ALLOCORD- human cord blood hematopoietic progenitor cell injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

SSM Cardinal Glennon Children's Medical Center St. Louis Cord Blood Bank

DCI (Denominação Comum Internacional):

Human Cord Blood Hematopoietic Progenitor Cell

Composição:

Human Cord Blood Hematopoietic Progenitor Cell 500000000 in 35 mL

Via de administração:

INTRAVENOUS

Indicações terapêuticas:

ALLOCORD, 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 ALLOCORD. It is also not known whether ALLOCORD can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well-controlled st

Resumo do produto:

ALLOCORD 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 35 milliliters (ISBT 128 Product Code S1393, ISBT 128 Facility Identifier Number W1205). The exact pre-cryopreservation nucleated cell content is provided in accompanying records. Store ALLOCORD at or below -150 °C until ready for thawing and preparation.

Status de autorização:

Biologic Licensing Application

Características técnicas

ALLOCORD- HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL INJECTION,
SOLUTION
SSM CARDINAL GLENNON CHILDREN'S MEDICAL CENTER ST. LOUIS CORD BLOOD
BANK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALLOCORD SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ALLOCORD.
ALLOCORD (HPC, CORD BLOOD)
INJECTABLE SUSPENSION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: MAY 30, 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
Box Warning
07/2015
Contraindications (4.0)
07/2015
INDICATIONS AND USAGE
ALLOCORD,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 ALLOCORD should be done under the
di