HPC, CORD BLOOD- hpc, cord blood injection
Bloodworks
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use HPC, Cord Blood safely and effectively. See full prescribing information for HPC, Cord Blood.
HPC, Cord Blood Injectable Suspension for Intravenous Use Initial U.S. Approval: 2016 WARNING: FATAL INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE.See full prescribing information for complete boxed warning.
INDICATIONS AND USAGEHPC (Hematopoietic Progenitor Cell), Cord Blood is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor 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. (1) 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. (1) DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSEach unit contains a minimum of 5 x 108 nucleated cells with at least 1.25 x 106 viable CD34+ cells at the time of cryopreservation. The exact pre-cryopreservation nucleated cell content of each unit is provided on the container label and accompanying records. (3) CONTRAINDICATIONSNone (4) WARNINGS AND PRECAUTIONSADVERSE REACTIONSMortality, from all causes, at 100 days post-transplant was 25%. (6.1) The most common infusion-related adverse reactions (≥ 5%) are hypertension, vomiting, nausea, bradycardia, and fever. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bloodworks at 1-206-321-3108 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. Revised: 1/2016 |
Fatal infusion reactions: HPC, Cord Blood administration can result in serious, including fatal, infusion reactions. Monitor patients and discontinue HPC, Cord Blood infusion for severe reactions. [See Warnings and Precautions (5.1, 5.2)]
Graft-versus-host disease (GVHD): GVHD is expected after administration of HPC, Cord Blood, and may be fatal. Administration of immunosuppressive therapy may decrease the risk of GVHD. [See Warnings and Precautions (5.3)]
Engraftment Syndrome: Engraftment syndrome may progress to multiorgan failure and death. Treat engraftment syndrome promptly with corticosteroids. [See Warnings and Precautions (5.4)]
Graft Failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. Prior to choosing a specific unit of HPC, Cord Blood unit, consider testing for HLA antibodies to identify patients who are alloimmunized. [See Warnings and Precautions (5.5)]
HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor 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 other available treatments or types of hematopoietic progenitor cells.
Unit selection and administration of HPC, Cord Blood, should be done under the direction of a physician experienced in hematopoietic progenitor cell transplantation.
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.
HPC, Cord Blood should be prepared by a trained healthcare professional.
HPC, Cord Blood should be administered under the supervision of a qualified healthcare professional experienced in hematopoietic progenitor cell transplantation.
NOTE: If product is being prepared for a multi-unit infusion, infuse units independently. Should a reaction occur, appropriately manage the reaction before the second unit is thawed for infusion.
Each HPC, Cord Blood unit contains a minimum of 5.0 x 108 total nucleated cells with a minimum of 1.25 x 106 viable CD34+ cells, suspended in 10% dimethyl sulfoxide (DMSO) and 1% Dextran 40, at the time of cryopreservation.
The exact pre-cryopreservation nucleated cell content is provided on the container label and in accompanying records.
Allergic reactions may occur with infusion of HPC, Cord Blood. Reactions include bronchospasm, wheezing, angioedema, pruritus, and hives. [See Adverse Reactions (6)]. Serious hypersensitivity reactions, including anaphylaxis, also have been reported. These reactions may be due to dimethyl sulfoxide (DMSO), Dextran 40, hydroxyethyl starch, or a plasma component of HPC, Cord Blood.
HPC, Cord Blood may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following HPC, Cord Blood administration.
Infusion reactions are expected to occur and include nausea, vomiting, fever, rigors or chills, flushing, dyspnea, hypoxemia, chest tightness, hypertension, tachycardia, bradycardia, dysguesia, hematuria, and mild headache. Premedication with antipyretic, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions.
Severe reactions, including respiratory distress, severe bronchospasm, severe bradycardia with heart block or other arrhythmias, cardiac arrest, hypotension, hemolysis, elevated liver enzymes, renal compromise, encephalopathy, loss of consciousness, and seizure also may occur. Many of these reactions are related to the amount of DMSO administered. Minimizing the amount of DMSO administered may reduce the risk of such reactions, although idiosyncratic responses may occur even at DMSO doses thought to be tolerated. The actual amount of DMSO depends on the method of preparation of the product for infusion. Limiting the amount of DMSO infused to no more than 1 gram per kilogram per day is recommended. [See Overdosage (10)]
Infusion reactions may begin within minutes of the start of infusion of HPC, Cord Blood, although symptoms may continue to intensify and not peak for several hours after completion of the infusion. Monitor the patient closely during this period. When a reaction occurs, discontinue the infusion and institute supportive care as needed.
