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

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL (UNII: XU53VK93MC) (HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL - UNII:XU53VK93MC)

Предлага се от:

Clinimmune Labs, University of Colorado Blood Bank

INN (Международно Name):

HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL

Композиция:

HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL 500000000 in 30 mL

Начин на приложение:

INTRAVENOUS

Терапевтични показания:

HPC (hematopoietic progenitor cells), 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. HPC, Cord Blood is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40 or plasma proteins. [See Description (11) and Dosage and Administration (2.2)] Pregnancy Category C. Animal reproduction studies have not been conducted with HPC, Cord

Каталог на резюме:

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 30-124 milliliters (ISBT 128 Product Code S1393, ISBT 128 Facility Identifier Number W3213). The exact pre-cryopreservation volume and nucleated cell content are provided on the container label and accompanying records. Store HPC, Cord Blood at or below -150°C until ready for thawing and preparation.

Данни за продукта

HEMATOPOIETIC PROGENITOR CELLS, CORD BLOOD- HUMAN CORD BLOOD
HEMATOPOIETIC
PROGENITOR CELL LIQUID
CLINIMMUNE LABS, UNIVERSITY OF COLORADO BLOOD BANK
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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: 2012
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. USE IS
CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO DIMETHYL SULFOXIDE
(DMSO), DEXTRAN 40 OR HUMAN
SERUM ALBUMIN. (4, 5.1, 5.2)
GRAFT-VS-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
HPC (hematopoietic progenitor cells), 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
Unit selection and administration of HPC, Cord Bloo