美国FDA对金霉素使用指南英文件.docx
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美国FDA对金霉素使用指南英文件.docx
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美国FDA对金霉素使用指南英文件
Sec.558.128Chlortetracycline.
(a)Specifications.TypeAmedicatedarticlescontainingeitherchlortetracyclinecalciumcomplexequivalenttochlortetracyclinehydrochlorideor,forproductsintendedforuseinmilkreplacer,chlortetracyclinehydrochloride.
(b)Approvals.Seesponsorsin510.600(c)ofthischapterforuseasinparagraph(e)ofthissection.
(1)Nos.046573,048164,and066104:
50to100gramsperpound(g/lb)ofTypeAmedicatedarticle.
(2)No.012286:
50,90,or100gramsperpoundofTypeAmedicatedarticle.
(c)Relatedtolerances.See556.150ofthischapter.
(d)Specialconsiderations.
(1)Inmilkreplacersorstarterfeed;includeonlabelingthewarning:
"Awithdrawalperiodhasnotbeenestablishedforthisproductinpreruminatingcalves.Donotuseincalvestobeprocessedforveal."
(2)Manufactureforuseinfree-choicefeedsasinparagraph(e)(4)(iii)ofthissectionmustconformto510.455ofthischapter.
(3)Whenmanufacturedforuseasinparagraph(e)(5)(iv)ofthissection,includeonlabelingthewarning:
"Psittacosis,avianchlamydiosis,orornithosisisareportablecommunicabledisease,transmissiblebetweenwildanddomesticbirds,otheranimals,andman.Contactappropriatepublichealthandregulatoryofficials."
(e)Conditionsofuse--
(1)Chickens.Itisusedasfollows:
Chlortetracyclineamount
Indicationsforuse
Limitations
Sponsor
(i)10to50g/ton
Chickens:
Forincreasedrateofweightgainandimprovedfeedefficiency.
Donotfeedtochickensproducingeggsforhumanconsumption.
046573.012286,046573,048164,066104.
(ii)100to200g/ton
Chickens:
ForcontrolofinfectioussynovitiscausedbyMycoplasmasynoviaesusceptibletochlortetracycline.
1.Feedcontinuouslyfor7to14d.2.Feedcontinuouslyfor7to14d;donotfeedtochickensproducingeggsforhumanconsumption.
046573.012286,046573,048164,066104.
(iii)200to400g/ton
Chickens:
Forthecontrolofchronicrespiratorydisease(CRD)andairsacinfectioncausedbyM.gallisepticumandEscherichiacolisusceptibletochlortetracycline.
1.Feedcontinuouslyfor7to14d.2.Feedcontinuouslyfor7to14d;donotfeedtochickensproducingeggsforhumanconsumption.
046573.012286,046573,048164,066104.
(iv)500g/ton
Chickens:
ForthereductionofmortalityduetoE.coliinfectionssusceptibletochlortetracycline.
1.Feedfor5d;0-daywithdrawaltimewhenformulatedfromAUREOMYCINTypeAmedicatedarticlesorTypeBmedicatedfeedsunderNADA48-761.2.Feedfor5d;withdraw24hpriortoslaughter;donotfeedtochickensproducingeggsforhumanconsumption.
046573.012286,046573,048164,066104.
(2)Turkeys.Itisusedasfollows:
Chlortetracyclineamount
Indicationsforuse
Limitations
Sponsor
(i)10to50g/ton
Growingturkeys:
Forincreasedrateofweightgainandimprovedfeedefficiency.
Donotfeedtoturkeysproducingeggsforhumanconsumption.
012286,046573,048164,066104.
(ii)200g/ton
Turkeys:
ForcontrolofinfectioussynovitiscausedbyM.synoviaesusceptibletochlortetracycline.
Feedcontinuouslyfor7to14d;donotfeedtoturkeysproducingeggsforhumanconsumption.
012286,046573,048164,066104.
