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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91028213 | 9102821 | 3 | F | 20130201 | 20130219 | 20160831 | PER | US-JNJFOC-20130208552 | JANSSEN | BEAN LM, JACKSON JR, DOBAK WJ, BEISWENGER TR, THORP JA. INTRA-AMNIOTIC FLUCONAZOLE THERAPY FOR CANDIDA ALBICANS INTRA-AMNIOTIC INFECTION.. OBSTETRICS + GYNECOLOGY FEB-2013;121 (2):452-4. | 23.00 | YR | A | F | Y | 0.00000 | 20160831 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91028213 | 9102821 | 1 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Intravenous (not otherwise specified) | LOADING DOSE | N | 0 | 800 | MG | UNSPECIFIED | ||||||
| 91028213 | 9102821 | 2 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Intravenous (not otherwise specified) | N | 0 | 40 | MG | UNSPECIFIED | |||||||
| 91028213 | 9102821 | 3 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Intravenous (not otherwise specified) | N | 0 | 100 | MG | UNSPECIFIED | |||||||
| 91028213 | 9102821 | 4 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Intravenous (not otherwise specified) | N | 0 | 80 | MG | UNSPECIFIED | |||||||
| 91028213 | 9102821 | 5 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | UNSPECIFIED | |||||||
| 91028213 | 9102821 | 6 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | UNSPECIFIED | |||||||
| 91028213 | 9102821 | 7 | PS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Intravenous (not otherwise specified) | N | 999999 | 800 | MG | UNSPECIFIED | |||||||
| 91028213 | 9102821 | 8 | SS | IBUPROFEN. | IBUPROFEN | 1 | Transplacental | U | U | 0 | 600 | MG | LIQUID | Q6H | |||||
| 91028213 | 9102821 | 9 | SS | TERCONAZOLE. | TERCONAZOLE | 1 | Transplacental | U | U | 19641 | 80 | MG | SUPPOSITORY | QD | |||||
| 91028213 | 9102821 | 10 | SS | GENTAMICIN. | GENTAMICIN | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 91028213 | 9102821 | 11 | SS | AMPICILLIN | AMPICILLIN | 1 | Transplacental | U | 0 | UNSPECIFIED | |||||||||
| 91028213 | 9102821 | 12 | SS | AMPHOTERICIN B. | AMPHOTERICIN B | 1 | Transplacental | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 91028213 | 9102821 | 1 | Candida infection |
| 91028213 | 9102821 | 2 | Candida infection |
| 91028213 | 9102821 | 3 | Candida infection |
| 91028213 | 9102821 | 4 | Candida infection |
| 91028213 | 9102821 | 5 | Candida infection |
| 91028213 | 9102821 | 6 | Candida infection |
| 91028213 | 9102821 | 7 | Candida infection |
| 91028213 | 9102821 | 8 | Tocolysis |
| 91028213 | 9102821 | 9 | Candida infection |
| 91028213 | 9102821 | 10 | Candida infection |
| 91028213 | 9102821 | 11 | Candida infection |
| 91028213 | 9102821 | 12 | Candida infection |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 91028213 | 9102821 | Exposure during pregnancy | |
| 91028213 | 9102821 | Incorrect route of drug administration |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |