Albuminex

Product manufactured by Bpl

Application Nr Approved Date Route Status External Links
BLA125644 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Albuminex 25% Is A 25% Albumin Solution Indicated For Adults And Children: Hypovolemia ( 1.1 ) Ascites ( 1.2 ) Hypoalbuminemia Including From Burns ( 1.3 ) Acute Nephrosis ( 1.4 ) Acute Respiratory Distress Syndrome (Ards) ( 1.5 ) Cardiopulmonary Bypass ( 1.6 ) Indication Dose Hypovolemia Adults: Initial Dose Of 25 G (Including Renal Dialysis). For Acute Liver Failure: Initial Dose Of 12 To 25 G. ( 2.1 ) Prevention Of Central Volume Depletion After Paracentesis Due To Cirrhotic Ascites Adults: 8 G For Every 1000 Ml Of Ascitic Fluid Removed. ( 2.1 ) Hypoalbuminemia Including From Burns Adults: 50 To 75 G For Pre- And Post-Operative Hypoproteinemia: 50 To 75 G. For Burn Therapy After The First 24 H: Initial Dose Of 25 G And Dose Adjustment To Maintain Plasma Protein Concentration Of 2.5 G Per 100 Ml. Third Space Protein Loss Due To Infection: Initial Dose Of 50 To 100 G. ( 2.1 ) Acute Nephrosis Adults: 25 G Together With Diuretic Once A Day For 7-10 Days. ( 2.1 ) Adult Respiratory Distress Syndrome (Ards) Adults: 25 G Over 30 Minutes And Repeated At 8 Hours For 3 Days, If Necessary. ( 2.1 ) Cardiopulmonary Bypass Procedures Adults: Initial Dose Of 25 G. ( 2.1 ) 1.1 Hypovolemia Albuminex 25% Is Indicated For Restoration And Maintenance Of Circulating Blood Volume Where Volume Deficiency Has Been Demonstrated, And Use Of A Colloid Is Appropriate E.g. Hypovolemia Following Shock Due To Trauma Or Sepsis, In Surgical Patients And In Other Similar Conditions With Volume Deficiency When Restoration And Maintenance Of Circulating Blood Volume Is Required In Both Adult And Pediatric Patients. In Pediatric Patients To Reverse Hypovolemia And Achieve Normal Capillary Refill Time. 1, 2, 3, 4, 5, 6, 7, 8 1.2 Ascites Albuminex 25% Is Indicated For Prevention Of Central Volume Depletion And Maintenance Of Cardiovascular Function After Large Volume Parencentesis In Patients With Liver Cirrhosis Or Other Chronic Liver Disease In Adults And Children. 9, 10, 11, 12 Albuminex 25% Infusion Plus Administration Of Vasoactive Drugs Is Indicated In The Treatment Of Type I Hepatorenal Syndrome. 6 For Patients With Spontaneous Bacterial Peritonitis, Albuminex 25% Is Indicated As Adjuvant Treatment To Antibiotic Therapy. 1.3 Hypoalbuminemia Including From Burns Albuminex 25% Is Indicated In Patients With Severe Burn Injury (> 20% Total Body Surface Area), But Not Until At Least 12 To 24 Hours After The Burn, In Order To Correct Protein Loss, Decrease Overall Fluid Requirements, Decrease Systemic Edema And Stabilize Cardiovascular Hemodynamics Without Fluid Overload (Initial Resuscitation Should Be With Crystalloids). 8, 14 Albuminex 25% Is Also Indicated In Patients With Pre- Or Post-Operative Hypoproteinemia And For Third Space Protein Loss Due To Infection Or Burns. 1.4 Acute Nephrosis Albuminex 25% Is Indicated In Patients With Acute Nephrosis In Combination With Loop Diuretics To Reinforce The Diuretic Therapeutic Effect, Which Is Reduced By Hypoalbuminemia, And For The Correction Of Reduced Oncotic Pressure. 15, 16 1.5 Acute Respiratory Distress Syndrome (Ards) Albuminex 25% Is Indicated In Conjunction With Diuretics To Correct Fluid Volume Overload Associated With Ards. 17, 18, 19 1.6 Cardiopulmonary Bypass Albuminex 25% Is Indicated In Cardiopulmonary Bypass Procedures As Part Of The Priming Fluids To Passivate The Synthetic Surfaces Of The Extracorporeal Circuit And Maintain The Patient's Colloid Oncotic Pressure. 20, 21, 22, 23, 24, 25

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Albumin Human

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