Adverse Event Report

Report

Safety Report ID4318221-5transmissiondateformat102transmissiondate29/11/2004serious1seriousnessdeath1seriousnesslifethreatening1seriousnesshospitalization1receivedateformat102Date Received15/03/2004receiptdateformat102Date Last Updated28/02/2004fulfillexpeditecriteria1companynumbWAES 97101426Primary Source-

Sender

senderorganizationFDA-Public UseReceiver-

Patient

Onset Age8Unit of Onset AgedaysSexFemale

Reaction

1)

ReactionENTERITIS NECROTICANS

2)

ReactionGASTROINTESTINAL PERFORATION

3)

ReactionNEONATAL DISORDER

4)

ReactionSEPSIS

Drug

1)

drugcharacterization1medicinalproductINDOCIN I.V.drugauthorizationnumb18878drugadministrationroute042drugindicationPATENT DUCTUS ARTERIOSUSdrugstartdateformat102drugstartdate23/01/1997drugenddateformat102drugenddate23/01/1997drugtreatmentduration1drugtreatmentdurationunit804

2)

drugcharacterization1medicinalproductINDOCIN I.V.drugauthorizationnumb18878drugadministrationroute042drugindicationPATENT DUCTUS ARTERIOSUSdrugstartdateformat102drugstartdate24/01/1997drugenddateformat102drugenddate24/01/1997drugtreatmentduration1drugtreatmentdurationunit804

3)

drugcharacterization2medicinalproductDOPAMINE HCL