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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/15 | Not Applicable | Active, not recruiting | Sheikh Hasina National Institute of Burn and Plastic Surgery | ||
2023/11/22 | Phase 4 | Not yet recruiting | |||
2020/11/10 | Phase 2 | Completed | |||
2020/01/28 | Phase 4 | Recruiting | Chinese Academy of Medical Sciences, Fuwai Hospital | ||
2016/04/04 | Not Applicable | Completed | |||
2011/01/04 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| EVICEL Fibrin Sealant (Human) Solution, 50-90 mg/ml, 800-1200 IU/ml | SIN13921P | SOLUTION | 50-90 mg/ml | 2/23/2011 | |
| HBVAXPRO INJECTION 10 MCG/ML | SIN13089P | INJECTION | 10 MCG/ML | 4/14/2005 | |
| PLASMANATE INJECTION 5% | SIN01064P | INJECTION | 5 g/100 ml | 5/12/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BISEKO SOLN FOR INTRAVENOUS INFUSION 5% | N/A | N/A | N/A | 1/29/1983 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| OCTAPLAS LG Solvent-Detergent Treated Human Plasma Solution for Intravenous Infusion | 96613 | Octapharma Australia Pty Ltd | Medicine | A | 3/1/2005 |
| PRONATIV human prothrombin complex powder for injection vial and solution for injection vial | 129151 | Octapharma Australia Pty Ltd | Medicine | A | 10/12/2007 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OCTAPLASMA | octapharma pharmazeutika produktionsges m b h | 02270013 | Solution - Intravenous | 14 G / 200 ML | 5/31/2012 |
| WILATE | octapharma pharmazeutika produktionsges m b h | 02286750 | Powder For Solution - Intravenous | 7.5 MG / 5 ML | 4/29/2008 |
| PLASMA PROTEIN FRACTION (HUMAN) PROTENATE | hyland, division of baxter healthcare corporation | 00118354 | Liquid - Intravenous | 5 G / 100 ML | 12/31/1963 |
| WILATE | octapharma pharmazeutika produktionsges m b h | 02286769 | Powder For Solution - Intravenous | 15 MG / 10 ML | 4/29/2008 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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