ALBUTEIN Solution for infusion Ref.[11119] Active ingredients: Albumin

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

ALBUTEIN 20% is a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). ALBUTEIN 20% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 20% is approximately four times that of normal human plasma. A liter of ALBUTEIN 20% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives.

ALBUTEIN 20% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 20% is heated at 60°C for ten hours against the possibility of transmitting viruses.

Dosage Forms and Strengths

ALBUTEIN 20% is a solution containing 200 g per L of total protein of which at least 95% is human albumin.

How Supplied

ALBUTEIN 20% is supplied in single-use, individually laser etched vials.

The following vial sizes of ALBUTEIN 20% are available:

NDC Number Fill Size Grams Protein<:/u>

68516-5215-1 50 mL 10 g
68516-5215-2 100 mL 20 g

Each vial size label incorporates integrated hangers. Each label has a peel-off strip showing the product name and lot number.

Manufactured by: Grifols Biologicals LLC, 5555 Valley Boulevard, Los Angeles, CA 90032, U.S.A.

Drugs

Drug Countries
ALBUTEIN Spain, Hong Kong, Croatia, Ireland, Poland, Romania, Singapore, United Kingdom, United States

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