FLEXBUMIN 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.
FLEXBUMIN solutions must not be diluted with Sterile Water for Injection as this may cause hemolysis in recipients (see Contraindications).
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 FLEXBUMIN gives a solution, which is approximately isotonic and isosmotic with citrated plasma.
Albumin solutions should not be mixed with protein hydrolysates or solutions containing alcohol since these combinations may cause the proteins to precipitate.
Do not add supplementary medication.
Hypervolemia may occur if the dosage and rate of infusion are not adjusted, giving consideration to the solution concentration and the patient's clinical status. Hemodynamic parameters should be monitored in patients receiving FLEXBUMIN and should be used to check for the risk of hypervolemia and cardiovascular overload. (See Precautions).
It is strongly recommended that every time that FLEXBUMIN is administered to a patient, the name and batch number of the product be recorded in order to maintain a link between the patient and the batch of the product.
Recommended Dosages: Hypovolemic Shock: The dosage of FLEXBUMIN must be individualized. As a guideline, the initial treatment should be in the range of 125 to 250 ml (for 20%) and 100 to 200 ml (for 25%) for adults and 3 to 6 ml (for 20%) and 2.5 to 5 ml (for 25%) per kilogram 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 (Human).
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.
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.
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 kilogram of body weight.
Hemolytic Disease of the Newborn: FLEXBUMIN may be administered prior to or during exchange transfusion in a dose of 1 g per kilogram body weight.
Preparation for Administration: Check the GALAXY container for minute leaks prior to use by squeezing the bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear of particulate matter and seal is intact. FLEXBUMIN is a transparent or slightly opalescent solution, which may have a greenish tint or may vary from a pale straw to an amber color. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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.
Administration: Suspend container from eyelet support.
Remove plastic protector from outlet port at bottom of container.
Attach administration set. Refer to complete directions accompanying set. Make certain that the administration set contains an adequate filter (15-micron or smaller).