If infusing more than one unit of HPC, Cord Blood on the same day, do not administer subsequent units until all signs and symptoms of infusion reactions from the prior unit have resolved.
Acute and chronic graft-versus-host disease (GVHD) may occur in patients who have received HPC, Cord Blood. Classic acute GVHD is manifested by fever, rash, elevated bilirubin and liver enzymes, and diarrhea. Patients transplanted with HPC, Cord Blood should receive immunosuppressive drugs to decrease the risk of GVHD. [See Adverse Reactions (6.1)]
Engraftment syndrome is manifested as unexplained fever and rash in the peri-engraftment period. Patients with engraftment syndrome also may have unexplained weight gain, hypoxemia, and pulmonary infiltrates in the absence of fluid overload or cardiac disease. If untreated, engraftment syndrome may progress to multiorgan failure and death. Once engraftment syndrome is recognized, begin treatment with corticosteroids to ameliorate the symptoms. [See Adverse Reactions (6.1)]
Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Patients should be monitored for laboratory evidence of hematopoietic recovery. Consider testing for HLA antibodies in order to identify patients who are alloimmunized prior to transplantation and to assist with choosing a unit with a suitable HLA type for the individual patient. [See Adverse Reactions (6.1)]
Patients who have undergone HPC, Cord Blood transplantation may develop post-transplant lymphoproliferative disorder (PTLD), manifested as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated.
The incidence of PTLD appears to be higher in patients who have received antithymocyte globulin. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in high-risk groups.
Leukemia of donor origin also has been reported in HPC, Cord Blood recipients. The natural history is presumed to be the same as that for de novo leukemia.
Transmission of infectious disease may occur because HPC, Cord Blood is derived from human blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection with human immunodeficiency virus (HIV), human T-cell lymphotrophic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV), T. Pallidum, T. cruzi, West Nile Virus (WNV), transmissible spongiform encephalopathy (TSE) agents, and vaccinia. Donors are also screened for clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal blood samples are tested for HIV types 1 and 2, HTLV types I and II, HBV, HCV, T. Pallidum, WNV, and T. cruzi. HPC, Cord Blood is tested for sterility. There may be an effect on the reliability of the sterility test results if the cord blood donor mother was treated with antibiotics. These measures do not totally eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Report the occurrence of transmitted infection to Bloodworks at 1-206-321-3108.
Testing is also performed for evidence of donor infection due to cytomegalovirus (CMV).
Test results may be found in accompanying records.
HPC, Cord Blood may transmit rare genetic diseases involving the hematopoietic system for which donor screening and/or testing has not been performed [See Adverse Reactions (6.1)]. Cord blood donors have been screened by family history to exclude inherited disorders of the blood and marrow. HPC, Cord Blood has been tested to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time HPC, Cord Blood collection takes place, the ability to exclude rare genetic diseases is severely limited.
Day-100 mortality from all causes was 25%.
The most common infusion-related adverse reactions (≥ 5%) are hypertension, vomiting, nausea, bradycardia, and fever.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety assessment of HPC, Cord Blood is based primarily on review of the data submitted to the FDA dockets from various sources, the dataset for the COBLT Study, and published literature.
Infusion Reactions
The data described in Table 1 reflect exposure to 442 infusions of HPC, Cord Blood (from multiple cord blood banks) in patients treated using a total nucleated cell dose of ≥ 2.5 x 107/kg on a single-arm trial or expanded access use (the COBLT Study). The population was 60% male and the medical age was 5 years (range 0.05 to 68 years), and included patients treated for hematologic malignancies, inherited metabolic disorders, primary immunodeficiencies, and bone marrow failure. Preparative regimens and graft-versus-host disease prophylaxis were not standardized. The most common infusion reactions were hypertension, vomiting, nausea, and sinus bradycardia. Hypertension and any grades 3-4 infusion-related reactions occurred more frequently in patients receiving HPC, Cord Blood in volumes greater than 150 milliliters and in pediatric patients. The rate of serious adverse cardiopulmonary reactions was 0.8%.
