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Alburx (Albumin Human) - Description and Clinical Pharmacology

 
 



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1. DESCRIPTION

AlbuRx® 25, Albumin (Human) 25% 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 130-160 milliequivalents of sodium per liter (mEq/L) and the potassium content is not over 2 mEq/L. The aluminum content does not exceed 200 µg/L. The solution is stabilized with 0.08 millimole of sodium acetyltryptophanate plus 0.08 millimole of sodium caprylate per gram of albumin. The solution contains no preservative.

2. CLINICAL PHARMACOLOGY13,17

2.1 AlbuRx® 25, Albumin (Human) 25% solution should not be used as an intravenous nutrient because of the slow breakdown and relatively unfavorable composition of the albumin molecule with respect to its content of essential amino acids. Oral provision of proteins or an intravenous regimen providing adequate calories and a suitable amino acid mixture are the methods of choice for the treatment of protein malnutrition as such, though they do not permit the rapid correction of hypoproteinemia.

2.2 The binding properties of albumin may provide an indication for its use in severe hemolytic disease of the newborn, where it may lower the plasma concentration of free bilirubin pending an exchange transfusion. This effect is possibly also relevant in certain cases of acute liver failure with rapidly increasing levels of serum bilirubin, particularly in the presence of severe hypoproteinemia.

2.3 The colloid osmotic or oncotic properties of albumin at this moment constitute the predominant reason for its clinical use. The rationale for this is the Starling concept of the capillary balance of hydrostatic and oncotic pressure gradients across the capillary walls as the determinant of the fluid – i.e. volume – distribution between the intravascular and the interstitial compartment.16 The two main indications for the use of AlbuRx® 25, Albumin (Human) 25% solution are therefore a plasma or blood volume deficit and the oncotic deficit resulting from hypoproteinemia. The 25% concentration is oncotically equivalent to approximately five times its volume of normal human plasma. The effective colloid osmotic pressure of the serum proteins depends very largely on the relatively small and numerous albumin molecules, which therefore play a decisive role in the maintenance of the circulating plasma volume.

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