4.2. Posology and method of administration

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 and the type of camera used), administered by direct intravenous injection. Only few clinical data are available for patients aged under 18 years concerning safety and diagnostic effi cacy of the product. Therefore, the use in oncologic paediatrics has to be carefully weighted. For these patients, the activity to be administered should be calculated by multiplying the activity recommended for adults by a factor displayed in the following table (Pediatric European Task Group EANM).

3 kg = 0.10 12 kg = 0.32 22 kg = 0.50 32 kg = 0.65 42 kg = 0.78 52-54 kg = 0.90
4 kg = 0.14 14 kg = 0.36 24 kg = 0.53 34 kg = 0.68 44 kg = 0.80 56-58 kg = 0.92
6 kg = 0.19 16 kg = 0.40 26 kg = 0.56 36 kg = 0.71 46 kg = 0.82 60-62 kg = 0.96
8 kg = 0.23 18 kg = 0.44 28 kg = 0.58 38 kg = 0.73 48 kg = 0.85 64-66 kg = 0.98
10 kg = 0.27 20 kg = 0.46 30 kg = 0.62 40 kg = 0.76 50 kg = 0.88 68 kg = 0.99

The initial images may be acquired between 45 minutes and 60 minutes after injection of the substance.

4.3. Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Pregnancy

4.4. Special warnings and precautions for use

This medicinal product contains 2,4 mg sodium per mL. This can be more than 1 mmol (23 mg) for an injection depending on
the volume of the solution injected. To be taken into consideration by patients on a controlled sodium diet.

Indication of the examination:

For all patients, the radiation exposure must be justifi able by the expected diagnostic achieved with the lowest possible radiation dose. In patients with reduced kidney function, a very careful indication is required since an increased radiation exposure is possible in these patients. It should be taken into consideration that the effective dose per MBq is higher in children than in adults.

Patient preparation:

EFDEGE should be given to patients fasting for a minimum of 4 hours. In order to avoid hyperfi xation of the tracer in muscle, it is advisable for patients to avoid all strenuous physical activity prior to the examination and to remain at rest between the injection and examination and during acquisition of images (patients should be comfortably lying down without reading or speaking). A blood glucose test should be performed prior to administration since hyperglycaemia may result in a reduced sensitivity of EFDEGE, especially when glycaemia is greater than 8 mmol/L. Similarly, this product should be avoided in subjects presenting uncontrolled diabetes. The injection must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts. In order to reduce the radiation exposure of the bladder, the patients’ water balance should be regulated at the time of examination. Patients should be encouraged to drink suffi cient amounts and to empty the bladder frequently after the examination.

Interpretation of the FDG PET examination:

Infectious and/or infl ammatory diseases as well as regenerative processes after surgery can result in a signifi cant uptake of FDG and therefore lead to false positive results. False positive results cannot be excluded after radiotherapy within the fi rst 2-4 months. If the clinical indication is demanding an earlier diagnosis by FDG-PET, the reason for earlier FDG-PET examination must be reasonably documented. A delay of at least 4-6 weeks after the last administration of chemotherapy is optimal, in particular to avoid false negative results. If the clinical indication is demanding an earlier diagnosis by FDG-PET, the reason for earlier FDG-PET examination must be reasonably documented. In case of chemotherapy regimen with cycles shorter than 4 weeks, the FDG PET examination should be done just before re-starting a new cycle. In low-grade lymphoma only positive predictive values have to be considered because of a limited sensitivity.
Fludeoxyglucose (18F) is not effective in detecting brain metastases. When applying a coincidence PET (positron emission tomography) scanner system, sensitivity is reduced in comparison to dedicated PET, resulting in a probably reduced detection of lesions smaller than 1 cm.

General warnings:

It is recommended to avoid any close contact between the patient and young children during the initial 12 hours following the injection. Radiopharmaceutical products should only be received, handled and administered by staff authorised by the competent authorities. The reception, storage, handling, transfer and disposal of these products are subject to appropriate authorisations and regulations issued by the competent authorities. Radiopharmaceuticals must be prepared in such a way as to meet standards governing both radioprotection and pharmaceutical quality. Appropriate asepsis procedures must be followed in order to meet the requirements set out in pharmaceutical Good Manufacturing Practice. When a hybrid PET-CT scanner is used with contrast media, some artefacts may occur on the PET images, mostly the attenuation-corrected images.

4.5. Interaction with other medicinal products and other forms of interaction

All medicinal products that modify blood glucose levels can affect the sensitivity of the examination (e.g. corticosteroids, valproate, carbamazepine, phenytoin, phenobarbital and catecholamines). Under administration of colony-stimulating factors (CSFs) there is an increased uptake of fl udeoxyglucose (18F) in the bone marrow and the spleen for several days. This must be taken into account for the interpretation of PET imaging. Separating CSF therapy from PET imaging by an interval of at least 5 days may diminish this interference.

4.6. Pregnancy and lactation

Pregnancy:

EFDEGE is contraindicated in pregnancy. When it is necessary to administer radioactive medicinal products to women of childbearing potential information should always be sought about pregnancy. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. Where uncertainty exists it is important that radiation exposure should be the minimum consistent with achieving the required clinical information. Alternative methods not involving ionising radiation should be considered. No data are available concerning the use of this product during pregnancy. No studies of reproductive function have been performed in animals.
Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Administration of EFDEGE at activity of 500 MBq results in an absorbed dose to the uterus of 10 mGy.

Lactation:

When administration during lactation is unavoidable, breast milk may be drawn off before injection and stored for subsequent use. Breast feeding should be suspended for at least 12 hours and any milk produced during this period should be discarded. Moreover, for radioprotection reasons, it is recommended to avoid any close contact between the mother and young children during the initial 12 hours following injection.

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8. Adverse effects

No adverse effects have been observed to date. Since the administered substance quantity is very low, the major risk is caused by the radiation. Exposure to ionising radiation can lead to cancer or development of hereditary defects. Experience has shown that the frequency of such adverse events associated with diagnostic procedures involving nuclear medicine is very low as a result of the low levels of radioactivity employed. Most examinations involving nuclear medicine involve levels of radiation (effective dose) less than 20 mSv.

4.9. Overdose

An overdose in the pharmacological sense is unlikely given with the doses used for diagnostic purposes. If an overdose of fl udeoxyglucose (18F) is administered, the dose delivered to the patient must be reduced by increasing elimination of the radiopharmaceutical as far as possible through forced diuresis with frequent voiding.