Any Grade % | Grade 3-4 % | |
Any reaction | 65.4 | 27.6 |
Hypertension | 48.0 | 21.3 |
Vomiting | 14.5 | 0.2 |
Nausea | 12.7 | 5.7 |
Sinus bradycardia | 10.4 | 0 |
Fever | 5.2 | 0.2 |
Sinus Tachycardia | 4.5 | 0.2 |
Allergy | 3.4 | 0.2 |
Hypotension | 2.5 | 0 |
Hemoglobinuria | 2.1 | 0 |
Hypoxia | 2.0 | 2.0 |
Information on infusion reactions was available from voluntary reports for patients who received HPC, Cord Blood, with a total nucleated cell dose of ≥ 2.5 x 107/kg. Of 212 infusions, there were 22 reports of grade 3 or higher reactions at time of infusion (10.3%). The population included 59% males and 41% females with median age of 35 years (range <1-72 years). The most common infusion reactions in these patients were hypertension (63.6%), nausea (27.3%), and chest pain (18.2%). Preparative regimens and graft-vs-host disease prophylaxis were not standardized.
Other Adverse Reactions
For other adverse reactions, the raw clinical data from the docket were pooled for 1299 (120 adult and 1179 pediatric) patients transplanted with HPC, Cord Blood (from multiple cord blood banks) with total nucleated cells ≥ 2.5 x 107/kg. Of these, 66% (n=862) underwent transplantation treatment for hematologic malignancy. The preparative regimen and graft-versus-host disease prophylaxis varied. The median total nucleated cell dose was 6.4 x 107/kg (range, 2.5-73.8 x 107/kg). For these patients, Day-100 mortality from all causes was 25%. Primary graft failure occurred in 16%; 42% developed grades 2-4 graft-versus-host disease; and 19% developed grades 3-4 acute graft-versus-host disease.
Data from the published literature and from observational registries, institutional databases, and cord blood bank reviews reported to the docket for HPC, Cord Blood (from multiple cord blood banks) revealed nine cases of donor cell leukemia, one case of transmission of infection, and one report of transplantation from a donor with an inheritable genetic disorder. The data are insufficient to support reliable estimates of the incidences of these events.
In the COBLT Study, 15% of the patients developed engraftment syndrome.
Risk Summary
There are no data with HPC, Cord Blood use in pregnant women to inform a product-associated risk. Animal reproduction studies have not been conducted with HPC, Cord Blood. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Risk Summary
There is no information regarding the presence of HPC, Cord Blood in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HPC, Cord Blood and any potential adverse effects on the breastfed infant from HPC, Cord Blood or from the underlying maternal condition.
HPC, Cord Blood has been used in pediatric patients with disorders affecting the hematopoietic system that are inherited, acquired, or resulted from myeloablative treatment. [See Dosage and Administration (2), Adverse Reactions (6), and Clinical Studies (14)].
Clinical studies of HPC, Cord Blood (from multiple cord blood banks) did not provide sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects. In general, administration of Bloodworks HPC, Cord Blood to patients over age 65 should be cautious, reflecting their greater frequency of decreased hepatic, renal or cardiac function, and concomitant disease or other drug therapy.
There has been no experience with overdosage of HPC, Cord Blood, in human clinical trials. Single doses of HPC, Cord Blood from Bloodworks of 29.6 x 107/kg have been administered. HPC, Cord Blood prepared for infusion may contain dimethyl sulfoxide (DMSO). The maximum dose of DMSO has not been established, but it is customary not to exceed a DMSO dose of 1 gm/kg/day when given intravenously. Several cases of altered mental status and coma have been reported with higher doses of DMSO.
HPC, Cord Blood 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 the cord blood is determined by measuring the numbers of total nucleated cells (TNC) and CD34+ cells, and cell viability. Each unit of HPC, Cord Blood 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 HPC, Cord Blood 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 on the container label and/or accompanying records sent with each individual unit.
HPC, Cord Blood has the following inactive ingredients: dimethyl sulfoxide (DMSO), citrate phosphate dextrose (CPD), hydroxyethyl starch, and Dextran 40. When prepared for infusion according to instructions, the infusate contains the following inactive ingredients: Dextran 40, human serum albumin, DMSO, and CPD.
Hematopoietic stem/progenitor cells from HPC, Cord Blood migrate to the bone marrow where they divide and mature. The mature cells are released into the bloodstream, where some circulate and others migrate to tissue sites, partially or fully restoring blood counts and function, including immune function, of blood-borne cells of marrow origin. [See Clinical Studies (14)].
