Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride
Potassium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Disodium phosphate
Sodium dihydrogen phosphate dihydrate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections

6.2   Incompatibilities

Not applicable.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.

6.4   Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
If no refrigeration is available, Spinraza may be stored in its original carton, protected from light at or below 30°C for up to 14 days.

Prior to administration, unopened vials of Spinraza can be removed from and returned to the refrigerator if necessary. If removed from the original carton, the total combined time out of refrigeration should not exceed 30 hours, at a temperature that does not exceed 25°C.

6.5   Nature and contents of container

5 ml in a Type I glass vial with bromobutyl rubber stopper and an aluminium over-seal and plastic cap.
Pack size of one vial per carton.



6.6   Special precautions for disposal and other handling

For single use only.
Instructions for preparation of the medicinal product before administration 
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 (see section 6.4).
5. Just prior to administration, remove the plastic cap and insert the syringe needle into the vial through the centre of the over-seal to remove the appropriate volume. Spinraza must not be diluted.
The use of external filters is not required.
6. Once drawn into the syringe, if the solution is not used within 6 hours, it must be discarded.
7. Any unused product or waste material must be disposed of in accordance with local requirements.