EFDEGE®
Fludeoxyglucose [18F] solution injectabilis
Therapeutic indications
This pharmaceutical is a diagnostic reagent for the positron emission tomography (PET) and is administered prior to such an examination.
EFDEGE is a radiopharmaceutical diagnostic reagent for tumour detection.
The radioactive agent of EFDEGE (for displaying the glucose metabolism) is recorded by the PET and displayed as an image.
EFDEGE is indicated for imaging PET procedures within the framework of oncological diagnostics for examining the function and diseases, aiming at displaying an increased glucose intake in specific organs and tissues. The following areas of application are sufficiently documented:
Diagnosis
- Characterisation of solitary pulmonary nodules
- Metastatic cervical adenopathy of unknown origin
Determination of the tumour stage
- Primary lung carcinomas, including the detection of pulmonary distant metastases
- Carcinomas of the head and neck region, including the support of the PET controlled biopsy
- Recurrent colorectal carcinomas
- Malignant lymphomas
- Malignant melanomas: Breslow > 1.5 mm or lymph node metastases at the first diagnosis
Monitoring of the therapeutic response
- Carcinomas of the head and neck region
- Malignant lymphomas
Detection in cases of serious grounds for recurrences
- Carcinomas of the neck and head region
- Primary lung carcinomas
- Colorectal carcinomas
- Malignant lymphomas
- Malignant melanomas
Approvals
| Approval number | Date of registration | Country | |
|---|---|---|---|
| 4-00020 | 25.05.2004 | Austria | SPC |
| 6511 IE 1 F 12 | 24.07.2006 | Belgium | SPC |
| 59726.00.00 | 22.06.2004 | Germany | SPC |
| 564 456-4 | 15.12.2003 | France | SPC |
| 68514/2-12-2004 | 31.12.2004 | Greece | SPC |
| RVG 30417 | 03.02.2005 | Netherlands | SPC |
| 036751016/M | 19.12.2005 | Italy | SPC |
| UP/I-530-09/09-01/15 | 18.12.2009 | Croatia | SPC |
| 1523/04070003 | 30.07.2004 | Luxembourg | SPC |
| 12105 | 15.02.2006 | Poland | SPC |
| 5628383 | 28.10.2005 | Portugal | SPC |
| 5363-I-1174/11 (11ml) | 12.12.2005 | Slovenia | SPC |
| 5363-I-1175/11 (25ml) | 12.12.2005 | Slovenia | SPC |
| 88/328/05-C | 19.10.2005 | Czech Republic | SPC |
| OGYI-T-10441/01 | 15.09.2005 | Hungary | SPC |
