inister the Recombinant Human Hyaluronidase of HYQVIA at an initial rate per site of approximately 1 to 2 mL per minute, or as tolerated.
Administer Immune Globulin Infusion 10% (Human) of HYQVIA at rates as shown in Table 3 for the initial infusions. If the patient tolerates these infusions at the full dose and maximum rate, adjust both the time intervals and number of rate changes of the ramp-up used for successive infusions at the discretion of the physician and patient.
Table 3 Immune Globulin Infusion 10% (Human) Infusion Rates First 2 Infusions
Subsequent 2 or 3 Infusions
Subjects < 40 kg (< 88lbs)
Subjects ≥ 40 kg (≥ 88lbs)
Subjects < 40 kg (< 88lbs)
Subjects ≥ 40 kg (≥ 88lbs)
Intervals
Rate per site
Rate per site
Rate per site
Rate per site
Minutes
mL per hour
mL per hour
mL per hour
mL per hour
5 - 15 5
10
10
10
5 - 15 10
30
20
30
5 - 15 20
60
40
120
5 - 15 40
120
80
240
Remainder of infusion
80
240
160
300
2.3 Preparation and Handling•
Visually inspect both vials of HYQVIA for discoloration and particulate matter prior to administration.
•
The appearance of the Immune Globulin Infusion 10% (Human) of HYQVIA can vary from clear or slightly opalescent and colorless or pale yellow.
•
The appearance of the Recombinant Human Hyaluronidase of HYQVIA should be clear and colorless.
•
Do not use either component of HYQVIA if either solution is cloudy or has particulates.
•
Allow refrigerated product to come to room temperature before use. Do not apply heat or place in microwave.
•
Do not shake HYQVIA.
•
Do not mix the Recombinant Human Hyaluronidase and the Immune Globulin Infusion 10% (Human) of HYQVIA into the same container prior to administration.
•
Do not mix or administer components of HYQVIA with other products. Administer components of HYQVIA sequentially. Do not use either component alone.
•
Flush the infusion line with normal saline or Dextrose 5% in water (D5W) if required.
•
HYQVIA contains no preservative. Discard any unused product according to local standards for biohazard products.
2.4 Instructions for AdministrationUse aseptic technique when preparing and administering HYQVIA for infusion.
For more detail on steps, see accompanying Information for Patients.
1.
Inspect the vials:Inspect for clarity, color, and expiration date(s)
2.
Prepare for infusion:
•
Gather supplies: HYQVIA dual vial unit(s), ancillary supplies, sharps container and infusion pump (program pump per physician recommendation following manufacturer’s instructions).
•
Prepare a clean work area.
•
Wash hands.
•
If the Immune Globulin Infusion 10% (Human) and Recombinant Human Hyaluronidase are pooled into separate containers, skip to Step 5.
3.
Prepare the Recombinant Human Hyaluronidase of HYQVIA (Labeled as “HY”):
•
Remove the protective cap.
•
Wi