Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10159447primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious1seriousnessdisabling1seriousnessother1receivedateformat102Date Received08/05/2014receiptdateformat102Date Last Updated08/05/2014fulfillexpeditecriteria1companynumbUS-BEH-2012032936duplicate1

Report Duplicate

duplicatesourceCSL BEHRINGduplicatenumbUS-BEH-2012032936

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age56Unit of Onset AgeyearsWeight81SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionSinusitisOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionStaphylococcal infectionOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionAsthmaOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionTendonitisOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.0ReactionChillsOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionNauseaOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.0ReactionInfusion site swellingOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.0ReactionInfusion site erythemaOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.0ReactionInfusion site pruritusOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.0ReactionOedemaOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeRecovered/resolved

13)

reactionmeddraversionpt17.0ReactionBack painOutcomeRecovered/resolved

14)

reactionmeddraversionpt17.0ReactionFlank painOutcomeRecovered/resolved

15)

reactionmeddraversionpt17.0ReactionFatigueOutcomeRecovered/resolved

16)

reactionmeddraversionpt17.0ReactionMyalgiaOutcomeRecovered/resolved

17)

reactionmeddraversionpt17.0ReactionMalaiseOutcomeRecovered/resolved

18)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeUnknown

19)

reactionmeddraversionpt17.0ReactionChillsOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductHIZENTRAdrugauthorizationnumb125350drugstructuredosagenumb8drugstructuredosageunit002drugdosagetext??-SEP-2011drugadministrationroute058drugindicationIMMUNODEFICIENCY COMMON VARIABLEactiondrug5

2)

drugcharacterization1medicinalproductHIZENTRAdrugauthorizationnumb125350drugstructuredosagenumb2drugstructuredosageunit002drugadministrationroute058actiondrug5

3)

drugcharacterization1medicinalproductHIZENTRAdrugauthorizationnumb125350drugstructuredosagenumb3drugstructuredosageunit002drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition803drugadministrationroute058actiondrug5

4)

drugcharacterization1medicinalproductGAMMAGARD LIQUIDdrugadministrationroute058

5)

drugcharacterization2medicinalproductTHYROID

openFDA Info on Medication

Brand NameTHYROIDINUM, THYROIDGeneric Name THYROID, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, IODIUM,BADIAGA,F ... ManufacturersSeroyal USA, Apotheca Company, White Manufacturing Inc. DBA Micro-Westproduct_ndc62106-7140, 57520-0369, 61657-0952Product TypeHUMAN OTC DRUGRouteORALActive Ingredients THYROID, UNSPECIFIED, BARIUM CARBONATE, CALCIUM IODIDE, FUCUS VESICULOSUS, IODIN ... spl_id 9a074048-5cf3-80a5-e053-2995a90a5e2f, 7c905032-6f8e-4364-9141-a35d59b935d2, b970 ... spl_set_id 120ae248-4bb3-6892-e054-00144ff88e88, fb6a3cca-c449-4900-9464-29cb6a565073, 5b02 ... Package NDC62106-7140-4, 57520-0369-1, 61657-0952-1UNII 0B4FDL9I6P, 6P669D8HQ8, 8EKI9QEE2H, 535G2ABX9M, 9679TC07X4, 2E32821G6I, I76KB35J ...

6)

drugcharacterization2medicinalproductALLEGRA

7)

drugcharacterization2medicinalproductPREVACID

openFDA Info on Medication

Application NumberNDA020406, NDA022327Brand NamePREVACID, PREVACID 24 HRGeneric NameLANSOPRAZOLEManufacturers Takeda Pharmaceuticals America, Inc., GlaxoSmithKline Consumer Healthcare Holdin ... product_ndc64764-046, 64764-541, 64764-543, 64764-544, 0067-6286Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI206205, 206206, 311277, 351260, 351261, 596843, 596918, 866152spl_idcb972f0e-170e-4c9b-bc44-caa4b584ba4a, 7f6cc3d5-6355-48cb-b50a-958b1e96aa90spl_set_id71ba78cb-7e46-43eb-9425-fa130f537f84, fd4629d5-b876-4ae9-bb32-c3560ad416a9Package NDC 64764-541-30, 64764-541-19, 64764-541-11, 64764-541-05, 64764-046-13, 64764-046- ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

8)

drugcharacterization2medicinalproductVERAMYST

9)

drugcharacterization2medicinalproductSINGULAIRdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA020830, NDA021409, NDA020829Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersOrganon LLCproduct_ndc78206-170, 78206-171, 78206-173, 78206-172Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id679860ff-4c1d-432d-856a-90d4eea82ea0spl_set_id482dcc92-b47f-4ea6-854a-f5ac2aea7842Package NDC78206-171-01, 78206-170-01, 78206-173-01, 78206-172-01, 78206-172-02UNIIU1O3J18SFL

