Introduction

Protein colloid; sterile solution of selected proteins prepared from pooled human plasma.

Uses for Plasma Protein Fraction

Fluid Resuscitation (Shock)

Used for plasma volume expansion in the treatment of certain types of shock, including shock resulting from burns, crushing injuries, abdominal emergencies, or any other cause where there is a predominant loss of plasma fluids and not RBCs.

Adequate replacement for human plasma in the treatment of shock and suitable means of providing human proteins for their osmotic effect; however, albumin solutions may be preferable because they contain a greater percentage of albumin and, since they are more purified, are less likely to cause hypotensive reactions. (See Hypotension under Cautions.)

Initial therapy in infants and small children for shock resulting from dehydration and infection.

Emergency treatment of shock due to hemorrhage. Following the emergency phase of therapy, transfusions of whole blood or RBCs may be indicated, depending on the severity of the blood loss.

Plasma Protein Fraction Dosage and Administration

Administration

IV Administration

Administer by IV infusion, preferably at a site at some distance from any site of infection or trauma.

Swab the rubber stopper on vial with iodine tincture followed by a sterile antiseptic swab. Insert a 16-gauge needle or dispensing pin perpendicular to the stopper in the area delineated by a raised ring.

Does not contain preservatives; discard any partially used vials.

Do not mix with protein hydrolysates or solutions containing alcohol.

To minimize administration errors, consult the manufacturer’s administration instructions for proper use.

Rate of Administration

Adjust rate of infusion according to the clinical response of the patient and changes in BP.

For hypovolemic shock in infants and young children: Infusion at a rate of up to 5–10 mL/minute has been suggested.

As plasma volume approaches normal, do not exceed 5–8 mL/minute. Rapid IV infusion (e.g., >10 mL/minute) may cause vascular overload. (See Infusion Effects under Cautions.)

Dosage

Dosage depends on the patient’s condition and response to therapy.

Pediatric Patients

Fluid Resuscitation (Shock)

Hypovolemic Shock

Infants and young children: Initially, 6.6–33 mL/kg (0.33–1.65 g/kg of protein). Subsequent dosage is determined by the patient’s condition.

Adults

Fluid Resuscitation (Shock)

Hypovolemic Shock

Usual minimum effective dosage: 250–500 mL (12.5–25 g of protein). Subsequent dosage is determined by the patient’s condition.

Prescribing Limits

Adults

Fluid Resuscitation (Shock)

Hypovolemic Shock

Do not exceed 5–8 mL/minute.

Special Populations

No special population dosage recommendations at this time.

Contraindications

• Cardiopulmonary bypass procedures. (See Hypotension under Cautions.)

• Severe anemia.

• CHF.

• Increased blood volume.

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Potential vehicle for transmission of human viruses, including hepatitis virus, or other infectious agents.

Despite screening for certain viruses (e.g., human immunodeficiency virus [HIV], hepatitis B virus [HBV], hepatitis C virus [HCV]) and a pasteurization procedure to reduce viral infectious potential associated with plasma protein fraction (PPF), a risk for transmission of infectious agents still remains.

Transmission of nonenveloped viruses, including hepatitis HAV and parvovirus B19, has been documented following administration of plasma-derived coagulation factors.

Report any suspected PPF-associated infections to the manufacturer.

Risk of Creutzfeldt-Jakob Disease

May carry a risk of transmitting the causative agent of Creutzfeldt-Jacob disease (CJD) or variant CJD (vCJD).

There have been 3 probable cases of vCJD acquired through transfusion of human RBCs, although, transmission via human plasma derivatives (including plasma-derived albumin) has not been documented to date.

Risk of West Nile Virus

Evidence exists that West Nile Virus (WNV) can be transmitted in transplanted organs (e.g., heart, liver, kidney) and blood products (e.g., whole blood, packed RBCs, fresh frozen plasma). However, WNV transmission unlikely through commercially available plasma-derived preparations since WNV is an enveloped virus, like HCV, which is known to be inactivated by the heat and solvent/detergent viral inactivation procedures used in the manufacture of these preparations.

For further information on WNV precautions related to blood and blood products, the FDA’s guidance for industry should be consulted ().

General Precautions

Infusion Effects

Rapid infusion may cause vascular overload.

Observe all patients (especially those with normal or increased circulatory volumes) for signs of hypervolemia, including dyspnea, fluid in the lungs, pulmonary edema, cardiac failure, or abnormal increases in BP or central venous pressure.

Hypotension

Hypotension may occur, especially following rapid IV infusion (i.e., at rates >10 mL/minute) in patients undergoing surgery or in the pre- or postoperative period or during intra-arterial administration in patients on cardiopulmonary bypass. Monitor BP during administration; slow or stop the infusion if sudden hypotension occurs. BP may return to normal spontaneously following slowing or discontinuance of the infusion; vasopressors also may be used to correct hypotension.

Sodium Content

Commercially available PPF contains approximately 145 mEq of sodium per liter.

Trauma or Surgery Risk

Rapid rise in BP accompanying administration of PPF following injuries or surgery may reveal bleeding points that were not apparent at the lower BP; observe patient carefully to prevent hemorrhage and subsequent shock.

Hematologic Effects

Does not contain coagulation factors and, therefore, cannot be used to correct coagulation disorders. Contains trace amounts of blood groups A and B isohemagglutins; however, these are at such low concentrations that use of PPF should have no effect on routine blood typing procedures.

Specific Populations

Pregnancy

Category C.

Pediatric Use

Manufacturer states that safety and efficacy not established in pediatric patients; however, protein colloid has been found to be very useful in infants and small children for initial treatment of shock resulting from dehydration and infection.

Hepatic Impairment

Use with caution in patients with hepatic failure because of added protein, fluid, and sodium load.

Renal Impairment

Use with caution in patients with renal failure because of added protein, fluid, and sodium load.

Common Adverse Effects

Flushing, urticaria, nausea, headache, back pain.

Administration

IV Administration

Administer by IV infusion, preferably at a site at some distance from any site of infection or trauma.

Swab the rubber stopper on vial with iodine tincture followed by a sterile antiseptic swab. Insert a 16-gauge needle or dispensing pin perpendicular to the stopper in the area delineated by a raised ring.

Does not contain preservatives; discard any partially used vials.

Do not mix with protein hydrolysates or solutions containing alcohol.

To minimize administration errors, consult the manufacturer’s administration instructions for proper use.

Rate of Administration

Adjust rate of infusion according to the clinical response of the patient and changes in BP.

For hypovolemic shock in infants and young children: Infusion at a rate of up to 5–10 mL/minute has been suggested.

As plasma volume approaches normal, do not exceed 5–8 mL/minute. Rapid IV infusion (e.g., >10 mL/minute) may cause vascular overload. (See Infusion Effects under Cautions.)

Dosage

Dosage depends on the patient’s condition and response to therapy.

Pediatric Patients

Fluid Resuscitation (Shock)

Hypovolemic Shock

Infants and young children: Initially, 6.6–33 mL/kg (0.33–1.65 g/kg of protein). Subsequent dosage is determined by the patient’s condition.

Adults

Fluid Resuscitation (Shock)

Hypovolemic Shock

Usual minimum effective dosage: 250–500 mL (12.5–25 g of protein). Subsequent dosage is determined by the patient’s condition.

Prescribing Limits

Adults

Fluid Resuscitation (Shock)

Hypovolemic Shock

Do not exceed 5–8 mL/minute.

Special Populations

No special population dosage recommendations at this time.