Dosage and Administration

FLEXBUMIN 25% [Albumin (Human)], 25% Solution must be administered intravenously. This solution may be administered in conjunction with or combined with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate. The addition of four volumes of normal saline or 5% glucose to 1 volume of FLEXBUMIN gives a solution, which is approximately isotonic and isosmotic with citrated plasma.¹

Albumin solutions should not be mixed with protein hydrolysates or solutions containing alcohol.¹

Usage	Recommended Dosage
Hypovolemic Shock	The dosage of FLEXBUMIN must be individualized. As a guideline, the initial treatment should be in the range of 100 to 200 mL for adults and 2.5 to 5 mL per kg body weight for children. This may be repeated after 15-30 minutes if the response is not adequate. For patients with significant plasma volume deficits, albumin replacement is best administered in the form of 5% Albumin.¹ Upon administration of additional albumin or if hemorrhage has occurred, hemodilution and a relative anemia will follow. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.¹
Burns	The optimal therapeutic regimen for administration of crystalloid and colloid solutions after extensive burns has not been established. When FLEXBUMIN is administered after the first 24 hours following burns, the dose should be determined according to the patient's condition and response to treatment.¹
Hypoalbuminemia	Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia. When using patient's serum albumin concentration to estimate the deficit, the body albumin compartment should be calculated to be 80 to 100 mL per kg of body weight. Daily dose should not exceed 2 g of albumin/kg.¹
Hemolytic Disease of the Newborn	FLEXBUMIN may be administered prior to or during exchange transfusion in a dose of 1 g per kg body weight.¹

Preparation for administration:

Suspend container from eyelet support.
Remove plastic protector from outlet port at bottom of container.
Attach administration set. If using flexible container, insert spike into solution container.

Follow directions for use printed on the administration set container. make certain that the administration set contains and adiquate filter (15-micron or smaller).

Storage information:

Store FLEXBUMIN at room temperature, not to exceed 30°C (86°F). Protect from freezing.

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.

BUMINATE 5% [Albumin (Human)], USP, 5% Solution

BUMINATE 5% is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. BUMINATE 5% is indicated in hypovolemia, hypoalbuminemia, burns, and cardiopulmonary bypass surgery.

Please see Important Risk Information for BUMINATE 5% and Full Prescribing Information.

BUMINATE 25% [Albumin (Human)], USP, 25% Solution

BUMINATE 25% is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. BUMINATE 25% is indicated in hypovolemia, hypoalbuminemia, burns, adult respiratory distress syndrome (ARDS), nephrosis, cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN).

Please see Important Risk Information for BUMINATE 25% and Full Prescribing Information.

FLEXBUMIN 25% [Albumin (Human)] Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; September 2009.