10)

drugcharacterization2medicinalproductPROVENTIL

11)

drugcharacterization2medicinalproductPREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA215246, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., Novitium Pharma LLC, GeneYork Pharmaceuticals Gr ... product_ndc 75987-020, 75987-021, 75987-022, 70954-056, 71329-106, 0378-0640, 0378-0641, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id 96a17428-b512-4fd9-a64d-50160d22aaaa, 7335a293-992b-490c-ab8a-66a7ca1eea30, 4384 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, 7335a293-992b-490c-ab8a-66a7ca1eea30, be50 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

12)

drugcharacterization2medicinalproductHYDROCORTISONE

openFDA Info on Medication

Application Number part348, ANDA088799, ANDA040351, ANDA089682, ANDA207029, ANDA080706, NDA213876, ... Brand Name DG HEALTH HYDROCORTISONE, RITE AID ANTI-ITCH, PROCTOSOL-HC, GOOD NEIGHBOR PHARMA ... Generic Name HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH, HYDROCORTISONE 1%, HYDROCOR ... Manufacturers Dolgencorp, LLC, Rite Aid Corporation, Sun Pharmaceutical Industries, Inc., Amer ... product_ndc 55910-646, 11822-2099, 10631-407, 24385-276, 41415-048, 69396-069, 61010-4402, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICAL, ORAL, RECTALActive IngredientsHYDROCORTISONE, HYDROCORTISONE ACETATERXCUI 103403, 106258, 310891, 1540356, 203105, 197785, 1790684, 197782, 197783, 197787 ... spl_id 27dc9e09-fc4f-4b66-a303-177725f3a513, a678a8ef-921b-4ae1-ba9c-3ec84aa2aa78, 297a ... spl_set_id 27dc9e09-fc4f-4b66-a303-177725f3a513, 2a232dd1-9071-4c55-a7f7-19d8404b99a6, 5652 ... Package NDC 55910-646-25, 11822-2099-3, 10631-407-01, 24385-276-03, 41415-048-75, 69396-069- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIWI4X0X7BPJ, 3X7931PO74

13)

drugcharacterization2medicinalproductLUNESTA

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

14)

drugcharacterization2medicinalproductFUROSEMIDE

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 29531d06-4e7f-4e26-93d0-1d98e58966d2, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

15)

drugcharacterization2medicinalproductMECLIZINE

openFDA Info on Medication

Application Numberpart336, ANDA201451Brand NameMECLIZINE, MECLIZINE HYDROCHLORIDEGeneric NameMECLIZINE HCL 12.5 MG, MECLIZINE HCL 25MG, MECLIZINE, MECLIZINE HCL 12.5MGManufacturers RUGBY LABORATORIES, Pharbest Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, ... product_ndc0536-1297, 16103-387, 65162-441, 65162-442, 65162-444, 73057-386Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMECLIZINE HYDROCHLORIDERXCUI995624, 995632, 995666, 995686spl_id 4f0c6a9a-982d-4efd-be18-ba305c39772d, 887b312d-3c2c-4dcb-86eb-316dfb068bc9, a9e0 ... spl_set_id 8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35, 4bac2765-045c-405e-8006-8c5cfdfa89bc, 666d ... Package NDC 0536-1297-01, 0536-1297-10, 16103-387-08, 16103-387-11, 65162-441-03, 65162-441- ... UNIIHDP7W44CIO

16)

drugcharacterization2medicinalproductPATADAY

17)

drugcharacterization2medicinalproductVIVELLE

18)

drugcharacterization2medicinalproductALBUTEROLdrugadministrationroute055

openFDA Info on Medication

Application Number ANDA210948, ANDA213657, ANDA211397, ANDA208804, ANDA072894, ANDA207046, ANDA2088 ... Brand NameALBUTEROLGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, Aurobindo Pharma Limited, Virtus Pharmaceuticals LL ... product_ndc 75834-273, 75834-274, 59651-333, 59651-334, 69543-290, 69543-291, 69238-1344, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318spl_id 5b89a3bb-e3bb-421d-89f7-f180e01a1b4d, d3cb4534-a60a-4476-928c-6eb52ac01cf8, b9cd ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, 3f81 ... Package NDC 75834-273-01, 75834-274-01, 59651-333-01, 59651-333-05, 59651-334-01, 59651-334- ... UNII021SEF3731

19)

