|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).|
|Enclosure||2021.09.06 – ItraPol SmPC|
2021.09.07 – ItraPol package leaflet – information for the patient