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Kedrion Biopharma is QSEAL Certified by the Plasma Protein Therapeutics Association (PPTA).1 QSEAL Certification is based on voluntary standards that go beyond regulatory requirements to assure the quality and safety of plasma therapeutics.
ALBUKED is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
References: 1. Quality Standards of Excellence, Assurance and Leadership (QSEAL). PPTA Website. https://www.pptaglobal.org/safety-quality/standards/qseal. Accessed March 26, 2019. 2. AlbukedTM 5 [prescribing information]. Fort Lee, NJ. Kedrion Biopharma Inc. 2018. 3. AlbukedTM 25 [prescribing information]. Fort Lee, NJ. Kedrion Biopharma Inc. 2018. 4. Klamroth R, Groner A, Simon TL. Pathogen inactivation and removal methods for plasma-derived clotting factor concentrates; Transfusion. 2014;54:1406-17. 5. Matejtschuk P, Dash CJ and Gascoigne EW. Production of human albumin solution: a continually developing colloid. Br J Anaesthes. 2000;6:887-95.
ALBUKED (Albumin [Human], USP) is available in two concentrations, 5% (ALBUKED 5) and 25% (ALBUKED 25), for the following indications: emergency treatment of hypovolemic shock, burn therapy, hypoproteinemia with or without edema, adult respiratory distress syndrome (ARDS), cardiopulmonary bypass, acute liver failure, sequestration of protein rich fluids. See Indications for additional information.
Situations in Which ALBUKED is NOT Warranted: In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.