Plasmanate

Absorption

Duration

Following IV administration, increased blood volume may last up to 48 hours.104

This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USPPlasmanate® contains 5 g selected plasma proteins buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The plasma proteins consist of approximately 88% normal human albumin, 12% alpha and beta globulins and not more than 1% gamma globulin as determined by electrophoresis.[1] The concentration of these proteins is such that this solution is iso-oncotic with normal human plasma and is isotonic. The approximate concentrations of the significant electrolytes in Plasmanate are: sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L. Plasmanate must be administered intravenously.

This product is designed to bring to the medical profession a preparation derived from human blood and similar to human plasma. Each vial of Plasmanate is sterile and heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses.

The blood group agglutinins and agglutinogens A and B are at such a low level in Plasmanate solution that its use has no effect on routine blood typing procedures. No chemical or microscopic alterations of the urine have been observed with its use.

Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.[5-8] The production steps from Pooled Plasma to Effluent IV‑1 in the Plasmanate manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥ 7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.

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.

Store at room temperature not exceeding 30°C (86°F). Solution that has been frozen should not be used. Do not use after expiration date.

CAUTION

Rx only

U.S. federal law prohibits dispensing without prescription.

This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USP--Plasmanate contains 5 g selected plasma proteins buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The plasma proteins consist of approximately 88% normal human albumin, 12% alpha and beta globulins and not more than 1% gamma globulin as determined by electrophoresis. 1 The concentration of these proteins is such that this solution is iso-oncotic with normal human plasma and is isotonic. The approximate concentrations of the significant electrolytes in Plasmanate are: sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L. Plasmanate must be administered intravenously.

This product is designed to bring to the medical profession a preparation derived from human blood and similar to human plasma. Each vial of Plasmanate is sterile and heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses.

The blood group agglutinins and agglutinogens A and B are at such a low level in Plasmanate solution that its use has no effect on routine blood typing procedures. No chemical or microscopic alterations of the urine have been observed with its use.

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.