IASOflu®
[18F]Natriumfluorid
Therapeutic indications
IASOflu is a diagnostic reagent for the positron emission tomography (PET) and is administered prior to such an examination.
The radioactive agent of IASOflu (for displaying the bone metabolism) is recorded by the PET and displayed as an image.
IASOflu is indicated for functional imaging procedures for the examination of unusual changes in osteogenic activity.
In particular, the following indications were documented for PET with [18F] sodium fluoride:
- Detection and localisation of bone metastases for proven carcinoma in adults
- As help/support with the diagnosis of backache of questionable origin if conventional imaging procedures are inconclusive
- With regard to children: as help/support in the detection of bone lesions in connection with suspicion of child abuse
Approvals
| Approval number | Date of registration | Country | |
|---|---|---|---|
| 573 228-0 | 21.07.2008 | France | SPC |
| BE379102 (15ml) | 11.10.2010 | Belgium | SPC |
| BE379111 (25ml) | 11.10.2010 | Belgium | SPC |
| 4-00043 | 20.10.2010 | Austria | SPC |
| 76609.00.00 | 22.11.2010 | Germany | SPC |
| 17727 | 20.01.2011 | Poland | SPC |
| 88/0832/10-S | 31.01.2011 | Slovakia | SPC |
| 5363-I-463/11 (15ml) | 24.02.2011 | Slovenia | SPC |
| 5363-I-464/11 (25ml) | 24.02.2011 | Slovenia | SPC |
| OGYI-T-21705/01 (15ml) | 28.04.2011 | Hungary | SPC |
| OGYI-T-21705/02 (25ml) | 28.04.2011 | Hungary | SPC |
| 3426/2011/01-02 | 13.05.2011 | Romania | SPC |
| 1523/11050028 (15ml) | 17.06.2011 | Luxembourg | SPC |
| 1523/11050028 (25ml) | 06.07.2011 | Luxembourg | SPC |
