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

3)

drugcharacterization2medicinalproductSOMACdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

4)

drugcharacterization1medicinalproductSANDOSTATIN LAR DEPOTdrugauthorizationnumb021008drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute030actiondrug4

activesubstance

activesubstancenameOCTREOTIDE ACETATE

openFDA Info on Medication

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

Adverse Event Report

Report

Primary Source

Patient

Reaction

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

11)

Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

openFDA Info on Medication

6)

activesubstance

summary

Report Duplicate

Receiver

Sender

Media

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