HEMATOPOIETIC PROGENITOR CELLS, CORD BLOOD- human cord blood hematopoietic progenitor cell solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Human Cord Blood Hematopoietic Progenitor Cell (UNII: XU53VK93MC) (Human Cord Blood Hematopoietic Progenitor Cell - UNII:XU53VK93MC)

Beschikbaar vanaf:

University of Texas MD Anderson Cancer Center

Toedieningsweg:

INTRAVENOUS

therapeutische indicaties:

Hematopoietic Progenitor Cell (HPC), 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 benefit-risk 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. None. 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 misc

Product samenvatting:

HPC, Cord Blood is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 9.0 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 W2263). 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.

Autorisatie-status:

Biologic Licensing Application

Productkenmerken

HEMATOPOIETIC PROGENITOR CELLS, CORD BLOOD- HUMAN CORD BLOOD
HEMATOPOIETIC
PROGENITOR CELL SOLUTION
UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE 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: 2018
WARNING: FATAL INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE,
ENGRAFTMENT
SYNDROME, AND GRAFT FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FATAL INFUSION REACTIONS: MONITOR PATIENTS DURING INFUSION AND
DISCONTINUE FOR SEVERE REACTIONS.
(5.1, 5.2)
GRAFT-VERSUS-HOST DISEASE (GVHD): GVHD MAY BE FATAL. ADMINISTRATION OF
IMMUNOSUPPRESSIVE THERAPY
MAY DECREASE THE RISK OF GVHD. (5.3)
ENGRAFTMENT SYNDROME: ENGRAFTMENT SYNDROME MAY BE FATAL. TREAT
ENGRAFTMENT SYNDROME PROMPTLY
WITH CORTICOSTEROIDS. (5.4)
GRAFT FAILURE: GRAFT FAILURE MAY BE FATAL. MONITOR PATIENTS FOR
LABORATORY EVIDENCE OF HEMATOPOIETIC
RECOVERY. (5.5)
INDICATIONS AND USAGE
Hematopoietic Progenitor Cell (HPC), 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 benefit-risk 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
FOR INTRAVENOUS USE ONLY.
DO NOT IRRADIATE.
Unit selection and administration of HPC, Cord Blood should be done
under the direction of a physician experienced in
hematopoie