le syringe “Brineura” and attach the syringe needle. Remove the green flip-off caps from the two Brineura vials. Use the “Brineura” labeled syringe to withdraw a total of 10 mL from the Brineura vials. Do not dilute Brineura. Do not mix Brineura with any other drug.
2. Label the infusion line “intraventricular infusion only” (see Figure 1).
3. Attach the syringe containing Brineura to the extension line (see Figure 2). Then connect the extension line to the infusion set with a 0.2 micron inline filter (see Figure 1).
Figure 2
Figure 2
4. Prime the infusion components with Brineura.
5. Inspect scalp for signs of intraventricular access device leakage or failure and for potential infections [see Warnings and Precautions (5.1)].
6. Prepare the scalp for intraventricular infusion per institution standard of care.
7. Insert port needle into intraventricular access device (see Figure 3).
Figure 3
Figure 3
8. Connect a separate empty sterile single-use luer lock syringe, no larger than 3 mL (not provided) to the port needle. Withdraw 0.5 mL to 1 mL of CSF to check patency of intraventricular access device (see Figure 4) and send specimen for culture.
Do not return CSF to intraventricular access device.
Routinely send CSF samples for infection monitoring [see Warnings and Precautions (5.1)].
Figure 4
Figure 4
9. Attach the infusion set with 0.2 micron inline filter to the port needle (see Figure 1).
Secure the components per institution standard of care.
10. Place the syringe containing Brineura into the syringe pump and program pump to deliver at an infusion rate of 2.5 mL per hour. Set the occlusion alarm setting to alert at pressure ≤ 281 mm Hg. See syringe pump operating manual for details. Do not deliver as a bolus or manually.
11. Administer pre-medication 30 to 60 minutes prior to the start of infusion [see Dosage and Administration (2.2)].
12. Monitor vital signs (blood pressure, heart rate) prior to the start of infusion, periodically during infusion, and post-infusion [see Warnings and Precautions (5.2)].
13. Initiate infusion of Brineura at a rate of 2.5 mL per hour.
14. Periodically inspect the infusion system during the infusion for signs of leakage or delivery failure [see Warnings and Precautions (5.1)].
15. When the Brineura infusion is complete, detach and remove the empty syringe from the pump and disconnect from the tubing (see Figure 5). Proceed to Step 16 for Intraventricular Electrolytes infusion.
Figure 5
Figure 5
Intraventricular Infusion of Intraventricular Electrolytes
Administer the Intraventricular Electrolytes provided after Brineura infusion is complete.
16. Use aseptic technique when preparing the Intraventricular Electrolytes syringe for infusion. Label one sterile syringe “Intraventricular Electrolytes” and attach the syringe needle. Remove the yellow flip-off cap from the Intraventricular Electrolytes Injection vial. Withdraw 2 mL of Intraventricular Electrolytes. Discard the remaining unused portion.
17. Attach the syringe to the extension line (see Figure 6).
Figure 6
Figure 6
18. Place the syringe containing Intraventricular Electrolytes into the syringe pump and program pump to deliver at an infusion rate of 2.5 mL per hour. Set the occlusion alarm setting to alert at pressure ≤ 281 mm Hg. See syringe pump operating manual for details. Do not deliver as a bolus or manually.
19. Initiate inf |
