Description
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Therapeutic indications: |
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]. |
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. |
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. |