2009-04-07 - Unknown
321485
| Adverse reaction report number | 321485 |
| Latest AER version number | 1 |
| Market authorization holder AER number | WAES0903CAN00099 |
| Initial received date | 2009-04-07 |
| Latest received date | 2009-08-25 |
| Age | N/A |
| Gender | Unknown |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | MAH |
| Report outcome | Not recovered/not resolved |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | Yes |
| 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) |
|---|---|---|---|---|---|---|---|
| CELSENTRI | TABLET | Suspect | Oral | 150 Milligram | 2 every 1 Day(s) | 4 Month(s) | |
| COMBIVIR | TABLET | Suspect | Oral | ||||
| INTELENCE | TABLET | Suspect | Oral | 400 Milligram | 2 every 1 Day(s) | 4 Month(s) | |
| ISENTRESS | TABLET | Suspect | Oral | 400 Milligram | 2 every 1 Day(s) | 4 Month(s) | HIV infection |
| PREZISTA | TABLET | Suspect | Oral | ||||
| RITONAVIR | NOT SPECIFIED | Suspect | Oral | 100 Milligram | 2 every 1 Day(s) | ||
| CHAMPIX | TABLET | Concomitant | Unknown |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Blood creatine phosphokinase increased | |
| Myositis | |
| Peripheral swelling | |