Plasma protein fraction (human)

In normal human volunteers, Plasmanate has resulted in an increased blood volume which has lasted up to 48 hours. 2 Clinical experience has indicated that it is an adequate replacement for human plasma in the treatment of shock and is a suitable means of providing human proteins for their osmotic effect.

Treatment of Shock --Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage. 3,4 Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss.

In infants and small children, Plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection.

Plasmanate is contraindicated for use in patients on cardiopulmonary bypass. Severe hypotension has been reported in such patients when given Plasma Protein Fraction. 4

Plasma Protein Fraction is contraindicated in patients with severe anemia, congestive heart failure, or increased blood volume.

General

Rapid infusion of Plasmanate (greater than 10mL/minute) has produced hypotension in patients undergoing surgery or in the preoperative or postoperative period. Blood pressure should be monitored during use and infusion slowed or ceased if sudden hypotension occurs.

Plasmanate does not provide coagulation factors and therefore does not correct coagulation disorders.

Drug Interactions

Plasma Protein Fraction (Human) 5%, USP--Plasmanate is compatible with whole blood, packed red cells as well as the standard carbohydrate and electrolyte solutions intended for intravenous use. It should, however, not be mixed with protein hydrolysates or solutions containing alcohol.

Pregnancy Category C

Animal reproduction studies have not been conducted with Plasmanate. It is also not known if Plasmanate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plasmanate should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

1. Hink JH Jr, Hidalgo J, Seeberg VP, et al: Preparation and properties of a heat-treated human plasma protein fraction. Vox Sang 2:174-86, 1957.
2. Bertrand JJ, Feichtmeir TV, Kolomeyer N, et al: Clinical investigations with a heat-treated plasma protein fraction--Plasmanate Vox Sang 4:385-402, 1959.
3. Tullis JL: Albumin. 1. Background and use. 2. Guidelines for clinical use. JAMA 237:355-60; 460-3, 1977.
4. Bland JHL, Laver MB, Lowenstein E: Vasodilator effect of commercial 5% plasma protein fraction solutions. JAMA 224:1721-4, 1973.

Bayer Corporation

Pharmaceutical Division

Elkhart, IN 46515 USA

U.S. License No. 8

Printed in USA

08705065

(Rev. February 2002)