WIN THE FIGHT AGAINST BRD WITH ZUPREVO

Z U P R E VO WIN THE FIGHT

?

AGAINST BRD WITH

(TILDIPIROSIN)

Take on the bacteria that cause BRD with the simple, single dose you want and the withdrawal time and results you need.

TILDIPIROSIN

(ACTIVE INGREDIENT)

DOSE

TREATMENT OF BRD

& CONTROL OF RESPIRATORY DISEASE

( I N D I C AT I O N S )

APPROVED

DOSAGE

1.10 mL 1.50?3.00 mL DRAXXIN? MICOTIL?

1.82 mL ZACTRAN?

6.00 mL NUFLOR?

1.00 mL 1.50 mL ZUPREVO 18% EXCEDE?

6.00 mL RESFLOR GOLD?

PRE-SLAUGHTER WITHDRAWAL

21

DAY S

ZUPREVO 18%

28 DAYS - BAYTRIL? 100 18 DAYS - DRAXXIN 13 DAYS* - EXCEDE (*PER DOSE) 42 DAYS - MICOTIL 28 DAYS IM - NUFLOR 38 DAYS - RESFLOR GOLD 35 DAYS - ZACTRAN

38 DAYS SC - NUFLOR

SEE THE ZUPREVO DIFFERENCE

PRODUCT ZUPREVO 18%

NUFLOR RESFLOR GOLD

BAYTRIL 100 DRAXXIN EXCEDE MICOTIL

ACTIVE INGREDIENT

tildipirosin

florfenicol

INDICATIONS

Treatment of BRD and control of

respiratory disease

Treatment of BRD and foot rot

florfenicol flunixin megilumine

Treatment of BRD

enrofloxacin

Treatment and control of BRD

tulathromycin

Treatment and control of calf pneumonia, Treatment of pinkeye

ceftiofur crystalline free acid

Treatment of BRD

APPROVED DOSAGE 1 mL/100 lb. 6 mL/100 lb. 6 mL/100 lb.

refer to label 1.1 mL/100 lb. 1.5 mL/100 lb.

tilmicosin

Treatment of BRD

1.5 ? 3 mL/100 lb.

ZACTRAN

gamithromycin

Treatment of BRD

2 mL/110 lb.

LABEL TREATMENT

1 dose

1 dose

1 dose

PRE-SLAUGHTER WITHDRAWAL

21 days

28 days IM 38 days SC

38 days

refer to label

28 days

1 dose

18 days

2 doses

13 days

1 dose

42 days

1 dose

35 days

Resflor Gold (florfenicol and flunixin meglumine) IMPORTANT SAFETY INFORMATION: NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product contains material that can be irritating to skin and eyes. Animals intended for human consumption must not be slaughtered within 38 days of treatment. This product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Do not use in animals that have shown hypersensitivity to florfenicol or flunixin. Not for use in animals intended for breeding purposes. The effects of florfenicol and flunixin on bovine reproductive performance, pregnancy, and lactation have not been determined. When administered according to the label directions, RESFLOR GOLD may induce a transient local reaction in the subcutaneous and underlying muscle tissue.

Zuprevo 18% (tildipirosin) IMPORTANT SAFETY INFORMATION: FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. TO AVOID ACCIDENTAL INJECTION, DO NOT USE IN AUTOMATICALLY POWERED SYRINGES WHICH HAVE NO ADDITIONAL PROTECTION SYSTEM. IN CASE OF HUMAN INJECTION, SEEK MEDICAL ADVICE IMMEDIATELY AND SHOW THE PACKAGE INSERT OR LABEL TO THE PHYSICIAN. DO NOT USE Zuprevo? 18% IN SWINE. Fatal adverse events have been reported following the use of tildipirosin in swine. NOT FOR USE IN CHICKENS OR TURKEYS. Cattle intended for human consumption must not be slaughtered within 21 days of the last treatment. Do not use in female dairy cattle 20 months of age or older. Use of this drug product in these cattle may cause milk residues. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal. The effects of Zuprevo? 18% on bovine reproductive performance, pregnancy and lactation have not been determined. Swelling and inflammation, which may be severe, may be seen at the injection site after administration. Subcutaneous injection may result in local tissue reactions which persist beyond slaughter withdrawal period. This may result in trim loss of edible tissue at slaughter.

