2018-08-14 - Unknown
716869
| Adverse reaction report number | 716869 |
| Latest AER version number | 0 |
| Market authorization holder AER number | 614441 |
| Initial received date | 2018-08-14 |
| Latest received date | 2018-08-14 |
| Age | N/A |
| Gender | Unknown |
| Weight | N/A |
| Type of report | Study |
| Reporter type | Other Health Professional |
| Source of report | MAH |
| Report outcome | Recovered/resolved |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | |
| Other medically important | Yes |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| OZEMPIC | SOLUTION SUBCUTANEOUS | Suspect | Subcutaneous | 0.5 Milligram | 1 every 1 Week(s) | Type 2 diabetes mellitus | |
| TRESIBA | Suspect | Subcutaneous | 14 Units | 1 every 1 Day(s) | Type 2 diabetes mellitus |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Urinary tract infection | |