For intravenous use only.
Do not irradiate.
2.1 Dosing
The recommended minimum dose is 2.5 x 107 nucleated cells/kg at cryopreservation. Multiple units may be required in order to achieve the appropriate dose.
Matching for at least 4 of 6 HLA-A antigens, HLA-B antigens, and HLA-DRB1 alleles is recommended. The HLA typing and nucleated cell content for each individual unit of HPC, Cord Blood are documented on the container label and/or in accompanying records.
2.2 Preparation for Infusion
HPC, Cord Blood should be prepared by a trained healthcare professional.
Do not irradiate HPC, Cord Blood.
See the appended detailed instructions for preparation of HPC, Cord Blood for infusion.
Once prepared for infusion, HPC, Cord Blood may be stored at 1 to 8°C for up to 4 hours.
The recommended limit on DMSO administration is 1 gram per kg body weight per day. [See Warnings and Precautions (5.2)]
2.3 Administration
HPC, Cord Blood should be administered under the supervision of a qualified healthcare professional experienced in hematopoietic progenitor cell transplantation.
Confirm the identity of the patient for the specified unit of HPC, Cord Blood prior to administration.
Confirm that emergency medications are available for use in the immediate area.
Ensure the patient is hydrated adequately.
Premedicate the patient 30 to 60 minutes before the administration of HPC, Cord Blood. Premedications can include any or all of the following: antipyretic, histamine blocker, and corticosteroids.
Inspect the product for any abnormalities such as unusual particulates and for breaches of container integrity prior to administration. Prior to infusion, discuss all such product irregularities with the laboratory issuing the product for infusion.
Administer HPC, Cord Blood by intravenous infusion. Do not administer in the same tubing concurrently with products other than 0.9% Sodium Chloride, Injection (USP). HPC, Cord Blood may be filtered through a 170 to 260 micron filter designed to remove clots. Do NOT use a filter designed to remove leukocytes.
For adults, begin infusion of HPC, Cord Blood at 100 milliliters per hour and increase the rate as tolerated. For children, begin infusion of HPC, Cord Blood at 1 milliliter per kg per hour and increase as tolerated. The infusion rate should be reduced if the fluid load is not tolerated. The infusion should be discontinued in the event of an allergic reaction or if the patient develops a moderate to severe infusion reaction. [See Warnings and Precautions (5) and Adverse Reactions (6)]
Monitor the patient for adverse reactions during, and for at least six hours after, administration. Because HPC, Cord Blood contains lysed red cells that may cause renal failure, careful monitoring of urine output is also recommended.