Nuflor (florfenicol) Injectable Solution: IMPORTANT SAFETY INFORMATION: NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product contains materials that can be irritating to skin and eyes. RESIDUE WARNINGS: Animals intended for human consumption must not be slaughtered within 28 days of the last intramuscular treatment. Animals intended for human consumption must not be slaughtered within 38 days of subcutaneous treatment. Do not use in female dairy cattle 20 months of age or older. Use of florfenicol in this class of cattle may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Not for use in animals intended for breeding purposes. The effects of florfenicol on bovine reproductive performance, pregnancy, and lactation have not been determined. Intramuscular injection may result in local tissue reaction which persists beyond 28 days. This may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck is likely to be more severe.

BAYTRIL is a registered trademark of Bayer. DRAXXIN is a registered trademark of Zoetis. EXCEDE is a registered trademark of Zoetis. MICOTIL is a registered trademark of Elanco. ZACTRAN is a registered trademark of Merial.

merck-animal-health- ? 800-521-5767 Copyright ? 2018 Intervet Inc., d/b/a Merck Animal Health, a subsidiary of Merck & Co., Inc. All rights reserved. 1/18 BV-ZUP-56948

PRODUCT INFORMATION NADA 141-299, Approved by FDA.

E-376

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40 mg florfenicol/kg weigh3t 0(60 mL/100 lb).

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be

PRODUCT INFORMATION

(FNlAoDrfAe1n4i1c-o29l 9a,nAdppFrlouvneidxibny MFDeAg. lumine)

Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

site. T4h0e0injection should b2e4g.0iven only in the neck. Injection siteesffeFclutsnoixninbiostahcpyacrlotu-orixtiyognenaansdetihnehiebsittororuysNcSyAcIlDe., aTnhdeares wmiathy obtehers

dotohneor tt5hp0au0nncthtuerneethcke

hsatovpepneor3t0mb.0eoeren

evaluated. For than 20 times.

the

500

mL

viaal, dienlatyhiins cthlaesos,nasedtvoefrseesteruffseciftsflumnaixyinociscuadr mwiinthisittesreudsed.urTinhge tmheost profsrteaqgulaenndtliyn rpehpaosreteodf athdeveerssteroeufsfeccytcsleh.avTehebeeeffnecgtassotrfofliunnteixstininal

RE6S00FLOR GOLD ? Dosa3g6.e0Guide*

700

42.0

122996 R3

on simignmsi.neEnvtenptasrtinuvriotilovninghasvuespneocttbedeerneneavla, lhueamteadtoinloagicco, nnetruorlolelodgic, studdey.rmNaStAoIlDosgiacr,eaknndowhenptoathicaveefftehcetspohtaevnetiaallstoo dbeeleayn preaprtourrtietidonfor

ANIMAL WEIGHT

DOSAGE

throouthgehr adrtoucgosliyntitcheisffeclcats. s.

800(lbs) 900100

48.(0mL) 54.06.0

Recommended RESNFoLtOfoRr GusOeLiDn ?a,nwimhaelns iandtemnidneisdteforer dbraeseddiinregcpteudrp, omsaeys.inTdhueceeffaects Injection Location tranosfifleonrtfreenaicctoiol onnatbtohveinseitereopfriondjeuccttioivneapnedrfuonrmdearnlycien,gprtiesgsnuaenscthy,aatnd

For subcutaneous use in beef and non-lactating dairy cattle only. Not for use in female dairy cattle 20 months

1000200

60.012.0

* Do not adminis3te0r0more than 10 mL at each1s8it.e0.

CONTRAIND4I0C0ATIONS: Do not u2s4e.0in animals that have shown

malyacretastuioltninhatrvime nlootssbeoefneddiebtleermtisisnueed.atTsolxaiucigtyhtsetru. dies in dogs, rats, and mice have associated the use of florfenicol with testicular deRcofoefEfegnStcersIetnuDsaemUtormanpEtteibioWnoontnAt.haRmnTpNduhaIrsiNastttuGrprnoiSrpotoi:htodynbAu. eancNntismdSilsaAatuhIlnDsgeoshteitnaseatrtrepreeonpdkudrnsoewovcdwieytdhcnfolietnfroo. r3hhT8uuahvmsedeeraaepyinnmostaeyntbiael

of age or older or in calves to be processed for veal. hypersensiti5v0it0y to florfenicol or fl3u0n.0ixin.

