ALBURX (albumin- human solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

ALBUMIN HUMAN (UNII: ZIF514RVZR) (ALBUMIN HUMAN - UNII:ZIF514RVZR)

Disponibbli minn:

CSL Behring AG

INN (Isem Internazzjonali):

ALBUMIN HUMAN

Kompożizzjoni:

ALBUMIN HUMAN 12.5 g in 50 mL

Rotta amministrattiva:

INTRAVENOUS

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

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.

L-istatus ta 'awtorizzazzjoni:

Biologic Licensing Application

Karatteristiċi tal-prodott

ALBURX- ALBUMIN (HUMAN) SOLUTION
CSL BEHRING AG
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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