CLEVECORD (hpc- hematopoietic progenitor cell, cord blood injection, suspension

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

human cord blood hematopoietic progenitor cell (UNII: XU53VK93MC) (human cord blood hematopoietic progenitor cell - UNII:XU53VK93MC)

Beszerezhető a:

Cleveland Cord Blood Center

INN (nemzetközi neve):

human cord blood hematopoietic progenitor cell

Összetétel:

human cord blood hematopoietic progenitor cell 500000000 in 25 mL

Az alkalmazás módja:

INTRAVENOUS

Terápiás javallatok:

CLEVECORD, 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. None. Risk Summary There are no data with CLEVECORD use in pregnant women to inform a product-associated risk.  Animal reproduction studies have not been conducted with CLEVECORD. In the U.S. general population, the estimated background risk of major birth defects and misca

Termék összefoglaló:

CLEVECORD 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 W4215). The exact pre-cryopreservation nucleated cell content is provided in the accompanying records. Store CLEVECORD at or below -150°C until ready for thawing and preparation.

Engedélyezési státusz:

Biologic Licensing Application

Termékjellemzők

CLEVECORD- HPC (HEMATOPOIETIC PROGENITOR CELL), CORD BLOOD INJECTION,
SUSPENSION
CLEVELAND CORD BLOOD CENTER
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLEVECORD SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CLEVECORD.
CLEVECORD (HPC, CORD BLOOD)
INJECTABLE SUSPENSION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1 SEPTEMBER 2016
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
CLEVECORD, 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. (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
FOR INTRAVENOUS USE ONLY.
DO NOT IRRADIATE.
Unit selection and administration of CLEVECORD should be done under
the direction of a physician experienced in
hematopoietic progenitor cel