CAUTION: Federal law restricts this drug to use by or on the order FoWrAcRuNsItNoGmSe6:r0Ns0OeTrvFicOeRoHrUtMo AoNbtUa3iSn6E.0a. KcEoEpPyOoUf TthOeFMRESADCSH, OcaFll

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E-376

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Moyfcaolpiclaesnmseadbvoevteisr,iannadriacno.ntrol of BRD-associated pyrexia in beef

and non-lactating dairy cattle. DESCRIPTION: RESFLOR GOLD

?

is

an

injectable

solution

of

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PSC020D02_01_R2 (148x210mm) Black DtOhSeAsGynEtAheNtDic AaDntMibINioItSicTRAoTrfIeOnNic: oRlEaSnFdLOtRheGnOoLnD-?steshrooiudladl baenti- mPaRnEcyCaNsAeSUoATfIIDaOcsNcpiSdo:esnAstseaslaseyctelhaeesxsp,pocotysecunlrotei-a,olflxtuyosghperwnoaidtshuecwienaghteaibrsifttoroorriy1n5tNemsStiAinnIuDatless.

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4R0 EmSgFLflOoRrfGenOicLoDl?/kcgonbtoadinysw3e0i0gmhtgaflnodrf2e.n2icmogl, fl16u.n5imxing/kflgunbioxdinyas inSfleanRmseimmtiavotivotyerytcodorndutrgaumsg, is-nauasctsheodacsicaNltoeStdhAinIaDgds.voeCrrsocenorsetuivcletonasttseprhvoyaidsrisce,issahnwoiiufthlidrrtbihteaetion

IInnjjeeccttaabbllee SSoolluuttiioonn wfleuignhixti(n6mmeLg/1lu0m0 libn)e., D30o0nmotga2d-mpyinrriostliedromneo,re35thmang 1m0amlicLaactidea, cahndavinodidpiveeiddrsuoiasrtlcspl.oastAieeclnyctim.dePonantiaiteolnrietnsdjea. ct tgiorenatoefsthriskpfroordaudcvtemrsaeyevceanutssealroecal

dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A wiRthEdSrIDaUwEalWpAeRrNioINdGhSa: sAnnimotalsbeinetenndeesdtafobrlihsuhmeadn in pren-atural infections fr rfourmvieconaofanltt.hsinuemglapscttiaoilnnvtermasmu.sutDsncooutlanbroettrseluaasutmegheitnnetr.ecAdanlwivmeitahslisntoi2nt8beenddapeydrsocessepfdrholmegnmaotunraolrginafneicstmio

for human consumption must not be slaughtered ADVERSwEitRhEinA3C8TdIOayNsSo:f Tsruabncsuiteannetoinuasptrpeeattemnecnet.,Tdhiaisrrphroeda-, decreasedTABLE 2. Florfe water councstuims npottioanp,paronvdedinfjoerctuisoenisnitfeemswaleelldinaigryhcaavtetlebe2e0n associated(MIC) Values*

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sittreia. cTehtieniqnsje. ction should be given only in the neck. Injection sites Fltuhnoiisrxeriinthaitasitoaancr.eycdCleooh-noysxduyrlagtteeandpa,hsoeynsidnicihuiairbneittiocmrtyhmeNerSadpAiayIt,Deo,lrya.tnhdTohsaeswwMiitathhteeorxitaihsletiSrnsagfety with themuosnethos foflf oagrefeonricooldleri,ninccaluttdlien.g Idnryaddadiriytioconw, sa.nUaspehylaxis and

