DOPACIS Solution for injection Ref.[51143] Active ingredients: Fluorodopa ¹⁸F

Posology

In oncology, the activity usually recommended for an adult can vary from 2 to 4 MBq/kg of body weight, depending on the PET equipment and acquisition mode used.

In neurological indications, the activity usually recommended for an adult can vary from 1 to 2 MBq/kg of body weight, depending on the PET equipment and acquisition mode used.

For repeated use, see section 4.4.

Paediatric population

There is very limited clinical data on safety and efficacy of this product in patients under 18, except in the search of insulinoma in infants or in very young children. The use in paediatric children and adolescents in the oncological indications has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. The activity to be administered to children and adolescents can vary from 2 to 4 MBq/kg of body weight, depending on the PET equipment and acquisition mode used.

Patients with renal impairment

Extensive dose-range and adjustment studies with this product in normal and special populations have not been performed. The pharmacokinetics of fluorodopa (¹⁸F) in patients with renal impairment has not been characterised.

Method of administrat

For patient preparation, see section 4.4.

Precautions to be taken before handling or administering the medicinal product

The activity of fluorodopa (¹⁸F) should be measured with an activimeter just before injection.

The injection of fluorodopa (¹⁸F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts.

The product should be administered slowly by direct intravenous injection over a period of about one minute.

Image acquisition

Neurology:

• Acquisition of “dynamic” PET brain images from the injection during 90 to 120 min, or
• Single "static "PET acquisition starting 90 min after injection.

Oncology:

• Foci in the hepatic, pancreatic and cervical area: early “static” images from 5 min after injection, or “dynamic” acquisition starting immediately after injection for about ten minutes.
• Brain tumors: “static” acquisition between 10 and 30 min after injection.
• Whole body: images generally acquired 60 min after injection.

Dosimetry

The data listed below are from ICRP No 106 and are calculated according to the following assumptions:

100% of the activity of fluorine-18 is distributed homogeneously in the body and eliminated through the kidneys with biological half-times of 1 hour (50%) and 12 hours (50%), independently of age.

The effective dose resulting from the administration of an activity of 280 MBq for an adult weighing of 70 kg is about 7 mSv. For an administered activity of 280 MBq the typical radiation dose to the target organs are: adrenals 2.8 mGy, brain 2.0 mGy, pancreas 2.8 mGy and thyroid 2.3 mGy and the typical radiation doses to the critical organs are: bladder 84 mGy, uterus 7.8 mGy, kidneys 8.7 mGy.

In the event of administration of a radiation overdose with fluorodopa (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.

12 hours from manufacturing time.

After the first withdrawal, store in a refrigerator (2-8°C).

The expiry date and time are mentioned on the original packaging and on the vial label.

Store in the original lead shielding.

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 colorless type I multidose glass vial, closed with a teflon-coated rubber stopper and sealed with an aluminium cap.

Packaging: One multidose vial containing 1 to 10 mL of solution, corresponding to 90 to 900 MBq at calibration time.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.