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Prescribing Information Indications and
Important Safety Information
  • About Albumin
    • USES OF ALBUMIN
    • SAFETY Profile
  • Portfolio
    • flexbumin 25%
    • flexbumin 5%
  • Benefits of the Bag
    • SAFETY Features
    • EFFICIENCY Features
    • SUSTAINABILITY Features
  • Ordering
    • CONTACT INFO

FLEXBUMIN® for your
top priorities:

Safety

GALAXY® shatterproof flexible plastic container: Eliminates safety concerns from glass breakage and spills1,2

Important Safety Information

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.


1. Baxalta US Inc. FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution. Package insert.
2. Baxalta US Inc. FLEXBUMIN 5%, Albumin (Human), USP, 5% Solution. Package insert.

FLEXBUMIN® for your
top priorities:

Efficiency

FLEXBUMIN 25% (50mL) in cartons on a pharmacy shelf can potentially take up less than 1/2 the storage space compared to cartons of albumin in glass bottles of equal volume. FLEXBUMIN 5% (250mL) can potentially reduce more than half of the storage space compared to cartons of albumin in glass bottles of equal
volume 1,2*

*Calculations based on bottles of BUMINATE® 25% and 5% [Albumin (Human)] USP, 25% and 5% Solution

1. Data on file, VV-MED-7220, Shire Inc.

2. Data on file, VV-MED-7463, Shire Inc.

FLEXBUMIN® for your
top priorities:

Sustainability

FLEXBUMIN 25% (100 mL) has a 28% lower carbon footprint and FLEXBUMIN 5% (250 mL) has a 46% lower carbon footprint when compared to albumin glass bottles of equal volume1*



*Global CO2 output calculations based on bottles of BUMINATE® 25% and 5% [Albumin (Human)] USP, 25% and 5% Solution

1. Data on file, VV-MED-7406, Shire Inc.

The first human albumin product in the
GALAXY® shatterproof flexible plastic container1,2

FLEXBUMIN® [Albumin (Human)], USP

Designed with safety, efficiency and
sustainability in mind for the demands
of the critical care setting



1. Baxalta US Inc. FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution. Package insert.

2. Baxalta US Inc. FLEXBUMIN 5%, Albumin (Human), USP, 5% Solution. Package insert.

See for yourself Request a sample of the FLEXBUMIN GALAXY container (sample bag will not contain albumin)

BACK

Important Safety Information

Please read below for Indications and Detailed Important Safety Information for FLEXBUMIN 25% AND 5%.

Indications and Important Safety Information for FLEXBUMIN 5% [Albumin (Human)], USP, 5% and FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solutions

Indications and Limitation of Use for FLEXBUMIN 5% and 25%

FLEXBUMIN 5% and 25% are indicated for hypovolemia, hypoalbuminemia (burns), and cardiopulmonary bypass surgery. Albumin is not indicated as an intravenous nutrient.

FLEXBUMIN 25% is also indicated for hypoalbuminemia due to adult respiratory distress syndrome (ARDS) and nephrosis and for hemolytic disease of the newborn (HDN).


IMPORTANT SAFETY INFORMATION

Contraindications

  • History of hypersensitivity reaction to albumin preparations or to any of the excipients (N-acetyltryptophan and sodium caprylate). Reactions have included anaphylactic shock, anaphylactic reaction, or hypersensitivity/allergic reactions.

  • Severe anemia or cardiac failure with normal or increased intravascular volume.

Warnings and Precautions

Hypersensitivity Reactions:

 have been observed (including anaphylactic reactions). If hypersensitivity reaction is suspected, discontinue administration immediately and implement appropriate standard medical treatment.

Hypervolemia/Hemodilution:

 Under conditions where hypervolemia and/or hemodilution may occur, adjust the dose and rate of infusion to the patient’s volume status. When administering large volumes, monitor hemodynamic parameters. Ensure adequate substitution of other blood constituents and monitor electrolyte balance. Discontinue administration at the first clinical signs of cardiovascular overload.

Hemodynamics:

 Closely monitor hemodynamic parameters after administration for evidence of cardiac or respiratory failure, renal failure or increasing intracranial pressure.

Blood Pressure:

 Monitor blood pressure in trauma patients and postoperative surgery patients in order to detect re-bleeding secondary to clot disruption.

Hemolysis:

 Do not dilute with Sterile Water for Injection, as there is potential risk of fatal hemolysis and acute renal failure in recipients.

Transmission of Infectious Agents:

 Because FLEXBUMIN 5% is made from human plasma it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No cases of transmission of viral diseases, Creutzfeldt-Jakob disease (CJD) or variant Creutzfeldt-Jakob disease (vCJD) have ever been identified.

Adverse Reactions

The most serious adverse reactions are hypersensitivity reaction (including anaphylactic reaction) and pulmonary edema.

Administration 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.

For full details please see the Prescribing Information for FLEXBUMIN 5% and FLEXBUMIN 25%.

© 2018 Shire US Inc., Lexington, MA 02421. All rights reserved. 1-800-828-2088

SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

BUMINATE and FLEXBUMIN are registered trademarks of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.

Baxter and Galaxy are registered trademarks of Baxter International Inc.

S44698 04/19


US-FLE-0040v2.0 05/20

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