N

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2mPpnbadyyeesNeehcnwdsowrnanDesec1-amrTtououTdetdameBrdgcnL-mioIIhpri1ti1mGhtnDueyfurjitioocuiidi2mrraaf0sTo,mItono4cOovNartlsaunrsglimetilteAnabslihNIlRI(c05iyageRneh(iiiioiiorTnaomeymvoabes(lgSs.deneotSiauScreOSe-laNn1nnttisgafstcsft.Ilpmklcinmanonosdei6tNo.idrDhsjisfi0uNchiiEolsyyhhpvDedeFhndUOlstira.oitns,mnrlyoqeen.cjm,tCs:tn,rk-mfeiustdNooeidcndoFTTi(eauepeerooeoyinaeeteoicte,NiocosSIuIsTadlhinii0)Fcsbaec4iND3irmshiibeNno3Bsta)sonosluboneeIfunsrlCcOrn.slhnnlirfdtimtnsoibeareSehlBvrtuw.ltnLodahbnsoetibarren6)yc0mIax.sfinbrutstdy.epnttHotiPdstpcaRo,uaeeOililtAPsLsceraldMm2i0ogreiRsOeoncleamr:oesetricrsactoi,siuteneAatdrioetan3haorclaoet2iebDNpeoasrruoivcTaahm/tihcefiuoDadTcaial4rtThasicmjoR)dtcnruNsesnRniMtsmaMnvdiotaoiitLttuitfo1mt1oeearlswn,sh.iiinDichi0ls2muNevNhtfOa32,eedlisSnlttdpeaUutrNeeeyeeeig111-pI,ntctnnlt2sf:i(l2uOdepfrmd0/viucUtsndiesdvnspe-tAlhyeFahOnloyoesism5grartjDo04582369rccyMedaaroeAoSLnifIenf1eUaiiojajFenasl1nnbues8o7hoe.tUemliWol.miS0elsdnihDsoctlleneoeF.ceOcplent/,betnanolgdt0ot,pnn0il/uaNistga(..........othcboLsTAoretorafhetosnaFcodLciyAt0NRdmwotus0000000000noekiycrIFjctoiuaLBiha1yIeeswrsfegUadngburnOfmRisppgepy0aoanckocrcelvtitL1ierfI)aGiNnSgrtotntenOe0Llela0rrleefbotirsaudfoRl,islroO/tttnitturticctmipiDidocIR*ChW Csktdrruuukiiiiinirti0OivRlpt4rCstleosouebfeiMfOmoanmtttiinoanEnoornohhocalehnubfshgee-ouksnteul0ReoofHIrheonty1ootsDmmakv.tDsltrlalaahafIdpiDicIR*ChW 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18%18%

AUC0-inf: AAUUCCe0s-tinifm: AaUteCdefrsotimatitmedefzroemro tiomteimzerionftionityimte?:inTefirnmityinat?l:eTliemrminiantaiol nelhimalifnalifteion half life

(Tild(iTpiilrdoipsiinro) sin) InjecItnajbelcetaSboleutSionluftoiornCfaotrtlCeattle

Due to theDeuxetetonstihve epxatretintisoinveingpaorftitmioancirnoglidoefsminatcorotlisdseuseisnatondtisbseuceasuasendofbethceaiursme uolftit-fhoeldir gmreualtti-efrolcdongcreanterartcionsceintrations in bronchial fbluroidncrehliatlivfleuitdortehlativoebsteorvtheadtionbtsheervbeldooind,thpleasbmloaodd,rupglacsomnacednrturgatcionsceunntdraetrieosntsimuantdeecreosntcimenattreatcionsceanttrtahteions at the site of actisointe1.oTfhaisctisons1h.oTwhnisfiosrsthilodwipnirofsoirntinlditphierofsoinlloinwitnhge tfaobllloew, iwnghetraebbler,onwchheiarel fbluroidncshaimalpflleusidwsearme pcolellsewctedreincollected in live, healthliyvec,ahlveeasl,thayndcaclvoemsp, arneddctomthpearceodnctoentthreatcionsceintpralatisomnsa ionbpselarsvmedaionbtsheersvedsainmteheasneimsalms:e animals:

ANTIMICRAONBTIIAMLIDCROUBGI:AL DRUG: 180 mg o1f 8ti0ldimpirgosoifn/tilmdiLpirosin/mL

Table 3 BrToanbclehi3alBflruoindc-htoia-pl lfalusmid-ator-aptliaosomfatilrdaitpioirosfintilidnipniorons-iannienstnhoenti-zaendesctahtetlteizfeodllocawtitnlegfaolsluowbcinugtaanesouubscutaneous injection aintjaecdtioosneaotfa4dmogse/kogf 4BWmgin/kthgeBnWecikn the neck

For subcutFaonreosubsciuntjaencteionusininbjecetfioanndinnboene-flaacntadtinognd-laicrtyatciantgtledaoinrylyc.aNttolet fonrluy.seNoint feomr uasle idnaifreymcaltetleda2ir0y mcaotntltehs20ofmonths of age or oldaergeoroirnocladlevreosrtoinbcealpvreoscetossbeed pfororcveesasel.d for veal.

