Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11044782primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received17/04/2015receiptdateformat102Date Last Updated28/04/2015fulfillexpeditecriteria2companynumbJP-SA-2015SA046116duplicate1

Report Duplicate

duplicatesourceAVENTISduplicatenumbJP-SA-2015SA046116

Primary Source

reportercountryJPqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age73Unit of Onset Ageyearspatientagegroup6SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionOrthostatic hypotensionOutcomeRecovering/resolving

2)

reactionmeddraversionpt18.0ReactionMalaiseOutcomeRecovering/resolving

3)

reactionmeddraversionpt18.0ReactionChillsOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductIMUNOMAX GAMMAdrugbatchnumbUNKNOWNdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextDOSE: 200MIU, ROUTE: DRdrugindicationMYCOSIS FUNGOIDESdrugstartdateformat102drugstartdate09/03/2015drugenddateformat102drugenddate17/03/2015actiondrug2

activesubstance

activesubstancenameINTERFERON GAMMA-1A

2)

drugcharacterization2medicinalproductLENDORMIN Ddrugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationINSOMNIA

activesubstance

activesubstancenameBROTIZOLAM

3)

drugcharacterization2medicinalproductARICEPTdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDEMENTIA

activesubstance

activesubstancenameDONEPEZIL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020690, NDA022568Brand NameARICEPTGeneric NameDONEPEZIL HYDROCHLORIDEManufacturersEisai Inc.product_ndc62856-245, 62856-246, 62856-247, 62856-831, 62856-832Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDONEPEZIL HYDROCHLORIDERXCUI997220, 997222, 997223, 997224, 997226, 997228, 997229, 997230, 1100184, 1100187spl_id5d9041c1-776f-48fc-b958-0b9050e26e80spl_set_id98e451e1-e4d7-4439-a675-c5457ba20975Package NDC 62856-245-30, 62856-245-90, 62856-245-41, 62856-245-11, 62856-246-11, 62856-246- ... UNII3O2T2PJ89D

4)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationINSOMNIA

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

5)

drugcharacterization2medicinalproductCRESTORdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationHYPERLIPIDAEMIA

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-7560, 0310-7570, 0310-7580, 0310-7590, 0310-0751, 0310-0755, 0310-0752, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id08039402-2a60-4599-83b5-1c63b85ead70, d9298e4d-e35f-4ba4-9fdf-1a8d0358707fspl_set_id325a5d0e-9a72-4015-9fcd-1655fb504cee, bb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-7560-90, 0310-7570-90, 0310-7580-90, 0310-7590-30, 0310-0755-90, 0310-0751- ... UNII83MVU38M7Q

6)

drugcharacterization2medicinalproductLOXONINdrugstructuredosagenumb120drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationBACK PAIN

activesubstance

activesubstancenameLOXOPROFEN SODIUM

7)

drugcharacterization2medicinalproductTAKEPRONdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationCHRONIC GASTRITIS

activesubstance

activesubstancenameLANSOPRAZOLE

8)

drugcharacterization2medicinalproductTALIONdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationMYCOSIS FUNGOIDES

activesubstance

activesubstancenameBEPOTASTINE

9)

drugcharacterization2medicinalproductATELECdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationHYPERTENSION

activesubstance

activesubstancenameCILNIDIPINE

10)

drugcharacterization2medicinalproductMIYA-BMdrugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationENTEROCOLITIS

activesubstance

activesubstancenameCLOSTRIDIUM BUTYRICUM SPORES STRAIN M-55

11)

drugcharacterization1medicinalproductIRBETANdrugbatchnumbUNKdrugauthorizationnumb020757drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONactiondrug5

activesubstance

activesubstancenameIRBESARTAN

12)

drugcharacterization2medicinalproductIRBETANdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationHYPERTENSION

activesubstance

activesubstancenameIRBESARTAN

13)

drugcharacterization1medicinalproductIMUNOMAX GAMMAdrugbatchnumbUNKNOWNdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextDOSE: 100MIU, ROUTE: DRdrugindicationMYCOSIS FUNGOIDESdrugstartdateformat102drugstartdate18/03/2015drugenddateformat102drugenddate20/03/2015actiondrug2

activesubstance

activesubstancenameINTERFERON GAMMA-1A

14)

drugcharacterization2medicinalproductMUCOSTAdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationCHRONIC GASTRITIS

activesubstance

activesubstancenameREBAMIPIDE

summary

narrativeincludeclinicalCASE EVENT DATE: 20150310