Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID11720574primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate04/03/2016reporttype1serious1seriousnesslifethreatening1receivedateformat102Date Received10/11/2015receiptdateformat102Date Last Updated02/12/2015fulfillexpeditecriteria1companynumbJP-SUNOVION-2015SUN000831duplicate1

Report Duplicate

duplicatesourceSUNOVIONduplicatenumbJP-SUNOVION-2015SUN000831

Primary Source

reportercountryJPqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age42Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionCardiac arrestOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.1ReactionBradycardiaOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.1ReactionDrug interactionOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductTHIAMYLAL SODIUMdrugdosagetextUNK

activesubstance

activesubstancenameTHIAMYLAL SODIUM

2)

drugcharacterization1medicinalproductLUNESTAdrugauthorizationnumb021476drugstructuredosagenumb2drugstructuredosageunit003drugdosagetext2 MG, UNKdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate10/08/2015actiondrug4

activesubstance

activesubstancenameESZOPICLONE

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

3)

drugcharacterization3medicinalproductSUCCINYLCHOLINE CHLORIDE.drugdosagetextUNKdrugadministrationroute065actiondrug5

activesubstance

activesubstancenameSUCCINYLCHOLINE CHLORIDE

openFDA Info on Medication

Application Number ANDA209467, ANDA216003, ANDA210231, ANDA211432, ANDA214491, ANDA211625, ANDA2113 ... Brand NameSUCCINYLCHOLINE CHLORIDE, ANECTINE, QUELICINGeneric NameSUCCINYLCHOLINE CHLORIDEManufacturers Cadila Healthcare Limited, BE Pharmaceuticals Inc., Amring Pharmaceuticals Inc., ... product_ndc 70771-1352, 71839-121, 69918-700, 70710-1377, 70121-1581, 73043-021, 75834-151, ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, PARENTERALActive IngredientsSUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE DIHYDRATERXCUI1594589, 2598128, 1594591, 1594585, 1594587, 1594593spl_id d1d02afe-69f6-4f4e-88b9-0e2cbb81a6fe, 21bab2f1-0fce-448f-b139-dc02612e78ea, 5f54 ... spl_set_id c7f409ed-e4f4-4cd6-8f37-93f505dd986d, 6e6e0ce7-c73c-407f-9678-724425f24976, 795b ... Package NDC 70771-1352-1, 70771-1352-7, 71839-121-01, 71839-121-25, 69918-700-02, 69918-700- ... UNIII9L0DDD30I, 8L0S1G435E

summary

narrativeincludeclinicalCASE EVENT DATE: 20151013