Time (hours)

CAUTION:CFAeUdTeIrOalN(:UFSeAd)erlawl (UreSsAtr)icltaswthriessdtriucgtsttohiussedrbuyg otor ounsethbeyoorrdeornotfhea loicrdeenrseodf avelitceerninsaerdiavne.terinarian.

4

DESCRIPTDIOENSC: RZuIPpTreIOvoNTM: Z1up8r%eviosTMa r1e8ad%y-itso-ausreasdtey-rtiole-uisnejesctearbile isnojleucttiaobnlecosnotlauitnioinngctoilndtiapinroinsgin,tiladispeirmosi-isny,nathseetmici-synthetic

10

macrolide manatcibroiolitdice. aEnatcibhiomtiLc.oEfaZcuhprmevLoo1f8Z%upcroenvota1in8s%1c8o0ntmaignso1f 8ti0ldimpirgosoifntaildsipthireosfrineeasbathse,f8re2e.5bamseg, c8it2ri.c5amcidg citric acid monohydramteonaonhdyd4r0a0temangdp4ro0p0ylemngepgrloypcoyl,enaendglwycaotle,raqnsdwwitahtecritqrisc wacitidh mcitorincoahcyidramteonaodhdyeddrattoeaaddjudsetdptHo.adjust pH.

24 72

Time (hours)

BronchialBflruoindch(BiaFl)fluid (BF) concentractoionnce(ntgr/agti)on (ng/g) Average Average SD SD

Plasma (PP)lasma (P) concentractoionnce(ntgr/amtioLn) (ng/mL) BF/P RatiBoF/P Ratio Average Average SD SD

4 1543 1543 895 895 297 297 81.8 81.8 5.20 5.20

10 2975 2975 1279 1279 242 242 96.7 96.7 12.3 12.3

24 3448 3448 1433 1433 136 136 53.9 53.9 25.4 25.4

72 3489 3489 1712 1712 70.7 70.7 29.0 29.0 49.3 49.3

CHEMICALCHNEOMMIECNACLLNAOTUMREENACNLADTUSTRREUACNTDURSET:RUCTURE: TildipirosinTisldtiphieronsoinnpisrotphreientoarnyprnoapmrietaforyr (n1a1mEe,1f3orE)(-11E,13E)-Figure 1 Figure 1 (4R,5S,6S(,47RR,,59SR,,61S5,R7,R1,69R),1-65-(R4,1-D6imR)e-6th-(y4la-mDiimnoe-t3h,ylamino-3, 5-dihydrox5y-d6i-hmyedtrhoyxly-t-6et-rmaheythdyrol-t-peytrraahny-2d-ryol-opxyyra)n-1-26-yeltohxyyl-)-16-ethyl4-hydroxy-45-,h9y,d1r3ox-tyri-m5,e9th,1y3l-7-tr-(im2-eptihpyelr-i7d-i(n2-1-p-yipl-ertihdyinl)-1- -yl-ethyl)15-piperid1in5-1-p-yiplmereidthiny-l1-o-yxlamcyecthloyhl-eoxxaadceycalo-1he1x,1ad3e-dcaie-n1e1-,21,3-diene-2,

96 96 1644 1644 2024 2024 60.2 60.2 29.0 29.0 27.3 27.3 120 120 1619 1619 1629 1629 52.3 52.3 19.9 19.9 30.9 30.9 240 240 1937 1937 1416 1416 27.1 27.1 10.8 10.8 71.5 71.5 336 336 1225 1225 1682 1682 26.1 26.1 9.2 9.2 47.0 47.0 504 504 935 935 1032 1032 16.8 16.8 1.7 1.7 55.6 55.6

10-dione. 1Th0e-deiomnpe.iriTchael feomrmpuirliacailsfCo4r1mHu7l1aN3isOC8.41THh7e1Nch3Oem8.iTcahle chemical

TildipirosinTcilodnipcieronstirnatcionsceintbrarotinocnhsiainl fbluroidnchoilalelcftleudidincovllievcotefrdomin vniovno-afrnoemsthneotniz-aendecsathtteletizrefdleccattthleerbeaflcetcetritahle bacterial

structure osftrtuilcdtiuprireosoifntisldsiphiorowsninbiselsohwo.wn below.

exposure teoxdprousgurceontocednrturgatcionsceanttrtahteiosnitseaotftahcetisointe. of action.

