Human Plasma Proteins
Human Plasma Proteins Uses, Dosage, Side Effects, Food Interaction and all others data.
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.
Preclinical studies were not performed as this product is exclusively human and any result in animals is not relevant. This factor creates the need for having very regulated manufacturing processes. From this control, the presence of two contaminants have been noticed (TNBP and Octoxynol). The administration of this two contaminants in rodents showed a very rapid elimination of TNBP with a terminal half-life of 20 min. TNBP was never found in urine and only traces were located in feces. In the case of octoxynol, it was not detected in plasma, urine or feces.
| Trade Name | Human Plasma Proteins |
| Generic | Plasma protein fraction (human) |
| Plasma protein fraction (human) Other Names | Human plasma protein, Human plasma protein fraction, Human plasma proteins, Plasma protein fraction, Plasma protein fraction human, Plasma protein fraction,human |
| Type | |
| Protein binding | This pharmacokinetic property is not relevant. |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Human Plasma Proteins is a plasma protein solution used to treat coagulation factor deficiencies, reverse anticoagulant effects, and shock from a loss of plasma fluids, and is also used in plasma exchange procedures.
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.
Human Plasma Proteins is also used to associated treatment for these conditions: Acquired Coagulation Factor Deficiency, Chickenpox, Hypoproteinemia, Kwashiorkor, Shock, Thrombocytopenic Purpura, Blood Plasma Therapy
How Human Plasma Proteins works
PPFh acts by replacing the missing blood plasma factor in the patient. It is important to highlight that as a part of the manufacturing process, PPFh has to be completely virus inactivated.
Toxicity
Overdosage of PPFh can result in hypervolemia, pulmonary edema and or cardiac failure. Studies regarding the mutagenic potential, effect in fertility and peri- and post-natal development, genotoxic potential and carcinogenic properties demonstrate that PPFh is an inactive product.
Food Interaction
No interactions found.Volume of Distribution
The registered volume of distribution is reported to be of approximately 25-50 ml/kg. This value depends on the studied factor.
Elimination Route
PPFh is administered always intravenously and thus, it is immediately available in the organism.
Half Life
The registered clearance rate is reported to be in a range of 5-60 h. This value depends on the studied factor.
Clearance
The registered clearance rate is reported to be in a range of 0.6-7.9 ml.kg/h. This value depends on the studied factor.
Elimination Route
The different proteins constituting PPFh are metabolized as the normal endogenous proteins. Under this thought, after the corresponding metabolism, the proteins that constitute PPFh can be eliminated via feces, urine or expiration.
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