Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10049812serious1Date Last Updated01/04/2014receiptdateformat102companynumbUS-SA-POMP-1002324occurcountryUSduplicate1Date Received01/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age16Unit of Onset AgeyearsWeight50.6SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPainOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionMuscle spasmsOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionNauseaOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.0ReactionAbdominal painOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionMyalgiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductLUMIZYMEdrugbatchnumbUNKNOWNdrugauthorizationnumb125291drugstructuredosagenumb17.8drugstructuredosageunit007drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosagetext17.8 MG/KG, Q2WdrugdosageformPOWDER FOR SOLUTION FOR INFUSIONdrugadministrationroute042drugindicationGLYCOGEN STORAGE DISEASE TYPE IIdrugstartdateformat102drugstartdate31/12/2010actiondrug4

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Application NumberBLA125291Brand NameLUMIZYMEGeneric NameALGLUCOSIDASE ALFAManufacturersGenzyme Corporationproduct_ndc58468-0160Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsALGLUCOSIDASE ALFARXCUI629568, 993072spl_id8884fa90-01b8-49b5-836c-303db62c7c6bspl_set_idd6bfbc45-2d34-439e-8aad-59ee2d53d4dfPackage NDC58468-0160-1, 58468-0160-2NUIM0000794, N0000175821Chemical Structurealpha-Glucosidases [CS]Established Pharmacologic ClassHydrolytic Lysosomal Glycogen-specific Enzyme [EPC]UNIIDTI67O9503

2)

drugcharacterization1medicinalproductLUMIZYMEdrugbatchnumbUNKNOWNdrugauthorizationnumb125291drugstructuredosagenumb19.8drugstructuredosageunit007drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosagetext19.8 MG/KG, Q2WdrugdosageformPOWDER FOR SOLUTION FOR INFUSIONdrugadministrationroute042drugindicationGLYCOGEN STORAGE DISEASE TYPE IIdrugstartdateformat102drugstartdate16/07/2012drugenddateformat102drugenddate16/07/2012actiondrug4

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3)

drugcharacterization2medicinalproductSOLU-MEDROLdrugdosagetextUNKdrugadministrationroute042drugindicationPREMEDICATION

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Application NumberNDA011856Brand NameSOLU-MEDROLGeneric NameMETHYLPREDNISOLONE SODIUM SUCCINATEManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0003, 0009-0758, 0009-0698, 0009-0796, 0009-0039, 0009-0047, 0009-0018, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHYLPREDNISOLONE SODIUM SUCCINATERXCUI 207191, 207193, 311659, 314099, 1357886, 1357888, 1743704, 1743707, 1743720, 174 ... spl_id8859cd6d-d589-4d14-9585-4ae8b7de8329, 2037261b-cc7a-42a2-af8e-7c8e7dc2d894spl_set_idcd99be87-c8d9-48d6-a8e5-e081052e3f19, 7271310c-7764-4812-aa30-a5e90987c7a9Package NDC 0009-0758-01, 0009-0698-01, 0009-0796-01, 0009-0039-30, 0009-0039-28, 0009-0039- ... UNIILEC9GKY20K

4)

drugcharacterization2medicinalproductBENADRYLdrugdosagetextUNKdrugadministrationroute042drugindicationPREMEDICATION

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Application Numberpart341Brand NameCHILDRENS ALLERGY RELIEF, BENADRYLGeneric NameBENADRYL, DIPHENHYDRAMINE HYDROCHLORIDEManufacturers Rite Aid Corporation, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcar ... product_ndc11822-0025, 50580-370, 50580-226Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI1049906, 1049630, 1049632spl_id fecb0ac3-0ede-4e4a-91c3-b6322f055b5c, ecd53790-6b06-46a1-a4ed-dd69293aa1c5, b09d ... spl_set_id 50434eaf-650c-4416-a357-d174f86d729f, 2884d2dc-2d4a-4ca6-ab73-688a80b428eb, 702f ... Package NDC 11822-0025-4, 50580-370-01, 50580-226-50, 50580-226-51, 50580-226-53, 50580-226- ... UNIITC2D6JAD40

5)

drugcharacterization2medicinalproductIBUPROFENdrugdosagetextUNKdrugadministrationroute042drugindicationPREMEDICATION

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Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

6)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QD

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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)

drugcharacterization2medicinalproductELAVILdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QD

8)

drugcharacterization2medicinalproductEPHEDRINEdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, BID

9)

drugcharacterization2medicinalproductGABAPENTINdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MG, TID

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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

10)

drugcharacterization2medicinalproductCELEBREXdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, BID

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Application NumberNDA020998Brand NameCELEBREXGeneric NameCELECOXIBManufacturersG.D. Searle LLC Division of Pfizer Incproduct_ndc0025-1515, 0025-1520, 0025-1525, 0025-1530Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381spl_idd2a1146b-f1a6-4467-9ba8-b10f94494f8espl_set_id8d52185d-421f-4e34-8db7-f7676db2a226Package NDC 0025-1515-01, 0025-1520-31, 0025-1520-51, 0025-1520-34, 0025-1525-31, 0025-1525- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

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