INDICATIOINDS:ICZAuTpIrOevNoS1: 8Zu%priesviond1ic8a%tedisfionrdtichaetetrdeafotmr tehnettorefabtomveinnet roefsbpoirvaitnoeryredsipseirasteor(yBdRiDse)aasess(oBciRaDte)dawssiothciated with 1Nightinga1leN,igCh.tHin.g(a1le9,9C7.)H.Ph(1ar9m9a7c)okPihnaertmicsacaonkdinpehtiacrsmaancdodpyhnaarmaiccsoodfynaemwiecrsmofacnreowlideersm. aThcreolPideedsia.tTrihceInPfeedcitaiotruics Infectious MannheimMiaahnanehmeiomlyiatichaa,ePmaostlyetuicreal,laPamsuteltuorceildla,maunldtoHcidsato,pahnildusHsisotmopnhiiliunsbseoemf naindinabnedefnoand-laacntadtinognd-laicrtyatciantgtled,airy cattle,Disease JoDuirsneaal,se16Jo,u4rn3a8l,-41463,.438-443.

and for theancdonftorrolthoef creosnptirroaltorfyredsipseirasteoriyndbieseafsaendinnboene-flaacntadtinognd-laicrtyatciantgtledaaitryhicgahttlreiskatohfigdehvreislokpoinfgdeBvReDloping BRD MICROBIOMLIOCGRYO:BTIiOldLipOirGoYsi:nThildaispisrhoosiwnnhains vsihtroowanndininvitvriovoanadntiinbavcivteorianl taibctaicvtiteyrialgacintisvtittyheagbaaicntsetritaheMb.ahcatermiaoMlyt.ichaa,emolytica,

associatedawssiothciaMte. dhaweimthoMlyt.ichaa,ePm. omlyutlitcoac,idPa.,maunldtoHci.dsao,mandi. H. somni.

P. multocidPa.,maunldtoHci.dsao,mannid, tHh.rseoempnait,htohgrenespastshocgiaentesdawssiothciaBtReDd.with BRD.

DOSAGE ADNODSAAGDEMAINIDSTARDAMTIIONNIS:TIRnjAeTcItOsNub:cIuntjaencteosubslcyutaasnaeosuinsglyleasdoasesiningltehedonseeckinatthae dnoescakgaet oafd4osmag/ekogf 4 mg/kg The minimTuhme minhinibimitourmy cinohnicbeitnotryatcionsce(nMtrIaCtsio)nosf (tMildIiCpsir)osoifntaildgiapiinrostsitnheaginadinicsatttehdeBinRdDicpaatethdoBgReDnspwatehroegdeentserwmeirneedetermined

(1 mL/10(01 lmb)L/bo1d0y0wlbe)igbhotd(yBWwe)i.gDhot (nBoWt i)n.jeDcot mnootreintjehcatnm1o0remtLhapner1i0njemcLtiopnersitneje. cDtioonostitpeu. nDcotunreotthpeunscttouprpeetrhe stoppeursing the museinthgotdhsedmesectrhiboedds idnesthcreibMed31in-At2hestMan3d1a-rAd2osftathnedaCrldinoicfatlhaenCdliLnaicbaolratnodryLaSbtaonradtaorrdysSIntasntidtuatreds(CInLsStIi)tuatend(CLSI) and

of the respoefcthiveerveisaplesciztievemvoiarel stihzaenmthoeretethstaendtnhuemtebsetredofnpuumnbcteurreosf,psuhnocwtunreisn, Tsahbolwe n1.in Table 1.

are shownairne Tsahbolwe n4.in Table 4.

Clinical fieCldlinsticuadliefiselidndsitcuadteiesthiantdaicdamteinthisatrtaatidomnionfisZtruaptrioenvoo1f 8Zu%pr(etvilodi1pi8ro%sin()tilIdnipjeircotasibnl)e ISnojeluctiaobnleisSeoflfuetciotinveisfoerfftehcetive for thTehe MICs oTfhetilMdipICirsosoifntwildeipreirodseitnerwmeirneedeftoerrmisoinlaetdesfoorfisMo.lahteasemofoMlyt.ichaa,ePm. omlyutlitcoac,idPa.,maunldtoHci.dsao,mandi oHb.tasoinmedniforobmtained from

