Dg Health Childrens Mucus Relief
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Uses
ALLOCORD, HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
The risk benefit assessment for an individual patient depends on the patient characteristics, including disease, stage, risk factors, and specific manifestations of the disease, on characteristics of the graft, and on other available treatments or types of hematopoietic progenitor cells.
History
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Other Information
ALLOCORD consists of hematopoietic progenitor cells, monocytes, lymphocytes, and granulocytes from human cord blood for intravenous infusion. Blood recovered from umbilical cord and placenta is volume reduced and partially depleted of red blood cells and plasma.
The active ingredient is hematopoietic progenitor cells which express the cell surface marker CD34. The potency of cord blood is determined by measuring the numbers of total nucleated cells (TNC) and CD34+ cells, and cell viability. Each unit of ALLOCORD contains a minimum of 5 x 108 total nucleated cells with at least 1.25 x 106 viable CD34+ cells at the time of cryopreservation. The cellular composition of ALLOCORD depends on the composition of cells in the blood recovered from the umbilical cord and placenta of the donor. The actual nucleated cell count, the CD34+ cell count, the ABO group, and the HLA typing are listed in accompanying records sent with each individual unit.
ALLOCORD has the following inactive ingredients: PrepaCyte-CB separation solution, citrate-phosphate-dextrose, dimethyl sulfoxide (DMSO) and Dextran 40. When prepared for infusion according to instructions, the infusate contains the following inactive ingredients: PrepaCyte-CB separation solution, citrate-phosphate-dextrose, Dextran 40, human serum albumin, and residual DMSO.
Sources
Dg Health Childrens Mucus Relief Manufacturers
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Dolgencorp Inc
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Dg Health Childrens Mucus Relief | Ssm Cardinal Glennon Children's Medical Center St. Louis Cord Blood Bank
For intravenous use only. Do not irradiate.Unit selection and administration of ALLOCORD should be done under the direction of a physician experienced in hematopoietic progenitor cell transplantation.
2.1 DosingThe 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 ALLOCORD are documented in accompanying records.
2.2 Preparation for InfusionALLOCORD should be prepared by a trained healthcare professional.
Do not irradiate ALLOCORD. See the appended detailed instructions for preparation of ALLOCORD for infusion. Once prepared for infusion, ALLOCORD may be stored at 4 to 25°C for up to 4 hours [see Instructions for Preparation for Infusion]. The recommended limit on DMSO administration is 1 gram per kg body weight per day [see Warnings and Precautions (5.2) and Overdosage (10)]. 2.3 AdministrationALLOCORD 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 ALLOCORD 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 ALLOCORD. Premedication can include any or all of the following: antipyretics, histamine antagonists, 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 ALLOCORD by intravenous infusion. Do not administer in the same tubing concurrently with products other than 0.9% Sodium Chloride, Injection (USP). ALLOCORD 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 ALLOCORD at 100 milliliters per hour and increase the rate as tolerated. For children, begin infusion of ALLOCORD at 1 milliliter per kg per hour and increase as tolerated. Reduce the infusion rate if the fluid load is not tolerated. Discontinue the infusion in the event of an allergic reaction or if the patient develops a moderate to severe infusion reaction [See Warnings and Precautions (5.2) and Adverse Reactions (6)]. Monitor the patient for adverse reactions during, and for at least six hours after, administration. Because ALLOCORD contains lysed red cells that may cause renal failure, careful monitoring of urine output is also recommended.NOTE: If product is being prepared for a multi-unit infusion, infuse units independently. Should a reaction occur, appropriately manage the reaction before second unit is thawed for infusion.
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