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ALBUKED is purified from human plasma. Each step in the manufacturing process, beginning with strict donor screening and testing, is designed to meet very high industry standards for plasma product safety.   

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 manufactured using the Cohn cold alcohol fractionation process, which has a demonstrated capacity to reduce viruses.2-4  
  • ALBUKED is heat-treated at 60ºC for 10 hours, to reduce the possibility of transmitting a range of enveloped and non-enveloped viruses, including the hepatitis viruses.2,3,5
  • The ALBUKED manufacturing process has been validated to reduce the infectivity of a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.2,3

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 February 22, 2018. 2. AlbukedTM 5 [prescribing information]. Fort Lee, NJ. Kedrion Biopharma Inc. 2014. 3. AlbukedTM 25 [prescribing information]. Fort Lee, NJ. Kedrion Biopharma Inc. 2014. 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.


INDICATIONS AND USAGE

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. 

IMPORTANT SAFETY INFORMATION