Adverse Event Report

Report

reporttype1Version of Safety Report ID7receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10330911serious1Date Last Updated23/12/2014receiptdateformat102authoritynumbCH-SM-2014-02863companynumbPHHY2014CH088248occurcountryCHduplicate1Date Received22/07/2014seriousnesshospitalization1transmissiondate28/05/2015primarysourcecountryGB

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Patient

Onset Age78Unit of Onset AgeyearsWeight65SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionCerebrovascular accidentOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionAcute kidney injuryOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionHaemorrhageOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionDrug interactionOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb077713drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugenddateformat102drugenddate23/01/2014actiondrug5

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, 6dce ... 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)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb077713drugdosagetextUNKdrugadministrationroute065actiondrug5

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, 6dce ... 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)

drugcharacterization1medicinalproductIRFENdrugstructuredosagenumb1200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb9600drugcumulativedosageunit003drugdosagetext1200 MG, QDdrugadministrationroute048drugindicationPAINdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameIBUPROFEN

4)

drugcharacterization1medicinalproductCLEXANEdrugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb480drugcumulativedosageunit003drugdosagetext80 MG, BIDdrugadministrationroute058drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate28/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameENOXAPARIN SODIUM

5)

drugcharacterization1medicinalproductSINTROMdrugdosagetextUNKdrugadministrationroute065drugindicationATRIAL FIBRILLATIONdrugenddateformat102drugenddate20/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameACENOCOUMAROL

6)

drugcharacterization3medicinalproductASPIRIN CARDIOdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, PER DAYdrugadministrationroute048drugindicationCORONARY ARTERY DISEASEactiondrug4

activesubstance

activesubstancenameASPIRIN

7)

drugcharacterization1medicinalproductCALCIPARINEdrugstructuredosagenumb25000drugstructuredosageunit025drugdosagetext25000 IU, UNKdrugadministrationroute042drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate28/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameHEPARIN CALCIUM

8)

drugcharacterization3medicinalproductSINTROMdrugdosagetextUNKdrugadministrationroute048drugstartdateformat102drugstartdate25/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameACENOCOUMAROL

9)

drugcharacterization3medicinalproductCO-DIOVANdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QD (80 MG VALS, 12.5 MG HCTZ)drugadministrationroute048drugindicationHYPERTENSIONactiondrug4

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\VALSARTAN

10)

drugcharacterization1medicinalproductCRESTORdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, QDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

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

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHHY2014CH088248

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use