CORDCYTE- human cord blood hematopoietic progenitor cell injection, suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

LifeSouth Community Blood Centers, Inc.

INN (International namn):

human cord blood hematopoietic progenitor cell

Sammansättning:

human cord blood hematopoietic progenitor cell 500000000 in 25 mL

Administreringssätt:

INTRAVENOUS

Terapeutiska indikationer:

CORDCYTE, 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. Pregnancy Category C. Animal reproduction studies have not been conducted with CORDCYTE. It is also not known whether CORDCYTE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well-controlled st

Produktsammanfattning:

CORDCYTE 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 W2434). The exact pre-cryopreservation nucleated cell content is provided in the accompanying records. Store CORDCYTE at or below -150°C until ready for thawing and preparation.

Bemyndigande status:

Biologic Licensing Application

Produktens egenskaper

CORDCYTE- HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL INJECTION,
SUSPENSION
LIFESOUTH COMMUNITY BLOOD CENTERS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CORDCYTE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CORDCYTE.
CORDCYTE (HPC, CORD BLOOD)
INJECTABLE SUSPENSION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2013
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-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).
RECENT MAJOR CHANGES
Boxed Warning
5/2015
Contraindications (4)
5/2015
INDICATIONS AND USAGE
CORDCYTE, 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 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 CORDCYTE should be done under the
direction of a physician experienced in
h