nusinersen: package leaflet
For patients
Package leaflet, verbatim
Package leaflet: Spinraza 12 mg solution for injection · Spinraza 28 mg solution for injection / Spinraza 50 mg solution for injection
1. The Spinraza vial should be inspected for particles prior to administration. If particles are observed
and/or the liquid in the vial is not clear and colourless, the vial must not be used.
2. Aseptic technique should be used when preparing Spinraza solution for intrathecal administration.
3. The vial should be taken out of the refrigerator and allowed to warm to room temperature (25°C)
without using external heat sources, prior to administration.
4. If the vial remains unopened and the solution is not used, it should be returned back to the refrigerator.
5. Just prior to administration, remove the plastic cap and insert the syringe needle into the vial through
the center of the over-seal to remove the appropriate volume. Spinraza must not be diluted. The use of external filters is not required.
6. Spinraza is administered as an intrathecal bolus injection over 1 to 3 minutes, using a spinal
anaesthesia needle.
7. The injection must not be administered in areas of the skin where there are signs of infection or inflammation.
8. It is recommended that the volume of CSF, equivalent to the volume of Spinraza to be injected, is removed prior to administration of Spinraza.
9. Once drawn into the syringe, if the solution is not used within 6 hours, it must be discarded.
10. Any unused product in the vial should be discarded and waste material must be disposed of in accordance with local requirements.
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.