Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10341919serious1Date Last Updated09/05/2018receiptdateformat102companynumbCH-BAYER-2014-106948occurcountryCHduplicate1Date Received25/07/2014seriousnesshospitalization1transmissiondate11/07/2018primarysourcecountryCH

Primary Source

reportercountryGBqualification3

Patient

Onset Age79Unit of Onset Ageyearspatientagegroup6Weight65.31SexMale

Reaction

1)

reactionmeddraversionpt21.0ReactionLabelled drug-drug interaction medication error

2)

reactionmeddraversionpt21.0ReactionMuscle haemorrhageOutcomeRecovering/resolving

3)

reactionmeddraversionpt21.0ReactionHaemarthrosisOutcomeUnknown

4)

reactionmeddraversionpt21.0ReactionHaemoglobin decreasedOutcomeRecovering/resolving

5)

reactionmeddraversionpt21.0ReactionHaemorrhageOutcomeRecovered/resolved

6)

reactionmeddraversionpt21.0ReactionDrug interaction

7)

reactionmeddraversionpt21.0ReactionHypotensionOutcomeUnknown

8)

reactionmeddraversionpt21.0ReactionDrug administration error

9)

reactionmeddraversionpt21.0ReactionIschaemic strokeOutcomeRecovered/resolved

10)

reactionmeddraversionpt21.0ReactionExtraocular muscle paresisOutcomeUnknown

11)

reactionmeddraversionpt21.0ReactionMotor dysfunctionOutcomeUnknown

12)

reactionmeddraversionpt21.0ReactionAcute kidney injuryOutcomeRecovered/resolved

13)

reactionmeddraversionpt21.0ReactionQuadrantanopiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductASPIRIN CARDIOdrugauthorizationnumb021317drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, QDdrugdosageformGASTRO-RESISTANT COATED TABLETdrugadministrationroute048drugindicationCORONARY ARTERY DISEASEactiondrug4

activesubstance

activesubstancenameASPIRIN

2)

drugcharacterization3medicinalproductCALCIPARINEdrugstructuredosagenumb25000drugstructuredosageunit025drugdosagetext25000 IU, UNKdrugadministrationroute041drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate28/01/2014

activesubstance

activesubstancenameHEPARIN CALCIUM

3)

drugcharacterization3medicinalproductCO-DIOVANdrugdosagetextUNKdrugadministrationroute048drugindicationHYPERTENSIONdrugenddateformat102drugenddate30/01/2014

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\VALSARTAN

4)

drugcharacterization3medicinalproductCLEXANEdrugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb480drugcumulativedosageunit003drugdosagetext80 MG, BIDdrugadministrationroute058drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate28/01/2014drugenddateformat102drugenddate30/01/2014

activesubstance

activesubstancenameENOXAPARIN SODIUM

5)

drugcharacterization3medicinalproductIRFENdrugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb9600drugcumulativedosageunit003drugdosagetext400 MG, TIDdrugadministrationroute048drugindicationPROCEDURAL PAINdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate30/01/2014

activesubstance

activesubstancenameIBUPROFEN

6)

drugcharacterization3medicinalproductSINTROMdrugdosagetextUNKdrugadministrationroute048drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate25/01/2014drugenddateformat102drugenddate30/01/2014

activesubstance

activesubstancenameACENOCOUMAROL

7)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKdrugenddateformat102drugenddate23/01/2014

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140130

Report Duplicate

duplicatesourceBAYERduplicatenumbCH-BAYER-2014-106948

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use