Plasmanate® (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.

This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USP contains approximately 88% normal human albumin, 12% alpha and beta globulins, and not more than 1% gamma globulin as determined by electrophoresis. The concentration of these proteins renders this solution iso-oncotic with normal human plasma and isotonic. The approximate concentrations of the significant electrolytes in Plasmanate are:

• Sodium: 145 mEq/L
• Potassium: 0.25 mEq/L
• Chloride: 100 mEq/L
• Plasmanate is clear and amber-colored and must be administered intravenously.

Sterility and Viral Inactivation

This product is designed for use by the medical profession as a preparation derived from human blood, similar to human plasma. Each vial is sterile and heat-treated at 60°C for 10 hours to mitigate the possibility of transmitting hepatitis viruses.
The blood group agglutinins and agglutinogens A and B are present at such low levels in Plasmanate that its use does not interfere with routine blood typing procedures. No chemical or microscopic alterations in urine have been observed with its administration.
The manufacturing process has been investigated for its ability to reduce infectivity of an experimental agent for transmissible spongiform encephalopathy (TSE), a model for variant Creutzfeldt-Jakob disease (vCJD) and classic CJD. Studies show that the steps from Pooled Plasma to Effluent IV-1 in Plasmanate production reduce TSE infectivity by ≥7.0 logs, providing reasonable assurance that if any vCJD/CJD agent were present, it would be effectively removed.

Indications and Usage

Treatment of Shock: Plasmanate is indicated in treating shock due to burns, crushing injuries, abdominal emergencies, and any cause of plasma fluid loss without significant red blood cell loss. It is also effective in emergency shock treatment due to hemorrhage. After the emergency phase, blood transfusion may be required based on the severity of blood loss. In infants and small children, Plasmanate is particularly effective for initial therapy of shock caused by dehydration and infection.

Contraindications

• Contraindicated in patients on cardiopulmonary bypass due to risk of severe hypotension.
• Not to be used in patients with severe anemia, congestive heart failure, or increased blood volume.

How Supplied

Plasmanate is available in single-dose, rubber-stoppered vials in the following sizes:

NDC Number	Size	Grams Protein
13533-613-20	50 mL	2.5
13533-613-25	250 mL	12.5
13533-613-27	500 mL	25.0

Storage

Store at room temperature not exceeding 30°C (86°F).

Package Label

Plasma Protein Fraction (Human) 5%, USP Plasmanate® Heated 60ºC for 10 hours For Intravenous Infusion Only Each 100 mL contains 5 g selected plasma proteins buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. No preservative. Volume-for-volume, osmotically equivalent to plasma.