Source: FDA, National Drug Code (US) Revision Year: 2020
ALBURX 5, Albumin (Human) 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood.
This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤200 mcg/L and the potassium content is ≤0.002 M. The solution is stabilized with 0.004 M sodium N-acetyltryptophanate and 0.004 M sodium caprylate. The solution contains no preservative.
| How Supplied | |||||||||
|---|---|---|---|---|---|---|---|---|---|
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ALBURX 5 is supplied as a 5% solution (50 g/L). Each product presentation includes a package insert and the following components listed in Table 1 below. Table 1. How Supplied:
Manufactured by: CSL Behring AG, Bern, Switzerland Distributed by: CSL Behring LLC, Kankakee, IL 60901 USA |
| Drug | Countries | |
|---|---|---|
| ALBURX | Ecuador, Hong Kong, United States |
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