MedPath

Plasma protein fraction (human)

Generic Name
Plasma protein fraction (human)
Drug Type
Biotech
Unique Ingredient Identifier
6D53G0FD0Z

Overview

The plasma protein fraction human (PPFh) is defined as a sterile solution of proteins composed mainly of albumin and globulin derived from human plasma. It is already reviewed under the category of biologics by the FDA where the processing, required tests, requirements and labeling are incorporated. This biologic should come from recovered plasma from whole blood or prepared source plasma. the final product should not include any type of additives. The composition of PPFh should be 5% of protein from which 83% should consist of albumin and no more of 17% should be globulin. It is also stated that no more than 1% of the total protein should be gamma globulin. PPFh is a sterile, frozen solution of solvent/detergent treated human plasma. The proteins in PPFh are stabilized with sodium caprylate and acetyltryptophan and it contains some electrolytes such as sodium, potassium and chloride.

Background

The plasma protein fraction human (PPFh) is defined as a sterile solution of proteins composed mainly of albumin and globulin derived from human plasma. It is already reviewed under the category of biologics by the FDA where the processing, required tests, requirements and labeling are incorporated. This biologic should come from recovered plasma from whole blood or prepared source plasma. the final product should not include any type of additives. The composition of PPFh should be 5% of protein from which 83% should consist of albumin and no more of 17% should be globulin. It is also stated that no more than 1% of the total protein should be gamma globulin. PPFh is a sterile, frozen solution of solvent/detergent treated human plasma. The proteins in PPFh are stabilized with sodium caprylate and acetyltryptophan and it contains some electrolytes such as sodium, potassium and chloride.

Indication

PPFh is used as a replacement therapy in patients with complex deficiencies of coagulation factors such as coagulopathy. It is also used as a substitution therapy in emergency cases of factor deficiencies, for rapid reversal of the effects of oral anticoagulants or in dangerous hemorrhages during fibrinolytic therapy. PPFh can be used in therapeutic plasma exchange procedures including thrombotic thrombocytopenic purpura. PPFh can be used in the treatment of shock where there is a predominant loss of plasma fluids and not red blood cells.

Associated Conditions

  • Acquired Coagulation Factor Deficiency
  • Chickenpox
  • Hypoproteinemia
  • Kwashiorkor
  • Shock
  • Thrombocytopenic Purpura

Clinical Trials

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

EVICEL Fibrin Sealant (Human) Solution, 50-90 mg/ml, 800-1200 IU/ml
Manufacturer:OMRIX biopharmaceuticals Ltd
Form:SOLUTION
Strength:50-90 mg/ml
Online:Yes
Approved: 2011/02/23
Approval:SIN13921P
HBVAXPRO INJECTION 10 MCG/ML
Manufacturer:Merck Sharp & Dohme LLC
Form:INJECTION
Strength:10 MCG/ML
Online:Yes
Approved: 2005/04/14
Approval:SIN13089P
PLASMANATE INJECTION 5%
Manufacturer:Grifols Therapeutics LLC
Form:INJECTION
Strength:5 g/100 ml
Online:Yes
Approved: 1988/05/12
Approval:SIN01064P

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