Adverse Event Report

Report

reporttype1receiptdateformat102companynumb43912Version of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10064249Date Received18/11/2013seriousnesshospitalization1transmissiondate11/07/2014serious1Date Last Updated26/11/2013primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age61Unit of Onset AgeyearsWeight40.82SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPneumonia

2)

reactionmeddraversionpt17.0ReactionChronic obstructive pulmonary disease

3)

reactionmeddraversionpt17.0ReactionNo therapeutic response

4)

reactionmeddraversionpt17.0ReactionRespiratory failure

Drug

1)

drugcharacterization1medicinalproductGLASSIAdrugbatchnumb AA1421011A,AA1441011A,AA1431011A,AA1390911A,AA1060112A,AA1020112A,AA1020112A,AB1 ... drugauthorizationnumb125325drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext2482, WEEKLY, IVdrugadministrationroute042drugindicationALPHA-1 ANTI-TRYPSIN DECREASEDdrugstartdateformat102drugstartdate08/04/2013drugenddateformat102drugenddate02/10/2013

2)

drugcharacterization2medicinalproductADVAIR

openFDA Info on Medication

Application NumberNDA021077Brand NameADVAIR DISKUSGeneric NameFLUTICASONE PROPIONATE AND SALMETEROLManufacturersGlaxoSmithKline LLCproduct_ndc0173-0695, 0173-0696, 0173-0697Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATE, FLUTICASONE PROPIONATERXCUI 896161, 896165, 896184, 896185, 896186, 896190, 896209, 896212, 896218, 896222, ... spl_idc03442a4-17dc-4c49-ae07-3f8f7f26e0dfspl_set_id4eeb5f6a-593f-4a9e-9692-adefa2caf8fcPackage NDC 0173-0695-00, 0173-0695-04, 0173-0696-00, 0173-0696-04, 0173-0697-00, 0173-0697- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

3)

drugcharacterization2medicinalproductALBUTEROL

openFDA Info on Medication

Application Number ANDA210948, ANDA077788, ANDA213657, ANDA211397, ANDA208804, ANDA207046, ANDA0728 ... Brand NameALBUTEROL, ALBUTEROL SULFATEGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, VistaPharm, Inc., Aurobindo Pharma Limited, Virtus ... product_ndc 75834-273, 75834-274, 66689-100, 59651-333, 59651-334, 69543-290, 69543-291, 692 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318, 755497spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, 737932ca-a391-48c3-96c5-14de8ae1000e, ff9b ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, c7713a63-af2a-40d3-8deb-cbb92d5f1cd3, ff9b ... Package NDC 75834-273-01, 75834-274-01, 66689-100-16, 66689-100-08, 59651-333-01, 59651-333- ... UNII021SEF3731

4)

drugcharacterization2medicinalproductNASONEX

openFDA Info on Medication

Application NumberNDA020762Brand NameNASONEXGeneric NameMOMETASONE FUROATE MONOHYDRATEManufacturersMerck Sharp & Dohme Corp.product_ndc0085-1288Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsMOMETASONE FUROATE MONOHYDRATERXCUI1797865, 1797870spl_id62324407-1c65-4934-86df-76545ecb974cspl_set_id12df48a0-fd2e-4e1c-b135-e616a1f31f42Package NDC0085-1288-01, 0085-1288-03UNIIMTW0WEG809

5)

drugcharacterization2medicinalproductSPIRIVA

openFDA Info on Medication

Application NumberNDA021395Brand NameSPIRIVA HANDIHALERGeneric NameTIOTROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0075Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION)Active IngredientsTIOTROPIUM BROMIDE MONOHYDRATERXCUI485032, 580261spl_id61e158db-bf32-4cb5-8e5e-72acd953e493spl_set_id820839ef-e53d-47e8-a3b9-d911ff92e6a9Package NDC0597-0075-41, 0597-0075-75, 0597-0075-47UNIIL64SXO195N

6)

drugcharacterization2medicinalproductGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

7)

drugcharacterization2medicinalproductSERTRALINE

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

8)

drugcharacterization2medicinalproductTHEOPHYLLINE

openFDA Info on Medication

Application Number ANDA090430, ANDA090355, ANDA040560, ANDA091586, ANDA091156, ANDA040086, ANDA2063 ... Brand NameTHEOPHYLLINE, THEOPHYLLINE (ANHYDROUS), THEOPHYLLINE ANHYDROUSGeneric NameTHEOPHYLLINEManufacturers Alembic Pharmaceuticals Limited, Glenmark Pharmaceuticals Inc., USA, Mylan Pharm ... product_ndc 46708-025, 46708-026, 68462-356, 68462-380, 0378-0486, 0378-0487, 62332-025, 623 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTHEOPHYLLINE ANHYDROUS, THEOPHYLLINERXCUI314241, 317769, 313291, 348472, 313306spl_id 059f65c6-e5fa-4c07-bebb-b24403753e2e, 10523a75-9c10-4475-8c9a-f43e81b05007, c643 ... spl_set_id 31f3c720-1597-4d43-9296-33017b90b15f, 56fc2167-ceb6-4e3e-8ff7-5e400dfbd533, 1f2a ... Package NDC 46708-025-30, 46708-025-31, 46708-025-71, 46708-025-91, 46708-026-30, 46708-026- ... NUIN0000175790, M0023046Established Pharmacologic ClassMethylxanthine [EPC]Chemical StructureXanthines [CS]UNII0I55128JYK, C137DTR5RG

9)

drugcharacterization2medicinalproductOXYGEN

openFDA Info on Medication

Brand Name OXYGEN COMPRESSED U.S.P, OXYGEN REFRIGERATED LIQUID U.S.P, OXYGEN, MEDICAL OXYGE ... Generic NameOXYGEN, 0XYGENManufacturers Apria Healthcare LLC, In Home Medical, Inc., NLR Welding Supply, Inc., AGL Inhal ... product_ndc 51319-072, 51319-073, 60941-001, 62045-4333, 17575-001, 19979-000, 23650-001, 51 ... Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION), NASAL, CUTANEOUSActive IngredientsOXYGENRXCUI 312173, 312172, 542304, 348831, 312174, 348381, 348017, 312175, 311998, 899761, ... spl_id 92e3d064-473a-4e09-bfa1-7306c4aef38f, b12e14c8-af49-4578-e053-2a95a90a6532, d595 ... spl_set_id 105a5557-c1af-42b1-859e-76cc1e83d9aa, 2260d92d-9a68-4e4f-a4bf-c6961851fdda, 49d5 ... Package NDC 51319-072-01, 51319-072-02, 51319-072-03, 51319-072-04, 51319-072-05, 51319-072- ... UNIIS88TT14065, N762921K75Application Number NDA205849, NDA205865, NDA205767, NDA206023, NDA205889, NDA212314, NDA205712, NDA ...

Report Duplicate

duplicatesourceKAMADAduplicatenumb43912