|Qualitative and quantitative composition:||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.
For a full list of excipients, see section 6.1. of SmPC.
|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.
|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 contents 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.
|Radionuclidic impurities:||177mLu ≤ 0,05%.|
Other γ impurities ≤ 0,01%.
|Chemical impurities:||Cu, Zn, Co, Ni, Fe, Pb (single impurity ≤ 0,1 µg/GBq).|
|Availability:||According to reactor schedule.|
|Enclosure||SmPC – LutaPol|