control of creosnptirroaltorfyredsipseirasteoriyndbieseafsaendinnboene-flaacntadtinognd-laicrtyatciantgtledaaitry"hcaigtthleriaskt ""hoifghderviseklo"poinfgdeBvReDlo.pCinaglveBsRaDt. hCiaglhves at higthwo BRD fitewldo sBtRudDiefise.ldInsbtuodthies.tuIdniebso,thtestuedieiso,ltaetsetsedofisMo.lahteasemofoMlyt.ichaaeamndolPy.timcaulatoncdidPa. mwuelrteocoibdtaaiwnedreforobmtained from

risk of devreislokpoinfgdeBvReDlotpyipnigcaBllRyDextyppeirciaelnlyceexopnerioernmceooreneofotrhmeoforelloowf itnhge rfioskllofwacintogrsr:isk factors:

nasopharynagseoaplhsawraynbgsetalkeswnapbrisortatkoetnrepartimoretnottfrreoamtmaellnsttfurdoymaanlilmsatulsd.yTeasntiemdailso. lTaetsetsedofisHo.lastoems noifwHe.rseoombntai iwnedre obtained

? Commin?gliCnogmfrmomingmlinugltifprolemsamleulbtiaprlnes/sasloeubrcaernss/sources ? Extende?d tErxatnesnpdoertdttirmanespaonrdt tsimhreinskand shrink

from nasopfrhoamrynagseoaplhsawraynbgsetalkeswnapbrisortatkoetnrepartimoretnottfrreoamtmaellnsttfurdoymaanlilmsatulsdyanadnifmroamls naansdopfrhoamrynagseoaplhsawraynbgsetalkeswnabs taken from salinefr-otrmeasteadlinaen-timrealtsedclasnsimifieadlsacslatsrseiafitemdeansttfraeialutmrees.nt failures.

? Exposure?tEoxwpoestuorer ctoldwweteoarthceorldcownedaitihoenrscoornwdiitdioentsemorpweridaetutremswpeinragtsure swings

Table 4 TiTldaibpliero4siTnilmdiipniirmosuinmmininhimbituomryincohnibcietonrtryactoionnce(nMtIrCa)tivoanlu(MesI*C)ovf ainludeicsa*teodf ipnadtihcaotgeednspaistohloagtednsfrisoomlated from

? Stressfu?l aSrrtirveaslspfurol caerrsisvianlgpprorocceesdsiunrgespr(oscuecdhuaressc(asutrcahtioans,cadsethraotrinoin,g,deohr obrnaindgi,nogr) branding)

BRD fieldBsRtuDdifeieslidnsthuediUes.Si.n the U.S.

? Recent w?eRaencinegntawndeapnoinogr vaancdcinpaotoior nvahcicsitnoarytion history

Table 1 NuTambbleer1oNfupmunbcetruroefsptuenstcetudriens theesteind-uinsethsetuidny-ufsoer stthuedryefsoprectthieverevsipael cstizivees vial sizes

IndicatedIndicateYdear of PathogenPs athogeisnoslation

isYoelaartioofnStudy

StudNyuismolbaetersoNfuismolbaeterM(soIgCf/5m0*L*)

MIC50M**IC90** (g/m(L)g/mL)

MIC90M*I*C rangeMIC range (g/m(L)g/mL) (g/mL)

Vial size [VmiaLl]size [mL] 50 50 100 100 250 250

Number oNfupmunbcetruroefsptuenstcetudriens theesteind-uinsethsetuidny-use study 88 88 16 16

MannheimMiaannheim2ia007 2007TreatmentTreatment484 haemolytichaaem2o0ly0ti7cato 22000087 to 2C0o0n8trol Control 178 PasteurellaPasteurell2a007 2007TreatmentTreatment235 multocida mult2o0ci0d7a to 22000087 to 2C0o0n8trol Control 273

484 1 178 1 235 0.5 273 0.5

12 11 0.5 1 0.5 1

20.25 to >03.225 to >32 10.25 to >03.225 to >32 10.12 to >03.212 to >32 10.03 to 40.03 to 4

