Dosage and Administration

BUMINATE [Albumin (Human)], 5% Solution must be administered intravenously. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion.

Albumin solutions should not be mixed with other medicinal products including blood and blood components, but can be used concomitantly with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate when deemed medically necessary. The volume of the total dose and the rate of infusion depends on the patient's condition and response.¹ Buminate 5% must not be diluted with Sterile Water for Injection as this may cause hemolysis in recipients.

Usage	Recommended Dosage
BUMINATE 5%
Hypovolemia	Although the volume of BUMINATE 5% administered must be individualized, the initial dose should be 250 to 500 mL for older children and adults and 12 to 20 mL per kg of body weight for infants and young children. It may be repeated after 30 minute intervals if the response is not adequate.¹ Hemodynamic parameters should be monitored and should be used to check for risk of hypervolemia and cardiovascular overload.
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 per kg of body weight.¹
Burns	When BUMINATE 5% is administered after the first 24 hours following burns, an initial dose of 500 mL is recommended.¹

BUMINATE [Albumin (Human)], 25% Solution must be administered intravenously. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion.

Albumin solutions should not be mixed with other medicinal products including blood and blood components, but can be used concomitantly with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate when deemed medically necessary. The addition of four volumes of normal saline or 5% glucose to 1 volume of BUMINATE 25% gives a solution, which is approximately isotonic and isosmotic with citrated plasma.²

Albumin solutions should not be mixed with protein hydrolysates or solutions containing alcohol.² Buminate 25% must not be diluted with Sterile Water for Injection as this may cause hemolysis in recipients.

Usage	Recommended Dosage
BUMINATE 25%
Hypovolemic Shock	The dosage of BUMINATE 25% 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 to 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.² 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.² Hemodynamic parameters should be monitored and should be used to check for risk of hypervolemia and cardiovascular overload.
Burns	The optimal therapeutic regimen for administration of crystalloid and colloid solutions after extensive burns has not been established. When BUMINATE 25% is administered after the first 24 hours following burns, the dose should be determined according to the patient's condition and response to treatment.²
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 per kg of body weight.²
Hemolytic Disease of the Newborn	BUMINATE 25% may be administered prior to or during exchange transfusion in a dose of 1 g per kg body weight.²

Preparation for administration:

Remove cap from bottle to expose center portion of rubber stopper.
Clean stopper with germicidal solution.
Attach administration set. If using rigid, non-vented container, open vent cap on spike and insert spike vertically into solution container.

Follow directions for use printed on the administration set container. Make certain that the administration set contains an adequate filter (15-micron or smaller).

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.

Storage information:

Store BUMINATE at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle.

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

BUMINATE 5% [Albumin (Human)], USP, 5% Solution is indicated for Hypovolemia, Hypoalbuminemia due to general causes and burns, and use during or prior to cardiopulmonary bypass surgery.

Important Risk Information for BUMINATE 5%

BUMINATE 5% 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.

BUMINATE 5% 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.

The stoppers used in BUMINATE 5% contain natural rubber latex. If a patient has a history of cardiac or circulatory disease, BUMINATE 5% should be administered slowly (5 to 10 mL per min) to avoid too rapid a rise in the blood pressure.

Patients should always be monitored in order to guard against the possibility of circulatory overload.

When BUMINATE 5% is used following injuries or surgery, the quick rise in blood pressure which follows administration makes it necessary to monitor the patient to detect and treat severed blood vessels that may not have bled at a lower blood pressure.

Adverse reactions to BUMINATE 5% are extremely rare, although nausea, fever, chills or urticaria may occasionally occur. Such symptoms usually disappear when the infusion is slowed or stopped for a short period of time.

Please review the BUMINATE 5% [Albumin (Human)] Prescribing Information for full prescribing details.

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

Buminate 25% [Albumin (Human)], USP, 25% Solution is indicated for Hypovolemia, Hypoalbuminemia due to general causes, burns, adult respiratory distress syndrome (ARDS), and nephrosis, for use during or prior to cardiopulmonary bypass surgery, and Hemolytic disease of the newborn (HDN).

Important Risk Information for BUMINATE 25%

BUMINATE 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 BUMINATE 25%. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.

BUMINATE 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.

The stoppers used in BUMINATE 25% contain natural rubber latex.

BUMINATE 25% must be administered intravenously at a rate not to exceed 1 mL/min to patients with normal blood volume, due to the risk of developing circulatory overload and pulmonary edema.

When BUMINATE 25% 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 BUMINATE 25% are extremely rare, although nausea, fever, chills or urticaria may occasionally occur. Such symptoms usually disappear when the infusion is slowed or stopped for a short period of time.

Please see Preparation for Administration for BUMINATE 25% in the Prescribing Information

Please review the BUMINATE 25% [Albumin (Human)] Prescribing Information for full prescribing details.

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).

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

BUMINATE 5% [Albumin (Human)] Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; September 2009.
BUMINATE 25% [Albumin (Human)] Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; September 2009.