Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL (UNII: XU53VK93MC) (HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL - UNII:XU53VK93MC)
Clinimmune Labs, University of Colorado Blood Bank
HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL
HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL 500000000 in 30 mL
INTRAVENOUS
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
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.
HEMATOPOIETIC PROGENITOR CELLS, CORD BLOOD- HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL LIQUID CLINIMMUNE LABS, UNIVERSITY OF COLORADO BLOOD BANK ---------- 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 Citiți documentul complet