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For restoration and maintenance of circulating blood volume where volume deficiency is demonstrated and colloid use is appropriate.
KEDBUMIN™ is indicated for severe albumin deficiency caused by illness or active bleeding. When albumin deficiency results from excessive protein loss, the effect of albumin administration will be temporary unless the underlying disorder is reversed.
KEDBUMIN™ is indicated for maintenance of cardiovascular function following the removal of large volumes of ascitic fluid due to cirrhosis [1, 2].
KEDBUMIN™ is indicated as a plasma expander in the fluid management in of severe forms of ovarian hyperstimulation syndrome (OHSS) [3, 4].
KEDBUMIN™ is indicated in conjunction with diuretics to correct fluid volume overload associated with ARDS .
KEDBUMIN™ is indicated after > 24 hours post burn in patients experiencing severe albumin depletion in order to favor edema re-absorption .
KEDBUMIN™ is indicated in patients undergoing long term dialysis or for those patients who are fluid-overloaded and cannot tolerate substantial volumes of salt solution for therapy of shock or hypotension .
KEDBUMIN™ is indicated in cardiopulmonary bypass procedures as part of the priming fluids [8, 9].
There is currently no drug history available for this drug.
KEDBUMIN™ is a sterile, aqueous solution for single dose intravenous administration. The product contains 0.25 g per mL human albumin and is prepared by cold ethanol fractionation from pooled human plasma obtained from venous blood at FDA-licensed facilities located in the USA. Intermediate source material (albumin paste) is obtained from a U.S. licensed manufacturer. The colloid osmotic effect of KEDBUMIN™ is approximately four times that of blood plasma.
KEDBUMIN™ is a clear, slightly viscous liquid, with a yellow, amber, or green tint. The productis stabilized by the addition of 0.08 mmol sodium caprylate and 0.08 mmol sodium acetyltryptophan per gram of albumin. Additionally, each liter of material contains 130-160 mEq of sodium ion and ≤ 200 µg of aluminum. The product contains no preservatives.
KEDBUMIN™ is heated for ten hours at 60°C. The KEDBUMIN manufacturing process results in viral reduction in in vitro studies (see table below). These reductions are achieved through a combination of process steps including Cohn fractionation and final container heat treatment.
|HIV-1: Human Immunodeficiency Virus Type 1|
BVDV: Bovine Viral Diarrhoea Virus
PRV: Pseudorabies Virus
REO: Reovirus Type 3
PPV: Porcine Parvovirus
HAV: Hepatitis A Virus
EMCV: Encephalomyocarditis virus
|Mean Reduction Factor (log10)|
|Enveloped viruses||Non enveloped viruses|
|Fractionation of Effluent I to Effluent II|
|Fractionation of Effluent IV-1 to Effluent|
|Ethanol inactication during fraction|
|Depth Filtration of Fraction V suspension||3.4||≥3.4||4.9||4.2||2.0|
|Generation of Albumin paste||1.5|
|Overall Reduction Factor||≥16.57||>10.17||≥15.75||11.62||5.2||>8.4||3.7|