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One mL of solution contains 1000 MBq of lutetium (177Lu) vipivotide tetraxetan at the date and time of calibration.
The total amount of radioactivity per single-dose vial is 7400 MBq ± 10% at the date and time of administration. Given the fixed volumetric activity of 1000 MBq/mL at the date and time of calibration, the volume of the solution in the vial can range from 7.5 mL to 12.5 mL in order to provide the required amount of radioactivity at the date and time of administration.
Physical characteristics: Lutetium-177 decays to a stable hafnium-177 with a physical half-life of 6.647 days by emitting beta-minus radiation with a maximum energy of 0.498 MeV (79%) and photon radiation (γ) of 0.208 MeV (11%) and 0.113 MeV (6.4%).
Excipient with known effect: Each mL of solution contains up to 0.312 mmol (7.1 mg) of sodium. Each vial contains up to 88.75 mg of sodium.
Excipients/Inactive Ingredients: Acetic acid, Sodium acetate, Gentisic acid, Sodium ascorbate, Pentetic acid, Water for injections.
