Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
 mannitol isomalt strawberry flavour tartaric acid sodium benzoate macrogol/polyethylene glycol 6000 sucralose ascorbic acid disodium edetate dihydrate
6.2   Incompatibilities

Not applicable.

6.3   Shelf life
Powder for oral solution
The expiry date of the product is indicated on the packaging materials 
Constituted oral solution
64 days stored in a refrigerator (2 to 8°C). Do not freeze.

If necessary, the patient or their caregiver may store the oral solution at room temperature (below 40˚C) for no more than a total of 120 hours (5 days). The oral solution should be returned to the refrigerator when it is no longer necessary to keep the bottle at room temperature. The total time outside the refrigerator (below 40˚C) should be monitored.

The oral solution should be discarded if it has been stored at room temperature (below 40°C) for more than a total of 120 hours (5 days), or for any period of time kept above 40°C 6.4 Special precautions for storage

Powder for oral solution

Do not store above 250C. Keep in the original amber glass bottle to protect from light.
Constituted oral solution

For storage conditions after constitution of the medicinal product, see section 6.3.
Keep the oral solution in the original amber glass bottle to protect from light and keep the bottle always in an upright position with the cap tightly closed.

6.5   Nature and contents of container

Amber type III glass bottle with a tamper-evident child resistant screw cap.
Each carton contains; one bottle, 1 press-in bottle adaptor, two re-usable 1 mL, two re-usable 6 mL and one re-usable 12 mL graduated amber oral syringes.

6.6   Special precautions for disposal and other handling

Evrysdi powder must be constituted to the oral solution by a HCP (eg. pharmacist) prior to being dispensed.

Preparation

Caution should be exercised in the handling of Evrysdi powder for oral solution (see section 4.4).
Avoid inhalation and direct contact with skin or mucous membranes with the dry powder and the constituted solution.

Wear disposable gloves during constitution and while wiping the outer surface of the bottle/cap and cleaning the working surface after constitution. If contact occurs, wash thoroughly with soap and water; rinse eyes with water.

Instructions for constitution:

1.    Gently tap the bottom of the closed glass bottle to loosen the powder.
2.    Remove the cap. Do not throw away the cap.
3.    Carefully pour 79 mL of purified water or water for injection into the Evrysdi bottle to yield the 0.75 mg/mL oral solution.
4.    Hold the medicine bottle on the table with one hand. Insert the press-in bottle adaptor into the opening by pushing it down with the other hand. Ensure the adaptor is completely pressed against the bottle lip.
5.    Put the cap back on the bottle and close the bottle tightly. Ensure it is completely closed and then shake well for 15 seconds. Wait for 10 minutes. You should have obtained a clear solution.
Afterwards, shake well again for another 15 seconds.
6.    Write the “Discard after” date of the solution on the bottle label and carton. (The “Discard after” date is calculated as 64 days after constitution, the day of constitution is counted as day 0). Put the bottle back in its original carton with syringes (in pouches), Package Leaflet, and Instructions for Use booklet. Store the carton in the refrigerator (2 to 8°C).

Discard any unused portion 64 days after constitution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7.    MARKETING AUTHORISATION HOLDER

Roche Pharmaceuticals (Israel) Ltd., P.O.Box 6391 Hod Hasharon 4524079.
8.    MARKETING AUTHORISATION NUMBER(S)

167-71-36630-99