Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10156397serious1Date Last Updated24/07/2014receiptdateformat102companynumbIT-RANBAXY-2014RR-78296occurcountryITduplicate1Date Received07/05/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryIT

Primary Source

reportercountryITqualification3

Patient

Onset Age91Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionBradycardiaOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.1ReactionSyncopeOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductAMIODARONEdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb146600drugcumulativedosageunit003drugdosagetext200 MGdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2012drugenddateformat102drugenddate02/01/2014actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameAMIODARONE

2)

drugcharacterization1medicinalproductCARVEDILOL.drugauthorizationnumb076989drugstructuredosagenumb12.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb4975drugcumulativedosageunit003drugdosagetext12.5 MG, DAILYdrugadministrationroute065drugindicationMYOCARDIAL ISCHAEMIAdrugstartdateformat102drugstartdate01/12/2012drugenddateformat102drugenddate02/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameCARVEDILOL

openFDA Info on Medication

Application Number ANDA076373, ANDA078384, ANDA077316, ANDA077614, NDA020297, ANDA078332, ANDA07822 ... Brand NameCARVEDILOL, COREGGeneric NameCARVEDILOLManufacturers Teva Pharmaceuticals USA, Inc., Bayshore Pharmaceuticals LLC, Mylan Pharmaceutic ... product_ndc 0093-0051, 0093-0135, 0093-7295, 0093-7296, 76385-110, 76385-111, 76385-112, 763 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARVEDILOLRXCUI200031, 200032, 200033, 686924, 212388, 212389, 212390, 686926spl_id a369c0d5-8f93-4b0d-a5a0-8125af1309f7, 8df8b35d-dade-43e2-9f28-d47a452efb36, d19e ... spl_set_id 68c275e8-992a-4520-8065-ab6d615d89cc, 33dfcf29-19d6-46ba-b8ed-d59d2226ad07, e502 ... Package NDC 0093-0051-01, 0093-0051-05, 0093-0135-01, 0093-0135-05, 0093-7295-01, 0093-7295- ... NUIN0000000099, N0000009923, N0000009924, N0000175553, N0000175556Mechanism of Action Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenerg ... Established Pharmacologic Classalpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]UNII0K47UL67F2

3)

drugcharacterization2medicinalproductALDACTONEdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MGdrugdosageformCAPSULE, HARDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameSPIRONOLACTONE

openFDA Info on Medication

Application NumberNDA012151Brand NameALDACTONEGeneric NameSPIRONOLACTONEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-1001, 0025-1041, 0025-1031Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 200817, 200820, 200825, 313096spl_idba392fd1-82d0-4a79-a555-72ab9837d283spl_set_id0fed2822-3a03-4b64-9857-c682fcd462bcPackage NDC0025-1001-31, 0025-1041-31, 0025-1031-31NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

4)

drugcharacterization2medicinalproductCOUMADINdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameWARFARIN SODIUM

openFDA Info on Medication

5)

drugcharacterization2medicinalproductTAMSULOSINdrugstructuredosagenumb.4drugstructuredosageunit003drugdosagetext0.4 MGdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameTAMSULOSIN

6)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MGdrugdosageformCAPSULE, HARDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

7)

drugcharacterization2medicinalproductLASIXdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MGdrugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

summary

narrativeincludeclinicalCASE EVENT DATE: 20140102

Report Duplicate

duplicatesourceRANBAXYduplicatenumbIT-RANBAXY-2014RR-78296

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use