DOSAGE AND ADMINISTRATION
Plasbumin-25 should always be administered by intravenous infusion. Plasbumin-25 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Plasbumin-25 should only be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.
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.
For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.
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).(2) This is best achieved by the intravenous administration of Plasbumin-25. The duration of therapy is decided by the loss of protein from the 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.
Hypoproteinemia With Or Without Edema
Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Plasbumin-25 must be considered purely symptomatic or supportive (see section Situations In Which Albumin Administration Is Not Warranted).(2) The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Plasbumin-25 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.
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 a 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.
Plasbumin-25 is available in 20 mL, 50 mL, and 100 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.
1. Heyl JT, Gibson JG II, Janeway CA. Studies on the plasma proteins. V. The effect of concentrated solutions of human and bovine serum albumin on blood volume after acute blood loss in man. J Clin Invest. 1943;22:763-73.
2. Tullis JL. Albumin. 1. Background and use. 2. Guidelines for clinical use. JAMA. 1977;237:355-60; 460-3.
3. Comley A, Wood B. Albumin administration in exchange transfusion for hyperbilirubinaemia. Arch Dis Child. 1968;43:151-4.
4. Janeway CA, Gibson ST, Woodruff LM, Heyl JT, Bailey OT, Newhouser LR. Chemical, clinical, and immunological studies on the products of human plasma fractionation. VII. Concentrated human serum albumin. J Clin Invest. 1944;23:465-90.
5. Skillman JJ, Tanenbaum BJ. Unrecognized losses of albumin, plasma, and red cells during abdominal vascular operations. Curr Top Surg Res. 1970;2:523-33.
6. Zubiate P, Kay JH, Mendez AM, Krohn BG, Hochman R, Dunne EF. Coronary artery surgery: a new technique with use of little blood, if any. J Thorac Cardiovasc Surg. 1974;68(2):263-7.
7. 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;163:866-85.
Manufactured by: Grifols Therapeutics LLC. Research Triangle Park, NC 27709 USA. Revised: Jan 2020