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Prescribing Information Indications and
Important Risk Information

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FLEXBUMIN 25%
[Albumin (Human)],
USP, 25% Solution
FLEXBUMIN 5%
[Albumin (Human)],
USP, 5% Solution
Buminate [Albumin (Human)], USP, 5%
and 25% Solutions

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See for yourself Request a sample of the FLEXBUMIN 25% GALAXY container (sample bag will not contain albumin)

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Important Risk Information

Please read below for Indications and Detailed Important Risk Information for FLEXBUMIN 25%, FLEXBUMIN 5%, Buminate 25% and Buminate 5%.

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

Indications

FLEXBUMIN [Albumin (Human)] USP Solutions are sterile, nonpyrogenic preparations of albumin in single dosage forms for
intravenous administration.

FLEXBUMIN is indicated for hypovolemia, hypoalbuminemia due to general causes, burns, and for use during cardiopulmonary
bypass surgery as a component of the pump prime.

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

Detailed Important Risk Information for FLEXBUMIN 5% and 25% [Albumin (Human)] USP Solutions

FLEXBUMIN is contraindicated in patients with a history of allergic reactions to human albumin and any of the excipients, severe
anemia, and heart failure.

Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered.

Do not dilute with Sterile Water for injection as this can cause hemolysis. There exists a risk of potentially fatal hemolysis and acute
renal failure from the use of Sterile Water for Injection as a diluent for Albumin (Human). Acceptable diluents include 0.9% Sodium
Chloride or 5% Dextrose in Water.

FLEXBUMIN is made from human blood. It carries an extremely remote risk for transmission of viral diseases and variant
Creutzfeldt-Jakob disease (vCJD) and theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD).

FLEXBUMIN must be administered intravenously and should be administered slowly. Rapid administration can cause circulatory
overload and pulmonary edema.

Monitor blood pressure in trauma patients and postoperative surgery patients resuscitated with FLEXBUMIN in order to detect
rebleeding secondary to clot disruption.

In post marketing experience anaphylactic shock, anaphylactic reaction, hypersensitivity/allergic reactions, headache, dysgeusia,
myocardial infarction, atrial fibrillation, tachycardia, hypotension, flushing, pulmonary edema, dyspnea, vomiting, nausea, urticaria,
rash, pruritus, pyrexia and chills have been reported.

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 the full Prescribing Information for FLEXBUMIN 5%.

Please see the full Prescribing Information for FLEXBUMIN 25%.

Indications and Detailed Important Risk Information for BUMINATE 5%, Albumin (Human), USP Solutions

Indication

BUMINATE 5%, Albumin (Human), USP Solutions are indicated for Hypovolemia, Hypoalbuminemia associated with general causes
and burns, and use during or prior to cardiopulmonary bypass surgery as a component of the pump prime

Detailed Important Risk Information for BUMINATE 5%, USP Solutions

BUMINATE 5% is contraindicated in patients with a history of allergic reactions to human albumin or any of the excipients, severe
anemia, and heart failure. Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.

Do not dilute with Sterile Water for Injection as this can cause hemolysis. There exists a risk of potentially fatal hemolysis and acute
renal failure from the use of Sterile Water for Injection as a diluent for Albumin (Human). Acceptable diluents include 0.9% Sodium
Chloride or 5% Dextrose in Water.

BUMINATE 5% is made from human plasma. It carries an extremely remote risk for transmission of viral diseases and theoretical risk for
transmission of Creutzfeldt-Jakob disease (CJD). No cases of transmission of CJD diseases have ever been identified for licensed albumin.

Certain components used in the packaging of this product contain natural rubber latex which may cause allergic reactions.

BUMINATE 5% must be administered intravenously. If a patient has a history of cardiac or circulatory disease, BUMINATE 5% should
be administered slowly (5 to 10 mL/min) to avoid too rapid a rise in the blood pressure. More rapid administration can cause circulatory
overload and pulmonary edema. Hypervolemia may occur if the dosage and rate of infusion are too high. Discontinue administration at
the first clinical signs of cardiovascular overload (e.g., headache, dyspnea, jugular venous distention, rales, and abnormal elevations in
systemic or central venous blood pressure).

Monitor blood pressure in trauma patients and postoperative patients resuscitated with BUMINATE 5% in order to detect rebleeding
secondary to clot disruption.

Adverse reactions to BUMINATE 5% are rare, although from post marketing experience anaphylactic shock, anaphylactic reaction,
hypersensitivity/allergic reactions, headache, dysgeusia, myocardial infarction, atrial fibrillation, tachycardia, hypotension, flushing,
pulmonary edema, dyspnea, vomiting, nausea, urticaria, rash, pruritus, pyrexia and chills may occur.

Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Do not add or mix with
other medications.

Please read the full Prescribing Information for BUMINATE 5%.

Indications and Detailed Important Risk Information for BUMINATE 25%, Albumin (Human), USP Solutions

Indication

Buminate 25%, Albumin (Human), USP Solutions are indicated for Hypovolemia, Hypoalbuminemia associated with general
causes, burns, adult respiratory distress syndrome (ARDS), and nephrosis, for use during or prior to cardiopulmonary bypass
surgery as a component of the pump prime, and Hemolytic disease of the newborn (HDN).

Detailed Important Risk Information for BUMINATE 25%, USP Solutions

BUMINATE 25% is contraindicated in patients with a history of allergic reactions to human albumin or any of the excipients, severe
anemia, and heart failure. Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.

Do not dilute with Sterile Water for Injection as this can cause hemolysis. There exists a risk of potentially fatal hemolysis
and acute renal failure from the use of Sterile Water for Injection as a diluent for Albumin (Human). Acceptable diluents include
0.9% Sodium Chloride or 5% Dextrose in Water.

Do not administer to patients with chronic renal insufficiencies due to the potential for accumulations of aluminum.

BUMINATE 25% is made from human plasma. It carries an extremely remote risk for transmission of viral diseases and theoretical
risk for transmission of Creutzfeldt-Jakob disease (CJD). No cases of transmission of CJD diseases have ever been identified for
licensed albumin.

Certain components used in the packaging of this product contain natural rubber latex which may cause allergic reactions.

BUMINATE 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. Hypervolemia may occur if the dosage and rate of infusion are
too high. Discontinue administration immediately at the first clinical signs of cardiovascular overload (e.g., headache, dyspnea,
jugular venous distention, rales, and abnormal elevations in systemic or central venous blood pressure).

Monitor blood pressure in trauma patients and postoperative patients resuscitated with BUMINATE 25% in order to detect
rebleeding secondary to clot disruption.

Adverse reactions to BUMINATE 25% are rare, although from post marketing experience anaphylactic shock, anaphylactic
reaction, hypersensitivity/allergic reactions, headache, dysgeusia, myocardial infarction, atrial fibrillation, tachycardia, hypotension,
flushing, pulmonary edema, dyspnea, vomiting, nausea, urticaria, rash, pruritus, pyrexia and chills may occur.

Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Do not add or mix with
other medications.

Please read the full Prescribing Information for BUMINATE 25%.

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.

S30403 06/17

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