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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 Approved Products

Sterile Diluent for Allergenic Extract
Manufacturer:Antigen Laboratories, Inc.
Route:INTRADERMAL, SUBCUTANEOUS
Strength:0.0003 mL in 1 mL
Approved: 2009/12/08
NDC:49288-9934
ALBUMINEX
Manufacturer:BPL
Route:INTRAVENOUS
Strength:0.25 g in 1 mL
Approved: 2018/08/15
NDC:64208-2512
ALBUMINEX
Manufacturer:BPL
Route:INTRAVENOUS
Strength:0.05 g in 1 mL
Approved: 2018/08/31
NDC:64208-2510
Albumin (Human)
Manufacturer:Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Route:Intravenous
Strength:50 g in 1000 mL
Approved: 2008/08/01
NDC:67467-623
Albumin (Human)
Manufacturer:Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Route:Intravenous
Strength:200 g in 1000 mL
Approved: 2008/08/01
NDC:67467-633

Singapore Approved Products

ZENALB 20 HUMAN ALBUMIN SOLUTION 20% w/v
Manufacturer:BIO PRODUCTS LABORATORY LIMITED
Form:INJECTION
Strength:20% w/v
Online:Yes
Approved: 1992/10/09
Approval:SIN07171P
ZENALB 4.5 HUMAN ALBUMIN SOLUTION 4.5% w/v
Manufacturer:BIO PRODUCTS LABORATORY LIMITED
Form:INJECTION
Strength:4.5% w/v
Online:Yes
Approved: 1992/10/09
Approval:SIN07170P
ALBUTEIN INFUSION 5%
Manufacturer:GRIFOLS BIOLOGICALS LLC.
Form:INJECTION
Strength:12.5 g/250 ml
Online:Yes
Approved: 1988/05/13
Approval:SIN01177P
ALBUMIN SG INJECTION 20%
Manufacturer:SK Plasma Co.,Ltd.
Form:INJECTION
Strength:10g/50mL
Online:Yes
Approved: 2023/04/20
Approval:SIN16765P
Niuliva Solution For Infusion 250 I.U./ml
Manufacturer:INSTITUTO GRIFOLS, S.A.
Form:INJECTION, SOLUTION
Strength:250 I.U./ml
Online:Yes
Approved: 2011/12/30
Approval:SIN14069P

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