Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102seriousnessother1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10086197Date Received17/04/2014transmissiondate12/12/2014serious1Date Last Updated17/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age41Unit of Onset AgeyearsWeight104SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionUrticaria

2)

reactionmeddraversionpt17.0ReactionBlood pressure increased

3)

reactionmeddraversionpt17.0ReactionHeart rate decreased

4)

reactionmeddraversionpt17.0ReactionErythema

5)

reactionmeddraversionpt17.0ReactionRash

6)

reactionmeddraversionpt17.0ReactionRash

Drug

1)

drugcharacterization1medicinalproductGAMUNEX-Cdrugbatchnumb26NP1T1drugstructuredosagenumb50drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 VIALSdrugadministrationroute042drugindicationCHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHYdrugstartdateformat102drugstartdate13/04/2014drugrecurreadministration2drugadditional1

2)

drugcharacterization1medicinalproductGAMUNEX-Cdrugbatchnumb26NP1W1drugrecurreadministration2

3)

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

4)

drugcharacterization2medicinalproductBICILLIN

5)

drugcharacterization2medicinalproductTRAZODONE

6)

drugcharacterization2medicinalproductDILAUDID

openFDA Info on Medication

Application NumberNDA019034, NDA019892, NDA019891Brand NameDILAUDIDGeneric NameHYDROMORPHONE HYDROCHLORIDEManufacturersFresenius Kabi USA, LLC, Rhodes Pharmaceuticals L.P.product_ndc76045-009, 76045-010, 76045-121, 42858-122, 42858-234, 42858-338, 42858-416Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORALActive IngredientsHYDROMORPHONE HYDROCHLORIDERXCUI 897756, 897757, 1433251, 1872265, 1872269, 1872752, 2277368, 2277370, 897657, 89 ... spl_id 91e4f1a1-03b1-4625-b4d4-19ab7667ee4c, f89754d5-a3d4-44c9-b175-1bf0581e18da, 487e ... spl_set_id 9eebd88a-5632-460f-b7b6-26c8a180540d, 4d77772f-874f-9c87-2d80-ca467c7690a1, d6b4 ... Package NDC 76045-009-96, 76045-009-06, 76045-009-01, 76045-009-11, 76045-010-01, 76045-010- ... UNIIL960UP2KRW

7)

drugcharacterization2medicinalproductZOLOFT

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