Kedbumin

Kedbumin

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

1.1 Hypovolemia

For restoration and maintenance of circulating blood volume where volume deficiency is demonstrated and colloid use is appropriate.

1.2 Hypoalbuminemia

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.

1.3 Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites

KEDBUMIN™ is indicated for maintenance of cardiovascular function following the removal of large volumes of ascitic fluid due to cirrhosis [1, 2].

1.4 Ovarian Hyperstimulation Syndrome (OHSS)

KEDBUMIN™ is indicated as a plasma expander in the fluid management in of severe forms of ovarian hyperstimulation syndrome (OHSS) [3, 4].

1.5 Adult Respiratory Distress Syndrome (ARDS)

KEDBUMIN™ is indicated in conjunction with diuretics to correct fluid volume overload associated with ARDS [5].

1.6 Burns

KEDBUMIN™ is indicated after > 24 hours post burn in patients experiencing severe albumin depletion in order to favor edema re-absorption [6].

1.7 Hemodialysis

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 [7].

1.8 Cardiopulmonary Bypass

KEDBUMIN™ is indicated in cardiopulmonary bypass procedures as part of the priming fluids [8, 9].

History

There is currently no drug history available for this drug.

Other Information

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 virusesNon enveloped viruses
Manufacturing StepHIV-1BVDVPRV REOPPVHAVEMCV
Fractionation of Effluent I to Effluent II
+III
3.43.53.92.11.01.4 
Fractionation of Effluent IV-1 to Effluent
IV-4
      3.7
Ethanol inactication during fraction
V precipitation
>3.71 >3.38    
Depth Filtration of Fraction V suspension3.4 ≥3.44.94.22.0 
Generation of Albumin paste 1.5     
Heat treatment≥6.06>5.17>5.074.62 >5.0 
Overall Reduction Factor≥16.57>10.17≥15.7511.625.2>8.43.7

Kedbumin Manufacturers


  • Kedrion S.p.a
    Kedbumin (Albumin (Human)) Injection, Solution [Kedrion S.p.a]

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