Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10082619serious1Date Last Updated24/07/2014receiptdateformat102authoritynumbIT-MINISAL02-245009companynumbIT-MYLANLABS-2014S1007827occurcountryITduplicate1Date Received16/04/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryIT

Primary Source

reportercountryITqualification1

Patient

Onset Age20Unit of Onset Ageyearspatientagegroup5SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionSuicide attemptOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.1ReactionComaOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.1ReactionIntentional overdoseOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.1ReactionMydriasisOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.1ReactionRhabdomyolysisOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductDEPAKENEdrugstructuredosagenumb8drugstructuredosageunit032drugdosagetext8 DF TOTALdrugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/03/2014drugenddateformat102drugenddate21/03/2014actiondrug1

activesubstance

activesubstancenameVALPROIC ACID

2)

drugcharacterization1medicinalproductDEPAKENEdrugstructuredosagenumb12drugstructuredosageunit032drugdosagetext12 DF TOTALdrugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/03/2014drugenddateformat102drugenddate21/03/2014actiondrug1

activesubstance

activesubstancenameVALPROIC ACID

3)

drugcharacterization1medicinalproductZOLOFTdrugstructuredosagenumb12drugstructuredosageunit032drugdosagetext12 DF TOTALdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/03/2014drugenddateformat102drugenddate21/03/2014actiondrug1

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

4)

drugcharacterization1medicinalproductDELORAZEPAMdrugstructuredosagenumb300drugstructuredosageunit003drugdosagetext300 MG TOTALdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/03/2014drugenddateformat102drugenddate21/03/2014actiondrug1

activesubstance

activesubstancenameDELORAZEPAM

5)

drugcharacterization1medicinalproductLORAZEPAM.drugauthorizationnumb077657drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG TOTALdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/03/2014drugenddateformat102drugenddate21/03/2014actiondrug1

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029 ... spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

summary

narrativeincludeclinicalCASE EVENT DATE: 20140321

Report Duplicate

duplicatesourceMYLANduplicatenumbIT-MYLANLABS-2014S1007827

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use