XOFIGO Solution for injection Ref.[9648] Active ingredients: Radium-223 dichloride

Each mL of solution contains 1100 kBq radium Ra 223 dichloride (radium-223 dichloride), corresponding to 0.58 ng radium-223 at the reference date. Radium is present in the solution as a free ion.

Each vial contains 6 mL of solution (6.6 MBq radium-223 dichloride at the reference date).

Radium-223 is an alpha particle-emitter with a half-life of 11.4 days. The specific activity of radium-223 is 1.9 MBq/ng.

The six-stage-decay of radium-223 to lead-207 occurs via short-lived daughters, and is accompanied by a number of alpha, beta and gamma emissions with different energies and emission probabilities. The fraction of energy emitted from radium-223 and its daughters as alpha-particles is 95.3% (energy range of 5.0-7.5 MeV). The fraction emitted as beta-particles is 3.6% (average energies are 0.445 MeV and 0.492 MeV), and the fraction emitted as gamma-radiation is 1.1% (energy range of 0.01-1.27 MeV).

Figure 1. Radium-223 decay chain with physical half-lives and mode of decay:

Excipients with known effect: Each mL of solution contains 0.194 mmol (equivalent to 4.5 mg) of sodium.

For the full list of excipients, see section 6.1.