Radiopharmaceutical Precursors

ItraPol (Y-90) – radiopharmaceutical precursor

medicinal product GMP - MAH no 22069



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.

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

Pharmaceutical form:

Radiopharmaceutical precursor.

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.

Shelf life:

7 days from the date of manufacture.

Special precautions for storage:

Store below 25°C, in the original package.
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.

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.
Pack size: 1 vial
During storage, due to ionizing radiation, the vial may change color into yellow-brown. This discoloration has no influence into the product quality.