy-open safety band.

25x1-dosevials 50x1-doseforVanguardCV

Product codes: VanguardDAMP-4952 VanguardDAP-4945 VanguardCV-4928

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P f i z e r B o r d e t e l l a V a c c i n e sBronchicineCAe,Vanguard-B

VACCINEANTIGENS BronchicineCAe Vanguard-B

Bordetella bronchiseptica parenteral •

Bordetella bronchiseptica intranasal •

Advantages •Studies*havesuggestedthattheuseofINandSCroutesmayhelpprovideadogwiththebestprotectionagainstBordetellaby generatingIgAantibodiesinthemucousmembranesandIgGantibodiesthathelpprotectagainstthecirculatingbacteria.1,2

•Bronchicine®CAeispreparedfromastrainofBordetella bronchiseptica grown to a high yield then subjected to a proprietary process which extractsthedesiredantigenicmaterial.Theresidualcelldebrisisremoved,resultinginaproductwhichretainsthenecessaryimmunologiccomponentsofthewholecell,whilereducingextraneousproteins.

•Vanguard®-B contains an avirulent live culture of B. bronchiseptica for intranasal (IN) vaccination of healthy dogs and puppies at least 3 weeks of age as an aid in preventing canine infectious tracheobronchitis (CITB) (“kennel cough”) caused by B. bronchiseptica.

Bronchicine CAe •BronchicineCAehasbeenconfirmedtobeaneffectivevaccinetohelpcontrolCITB. •Convenientsubcutaneous(SC)parenteraladministration. •Readytouse,doesnotrequirereconstitution. •Non-adjuvanted. •Noblowback.

Vanguard-B •Aneffectiveintranasaloptionforvaccinatingagainst Bordetella.

1. EllisJAetal.ComparativeefficacyofaninjectablevaccineandanintranasalvaccineinstimulatingBordetella bronchiseptica –reactive antibody responses in seropositive dogs. J Am Vet Med Assoc2002;220:43-48.

2. EllisJA.EffectofvaccinationonexperimentalinfectionwithBordetella bronchiseptica in dogs. J Am Vet Med Assoc2001;218:367-375.

* Vaccines used were Coughguard B (parenteral) and Nasaguard-B. Study results are specific to those vaccines.

P f i z e r B o r d e t e l l a V a c c i n e s (continued)

Vanguard-B Vanguard-B contains a highly antigenic modified-live B. bronchiseptica strain.

Sixhundredfifty-fivedogswerevaccinatedaccordingtolabelrecommendations.Oneofthevaccinateswasreportedtohaveintermittent sneezingfor2daysfollowingvaccination.Notreatmentwasrequired.Noneoftheremaining654dogshadanyadversereactions.

BronchicineCAe Proprietarycellularantigenextractionprocessisresponsiblefortheantigenicpotencyandthevaccinesafetyprofilethathavegivenusthe confidencetosaythatBronchicineCAeissmoothandeasy.

Demonstrated Where it Counts Most — In the Field •Bronchicineisthenumber-onesoldBordetellaproductinthecountry.1Bronchicineisfeaturedinover16,000veterinaryclinicsnationwide. •OfdogsthatarevaccinatedforBordetella intheUSA—nearlyhalfarevaccinatedwithBronchicine. •Pfizertrackslack-of-efficacyclaimswithallofitsvaccineproducts. — To date,†Bronchicinehasarecordof0.13callsper10,000dosessoldwhichequatesto1callper77,000dosessoldforlackofefficacy. That’s equal to or better than our modified-live intranasal product — Vanguard-B — and compares favorably to other licensed companion animal vaccines.

1.DOANEAnimalVaccineDispensedReports,October2008.

www.ISG.com†December8,2008

Efficacy

Bronchicine Challenge Study 1

Animals: Thestudyinvolved2groupsof10dogseach(GroupA–treatmentgroup;GroupB–controlgroup)*ofbothsexes≥ 8 weeks of age at the time of vaccination. The animals were bred specifically for research purposes and were determined to be negative to BordetellabronchisepticabynasalswabculturesandMATtiters≤1:64.

Procedures:GroupAreceivedsubcutaneousvaccinationatdayszeroand21ofthestudy.Onday35,groupsAandBwereexposedtoanaerosolchallengeandobservedforclinicalsignsfor21days(day56).CarefulobservationsofGroupAdogsfollowingeachvaccinationindicated no unacceptable local or systemic reactions attributed to the vaccination.

Results:

Nasal shedding:AlltestdogswerenegativeforculturalisolationofBordetellabronchiseptica(Bb)priortochallengeatday35.Followingaerosolchallenge,Bbwasisolatedondays38,42,45,49and56fromnasalswabscollectedfromtestdogs,indicativeofasuccessfulchallenge.

