DOSAGE AND ADMINISTRATION
BUMINATE 25% must be administered intravenously.
- Do not use if turbid.
- Do not begin administration more than 4 hours after the
container has been entered.
- Monitor hemodynamic parameters in patients receiving
BUMINATE 25% and check for the risk of hypervolemia and cardiovascular
overload. [see PRECAUTIONS] Hypervolemia can occur if the dosage and
rate of infusion are not adjusted, giving consideration to the solution
concentration and the patient's clinical status.
- Do not dilute with Sterile Water for Injection as this
can cause hemolysis in recipients [see CONTRAINDICATIONS].
- Do not mix with other medicinal products including blood
and blood components. BUMINATE 25% 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.
- Do not mix with protein hydrolysates or solutions
containing alcohol since these combinations can cause the proteins to
- Do not add supplementary medication.
- Record the name and batch number of the product to
maintain a link between the patient and the product.
- Discard unused portion.
The dosage of BUMINATE 25% must be individualized.
Initial dosage range for adults is 100 to 200 mL and for children 2.5 to 5 mL
per kilogram body weight. Repeat after 15 to 30 minutes if the response is not
adequate. Administer albumin replacement in the form of 5% Albumin (Human) in patients
with significant plasma volume deficits.
Upon administration of additional albumin or if
hemorrhage occurs, hemodilution and anemia can occur. Supplemental
administration of compatible red blood cells or compatible whole blood may be
required to treat this condition.
The optimal therapeutic regimen for administration of
crystalloid and colloid solutions after extensive burns has not been established.
Determine the appropriate dose according to the patient's condition and response
to treatment when BUMINATE 25% is administered after the first 24 hours
Hypoalbuminemia is usually accompanied by a hidden extravascular
albumin deficiency of equal magnitude. Consider total body albumin deficit when
determining the amount of albumin necessary to reverse the hypoalbuminemia.
Calculate the body albumin compartment to be 80 to 100 mL per kg of body weight
when using the patient's serum albumin concentration to estimate the deficit.5,6
Do not exceed a daily dose of 2 g of albumin per kilogram of body weight.
Hemolytic Disease Of The Newborn
Administer BUMINATE 25% prior to or during exchange
transfusion at a dose of 1g per kilogram body weight.15
Preparation For Administration
Visually inspect parenteral drug products for particulate
matter and discoloration prior to administration. BUMINATE 25% is a transparent
or slightly opalescent solution, which may have a greenish tint or may vary
from a pale straw to an amber color. Do not use unless solution is clear of particulate
matter and seal is intact.
Remove cap from bottle to expose center portion of rubber
Clean stopper with germicidal solution.
Follow directions for use printed on the administration
set container. Make certain that the administration set contains an adequate
filter (15-micron or smaller).
BUMINATE 25% is supplied in glass bottles:
20 mL NDC 0944-0490-01
50 mL NDC 0944-0490-02
100 mL NDC 0944-0490-03
Room temperature: Do not exceed 30°C
(86°F). Avoid freezing.
Stability testing for BUMINATE 25% showed that aluminum
concentration increased over time reaching levels that could exceed 1000 ppb
over the shelf life of the product. [see CONTRAINDICATIONS].
4.Tullis JL: Albumin, 1. Background and use, and 2.
Guidelines for clinical use. JAMA 237:355- 360, 460-463, 1977
5. Peters T Jr: Serum albumin, in The Plasma Proteins ,
2nd ed, Vol 1. Putnam FW (ed). New York, Academic Press, 1975, pp 133-181
6. Finlayson JS: Albumin products. Semin Thromb Hemos tas
. 6:85-120, 1980
12.Ott SM, Maloney NA, Klein GL, et al: Aluminum is
associated with low bone formation in patients receiving chronic parenteral
nutrition. Ann Intern Med 98:910-4,1983
15. Tsao YC, Yu VYH: Albumin in management of neonatal
hyperbilirubinaemia. Arch Dis Childhood 47:250-256, 1972
Baxalta US Inc., Westlake Village, CA 91362 USA. Revised Oct 2015