(iii)400g/ton
1.Turkeys:
ForcontrolofhexamitiasiscausedbyHexamitameleagridissusceptibletochlortetracycline.
Feedcontinuouslyfor7to14d;donotfeedtoturkeysproducingeggsforhumanconsumption.
012286,046573,048164,066104.
2.Turkeypoultsnotover4weeksofage:
ForreductionofmortalityduetoparatyphoidcausedbySalmonellatyphimuriumsusceptibletochlortetracycline.
012286,046573,048164,066104.
(iv)25mg/lbofbodyweight
Turkeys:
Forcontrolofcomplicatingbacterialorganismsassociatedwithbluecomb(transmissibleenteritis;coronaviralenteritis)susceptibletochlortetracycline.
Feedcontinuouslyfor7to14d;donotfeedtoturkeysproducingeggsforhumanconsumption.
012286,046573,048164,066104.
(3)Swine.Itisusedasfollows:
Chlortetracyclineamount
Indicationsforuse
Limitations
Sponsor
(i)10to50g/ton
Growingswine:
Forincreasedrateofweightgainandimprovedfeedefficiency.
012286,046573,048164,066104.
(ii)50to100g/ton
Swine:
Forreducingtheincidenceofcervicallymphadenitis(jowlabscesses)causedbyGroupE.Streptococcisusceptibletochlortetracycline.
012286,046573,048164,066104.
(iii)400g/ton
Breedingswine:
Forthecontrolofleptospirosis(reducingtheincidenceofabortionandsheddingofleptospirae)causedbyLeptospirapomonasusceptibletochlortetracycline.
Feedcontinuouslyfornotmorethan14d.
012286,046573,048164,066104.
(iv)10mg/lbofbodyweight
1.Swine:
ForthetreatmentofbacterialenteritiscausedbyE.coliandS.choleraesuisandbacterialpneumoniacausedbyPasteurellamultocidasusceptibletochlortetracycline.
Feedapproximately400g/t,varyingwithbodyweightandfeedconsumptiontoprovide10mg/lbperday.Feedfornotmorethan14d;withdraw5dpriortoslaughterforsponsor012286.
012286,046573,048164,066104.
2.Swine:
Forthecontrolofporcineproliferativeenteropathies(ileitis)causedbyLawsoniaintracellularissusceptibletochlortetracycline.
Feedfornotmorethan14d.
046573.
(4)Cattle.Itisusedasfollows:
Chlortetracyclineamount
Indicationsforuse
Limitations
Sponsor
(i)0.1mg/lbofbodyweightdaily.
Calves(upto250lb):
Forincreasedrateofweightgainandimprovedfeedefficiency.
Seeparagraph(d)
(1)ofthissection.
012286,046573,048164,066104.
(ii)0.5mg/lbofbodyweightdaily.
Beefcattle(over700lb);controlofactiveinfectionofanaplasmosiscausedbyAnaplasmamarginalesusceptibletochlortetracycline.
Withdraw48hpriortoslaughter.TosponsorNos.046573and048164:
zerowithdrawaltime.
012286,046573,048164,066104.
(iii)0.5to2.0mg/lbofbodyweightdaily.
Beefcattleandnonlactatingdairycattle:
AsanaidinthecontrolofactiveinfectionofanaplsmosiscausedbyA.marginalesusceptibletochlortetracycline.
Infree-choicecattlefeedssuchasfeedblocksorsalt-mineralmixesmanufacturedfromapprovedTypeAarticles.Seeparagraph(d)
(2)ofthissection.
046573.
(iv)10mg/lbofbodyweightdaily
1.Calves,beefandnonlactatingdairycattle;treatmentofbacterialenteritiscausedbyE.coliandbacterialpneumoniacausedbyP.multocidaorganismssusceptibletochlortetracycline.