Serological: Significantgeometricmeantiterswereevidentintheparenterallyvaccinatedgroup.Atthedayofthesecondvaccination,90%oftheparenterallyvaccinateddogshadfour-foldhigherMATtitersthantheirrespectivescreeningsampletiters.Titersreachedmaximumlevels by 14 days post-second vaccination. Titers in the control group remained at baseline levels prior to challenge.

Clinical Observations: Vaccinateswerefreeofclinicalsymptomsfor82%oftheobservationperiods.Unvaccinatedcontrolsweresymptom-less29.5%oftheobservationperiods.Clinicalsymptomsofthecontrolgroupbeganatday37,2dayspostchallenge.Untilday56–theyhadahigherdailymeanclinicalcoughscoreonascaleof0to5.Byday46–9/10ofthecontroldogsexhibitedcontinualcoughand2/10ofthevaccinateddogsexhibitedoccasionalclinicalsymptoms.Totalcoughscoresforthevaccinatedgroup=38,totalscoresforcontrols=191–P<0.001.

Temperature, Body Weight, and Adverse Reactions: Controlshadhighermeanbodytemperaturesondays36,37,38,39,41 and50.Percentchangeinbodyweightwassignificantlydifferentondays38,42and45infavorofthevaccinateddogs.1 No unacceptable localorsystemicobservationswereattributabletotheproductfor72hourspost-vaccination.

Conclusion: BronchicineCAeissafeandefficaciousindogsandwillhelpprovideprotectioninvaccinateddogs.

Vanguard-B Effective local immune response and competitive inhibition of colonization of B. bronchiseptica.

DosageandAdministration Bronchicine CAe General Directions: Shake well. Primary Vaccination: Asepticallyadminister1mLsubcutaneouslytohealthydogsatleast8weeksofage.Forinitialvaccination, aseconddoseisrequired2-4weekslater.Thisproductshouldbeadministeredbysubcutaneousinjectiononly.


1. Dataonfile,StudyReportNo.CAN-70-04P-462-99,PfizerInc.

*Fourtotaltreatmentgroupswereinvolvedinthestudy.Only1ofthe4groupsreceivedthefinalBronchicineformulationandistheonlyvaccinatedgroupincluded insummary,exceptintheSerological results. The Serological results include all parenterally vaccinated dogs.


Revaccination: Annualrevaccinationwithasingle1mLdoseisrecommended.

Vanguard-B General Directions: Rehydrate vaccine with the accompanying sterile diluent. Shake well, and draw back into the syringe the required

amount. Remove the needle from the syringe and attach applicator tip. Use immediately. Primary Vaccination: AdministerasingleIN(0.5mLintoeachnostril)doseusingasyringewithapplicatortiptohealthydogsandpup-

pies at least 3 weeks of age or older. Revaccination: Annualrevaccinationwithasingledoseisrecommended.

Precautions Bronchicine CAe Storeat2°Cto7°C.Donotfreeze.Useentirecontentswhenfirstopened.Careshouldbetakentoavoidmicrobialcontaminationofthe

product. In case of anaphylactoid reactions, epinephrine should be administered immediately. Transient local irritation at the site of injection, though rare, may occur subsequent to use of this product.

Vanguard-B This product is designed for intranasal use only with the enclosed applicator tip. DO NOT USE TO VACCINATE DOGS PARENTERALLY.

Storeinthedarkat2°Cto7°C(35°Fto45°F).Shakewellafterrehydration.Burncontainersandallunusedcontents.Incaseofanaphylac-toid reaction, administer epinephrine.

Product Information Customer-friendly packaging includes peel-off labels to make record-keeping faster and more accurate, a color-coded organizing system and an easy-open safety band.

Product codes: BronchicineCAe5x10-dosevials-3543 BronchicineCAe50x1-dosevials-3551 Vanguard-B25x1-dosevials-4275

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Advantages • Porphyromonas Denticanis-Gulae-Salivosa Bacterin is the first and only vaccine to aid in the prevention of canine periodontitis

whichaffects85%ofdogsover3yearsofage.1

•Thisproductisanimportantnewadjuncttoprofessionaldentalcleaning,periodontaltherapyandowner-administrateddentalcareroutines. •ThePorphyromonasVaccineispartofacompletecaninewellnessprogramthatencouragesannualvisits. •Safetyofthevaccinewasevaluatedinlaboratorystudiesandafieldsafetystudy.

Safety and Efficacy Safety of the Porphyromonas Denticanis-Gulae-Salivosa Bacterin was established in trials involving animals from multiple geographic locations. Healthydogsasyoungas7weeksofagewerevaccinatedaccordingtolabeldirections.Nosignificantadverseeventswereobservedin anyanimalsduringthestudyperiod.Efficacystudiesandpotencytestvalidationareinprogress.Areasonableexpectationofefficacyhas been demonstrated in dogs 8 months of age. Duration of immunity for this product has not been evaluated.

Notice: This product license is conditional. Efficacy and/or potency of this product have not been fully demonstrated, consultation with a veterinarian is recommended.

