DOSAGE AND ADMINISTRATION
Albuked 5 should always be administered by intravenous infusion. The choice between the use of Albuked 5 and Albumin (Human) 25%, USP (Albuked™ 25) depends upon whether the patient requires primarily volume (Albuked 5) or primarily colloid osmotic activity (Albuked 25). Below a serum oncotic level of 20 mm Hg (equal to a total serum protein concentration of 5.2 g per 100 mL) there is evidence which suggests that the risk of complications increases.1 When the oncotic pressure drops below this level, the patient should be treated with Albuked 25 together with diuretics. This is especially important in high risk patients who have undergone abdominal, cardiovascular, thoracic or urologic surgery or who have acute bacteremia.
The volume administered and the speed of administration should be adapted to the response of the individual patient.
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
The volume infused should be related to the estimated volume deficit and the speed of administration adapted to the response of the patient.
In neonates or infants, Albuked 5 may be given in large amounts.7 The recommended dose is 10 to 20 mL/kg equivalent to 0.5 to 1.0 g albumin/kg body weight.
After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).1 This is best achieved by the intravenous administration of Albuked, usually as Albuked 25. The duration of therapy is decided by the loss of protein from burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.
Other dosage recommendations are given under the specific indications referred to above.
Preparation For Administration
Remove seal to expose stopper. Always swab stopper top immediately with suitable antiseptic prior to entering vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
Albuked 5 is available in 50 mL and 250 mL rubber-stoppered vials. Each single dose vial contains albumin in the following approximate amounts:
|NDC Number||Size||Grams Albumin|
Store at room temperature not exceeding 30°C (86°F). Do not freeze. Do not use after expiration date.
CAUTION: U.S. federal law prohibits dispensing without prescription.
1. Tullis JL. Albumin. 1. Background and use. 2. Guidelines for clinical use. JAMA. 1977;237:355-60;460-3.
2. Clowes GHA Jr, Vucinic M, Weidner MG. Circulatory and metabolic alterations associated with survival or death in peritonitis: clinical analysis of 25 cases. Ann Surg. 1966;163(6):866-85.
7. Bennett EJ. Fluid balance in the newborn. Anesthesiology. 1975;43:210-24.
Manufactured for: Kedrion Biopharma, Inc. 400 Kelby Street, Fort Lee, NJ 07024. Manufactured by: Grifols Therapeutics LLC, Research Triangle Park, NC 27709 USA, U.S. License No. 1871. Reviesd: Jun 2018.