LUXTURNA(voretigene neparvovec-rzyl)intraocular suspension forsubretinal injection(三)
10-mL sterile empty glass vial.
5. Using the 3-mL syringe with 20G 1-inch needle, transfer 2.7 mL of Diluent to the 10-mL glass vial.
Dispose of the needle and syringe in an appropriate container.
6. Mix the contents of the thawed LUXTURNA single-dose vial by gently inverting approximately 5times.
7. Inspect the LUXTURNA single-dose vial. If particulates, cloudiness, or discoloration are visible, do notuse the vial; a new single-dose vial of LUXTURNA should be used.
8. Draw 0.3 mL of LUXTURNA into a 1-mL sterile syringe with a 27G ½-inch sterile needle. (Figure 1)Figure 1. Syringe with 0.3 mL LUXTURNA
9. Transfer 0.3 mL of LUXTURNA to the glass vial containing 2.7 mL of Diluent from Step 5. Gentlyinvert the 10-mL glass vial approximately 5 times to mix the contents.
10. Using the sterile plain label and sterile skin marker, label the 10-mL glass vial containing the diluted
LUXTURNA as follows: ‘Diluted LUXTURNA’.
11. Remove all items from the BSC except the glass vial labeled ‘Diluted LUXTURNA’ and the sterile skinmarker.
12. Re-sanitize the BSC prior to the next steps and place the glass vial and the sterile marker to the left sidein the BSC.
Preparation of LUXTURNA for Injection
To keep the syringes sterile, two operators are required for transfer of the contents of the 10-mL glass viallabeled ‘Diluted LUXTURNA’ into each of two sterile 1-mL syringes.
13. Place a sterile utility drape, a sterile plastic bag, and two sterile labels into the BSC.
14. Place the sterile drape near the Primary Operator on the right side of the sanitized BSC surface, awayfrom the diluted LUXTURNA.
15. The Secondary Operator unwraps two 1-mL syringes, two 27G ½-inch needles, and two syringe caps inthe BSC, ensuring that the Primary Operator touches only sterile surfaces while transferring the itemsonto the sterile drape.
16. The Secondary Operator changes to a new pair of sterile gloves and stands or sits to the left of thePrimary Operator. The Secondary Operator holds the 10-mL glass vial containing the dilutedLUXTURNA (Figure 2a).4Figure 2a. First Position of the Operators During Preparation of LUXTURNA Syringes
17. The Primary Operator withdraws 0.8 mL of the diluted LUXTURNA into a sterile 1-mL syringe using a27G ½-inch sterile needle while the secondary operator holds the 10-mL glass vial. After the insertion ofthe needle, the Secondary Operator inverts the 10-mL glass vial enabling the Primary Operator towithdraw 0.8 mL without touching the 10-mL glass vial (Figure 2b).
Figure 2b. Second Position of the Operators During Preparation Of LUXTURNA Syringes
18. The Primary Operator removes the needle and affixes a sterile cap to the sterile syringe, disposes of theneedle in an appropriate container, and attaches a sterile label to the administration syringe.
19. The Primary Operator repeats Steps 17 and 18 to prepare a total of two administration syringes. Labelthe first syringe “Diluted LUXTURNA” and label the second syringe “Back-up Diluted LUXTURNA”using the sterile skin marker. The second syringe will serve as a backup for the surgeon performing thesubretinal administration procedure. Discard the back-up syringe after surgery if not used.
20. Inspect both syringes. If particulates, cloudiness, or discoloration are visible, do not use the syringe.
21. Place the syringes into the sterile plastic bag after visual inspection and seal the bag.
22. Place the sterile plas |