PLASMANATE (plasma protein fraction- human solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Albumin Human (UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR)

Available from:

GRIFOLS USA, LLC

INN (International Name):

Albumin Human

Composition:

Albumin Human 2.5 g in 50 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

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.

Product summary:

Plasmanate is available in 50 mL pediatric size, 250 mL and 500 mL rubber-stoppered vials. Each single dose vial contains plasma protein in the following approximate amounts:

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

PLASMANATE - PLASMA PROTEIN FRACTION (HUMAN) SOLUTION
GRIFOLS USA, LLC
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PLASMA PROTEIN FRACTION (HUMAN) 5%, USP
PLASMANATE
DESCRIPTION
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 is
clear and
amber colored. 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 infectivit