Adverse Event Report

Report

reporttype1Version of Safety Report ID8receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10342440serious1Date Last Updated12/05/2018receiptdateformat102companynumbCH-SA-2014SA097229occurcountryCHseriousnessother1duplicate1Date Received25/07/2014seriousnesshospitalization1transmissiondate11/07/2018primarysourcecountryCH

Primary Source

reportercountryGBqualification5

Patient

Onset Age79Unit of Onset Ageyearspatientagegroup6Weight65SexMale

Reaction

1)

reactionmeddraversionpt21.0ReactionSensorimotor disorderOutcomeUnknown

2)

reactionmeddraversionpt21.0ReactionHypotensionOutcomeUnknown

3)

reactionmeddraversionpt21.0ReactionQuadrantanopiaOutcomeUnknown

4)

reactionmeddraversionpt21.0ReactionAcute kidney injuryOutcomeRecovered/resolved

5)

reactionmeddraversionpt21.0ReactionHaemorrhageOutcomeRecovered/resolved

6)

reactionmeddraversionpt21.0ReactionDrug interactionOutcomeUnknown

7)

reactionmeddraversionpt21.0ReactionHaemoglobin decreasedOutcomeRecovering/resolving

8)

reactionmeddraversionpt21.0ReactionCerebrovascular accidentOutcomeRecovered/resolved

9)

reactionmeddraversionpt21.0ReactionParesisOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugenddateformat102drugenddate23/01/2014actiondrug5drugadditional3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

2)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

3)

drugcharacterization3medicinalproductSINTROMdrugbatchnumbUNKdrugadministrationroute065drugindicationATRIAL FIBRILLATIONdrugenddateformat102drugenddate20/01/2014actiondrug1drugadditional1

activesubstance

activesubstancenameACENOCOUMAROL

4)

drugcharacterization1medicinalproductCLEXANEdrugbatchnumbUNKNOWNdrugauthorizationnumb020164drugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb480drugcumulativedosageunit003drugadministrationroute058drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate28/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1drugadditional1

activesubstance

activesubstancenameENOXAPARIN SODIUM

5)

drugcharacterization3medicinalproductASPIRIN CARDIOdrugbatchnumbUNKNOWNdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationCORONARY ARTERY DISEASEactiondrug4

activesubstance

activesubstancenameASPIRIN

6)

drugcharacterization3medicinalproductCO-DIOVANdrugbatchnumbUNKdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext80/12.5MGdrugadministrationroute048drugindicationHYPERTENSIONdrugenddateformat102drugenddate30/01/2014actiondrug4

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\VALSARTAN

7)

drugcharacterization3medicinalproductSINTROMdrugbatchnumbUNKdrugadministrationroute048drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate25/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1drugadditional1

activesubstance

activesubstancenameACENOCOUMAROL

8)

drugcharacterization1medicinalproductIRFENdrugbatchnumbUNKNOWNdrugstructuredosagenumb1200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb26400drugcumulativedosageunit003drugadministrationroute048drugindicationPAINdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1drugadditional1

activesubstance

activesubstancenameIBUPROFEN

9)

drugcharacterization1medicinalproductCRESTORdrugbatchnumbUNKNOWNdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048actiondrug5drugadditional3

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0751, 0310-0755, 0310-0752, 0310-0754Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id0abd2d1e-ee9a-4738-ad7e-610a2caa24abspl_set_idbb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-0755-90, 0310-0751-90, 0310-0751-39, 0310-0752-90, 0310-0752-39, 0310-0754- ... UNII83MVU38M7Q

10)

drugcharacterization1medicinalproductCALCIPARINEdrugbatchnumbUNKNOWNdrugstructuredosagenumb25000drugstructuredosageunit025drugadministrationroute041drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate28/01/2014actiondrug1drugadditional1

activesubstance

activesubstancenameHEPARIN CALCIUM

summary

narrativeincludeclinicalCASE EVENT DATE: 20140130

Report Duplicate

duplicatesourceAVENTISduplicatenumbCH-SA-2014SA097229

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use