WAPRCACORITDNEEICNNTGITOWAPSRCNL:ACOFRISINTODNYEJREISCENNTCUEGITSOMASIEONL:. NIFIINSNNO,YJDRASCENOTACUEISTSMNMEIEOA.ONITLINFNS,UHDAOCSNUOAENMISLIMNEYNAO.AONANTLFUSOIUNHTOTSOJUENFEMMOCLIYNATAR.ITNOANIHCNUOIUAN,TTMLOJSLFEAYMOCENAPTKRITOUOIHMWSCNUEEAE,.DMLRSKLIAEEYCEDENAEPKLPSOUYMAOWSRDEEUEI.DVNTRKIGECOEDEEAEFSLPISRMWYAOEMRDAHUIECVNITDCHIGCOHIEAOEFSTHFIREMAWCLEVMYHAHEECIAILNDCHNDHOIDAORTHEAFSENADHCLV.YDHOETIIWAOTLNNIDOATDRHNVEAOSEANDHIL.DDOTIWOTIOATHNVOEAILDHisstoomphniilusHisstoo2mp0hn0iilu72s0to072200008720to07T2rC0eoa0nt8mtroelnt TrCeoantmtroelnt 3332

33 2 32 2

24 24

4 1 to 4 1 to 4 4 1 to >32 1 to >32

PACKAGEPINACSKERATGOE RINLSAEBRETLOTROLTAHBEELPHTOYSTICHIEANPH. YSICIAN.

* The corr*elaTthioencobrertewlaeteionninbevtiwtroeesnusincevpitirboilsituyscdeaptatibainlitdycdliantiacaalnedffeclcitniivceanleesfsfeicstiuvneknneosswins.unknown.

Avoid direcAtvcoindtadcirtewctitchonsktainctawnditheyskeisn. Iafnadcceiydesn.taIfl aecyceideexnptoasl ueryeeoecxcpuorss,uriensoecceuyress, rwinisthe celyeeasnwwiathtecr.leIafnacwciadtenr.taIfl askccinidental sk*in* The low*e*stThMeIClotwoeesnt cMomICptaossen5c0o%mpaansds 950% oafndth9e0m%osotfstuhsecempotisbtlesuisocelaptteibs,lereisopleactteivs,elrye.spectively.

exposure oecxcpuorss,uwreaoshcctuhres,swkianshimtmheedskiainteilmy mwiethdiasotealpy awnitdhwsoaatepr.aTnidldiwpiarotesri.nTmildaiypircoasuinsemseanyscitaizuasetiosnenbsyitiszkaintiocnonbtyacstk.in contactE. FFECTIVEENFEFSESC:TInVEaNmESuSlt:i-Iloncatmiounltfi-eloldcastiuodnyf,iecaldlvsetsudwyi,thcanlvaetusrwaliltyhoncacuturrianllgyBoRccDurwrienrgeBtrReDatwederweithreatitldeidpiwroisthin.tildipirosin.

For technicFaolratsescihstnaicnacleaosrsitsotarnecpeorotratosursepeocrtead saudsvpeercsteedreadctvieorns,ecraelal:c1tio-8n0,0ca-2ll1: 91-9820806-2.19-9286. For customFeor sceursvtiocme eor stoerrveicqeueosrttao MreaqtueersiatlaSMafaeteyriDaal tSaaSfehteyeDt a(tMaSSDhSe)e,tc(aMll:S1D-S8)0,0ca-2ll1: 1-3850703-2.11-3573. For additioFnoarlaZdudpirteiovnoa1l 8Zu%prienvform18a%tioinnfgoormtoatwiownwg.ozutoprwevwow.c.ozmup.. For a compFloertea lcisotminpgleotfealdisvteinrgseorfeadctvieornssefroeraZcutipornesvofo1r 8Zu%prreevpoor1te8d%toreCpVoMrtesdeteo: CVM see: .

The treatmTehnettsruecactemsesnrtatseucocfetshseratitlediopfirothsein-ttirldeiaptierodsignr-otruepatwedasgcromuppawraesdctomthpearteredattomtehnettsruecactemsesnrtatseucincetshserate in the saline-treasteadlinceo-ntrteroaltegdrocuopn.trAoltrgeraotumpe. nAttsruecactemsesnwt assucdcefsinsewdaassdaefcinaelfdnaost adecsaiglfnnaotetddeasigantarteeadtmasenattfraeialutmreefnrotmfailure from Day 1 to 1D3ayan1dtwo i1th3naonrdmwalitahttnitourdmea, lnaotrtmituadl ere,snpoiramtiaolnr,easpnidraatiorenc,talntdema preecrtaatlutremopf e ................
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