drugcharacterization2medicinalproductPROGESTERONE

openFDA Info on Medication

Application Number NDA201110, ANDA075906, ANDA200900, NDA019781, ANDA207724, ANDA210965, ANDA211285 ... Brand Name FERRING PHARMACEUTICALS INC., PROGESTO-LIFE, PROGESTERONE, ADVANCED FORMULA PROG ... Generic NamePROGESTERONE, PROGESTERONE,Manufacturers Ferring Pharmaceuticals Inc., Smoky Mountain Naturals, LLC - DBA SMNutrition, Bi ... product_ndc 55566-9400, 82653-003, 43857-0120, 63323-261, 43857-0103, 69452-148, 69452-149, ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteVAGINAL, TOPICAL, ORAL, INTRAMUSCULAR, TRANSDERMALActive IngredientsPROGESTERONERXCUI 2537633, 312644, 260243, 312641, 261319, 262080, 153579, 153580, 312643, 312645, ... spl_id 4b80545a-0641-49cf-8f57-476862226a17, db874f40-222c-6cef-e053-2995a90abaab, d1fe ... spl_set_id de063435-6aa7-4711-8732-1c5d0358e98b, 321d86ca-af62-44c0-873d-3b7c0bcbac8c, cddb ... Package NDC 55566-9400-0, 55566-9400-1, 82653-003-01, 43857-0120-1, 63323-261-10, 43857-0103 ... NUIM0017672, N0000175601Chemical StructureProgesterone [CS]Established Pharmacologic ClassProgesterone [EPC]UNII4G7DS2Q64Y

20)

drugcharacterization2medicinalproductIPRATROPIUMdrugadministrationroute055

21)

drugcharacterization2medicinalproductSALINE

openFDA Info on Medication

Application Numberpart349, part334Brand NameSALINE, NATUREPLEX ENEMAGeneric NameNASAL, SALINE, (SALINE)Manufacturers PUBLIX SUPER MARKETS, INC, Raritan Pharmaceuiticals Inc, DISCOUNT DRUG MART, INC ... product_ndc41415-477, 68163-704, 53943-704, 63941-704, 55319-047, 67234-020Product TypeHUMAN OTC DRUGRouteNASAL, RECTALActive Ingredients SODIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM, SODIUM PHOSPHATE, ... RXCUI707251, 283100spl_id c68da549-16a0-4472-94c2-11459a9614b0, 5fe33262-3dfe-4a1a-9ddb-f27fbf5c8c7e, 26f6 ... spl_set_id 19841567-9511-43d6-ba4e-d1e1bd3481a4, 4b178e4e-a10f-4b75-8140-1f7548e203ad, aa5b ... Package NDC 41415-477-30, 68163-704-15, 53943-704-15, 53943-704-30, 63941-704-15, 55319-047- ... UNII451W47IQ8X, GR686LBA74, 3980JIH2SW

22)

drugcharacterization2medicinalproductCLARITINdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA020704, NDA019658, ANDA075209, NDA021952, NDA021891, NDA021993Brand NameCLARITIN REDITABS, CLARITIN, CLARITIN LIQUI-GELSGeneric NameLORATADINEManufacturersBayer Healthcare LLC., Bayer HealthCare LLC., Bayer HealthCare LLCproduct_ndc 11523-4329, 11523-7157, 11523-0007, 11523-6655, 11523-0800, 11523-1527, 11523-72 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINERXCUI311373, 744830, 206805, 311372, 828269, 836338, 665078, 668469, 672558, 904026spl_id de083f49-281f-89b3-e053-2a95a90a6fcd, de08d044-d572-48cd-e053-2a95a90a619f, d443 ... spl_set_id b681ea25-d00b-4c8a-8054-cc6f983ce337, acf2d393-53d7-062f-e053-2995a90a0d60, ac32 ... Package NDC 11523-7157-2, 11523-7157-3, 11523-7157-4, 11523-7157-7, 11523-7157-8, 11523-7157 ... UNII7AJO3BO7QN

23)

drugcharacterization2medicinalproductFLOVENT

openFDA Info on Medication

Application NumberNDA020833, NDA021433Brand NameFLOVENT DISKUS, FLOVENT HFAGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0600, 0173-0602, 0173-0601, 0173-0718, 0173-0719, 0173-0720Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATERXCUI 896018, 896019, 896021, 896023, 896025, 896027, 895994, 895996, 895999, 896001, ... spl_id995f7d42-c1ba-4de2-aff5-9b02187ab606, 55e108b2-ddd9-4175-b7c4-acbccba6ed67spl_set_id001f22f8-a83d-495f-9196-d0264ef4d76e, b49ed7c1-123e-4b1d-fea6-0c6839fd9d6aPackage NDC 0173-0602-02, 0173-0601-02, 0173-0600-02, 0173-0718-20, 0173-0719-20, 0173-0720- ... UNIIO2GMZ0LF5W

24)

drugcharacterization2medicinalproductPATANASE

openFDA Info on Medication

Application NumberNDA021861Brand NamePATANASEGeneric NameOLOPATADINE HYDROCHLORIDEManufacturersAlcon Laboratories, Inc., Novartis Pharmaceuticals Corporationproduct_ndc0065-0332, 0078-0834Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsOLOPATADINE HYDROCHLORIDERXCUI1797895, 1797898spl_idb3f44479-9ace-486a-a33e-c5cd0669ee9f, 3cbeda75-be25-4d55-83ea-ace367ab7332spl_set_idc4cffabd-774b-4cfd-b312-c86cf5206402, ac6fad67-4b45-4047-b410-3f683e0bb40ePackage NDC0065-0332-30, 0065-0332-08, 0078-0834-30UNII2XG66W44KF