Source: Web Search Revision Year: 2022 Publisher: Advanced Accelerator Applications SA (AAA), 20 rue Diesel, 01630 Saint Genis Pouilly, France
This medicinal product is for diagnostic use only.
Fludeoxyglucose (18F) is indicated for use with positron emission tomography (PET) in adults and paediatric population.
In patients undergoing oncologic diagnostic procedures describing function or diseases where enhanced glucose influx of specific organs or tissues is the diagnostic target. The following indications are sufficiently documented (see also section 4.4):
In the cardiologic indication, the diagnostic target is viable myocardial tissue that takes-up glucose but is hypoperfused, as it must be assessed beforehand using appropriate blood-flow imaging techniques.
candidates for revascularisation when conventional imaging modalities are not contributive.
In the neurologic indication the interictal glucose hypometabolism is the diagnostic target.
In infectious or inflammatory diseases, the diagnostic target is tissue or structures with an abnormal content of
activated white blood cells.
In infectious or inflammatory diseases, the following indications are sufficiently documented:
Localisation of abnormal foci guiding the aetiologic diagnosis in case of fever of unknown origin
Diagnosis of infection in case of:
Detection of the extension of inflammation in case of:
Therapy follow-up:
Unresectable alveolar echinococcosis, in search for active localisations of the parasite during medical treatment and after treatment discontinuation.
The recommended activity for an adult weighing 70 kg is 100 to 400 MBq (this activity has to be adapted according to the body weight of the patient, the type of camera used and acquisition mode), administered by direct intravenous injection.
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
Extensive dose-range and adjustment studies with this medicinal product in normal and special populations have not been performed. The pharmacokinetics of fludeoxyglucose (18F) in renally impaired patients has not been characterised.
The use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. The activities to be administered to children and adolescents may be calculated according to the recommendations of the European Association of Nuclear Medicine (EANM) paediatric dosage card; the activity administered to children and to adolescents may be calculated by multiplying a baseline activity (for calculation purposes) by the weight-dependent multiples given in the table below.
A[MBq]Administered = Baseline Activity × Multiple
The baseline activity for 2D imaging is 25.9 MBq and for 3D imaging 14.0 MBq (recommended in children).
| Weight [kg] | Multiple | Weight [kg] | Multiple | Weight [kg] | Multiple |
|---|---|---|---|---|---|
| 3 | 1 | 22 | 5.29 | 42 | 9.14 |
| 4 | 1.14 | 24 | 5.71 | 44 | 9.57 |
| 6 | 1.71 | 26 | 6.14 | 46 | 10.00 |
| 8 | 2.14 | 28 | 6.43 | 48 | 10.29 |
| 10 | 2.71 | 30 | 6.86 | 50 | 10.71 |
| 12 | 3.14 | 32 | 7.29 | 52-54 | 11.29 |
| 14 | 3.57 | 34 | 7.72 | 56-58 | 12.00 |
| 16 | 4.00 | 36 | 8.00 | 60-62 | 12.71 |
| 18 | 4.43 | 38 | 8.43 | 64-66 | 13.43 |
| 20 | 4.86 | 40 | 8.86 | 68 | 14.00 |
For intravenous use.
For multidose use.
The activity of fludeoxyglucose (18F) has to be measured with activimeter immediately prior to injection. The injection of fludeoxyglucose (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts.
For instructions on dilution of the medicinal product before administration, see section 12.
For patient preparation, see section 4.4.
The emission scans are usually started 45 to 60 minutes after the injection of fludeoxyglucose (18F). Provided a sufficient activity remains for adequate counting statistics, fludeoxyglucose (18F)-PET can also be performed up to two or three hours after administration, thus reducing background activity.
If required, repeated fludeoxyglucose (18F)-PET examinations can be reiterated within a short period of time.
In the event of administration of a radiation overdose with fludeoxyglucose (18F) the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and frequent bladder voiding. It might be helpful to estimate the effective dose that was applied.
10 hours after production time and 8 hours following the first use.
The date and time of the expiration are indicated on the external side of the original packaging as well as on the vial.
The medicinal product should be stored at a temperature below +25°C in its original packaging.
For storage conditions after first opening of the medicinal product, see section 6.3.
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
15 mL glass vial, colourless Type I of the European Pharmacopoeia, closed by a rubber stopper and sealed by an aluminium capsule.
One vial contains 0.5 to 10 mL of solution, corresponding to 250 to 5000 MBq at calibration time.
Multidose vial.
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with national regulations must be taken.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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