Plasbumin

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Plasbumin

Classes

Protein Solutions 5.0%

Administration
Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Intravenous Administration

Do not use solutions that are turbid or which have been frozen.
Remove seal to expose stopper. Always swab stopper top immediately with suitable antiseptic prior to entering the vial.
Use a 16-gauge needle or dispensing pin for penetrating the vial.
Insert needles or dispensing pins within the stopper area delineated by the raised ring. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
Administer IV and preferably through an area of the skin that is at some distance from any site of trauma or infection.
May be given initially at a rate up to 16 mL/minute in adults. However, infusion rates more than 10 mL/minute have produced hypotension in certain patients.
Adjust or slow the infusion rate according to clinical response and rising blood pressure.
Do not mix with protein hydrolysates or solutions containing alcohol.
Storage: Do not administer if more than 4 hours has passed since penetration of the vial. Discard partially used vials.

Adverse Reactions
Moderate

hypotension / Rapid / Incidence not known

Mild

urticaria / Rapid / Incidence not known
headache / Early / Incidence not known
nausea / Early / Incidence not known
back pain / Delayed / Incidence not known
flushing / Rapid / Incidence not known

Common Brand Names

Plasmanate

Dea Class

Rx

Description

Parenteral plasma volume expander prepared from large pools of human plasma
Used for the treatment of shock due to hypovolemia or hemorrhage
Plasma proteins consist of approximately 88% of normal human albumin, 12% alpha and beta globulins, and not more than 1% gamma globulin

Dosage And Indications
For treatment of shock due to hypovolemia or hemorrhage.
NOTE: Plasma protein fraction is indicated for the treatment of shock where there is a predominant loss of plasma fluids, such as burns, crush injuries, and abdominal emergencies. It is also effective in the emergency treatment of shock due to hemorrhage.
Intravenous dosage Adults

250 to 500 mL (12.5 to 25 g protein) IV as needed. Adjust or slow rate according to clinical response and rising blood pressure. Dosage is based almost entirely on the nature of the individual case and response to therapy.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Plasma Protein Fraction products.

How Supplied

Plasbumin Intravenous Inj Sol: 5%

Maximum Dosage
Adults

Specific maximum dosage information is not available. Infusion rates more than 10 mL/minute may cause hypotension, and doses more than 1,000 mL in 3 to 4 hours may cause hemodilution.

Geriatric

Specific maximum dosage information is not available. Infusion rates more than 10 mL/minute may cause hypotension, and doses more than 1,000 mL in 3 to 4 hours may cause hemodilution.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

Plasma protein fraction is prepared from large pools of human plasma, and the plasma proteins consist of approximately 88% of normal human albumin, 12% alpha and beta globulins, and not more than 1% gamma globulin. The concentrations of these proteins is such that the solution is iso-oncotic with normal human plasma and is isotonic. It is osmotically equivalent to plasma, volume for volume. Clinical experience has indicated that plasma protein fraction 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. The approximate concentrations of the significant electrolytes in plasma protein fraction are sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L, which are lower than with normal human serum albumin 5%. Plasma protein fraction does not contain coagulation factors.

Pharmacokinetics

Plasma protein fraction is administered intravenously. It is osmotically equivalent to plasma and the duration of volume expansion lasts up to 48 hours.

Pregnancy And Lactation
Pregnancy

Use plasma protein fraction during pregnancy only if clearly needed. It is not known if plasma protein fraction can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Animal reproduction studies have not been conducted with plasma protein fraction.

It is not known whether plasma protein fraction or albumin, its primary protein, is excreted in human milk. No human or animal data are available to indicate the presence or absence of drug-associated risk with plasma protein fraction or albumin use while breast-feeding.