Plasma Protein Fraction

Plasma Protein Fraction is a sterile solution of selected proteins derived from the blood plasma of adult human donors. It contains protein, of which about 83-90% is albumin and the remainder is a and ß globulins. Plasma Protein Fraction is used as a substitute for plasma in treating non-hemorrhagic shock and as a source of proteins for intravenous nutrition.

Plasma Protein Fraction is primarily indicated in conditions like Hypovolemia, Treatment of shock and can also be given in adjunctive therapy as an alternative drug of choice in Cardiac insufficiency.

Plasma Protein Fraction is contraindicated in conditions like Hypersensitivity to albumin, Severe anemia, CHF, Increases intravascular volume, Hypoproteinemia associated with chronic nephrosis, Chronic cirrhosis, malabsorption, proteins-losing enteropathies, Pancreatic insufficiency, and malnutrition.

The symptomatic adverse reactions produced by Plasma Protein Fraction are more or less tolerable and if they become severe, they can be treated symptomatically, these include Headache, Nausea, Urticaria, Hypotension, Flushing, Back pain, Anaphylaxis, Dyspnea, Pulmonary edema, Tachycardia, Erythema, Chills, Fever, Hypersalivation.

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. 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. 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 (). 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 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. Commercially available PPF contains approximately 145 mEq of sodium per liter. 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. 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. Category C. 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. Use with caution in patients with hepatic failure because of added protein, fluid, and sodium load. Use with caution in patients with renal failure because of added protein, fluid, and sodium load.

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. 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. 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 (). 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 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. Commercially available PPF contains approximately 145 mEq of sodium per liter. 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. 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. Category C. 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. Use with caution in patients with hepatic failure because of added protein, fluid, and sodium load. Use with caution in patients with renal failure because of added protein, fluid, and sodium load.

500 ml (500 (500)) As recommended. IV-inf — At rate not exceeding 10 ml/min.

20 to 30 ml/kg (25 (25)) As recommended. IV Infusion — Infuse at 10 ml/min.As required

20 to 30 (25 (25)) As recommended. IV Infusion — As required

Plasma Protein Fraction is known to interact with other drugs, the details of drug interactions is as follows:DrugDetailsSeverityOnsetManagementDoxepin (HCl) These interactions are sometimes beneficial and sometimes may pose threats to life. Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

No storage information is recorded for this medicine yet.