To be used only for the radiolabelling of medicinal products, which have been specifically developed and authorised for radiolabelling with this radionuclide.
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 [90YZr].
Clear, colourless solution.
List of excipents:
|Hydrochloric acid (concentrated).|
Water for injections.
Posology and method of administration:
The quantity of ItraPol required for radiolabelling and the quantity of Yttrium [90Y] 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.
ItraPol is intended for in vitro labelling of medicinal products which are subsequently administered by the approved route.
7 days from the date of manufacture.
Special precautions for storage:
Store below 25°C, in the original package.
Nature and content 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.