Adverse Event Report

Report

reporttype1Version of Safety Report ID6receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10347663serious1Date Last Updated06/01/2015receiptdateformat102companynumbCH-TEVA-495670ISRoccurcountryCHseriousnessother1duplicate1Date Received29/07/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryCH

Primary Source

reportercountryCHqualification1

Patient

Onset Age79Unit of Onset AgeyearsWeight65SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionParesisOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionMuscle haemorrhageOutcomeRecovering/resolving

3)

reactionmeddraversionpt18.0ReactionHypotensionOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionHaemorrhageOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionQuadranopiaOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionCerebrovascular accidentOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.0ReactionHaemarthrosisOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionDrug interactionOutcomeRecovered/resolved

9)

reactionmeddraversionpt18.0ReactionAcute kidney injuryOutcomeRecovered/resolved

10)

reactionmeddraversionpt18.0ReactionSensorimotor disorderOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionHaemoglobin decreasedOutcomeRecovering/resolving

12)

reactionmeddraversionpt18.0ReactionIschaemic strokeOutcomeRecovered/resolved

Drug

1)

drugcharacterization3medicinalproductCLEXANEdrugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext160 MILLIGRAM DAILY; 80 MG, TWICE DAILYdrugadministrationroute058drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate28/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1

activesubstance

activesubstancenameENOXAPARIN SODIUM

2)

drugcharacterization3medicinalproductIRFENdrugauthorizationnumb071145drugindicationTHROMBOSIS PROPHYLAXISactiondrug1

activesubstance

activesubstancenameIBUPROFEN

3)

drugcharacterization3medicinalproductASPIRIN CARDIOdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MILLIGRAM DAILY; 100 MG, PER DAY, LONG TERM, CONTINUINGdrugadministrationroute048drugindicationCORONARY ARTERY DISEASEactiondrug4

activesubstance

activesubstancenameASPIRIN

4)

drugcharacterization2medicinalproductCRESTORdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MILLIGRAM DAILY; 5 MG, QDdrugadministrationroute065actiondrug5

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

5)

drugcharacterization1medicinalproductIRFENdrugauthorizationnumb071145drugstructuredosagenumb1200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1200 MILLIGRAM DAILY;drugadministrationroute048drugindicationPAINdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1

activesubstance

activesubstancenameIBUPROFEN

6)

drugcharacterization3medicinalproductCALCIPARINEdrugstructuredosagenumb25000drugstructuredosageunit025drugdosagetext25000 IU (INTERNATIONAL UNIT) DAILY;drugadministrationroute042drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate28/01/2014actiondrug1

activesubstance

activesubstancenameHEPARIN CALCIUM

7)

drugcharacterization3medicinalproductSINTROMdrugdosagetextACCORDING INRdrugadministrationroute048drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate25/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1

activesubstance

activesubstancenameACENOCOUMAROL

8)

drugcharacterization3medicinalproductSINTROMdrugdosagetextACCORDING INRdrugadministrationroute048drugenddateformat102drugenddate20/01/2014actiondrug1

activesubstance

activesubstancenameACENOCOUMAROL

9)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb076465drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MILLIGRAM DAILY; 50 MG, PER DAYdrugadministrationroute065drugenddateformat102drugenddate23/01/2014actiondrug5

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

10)

drugcharacterization3medicinalproductCO-DIOVANdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationHYPERTENSIONdrugenddateformat102drugenddate29/01/2014actiondrug4

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\VALSARTAN

summary

narrativeincludeclinicalCASE EVENT DATE: 201401

Report Duplicate

duplicatesourceTEVAduplicatenumbCH-TEVA-495670ISR

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use