Qualitative and quantitative composition: Each vial contains 0.925-37 GBq Yttrium (90Y) on the reference date and time (corresponding to 46-1840 nanograms of Yttrium [90Y]) in a volume 0.010-2 ml as Yttrium [90Y] chloride in a diluted hydrochloric acid.

Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr). It decays by emission of beta radiation with maximum energy 2.281 MeV (99.98%), to stable Zirconium (90Zr).

Yttrium (90Y) has a half-life of 2.67 days (64.1 hours).

For a full list of excipients, see section 6.1. of SmPC.
Pharmaceutical form: Radiopharmaceutical precursor, solution.
Clear, colourless solution.
Therapeutic indications:To be used only for the radiolabelling of medicinal products, 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.
Calibration: 3 days from the production date.
Special precautions for storage:Store below 25°C.
Store in the original package.
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Nature and contents of container: Colourless type I glass vial of 2 ml volume closed with a rubber stopper and aluminium seal, placed in a shielding lead container.
Pack size: 1 vial
During storage, due to ionising radiation, the vial may change color into yellow-brown. This discoloration has no influence into the product quality.
Radionuclidic impurities: 90Sr ≤ 0,002%.
Other γ impurities ≤ 0,01%.
Chemical impurities:Cu, Zn, Co, Ni, Fe, Pb (single impurity ≤ 0,1 µg/GBq).
Enclosure2021.09.06 – ItraPol SmPC

2021.09.07 – ItraPol package leaflet – information for the patient