Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125152922 | 12515292 | 2 | F | 20160727 | 20160630 | 20160728 | EXP | IT-TEVA-672600ACC | TEVA | POGLIANI D,POZZI A,LAUDI C,RIMOLDI L,SOGNI E,FARFAGLIA P,FIGLIOLA C,JOVANE C,ZARCONE D,CARETTA E. GENERALIZED NON-CONVULSIVE EPILEPTIC SEIZURE SECONDARY TO INTOXICATION DUE TO FENTANYL IN HEMODIALYZED PATIENTS: ANALYSIS OF TWO CLINICAL CASES AND LITERATURE REVIEW. ITALIAN JOURNAL OF NEPHROLOGY. | 82.00 | YR | F | Y | 0.00000 | 20160728 | MD | IT | IT |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125152922 | 12515292 | 1 | PS | FENTANYL. | FENTANYL | 1 | Transdermal | 12 MCG / H | U | 20747 | 12 | UG | TRANSDERMAL PATCH | ||||||
| 125152922 | 12515292 | 2 | I | FENTANYL. | FENTANYL | 1 | INCREASED PATCH DOSAGE TO 25 MCG / H | U | 20747 | 25 | UG | ||||||||
| 125152922 | 12515292 | 3 | I | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | 500 MILLIGRAM DAILY; | U | 76361 | 500 | MG | QD | |||||||
| 125152922 | 12515292 | 4 | I | Rifampicin | RIFAMPIN | 1 | 300 MILLIGRAM DAILY; 300 MG / DAY | U | 0 | 300 | MG | ||||||||
| 125152922 | 12515292 | 5 | I | Vancomycin | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 1 G AS LOADING DOSE, THEN 500 MG | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125152922 | 12515292 | 1 | Ischaemic limb pain |
| 125152922 | 12515292 | 3 | Infection |
| 125152922 | 12515292 | 4 | Product used for unknown indication |
| 125152922 | 12515292 | 5 | Skin infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125152922 | 12515292 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125152922 | 12515292 | Drug interaction | |
| 125152922 | 12515292 | Generalised non-convulsive epilepsy | |
| 125152922 | 12515292 | Prescribed overdose |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125152922 | 12515292 | 1 | 20150521 | 0 |