DosageandAdministration General Directions:Vaccinationofhealthydogsisrecommended.Shakewell.Aspeticallyadminister1mLsubcutaneously. Primary Vaccination: Healthydogsshouldreceive2dosesadministered3weeksapart. Revaccination: Duration of immunity for this product has not been evaluated. Consultation with a veterinarian is recommended.

Precautions Storeat2°Cto7°C.Prolongedexposuretohighertemperaturesmayadverselyaffectpotency.Donotfreeze.Useentirecontentswhen first opened. Sterilized syringes and needles should be used to administer this vaccine. Transient lethargy and soreness may occur following vaccination.Incaseofanaphylaxis,administerepinephrineorequivalent.Foruseindogsonly.

P f i z e r P o r p h y r o m o n a s D e n t i c a n i s - G u l a e - S a l i v o s a B a c t e r i n

1. BeardG,EmilyP,Milligan&WilliamsC:AmericanAnimalHospitalAssociation,VeterinaryDentistry,Coursel,1989.

Product Information Customer-friendly packaging includes peel-off labels to make record-keeping faster and more accurate, a color-coded organizing system and an easy-open safety band.

25x1-dosevials

Product code: PorphyromonasDenticanis-Gulae-SalivosaBacterin-5250

P f i z e r P o r p h y r o m o n a s D e n t i c a n i s - G u l a e - S a l i v o s a B a c t e r i n (continued)

P f i z e r D e f e n s o r ® C a n i n e a n d F e l i n e R a b i e s V a c c i n e s

Advantages •Containsahighlyimmunogenic,fixedstrainofrabiesvirusthatoriginatedfromLouisPasteur’soriginal1882isolate. •Vaccineformulatedwithachemicallyinactivatedrabiesviruspreparedfromcellculture. •Exceptionallywelltoleratedafterinjectionduetothepurifiedadjuvantandanoveldual-bufferingsystemthatrestrictspH

to a narrow, safe range. •DefensorvaccinesproducedforsaleinCaliforniameetspecificpotencystandardsrequiredbythatstate.

Safety and Efficacy Studies conducted in mice to evaluate the relative effective dose of Defensor 3 vs a Centers for Disease Control and Prevention (CDC)

referencedvirusagainst5wildrabiesvirusesindicatedthatvaccineeffectivenessextendsbeyondcanineisolatestoincludenaturallyoccurringwildlifestrainswithexceptionalprotectionagainstraccoonandbatrabiesviruses.1

Because Defensor is produced on an established cell line, it has safety advantages over inactivated brain-origin rabies vaccines. Tissue-origin vaccinescontainextraneousproteininadditiontorabiesantigenthatcanleadtoautoimmunedisease.

TheestablishedcelllineusedinDefensorhasbeenextensivelytestedforfreedomfromcontaminatingagents.Inaddition,useofan established cell line yields a vaccine of consistent potency from serial to serial. Defensor has been demonstrated to be uniformly safe in experimentaltests,andnosignificantadversereactionswerereportedinextensiveclinicaltrialsofthevaccine.

Aduration-of-immunitystudy,conductedinaccordancewithfederalregulationandunderUSDepartmentofAgriculture(USDA)direction,demonstratedthata1mLdoseofDefensor3metfederalguidelinesforprotectionofdogsandcatsagainstvirulentchallengeadministered 3 years after vaccination.

Inafieldsafetystudy,with2,647dosesadministered,96.2%ofthedoseswereadministeredwithnovocalizationand99.9%ofdoseswere administeredwithnolameness,stiffness,hypersensitivityreactions,orinjectionsitelumpsfor21daysaftervaccination.2

DosageandAdministration General Directions: Shakewell.Asepticallyadminister1mLsubcutaneouslyforcats.Dogsmaybevaccinated

intramuscularly or subcutaneously. Primary Vaccination: Administerasingle1mLdoseat3monthsofageoroldertohealthydogsandcats.

Arepeatdoseshouldbegiven1yearlater. Revaccination: Defensor 1: Annualrevaccinationwithasingledoseisrecommended. Defensor 3: Subsequent revaccination every 3 years with a single dose is recommended.

1. Baer GM. Evaluation of an animal rabies vaccine by use of two types of potency tests. Am J Vet Res1997;58(8):837-840.2.Dataonfile.StudyreportJune28,1991.PfizerInc.

I n s i s t o n Q u a l i t y W i t h o u t C o m p r o m i s e .

Evidence-Based Science. In the lab and in the field, our vaccine products continue to demonstrate their efficacy and safety year after year.

Peer-Reviewed and Published Research. Pfizer vaccines are tested under a variety of conditions in large scale, multicenter studies. Whenever possible, this data is then

peer-reviewed and published, so you can vaccinate with confidence.

Confidence Based in Science. Peace of Mind with Unequaled Support. We are so confident in our products that we offer an unprecedented 4-year support

guarantee on our core vaccines, as well as a 1-year guarantee on other Pfizer vaccines.

www.ISG.com for additional information

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