ALBURX SOLUTION FOR INFUSION 5%

Approval Information

ALBURX SOLUTION FOR INFUSION 5% was registered with Health Science Authority of Singapore by CSL BEHRING PTE LTD. It is marketed with the registration number of SIN15903P with effective from 2020-03-11.

This product contains 50 g/L of Human Albumin in the form of INFUSION, SOLUTION.

The medicine was manufactured by CSL Behring AG (Bulk Production and Primary Packager) in SWITZERLAND, and CSL Behring L.L.C in UNITED STATES

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Human Albumin

Description

Serum albumin is the main protein of human blood plasma. It binds to water, cations (such as Ca2+, Na+ and K+), fatty acids, hormones, bilirubin, thyroxine (T4) and pharmaceuticals (including barbiturates). The main function of albumin is to maintain the oncotic pressure of blood [A33706]. There are various preparations of albumin that are well established and widely available in the clinical setting [L3108], [L3109], [L310]. 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 [F229]. 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 [L3101].

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 [F229].

Mechanism of Action

Albumin stabilizes circulating blood volume and carries hormones, enzymes, medicines, and toxins. Other physiological functions include antioxidant properties, free radical scavenging, in addition to maintenance capillary membrane integrity [F230]. Exogenously administered albumin increases the oncotic pressure of the intravascular system, moving fluids from the interstitial space, thereby decreasing edema and increasing the circulating blood volume. The increase in volume reduces the concentration and viscosity of blood in patients with decreased circulating blood volume while maintaining cardiac output in shock. In dehydrated patients, negligible effects on circulating blood volume. In addition to the above albumin replaces protein in patients with hypoproteinemia until the cause of the deficiency can be determined [L3104].

Toxicity

In general, human albumin solutions are well-tolerated and no specific, clinically relevant alterations in organ function or coagulopathy have been substantiated [F229]. The most common adverse reactions are rigors, hypotension, tachycardia with increased heart rate, fever, chills, nausea, vomiting, dyspnea and/or bronchospasm, skin rash/pruritus. Stop the infusion immediately if anaphylaxis, with or without shock is observed [F229]. Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the volume status of the patient. When clinical signs of cardiovascular overload occur (headache, dyspnea, jugular venous distention, increased blood pressure), the infusion must be slowed or stopped immediately [F230].

Active Ingredient/Synonyms

Albumin (human) | Albumin human | Albumin microspheres, human | Albumin, blood | Albumin, human | Albumin, human-kjda | Human albumin | Microspheres of human albumin | Serum albumin | Human Serum Albumin |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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