Therapeutic indications:

To be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.

Radiopharmaceutical precursor – Not intended for direct use in patients.

Qualitative and quantitative compositions:

1 vial contains 0.925–37 GBq Lutetium (¹⁷⁷Lu) on the reference date and time (corresponding to 1.86–74 micrograms of lutetium in volume from 0,010 mL to 2 mL as lutetium chloride in hydrochloric acid solution).
Lutetium (¹⁷⁷Lu) decays to stable Hafnium (¹⁷⁷Hf). It decays by emission of β- particles with maximum energy 498 keV (average 149.2 keV) and emission of gamma radiation with prominent energies 208 keV (10.4%) and 113 keV (6.2%). Lutetium (¹⁷⁷Lu) has a half-life of 6.65 days.
Lutetium (¹⁷⁷Lu) is produced in nuclear reactor by neutron irradiation of Lutetium enriched in isotope (¹⁷⁶Lu). Such obtained Lutetium (¹⁷⁷Lu) contains stable Lutetium (¹⁷⁶Lu) as carrier. The specific activity of Lutetium (¹⁷⁷Lu) in pharmaceutical product LutaPol is higher than 500 GBq/mg of Lutetium.

Pharmaceutical form:

Radiopharmaceutical precursor, solution.

Clear, colourless solution.

List of excipients:

Hydrochloric acid (concentrated)

Water for injections

Posology and method of administration:

Posology

The quantity of LutaPol required for radiolabelling and the quantity of Lutetium (¹⁷⁷Lu)-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use. Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.

Paediatric population

For more information concerning the paediatric use of Lutetium (¹⁷⁷Lu)-labelled medicinal products refer to the Summary of Products Characteristics/package leaflet of the particular medicinal product to be radiolabelled.

Method of administration

LutaPol is intended for in vitro labelling of medicinal products which are subsequently administered by the approved route.

Shelf life:

7 days from the date of manufacture.

Special precautions for storage:

Store below 25°C.

Store in the original package.

Storage should be in accordance with national regulation on radioactive material.

Nature and content of container:

Colourless type I glass vial of 2 mL sealed with rubber stopper and an aluminium crimp cap, placed in lead shielding container.

Pack size: 1 vial

During storage, due to ionizing radiation, the vial may change colour into yellow-brown. This discoloration has no influence into the product quality.