In patients with enzymatic abnormalities due to certain severe types of storage disorders, mature leukocytes resulting from HPC, Cord Blood transplantation may synthesize enzymes that may be able to circulate and improve cellular functions of some native tissues. However, the precise mechanism of action is unknown.
The effectiveness of Bloodworks HPC, Cord Blood, as defined by hematopoietic reconstitution, was demonstrated in one single-arm prospective study and in retrospective reviews of data from an observational database for Bloodworks, and in data in the dockets and public information. Of the 1299 patients in the dockets and public data, 66% (n=862) underwent transplantation as treatment for hematologic malignancy. Results for patients who received a total nucleated cell dose ≥ 2.5 x 107/kg are shown in Table 2. Neutrophil recovery is defined as the time from transplantation to an absolute neutrophil count more than 500 per microliter. Platelet count recovery is the time to a platelet count more than 20,000 per microliter. Erythrocyte recovery is the time to a reticulocyte count greater than 30,000 per microliter. The total nucleated cell dose and degree of HLA match were inversely associated with the time to neutrophil recovery in the docket data.
*FDA-1997-N-0010 |
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**Sample size for median age = 468. N for gender = 468. Median TNC dose n = 194 (from units ≥ 2.5 x 107) Neutrophil data n = 339. For ≥20k Platelet n=328. N for 50k platelet = 267. |
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βMedian TNC dose (all doses) = 3.2 x 107 |
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Data Source | The COBLT Study* | Docket* and Public Data* | Bloodworks Cord Blood Program** |
Design | Single-arm prospective | Retrospective | Retrospective |
Number of patients | 324 | 1299 | Variable* |
Median age (range) | 4.6 (0.07 – 52.2) yrs | 7.0 (<1 – 65.7) yrs | 35 (0 – 72) yrs |
Gender | 59% male 41% female | 57% male 43% female | 59% male 41% female |
Median TNC Dose (range) (x 107/kg) | 6.7 (2.6 – 38.8) | 6.4 (2.5 – 73.8) | 3.9 (2.5 – 42.3)β |
Neutrophil Recovery at Day 42 (95% CI) | 76% (71% – 81%) | 77% (75% – 79%) | 82% (77% – 87%) |
Platelet Recovery at Day 100 of 20,000/µL (95% CI) | 57% (51% – 63%) | - | 66% (60% – 72%) |
Platelet Recovery at Day 100 of 50,000/µL (95% CI) | 46% (39% – 51%) | 45% (42% – 48%) | 50% (42% – 59%) |
Erythrocyte Recovery at Day 100 (95% CI) | 65% (58% – 71%) | - | - |
Median time to Neutrophil Recovery | 27 days | 25 days | 21.5 days |
Median time to Platelet Recovery (20,000/µL) | 90 days | - | 46 days |
Median time to Platelet Recovery (50,000/µL) | 113 days | 122 days | 53 days |
Median time to Erythrocyte Recovery | 64 days | - | - |
HPC, Cord Blood is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 5 x 108 total nucleated cells with a minimum of 1.25 x 106 viable CD34+ cells in a volume of 25 milliliters (ISBT 128 Product Code S1393, ISBT 128 Facility Identifier Number W1640). The exact pre-cryopreservation nucleated cell content is provided on the container label and accompanying records.
Store HPC, Cord Blood at or below -150°C until ready for thawing and preparation.
Discuss the following with patients receiving HPC, Cord Blood.
I. MATERIALS, REAGENTS, AND EQUIPMENT
Materials:
Reagents:
Equipment:
NOTE: If performing wash step after dilution, then you will also need:
Forms:
II. PRODUCT RECEIPT
The HPC, Cord Blood unit is shipped frozen in a dry-shipper that maintains the temperature at ≤ -150°C. The dry shipper is capable of maintaining the temperature of ≤ -150°C for 5 days from the shipping date. If the unit will not be used within that timeframe, transfer the unit into a storage device capable of maintaining the unit at ≤ -150°C.
Temperature during shipment is continuously monitored and a printout can be obtained upon request.
Handle the cryobag with extreme caution when removing it from the liquid nitrogen, metal cassette, and protective overwrap, and during the thaw procedure. Cryobags can be very fragile. This is applicable both during inspection of the product upon arrival and during the thawing process.
NOTE: If the Warning or Alarm light is flashing, immediately contact Bloodworks. See section VI, Contact Information.
