Adverse Event Report

Report

reporttype2Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10135670serious1Date Last Updated23/01/2015receiptdateformat102companynumbPHHY2014AU050111occurcountryAUseriousnessother1duplicate1Date Received28/04/2014transmissiondate20/07/2015primarysourcecountryAU

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Patient

Onset Age63Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionInjection site painOutcomeRecovering/resolving

2)

reactionmeddraversionpt18.0ReactionMusculoskeletal stiffnessOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionMuscle tightnessOutcomeRecovering/resolving

4)

reactionmeddraversionpt18.0ReactionBurning sensationOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionPain in extremityOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.0ReactionMusculoskeletal painOutcomeRecovering/resolving

7)

reactionmeddraversionpt18.0ReactionDiscomfortOutcomeRecovering/resolving

8)

reactionmeddraversionpt18.0ReactionGait disturbanceOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionMuscular weaknessOutcomeRecovering/resolving

10)

reactionmeddraversionpt18.0ReactionSleep disorderOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionArthralgiaOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductSANDOSTATIN LAR DEPOTdrugauthorizationnumb021008drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosagetext20 MG, QMOdrugadministrationroute030drugstartdateformat102drugstartdate17/04/2014actiondrug4

activesubstance

activesubstancenameOCTREOTIDE ACETATE

openFDA Info on Medication

Application NumberNDA021008Brand NameSANDOSTATIN LAR DEPOTGeneric NameOCTREOTIDE ACETATEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0811, 0078-0818, 0078-0825Product TypeHUMAN PRESCRIPTION DRUGRXCUI898589, 898591, 898601, 898603, 898605, 898607spl_id13642792-8dbc-43c5-a5b5-ced9df3c30caspl_set_idd0b7fe9e-7000-4b79-ba3b-291ce92c14f9Package NDC 0078-0811-81, 0078-0790-61, 0078-0818-81, 0078-0797-61, 0078-0825-81, 0078-0804- ...

2)

drugcharacterization1medicinalproductSANDOSTATIN LAR DEPOTdrugauthorizationnumb021008drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute030drugindicationACROMEGALYactiondrug4

activesubstance

activesubstancenameOCTREOTIDE ACETATE

openFDA Info on Medication

Application NumberNDA021008Brand NameSANDOSTATIN LAR DEPOTGeneric NameOCTREOTIDE ACETATEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0811, 0078-0818, 0078-0825Product TypeHUMAN PRESCRIPTION DRUGRXCUI898589, 898591, 898601, 898603, 898605, 898607spl_id13642792-8dbc-43c5-a5b5-ced9df3c30caspl_set_idd0b7fe9e-7000-4b79-ba3b-291ce92c14f9Package NDC 0078-0811-81, 0078-0790-61, 0078-0818-81, 0078-0797-61, 0078-0825-81, 0078-0804- ...

3)

drugcharacterization2medicinalproductSOMACdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

4)

drugcharacterization1medicinalproductSANDOSTATIN LAR DEPOTdrugauthorizationnumb021008drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute030actiondrug4

activesubstance

activesubstancenameOCTREOTIDE ACETATE

openFDA Info on Medication

Application NumberNDA021008Brand NameSANDOSTATIN LAR DEPOTGeneric NameOCTREOTIDE ACETATEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0811, 0078-0818, 0078-0825Product TypeHUMAN PRESCRIPTION DRUGRXCUI898589, 898591, 898601, 898603, 898605, 898607spl_id13642792-8dbc-43c5-a5b5-ced9df3c30caspl_set_idd0b7fe9e-7000-4b79-ba3b-291ce92c14f9Package NDC 0078-0811-81, 0078-0790-61, 0078-0818-81, 0078-0797-61, 0078-0825-81, 0078-0804- ...

5)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

6)

drugcharacterization2medicinalproductTHYMINEdrugdosagetext200/100drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameTHYMINE

summary

narrativeincludeclinicalCASE EVENT DATE: 20140417

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHHY2014AU050111

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use