Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Water for injection
Sodium citrate
Sodium chloride
Hydrochloric acid

6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4   Special precautions for storage

This medicinal product does not require any special temperature storage conditions.
Storage of Xofigo should be in accordance with national regulation on radioactive materials.


6.5   Nature and contents of container

Colourless Type I glass vial closed with a grey bromobutyl rubber stopper either with or without foil-clad made of Ethylene tetrafluoroethylene (ETFE) both capped with aluminium seal, containing 6 mL of solution for injection.

The vial is stored in a lead pot.

6.6   Special precautions for disposal and other handling
General warnings

Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of the competent official organisation.

Xofigo should be handled in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.

Radiation protection

The gamma radiation associated with the decay of radium-223 and its daughters allows for the radioactivity measurement of Xofigo and the detection of contaminations with standard instruments.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, faeces, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken. Care should be used when handling materials, such as bed linen, that come into contact with such body fluids. Although radium-223 is predominantly an alpha emitter, gamma and beta radiation is associated with the decay of radium-223 and its radioactive daughter isotopes.
The external radiation exposure associated with handling of patient doses is considerably lower in comparison to other radiopharmaceuticals for therapeutic purposes as the administered radioactivity will usually be below 8 MBq. However, in keeping with the ALARA (“As Low As Reasonably Achievable”) principle, for minimisation of radiation exposure, it is recommended to minimise the time spent in radiation areas, to maximise the distance to radiation sources, and to use adequate shielding.

Any unused product or waste materials should be disposed of in accordance with local regulations.
Any materials used in connection with the preparation or administration of Xofigo are to be treated as radioactive waste.