Albutein 5%, 20% and 25% solution is a sterile aqueous solution for single dose IV administration containing 5%, 20% and 25% human albumin (weight/volume), respectively. Albutein is prepared by alcohol fractionation method from pooled human plasma obtained from venous blood. Albutein is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate/g albumin. Albutein 5% solution is osmotically and isotonically equivalent to an equal volume of normal human plasma. Albutein 20% and 25% is osmotically equivalent to 4 and 5 times its volume of normal human plasma, respectively. Albutein 5%, 20% and 25% solution contains 130-160 mEq sodium ion/L and has a pH 6.9±0.5. Albutein contains no preservatives. Albutein is heated at 60°C for 10 hrs. No positive assertion can be made, however, that this heat treatment completely destroys the causative agents of viral hepatitis.
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