Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Human Cord Blood Hematopoietic Progenitor Cell (UNII: XU53VK93MC) (Human Cord Blood Hematopoietic Progenitor Cell - UNII:XU53VK93MC)
SSM Cardinal Glennon Children's Medical Center St. Louis Cord Blood Bank
Human Cord Blood Hematopoietic Progenitor Cell
Human Cord Blood Hematopoietic Progenitor Cell 500000000 in 35 mL
INTRAVENOUS
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
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.
Biologic Licensing Application
ALLOCORD- HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL INJECTION, SOLUTION SSM CARDINAL GLENNON CHILDREN'S MEDICAL CENTER ST. LOUIS CORD BLOOD BANK ---------- 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 Baca dokumen lengkap