CLINICAL PARTICULARS
4.2. Posology and method of administration
The recommended activity for an adult weighting 70 kg is 200 to 500 MBq administered by direct intravenous injection.
This activity has to be adapted according to the body weight of the patient and the type of PET or PET/CT camera used.
No clinical data are available for patients aged less than 18 years concerning safety and diagnostic effi cacy of the product. Therefore, the use in oncologic paediatrics is not recommended. For prostate cancer: dynamic PET acquisition over the pelvis including the prostate bed and the pelvic bones, during 8 min, starting 1 min after injection, or if not feasible one 2 min static acquisition starting 1 min post injection. For all indications: Static whole-body PET acquisition started 10 to 20 min after injection. If there is doubt concerning lesions with a slow uptake (e.g. negative static images whereas serum PSA levels are increased), a second static acquisition may be performed after one hour.
4.3. Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Pregnancy.
4.4. Special warnings and precautions for use For all patients, the radiation exposure must be justifi able by the expected diagnostic result 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.
Patient preparation:
IASOcholineÆ should be given to patients fasting for a minimum of 4 hours. 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 patientsí 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. 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 the pharmaceutical Good Manufacturing Practice.
4.5. Interaction with other medicinal products and other forms of interaction
The indication of IASOcholineÆ PET must be particularly documented in patients receiving anti-androgen therapy.
Any recent change in therapy must lead to the revision of the IASOcholineÆ PET indication.
4.6. Pregnancy and lactation
Pregnancy
IASOcholineÆ is contraindicated in pregnancy.
If 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 reduced to 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.
Lactation If 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 Undesirable effects
No undesirable 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 uorocholine (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.
