The first and only formulation of human albumin available
in a flexible container.
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Albumin As Excipient
As a manufacturer of human albumin with an FDA-approved 5-year shelf life2 for further manufacture, Baxter is a natural choice. Common uses include:
- Use as an excipient to stabilize pharmaceutical products1
- Use as a carrier molecule or scaffold to deliver therapeutic peptides and proteins1
- Medium component for cell culture2
- Medium component for cryopreservation1
- Medium component for stem cell expansion2
Baxter Excipient Albumin – benefits include:
Longest Shelf Life – The FDA has approved Baxter’s excipient albumin for a 5-year shelf life.2
Global Reach – Baxter provides excipient albumin meeting United States Pharmacopeia (USP), European Pharmacopeia (EP), and/or Japanese specifications.2
Safety – Beginning with a carefully screened pool of repeat donors, Baxter utilizes multiple approaches to help ensure the safety of our albumin product. Baxter has over 50 years of clinical experience demonstrating pathogen safety with albumin therapy.2
Dedicated Support Team – Baxter albumin customers have access to a dedicated team ready to support technical, regulatory, manufacturing, quality control, and documentation questions on the global level.
FLEXBUMIN 25% [Albumin (Human)]
FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. FLEXBUMIN 25% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns, adult respiratory distress syndrome (ARDS), and nephrosis, and for use during or prior to cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN).
Important Risk Information for FLEXBUMIN 25%
FLEXBUMIN 25% is contraindicated in patients with cardiac failure, in patients with severe anemia and in patients with a history of allergic reactions to human albumin.
Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered.
Do not use Sterile Water for Injection as a diluent. There exists a risk of potentially fatal hemolysis and acute renal failure from the inappropriate use of Sterile Water for Injection as a diluent for FLEXBUMIN 25%. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.
FLEXBUMIN 25% is made from pooled human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt–Jakob disease (CJD) agent.
FLEXBUMIN 25% must be administered intravenously at a rate not to exceed 1ml/min to patients with normal blood volume, due to the risk of developing circulatory overload and pulmonary edema.
When 25% albumin is infused, a rise in blood pressure necessitates careful observation to detect and treat severed blood vessels that may not have bled at a lower blood pressure.
Adverse reactions to FLEXBUMIN 25% are extremely rare, although nausea, fever, chills or urticaria may occasionally occur.
CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.
Please see Preparation for Administration for FLEXBUMIN 25% in the Prescribing Information.
Please review the FLEXBUMIN 25% [Albumin (Human)] Prescribing Information for full prescribing details.
Please see detailed Important Risk Information for BUMINATE 5% and Full Prescribing Information.
Please see detailed Important Risk Information for BUMINATE 25% and Full Prescribing Information.
- Chaubal MV. Human serum albumin as a pharmaceutical excipient. Drug Delivery Technology. 2005;5. Available at: http://www.drugdeliverytech.com/ME2/ dirmod.asp?sid=1422453332174B129DB8EFFF82BF81E7&nm= Back+Issues&type=Publishing&mod=Publications%3A%3AArticle &mid=8F3A7027421841978F18BE895F87F791&tier=4 &id=E939D76B10EB4A82A10CC28C2AD08B38. Accessed June 25, 2009.
- Data on file: Baxter Healthcare Corporation.
