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 compositions:

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).

Pharmaceutical form:

Radiopharmaceutical precursor, solution.

Clear, colourless solution.

List of excipients:

Hydrochloric acid (concentrated)
Water for injections

Posology and method of administration:

Posology

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.

Method of administration

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.