Feedapproximately400g/ton,varyingwithbodyweightandfeedconsumptiontoprovide10mg/lbperday.Treatfornotmorethan5d;infeedincludingmilkreplacers;withdraw10dpriortoslaughter.TosponsorNo.048164:
zerowithdrawaltime.Seeparagraph(d)
(1)ofthissection.
012286,048164,066104.
2.Calves(upto250lb):
ForthetreatmentofbacterialenteritiscausedbyE.colisusceptibletochlortetracycline.
Seeparagraph(d)
(1)ofthissection.
012286,046573,048164,066104.
(v)500to4,000g/ton
Calves,beefandnonlactatingdairycattle;treatmentofbacterialenteritiscausedbyE.coliandbacterialpneumoniacausedbyP.multocidaorganismssusceptibletochlortetracycline.
Feedcontinuouslyfornotmorethan5daystoprovide10mg/lbbodyweightperday.TosponsorNo.046573underNADA046-699:
24-hwithdrawaltime.TosponsorNo.046573underNADA048-761:
zerowithdrawaltime.
046573.
(vi)4,000to20,000g/ton
Calves,beefandnonlactatingdairycattle;treatmentofbacterialenteritiscausedbyE.coliandbacterialpneumoniacausedbyP.multocidaorganismssusceptibletochlortetracycline.
Asatopdress,varyingwithbodyweightandfeedconsumption,toprovide10mg/lbperday.Treatfornotmorethan5days.Seeparagraph(d)
(1)ofthissection.
046573.
(vii)25to70mg/head/day
Calves(250to400lb):
Forincreasedrateofweightgainandimprovedfeedefficiency.
Seeparagraph(d)
(1)ofthissection.
012286,046573,048164,066104.
(viii)70mg/head/day
Growingcattle(over400lb):
Forincreasedrateofweightgain,improvedfeedefficiency,andreductionoflivercondemnationduetoliverabscesses.
Seeparagraph(d)
(1)ofthissection.
012286,046573,048164,066104.
(ix)350mg/head/day
1.Beefcattle:
ForcontrolofbacterialpneumoniaassociatedwithshippingfevercomplexcausedbyPasteurellaspp.susceptibletochlortetracycline.
Withdraw48hpriortoslaughter.TosponsorNo.046573underNADA046-699:
48-hwithdrawaltime.TosponsorNo.046573underNADA048-761andNo.048164:
zerowithdrawaltime.
012286,046573,048164,066104.
2.Beefcattle(under700lb):
ForcontrolofactiveinfectionofanaplasmosiscausedbyA.marginalesusceptibletochlortetracycline.
Withdraw48hpriortoslaughter.TosponsorNo.046573underNADA046-699:
48-hwithdrawaltime.TosponsorNo.046573underNADA048-761andNo.048164:
zerowithdrawaltime.
012286,046573,048164,066104.
(5)Minorspecies.Itisusedasfollows:
Chlortetracyclineamount
Indicationsforuse
Limitations
Sponsor
(i)20to50g/ton
Growingsheep;increasedrateofweightgainandimprovedfeedefficiency.
046573,048164,066104.
(ii)80mg/head/day
Breedingsheep;reducingtheincidenceof(vibrionic)abortioncausedbyCampylobacterfetusinfectionsusceptibletochlortetracycline.
046573,048164,066104.
(iii)200to400g/ton
Ducks:
ForthecontrolandtreatmentoffowlcholeracausedbyP.multocidasusceptibletochlortetracycline.
Feedincompleterationtoprovidefrom8to28mg/lbofbodyweightperdaydependinguponageandseverityofdisease,fornotmorethan21d.Donotfeedtoducksproducingeggsforhumanconsumption.
046573.
(iv)10mg/goffinishedfeeddaily.
Psittacinebirds(cockatoos,macaws,andparrots)suspectedorknowntobeinfectedwithpsittacosiscausedbyChlamydiapsittacisensitivetochlortetracycline.
Feedcontinuouslyfor45d;eachbirdshouldcon
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