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ID:41152060
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页数:6页
时间:2019-08-17
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1、HealthProductsRegulatoryAuthoritySummaryofProductCharacteristics1NAMEOFTHEVETERINARYMEDICINALPRODUCTAmoxival500mg/goralpowderforpigsandchickens.2QUALITATIVEANDQUANTITATIVECOMPOSITIONEachgramcontainsActivesubstance:Amoxicillin........................................
2、...............500.00mg(asamoxicillintrihydrate574.00mg)Excipients:Forthefulllistofexcipients,seesection6.1.3PHARMACEUTICALFORMOralpowder.Whiteoralmostwhitepowder.4CLINICALPARTICULARS4.1TargetSpeciesPigs(pigsafterweaning)andchickens(broilers).4.2Indicationsforuse,s
3、pecifyingthetargetspeciesPigs(afterweaning):TreatmentofswinepleuropneumoniaduetoActinobacilluspleuropneumoniae(susceptibletoamoxicillin).Broilerchickens:Preventionatthegrouplevel,whendiseaseispresent,ofrespiratoryinfectionscausedbyEscherichiacoli(susceptibletoamoxi
4、cillin).4.3ContraindicationsDonotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstancesoftheß-lactamgroup.Donotuseinanimalswithseriouskidneymalfunctionincludinganuriaandoliguria.Donotuseinpresenceof-lactamaseproducingbacteria.Donotuseinlagomorphsandro
5、dentssuchasrabbits,guineapigs,hamstersorgerbils.Donotuseinruminantsorhorses.4.4SpecialwarningsforeachtargetspeciesNone.______________________________________________________________________________________________________________________DatePrinted22/04/2016CRN7023
6、641pagenumber:1HealthProductsRegulatoryAuthority4.5SpecialprecautionsforuseSpecialprecautionsforuseinanimalsTheuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.Incaseofinsufficientuptakeoffeed/wateranimalsshouldbetreatedparenterally.Useoftheproductsho
7、uldbebasedonsusceptibilitytestingofthebacteriaisolatedfromanimals.Ifthisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformationaboutsusceptibilityofthetargetbacteria.Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresis
8、tanttoamoxicillin,otherpenicillinsandmaydecreaseitseffectiveness.Narrowspectrumantibacterialtherapyshouldbeusedforfirstlinetreatmentwheresuscepti
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