HYPERRAB Solution for injection Ref.[10828] Active ingredients: Human rabies immunoglobulin

For infiltration and intramuscular use only.

The strength of HYPERRAB is 300 IU/mL.

2.1 Dose

Use HYPERRAB in combination with rabies vaccine series to be effective. Do not use HYPERRAB alone for prevention.

Administer HYPERRAB within 7 days after the first dose of rabies vaccine.

Rabies Postexposure Prophylaxis Schedule^*:

^* Adapted from reference 1.
^† These regimens are applicable for all age groups, including children.
^‡ Day 0 is the day the first dose of vaccine is administered. Refer to vaccine manufacturer’s instructions or to the recommendations of the Advisory Committee on Immunization Practices (ACIP)(1-3) for appropriate rabies vaccine formulations, schedules and dosages.
^§ Any person with a history of rabies vaccination and a documented history of antibody response to the prior vaccination.

2.2 Preparation

• Calculate the volume of HYPERRAB for the recommended dose of 20 IU/kg.
• Ensure the correct strength is used for the calculation. HYPERRAB is formulated with a strength of 300 IU/mL. The predecessor product, HYPERRAB S/D was formulated at 150 IU/mL. The volume required of HYPERRAB (300 IU/mL) to achieve the recommended dose of 20 IU/kg is approximately one half of that required for the previous HYPERRAB S/D (150 IU/mL).
• Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. HYPERRAB is a clear or slightly opalescent, and colorless or pale yellow or light brown sterile solution.
• Do not use HYPERRAB if the product shows any sign of tampering. Notify Grifols Therapeutics LLC immediately [1-800-520-2807].
• Do not freeze. Do not use any solution that has been frozen.
• Discard unused portion.

2.3 Administration

• Administer HYPERRAB at the time of the first vaccine dose (day 0), but no later than day 7(1-3).
• Infiltrate the full dose of HYPERRAB in the area around the wound, if anatomically feasible. Dilute HYPERRAB with an equal volume of dextrose, 5% (D5W), if additional volume is needed to infiltrate the entire wound. Do not dilute with normal saline.
• Inject the remainder, if any, of the HYPERRAB dose intramuscularly into the deltoid muscle of the upper arm or into the lateral thigh muscle, and distant from the site of vaccine administration.
• Do not administer HYPERRAB in the same syringe or needle or in the same anatomic site as vaccine.

Because Rabies Immune Globulin (Human) may partially suppress active production of antibody in response to the rabies vaccine, do not give more than the recommended dose of rabies immune globin (human).(1)

• Store HYPERRAB at (2 to 8°C, 36 to 46°F).
• Do not freeze.
• Do not use after expiration date.
• Discard unused portion.