Seprafilm-说明书

CHEMICALLYMODIFIEDSODIUMHYALURONATE/CARBOXYMETHYLCELLULOSEABSORBABLEADHESIONBARRIERMANUFACTUREDBY:GenzymeBiosurgery76NewYorkAvenueFramingham,MA01701USAAdivisionofGENZYMECORPORATION500KendallStreetCambridge,MA02142USA(seeTable4).However,theplacementofSeprafilmundertheabdominalwallincisiondidnotaffectwoundhealingorsurgicalsiteinfectionrates.Inaddition,therewasnostatis-ticaldifferencebetweengroupsintheincidenceofeitherabdominopelvicabscessorpulmonaryembolism.Noforeignbodyreactionwasdetectedinthe882Seprafilmpatients.Asummaryofallseriousadverseeventsoccurringinthepivotalpre-markettrials(Tables1and2)andthepost-marketstudy(Tables3and4)areprovidedinthetablesbelow.SUMMARYOFSERIOUSADVERSEEVENTSINCLINICALTRIALSTABLE1.COLECTOMY/ILEALPOUCHANALANASTOMOSISPATIENTSPercentageofPercentageofSeprafilmMembraneControlPatientsEventDescriptionPatientsWithEventWithEventNumberofColectomy/IlealPouchN=91N=92AnalAnastomosisPatientsSmallBowelObstruction9%10%Abscess8%2%GeneralizedSignsandSymptoms–Nausea/Vomiting/Diarrhea4%5%PulmonaryEmbolus4%0%DeepVeinThrombosis2%1%Ileus2%1%Fever2%0%AdrenalInsufficiency2%0%Sepsis1%1%MyocardialInfarction/Death1%0%Pancreatitis1%0%MesentericThrombus1%0%Hepatotoxicity1%0%VentricularArrhythmia1%0%LargeBloodClot/Rectum0%1%UrinaryRetention1%0%Dehydration0%1%Pouchitis1%0%RectovaginalFistula0%1%NostatisticallysignificantdifferencesweredetectedbetweentheSeprafilmandcontrolgroup.Almost90%(n=39)ofallseriouseventsreportedinSeprafilmAdhesionBarrier-treatedpatientsandnearly81%(n=22)ofthosereportedincontrolpatientsoccurredduringthetrialwhichrequiredcolectomyfollowedbyilealpouchanalanastomosis(IPAA).TABLE2.MYOMECTOMYPATIENTSPercentageofPercentageofSeprafilmMembraneControlPatientsEventDescriptionPatientsWithEventWithEventNumberofMyomectomyN=59N=68PatientsIleusandFever2%*0%Fever-BloodTypingError2%0%LaparoscopyConvertedtoLaparotomy0%1%IntraabdominalBleeding0%1%AtelectasisandIleus0%1%PostoperativeFever0%1%NostatisticallysignificantdifferencesweredetectedbetweentheSeprafilmandcontrolgroup.*Associatedwithretainedlaparotomypack.Thefrequencyofseriousadverseeventsduringtheuterinemyomectomystudywas3%(n=2)intheSeprafilmAdhesionBarriergroupand4%(n=4)inthecontrolgroup.TABLE3.30-DAYAND6-MONTHSAESTHATOCCURREDIN≥1%OFALLRANDOMIZEDPATIENTS(N=1791)WHOHADEITHERINTESTINALRESECTIONSORADHESIOLYSIS(POST-MARKETSTUDY)30-Day30-Day6-Month6-MonthSeprafilmControlSeprafilmControlPatientsPatientsPatientsPatients(N=882(N=909(N=882(N=909EventDescriptionPatients)Patients)Patients)Patients)n(%)n(%)n(%)n(%)PatientsPatientsPatientsPatientsWithEventWithEventWithEventWithEventAnySAE264(30)237(26)350(40)324(36)Ileus40(5)40(4)51(6)46(5)IntestinalObstruction138(4)33(4)65(7)68(8)AnastomoticLeak33(4)*16(2)41(5)28(3)Dehydration26(3)32(4)44(5)47(5)AbdominopelvicAbscess230(3)27(3)48(5)43(5)Peritonitis26(3)*12(1)31(4)18(2)PostoperativeWoundInfection330(3)27(3)37(4)30(3)AbdominalPain18(2)15(2)28(3)26(3)Fever15(2)24(3)22(3)32(4)Fistula416(2)*2(1)26(3)*7(1)Vomiting13(2)13(1)22(3)20(2)Sepsis17(2)9(1)21(2)13(1)WoundDehiscence512(1)9(1)16(2)10(1)Gastro-intestinalDisorderNOS7(1)8(1)13(2)13(1)GIHemorrhage9(1)3(1)13(2)8(1)Nausea6(1)5(1)12(1)11(1)IntraabdominalFluidCollection9(1)6(1)11(1)6(1)UrinaryTractInfection8(1)7(1)11(1)10(1)LineInfection7(1)*1(1)10(1)5(1)ThrombophlebitisLegDeep3(1)4(1)9(1)7(1)SEPRAFILM®ADHESIONBARRIERDESCRIPTION:Seprafilm®AdhesionBarrier(membrane)isasterile,bioresorbable,translucentadhesionbarriercomposedoftwoanionicpolysaccharides,sodiumhyaluronate(HA)andcarboxymethylcellulose(CMC).Together,thesebiopolymershavebeenchemicallymodifiedwiththeactivatingagent1-(3-dimethylaminopropyl)-3-ethyl-carbodiimidehydrochloride(EDC).Seprafilmshouldbestoredbetween36-86°F(2-30°C)untilthepackageexpirationdate.INDICATIONS:SeprafilmAdhesionBarrierisindicatedforuseinpatientsundergoingabdominalorpelviclaparotomyasanadjunctintendedtoreducetheincidence,extentandseverityofpostoperativeadhesionsbetweentheabdominalwallandtheunder-lyingviscerasuchasomentum,smallbowel,bladder,andstomach,andbetweentheuterusandsurroundingstructuressuchastubesandovaries,largebowel,andbladder.ACTIONS:SeprafilmAdhesionBarrierservesasatemporarybioresorbablebarrierseparatingapposingtissuesurfaces.Thephysicalpresenceofthemembraneseparatesadhesiogenictissuewhilethenormaltissuerepairprocesstakesplace.Whenappliedasdirected,SeprafilmAdhesionBarriercanbeexpectedtoreduceadhesionswithintheabdominopelviccavity.Approximately24to48hoursafterplacement,themembranebecomesahydratedgelthatisslowlyresorbedwithinoneweek.Componentsareexcretedinlessthan28days.WARNINGS:SeprafilmAdhesionBarriershouldnotbewrappeddirectlyaroundafreshanastomoticsutureorstapleline,whetherornottheanastomosiswasdiverted.Anincreasedpotentialforabdominaleventsrelatedtoanastomoticleakwasidentifiedinapost-approvalstudywhenSeprafilmAdhesionBarrierwaswrappeddirectlyaroundafreshanastomoticsutureorstapleline.SeprafilmAdhesionBarrierissuppliedsterileandmustnotbere-sterilized.PRECAUTIONS:ThesafetyandeffectivenessofSeprafilmAdhesionBarrierincombinationwitho