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Albumin human

Generic Name
Albumin human
Brand Names
Albuked, Albuminex, Alburex, Alburx, Albutein, Flexbumin, Hizentra, Human Albumin Grifols, Kedbumin, Octalbin, Plasbumin, Plasmanate
Drug Type
Biotech
CAS Number
9048-46-8
Unique Ingredient Identifier
ZIF514RVZR

Overview

Human serum albumin is the primary protein present in human blood plasma. The main function of albumin is to maintain the oncotic pressure of blood . It binds to water, cations (such as Ca2+, Na+ and K+), fatty acids, hormones, bilirubin, thyroxine (T4) and pharmaceuticals (including barbiturates). Albumin represents approximately 50% of the total protein content in healthy humans . Human albumin is a small globular protein (molecular weight: 66.5 kDa), consisting of a single chain of 585 amino acids organized in three repeated homolog domains (sites I, II, and III). Each domain comprises two separate sub-domains (A and B) . There are various preparations of albumin that are well established and widely available in the clinical setting , , . Also known as Albuminex 5% or 25%, one brand of human serum albumin is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US . This is a biosimilar drug to existing human serum albumin and was approved for a biological license at both 5% and 25% concentrations by the FDA on June 21, 2018 .

Background

Human serum albumin is the primary protein present in human blood plasma. The main function of albumin is to maintain the oncotic pressure of blood . It binds to water, cations (such as Ca2+, Na+ and K+), fatty acids, hormones, bilirubin, thyroxine (T4) and pharmaceuticals (including barbiturates). Albumin represents approximately 50% of the total protein content in healthy humans . Human albumin is a small globular protein (molecular weight: 66.5 kDa), consisting of a single chain of 585 amino acids organized in three repeated homolog domains (sites I, II, and III). Each domain comprises two separate sub-domains (A and B) . There are various preparations of albumin that are well established and widely available in the clinical setting , , . Also known as Albuminex 5% or 25%, one brand of human serum albumin is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US . This is a biosimilar drug to existing human serum albumin and was approved for a biological license at both 5% and 25% concentrations by the FDA on June 21, 2018 .

Indication

Albuminex solution is indicated for adults and children for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass .

Associated Conditions

  • Acute Pyelonephritis(APN)
  • Burns
  • Hemolytic Disease of the Newborn
  • Hypoalbuminemia
  • Hypoproteinemia
  • Hypovolaemia
  • Shock, Hypovolemic
  • Acute fulminant liver failure
  • Central volume depletion
  • Post-operative albumin loss

FDA Drug Approvals

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No FDA approvals found for this drug.

EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Human Albumin
国药准字S10970074
生物制品
注射剂
11/6/2020
Human Albumin
国药准字S20043058
生物制品
注射剂
8/18/2020
Human Albumin
国药准字S20033029
生物制品
注射剂(注射液)
2/5/2020
Human Albumin
国药准字S20093023
生物制品
注射剂
5/28/2020
Human Albumin
国药准字S10930019
生物制品
注射剂
7/30/2020
Human Albumin
国药准字S10940028
生物制品
注射剂(注射液)
3/2/2020
Human Albumin
国药准字S10920009
生物制品
注射剂
7/30/2020
Human Albumin
国药准字S10970006
生物制品
注射剂
3/11/2020
Human Albumin
国药准字S10970068
生物制品
注射剂
2/12/2020
Human Albumin
国药准字SJ20210027
生物制品
注射剂
11/21/2021

PPB Drug Approvals

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