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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

  • Certain patients, e.g., those with a history of congestive cardiac failure, renal insufficiency, or stabilized chronic anemia, are at special risk of developing circulatory overload.
  • A history of allergic reaction to albumin is a specific contraindication for usage. Although adverse reactions to albumin are rare, such reactions may be allergic in nature or be due to high plasma protein levels from excessive albumin administration. Allergic manifestations include urticaria, chills, fever, and changes in respiration, pulse, and blood pressure.
  • 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.
  • As with any hyperoncotic protein solution likely to be administered in large volumes, severe hemolysis and acute renal failure may result from the inappropriate use of Sterile Water for Injection as a diluent for ALBUKED 25. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.  Please refer to the Dosage and Administration sections in the Full Prescribing Information for recommended diluents.
  • Solutions which have been frozen should not be used. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Partially used vials must be discarded.  Vials which are cracked or which have been previously entered or damaged should not be used, as this may have allowed the entry of microorganisms. 
  • ALBUKED contains no preservatives.
  • Patients should always be monitored carefully in order to guard against the possibility of circulatory overload. ALBUKED 5 is iso-oncotic with normal plasma and will not tend to aggravate tissue dehydration. Appropriate additional crystalloids should be administered, if required by the patient, to maintain normal fluid balance.  ALBUKED 25 is hyperoncotic; therefore, in the presence of dehydration, albumin must be given with or followed by the addition of fluids.
  • In hemorrhage, the administration of albumin should be supplemented by the transfusion of whole blood to treat the relative anemia associated with hemodilution. When circulating blood volume has been reduced, hemodilution following the administration of albumin persists for many hours. In patients with normal blood volume, hemodilution lasts for a much shorter period. 
  • ALBUKED should not be mixed with protein hydrolysates, amino acid solutions or those containing alcohol.
  • For Full Prescribing Information, please click here.
  • You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/MedWatch, or call 1-800-FDA-1088.