Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
ALBUMIN HUMAN (UNII: ZIF514RVZR) (ALBUMIN HUMAN - UNII:ZIF514RVZR)
CSL Behring AG
ALBUMIN HUMAN
ALBUMIN HUMAN 12.5 g in 50 mL
INTRAVENOUS
Since the oncotic pressure of ALBURX® 25, Albumin (Human) 25% solution is about four times higher than that of normal human serum, it will expand the plasma volume if interstitial water is available for an inflow through the capillary walls. However, many patients suffering from an acute volume deficit also have some degree of interstitial dehydration. In the absence of hyperhydration, the treatment of an acute volume deficit with ALBURX® 25 should therefore include isotonic electrolyte solutions with an albumin:electrolyte ratio of 1:3 or 1:4. By contrast, chronic volume deficits have usually been at least partially compensated for by the renal retention of sodium and water with some degree of tissue edema, and in these circumstances a trial with ALBURX® 25 only is indicated. In any case, an anemia of clinically relevant magnitude requires specific treatment, and the metabolic needs of the patient with respect to fluid and electrolytes must be cared for. The common causes of hypoproteinemia are protein-ca
ALBURX® 25 is supplied as a 25% solution (250 g/L). Each product presentation includes a package insert and the components listed in Table 1 below. ALBURX® 25, Albumin (Human) 25% solution should be stored at a temperature not exceeding 30°C (86°F). It should not be used after the expiration date printed on the label.
Biologic Licensing Application
ALBURX- ALBUMIN (HUMAN) SOLUTION CSL BEHRING AG ---------- ALBUMIN (HUMAN) 25% SOLUTION ALBURX 25 R ONLY DESCRIPTION ALBURX 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. The solution is clear and slightly viscous; it is almost colorless, or yellow, amber, or green. 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 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. The solution contains no preservative. CLINICAL PHARMACOLOGY 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. 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. The colloid osmotic or oncotic properties of albumin at Izlasiet visu dokumentu