Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-009507513-1404USA002895occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10069321Date Received09/04/2014transmissiondate12/12/2014serious2Date Last Updated09/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionGait disturbanceOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductINTRONAdrugauthorizationnumb103132drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext3 INJECTIONS PER WEEKdrugdosageformPOWDER FOR INJECTIONdrugadministrationroute058drugindicationHEPATITIS Cdrugstartdateformat610drugstartdate/04/1996actiondrug1drugrecurreadministration1

2)

drugcharacterization1medicinalproductINTRONAdrugauthorizationnumb103132drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext1 INJECTION WEEKLYdrugdosageformPOWDER FOR INJECTIONdrugadministrationroute058actiondrug1drugrecurreadministration1

3)

drugcharacterization2medicinalproductZOLOFTdrugrecurreadministration3

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)

drugcharacterization2medicinalproductCLORAZEPATE DIPOTASSIUMdrugrecurreadministration3

openFDA Info on Medication

Application NumberANDA075731, NDA017105, ANDA071858Brand NameCLORAZEPATE DIPOTASSIUM, TRANXENE T-TABGeneric NameCLORAZEPATE DIPOTASSIUMManufacturers Taro Pharmaceuticals U.S.A., Inc., RECORDATI RARE DISEASES, INC., Mylan Pharmace ... product_ndc 51672-4042, 51672-4043, 51672-4044, 55292-304, 55292-302, 0378-0030, 0378-0040, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLORAZEPATE DIPOTASSIUMRXCUI197464, 197465, 197466, 1149627spl_id f3a57d99-dd66-4260-8003-79cdfbf3e6a7, 894d45f5-ea77-47ba-be0b-8d46948ae800, f51a ... spl_set_id 499a6989-8912-44b7-b1eb-ee8f85ae378f, 9c7ab45c-7461-6e4e-ee6d-f0ebe3eb4a28, 9acb ... Package NDC 51672-4042-1, 51672-4042-2, 51672-4042-3, 51672-4043-1, 51672-4043-2, 51672-4043 ... UNII63FN7G03XY

5)

drugcharacterization2medicinalproductLORAZEPAMdrugrecurreadministration3

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

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-1404USA002895