NOTE: If there is damage to cryobag, replace the cryobag into storage at ≤ -150°C (contain the cryobag in additional overwrap if necessary). Consult with the transplant physician and contact Bloodworks.
NOTE: If there are any discrepancies in unit ID, consult with the transplant physician and contact Bloodworks.
Store the product in an LN2 Storage vessel that maintains a temperature at or below -150°C.
III. PREPARATION
NOTE: If DMSO removal and volume reduction is required, for the 300mL transfer labeled "Thawed Final Product", seal tubing approximately 4-5 inches above the bag to allow for sterile connection in step IV.4.a.
NOTE: The LMD/HSA Solution #1 must be used within 4 hours.
NOTE: The LMD/HSA Solution #2 must be used within 4 hours.
IV. PROCEDURE
Reconstitution or simple dilution of HPC, Cord Blood with LMD/HSA solution, using the Thaw and Diluting procedures described below (steps IV.1-IV.3), is recommended. The Alternate Procedure: Washing in Section IV.4 should be followed if the infusion volume and/or DMSO dose (>1 g/kg body weight) are contraindicated for the patient.
NOTE: Wiping the external surface of the cryobag with isopropyl alcohol before placing inside the sterile zip-lock bag allows the thawing laboratory to potentially recover the product in the case of an unexpected leak or container failure during thawing.
NOTE: If container integrity is observed to be compromised, position the cryobag and/or clamp with hemostats to prevent further escape of product. If visible cracks or breaks are observed, consult the transplant physician before proceeding. See Section V for Emergency Product Recovery procedures.
NOTE: Perform the transfer procedure in a Biological Safety Cabinet.
NOTE: Perform the following dilution procedure in a Biological Safety Cabinet.
NOTE: The recommended expiration time of thawed HPC, Cord Blood product is 4 hours from the time of thaw, if stored at 2-8°C.
Perform all steps of the Thaw and Transfer procedures, and steps 3.a through 3.i of the Dilute procedure as outlined above, and then complete the following steps:
NOTE: The recommended expiration time of thawed HPC, Cord Blood product is 4 hours from the time of thaw, if stored at 2-8°C.
V. EMERGENCY PRODUCT RECOVERY IN THE EVENT OF A CONAINER FAILURE
VI. CONTACT INFORMATION
Bloodworks
Cord Blood Services
921 Terry Ave.
Seattle, WA 98104
Hours: 7:30 AM - 6:00 PM, Pacific Standard Time
Phone Number: 206-689-6696
Alternate Phone Number: 1-800-366-2831, ext. 1896
After Hours
Cell Phone Number: 206-231-3108
Distributed by:
Bloodworks
Cord Blood Services
921 Terry Ave.
Seattle, WA 98104
License Number 2042
Principal Display Panel - Carton Label
"W1640 16 999999"
Product: S1393V00
HPC, CORD BLOOD
10% DMSO, Other additives present,
Cryopreserved, Buffy Coat Enriched
See Accompanying Documentation
Total Volume 25.13 mL
Store at -150 C or colder
Expires:
Bloodworks
921 Terry Ave
Seattle, WA 98104
Principal Display Panel - Bag Label
"W1640 16 999999"
Bloodworks
921 Terry Avenue
Seattle, WA 98104
Collection
Date/Time "0160281000"
28 Jan 2016 10:00 PST
(28 Jan, 2016 18:00 UTC)
Do Not Irradiate
Do Not Use Leukoreduction Filters
RX Only
"S1393V00"
HPC, CORD BLOOD
10% DMSO, Other additives present,
Cropreserved, Buffy Coat Enriched
See Accompanying Documentation
Total Volume 25.13 mL
Store at -150 C or colder
US License #: 2042
"6200"
A
Rh Positive
For Intravenous Administration
See package insert for full prescribing
information and instructions for
preparation.
Expiration
Date/Time
"0180281000"
28 Jan 2018 10:00 PST
(28 Jan, 2018 18:00 UTC)
Intended Recipient
Smith, Bob
Recipient ID: 9987-1234-5
Date of Birth: 04 Jul 1970
HPC, CORD BLOOD
hpc, cord blood injection |
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Labeler - Bloodworks (092881085) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Bloodworks | 092881085 | manufacture(W1640-S1393) , label(W1640-S1393) , pack(W1640-S1393) |