HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Human Albumin Grifols 20% safely and effectively. See full prescribing information for Human Albumin Grifols 20%.
Human Albumin Grifols 20%
Albumin (Human) U.S.P.
20% solution
Initial U.S. Approval: 1995
RECENT MAJOR CHANGES
Indications and Usage, Ovarian hyperstimulation syndrome (1.5), Adult Respiratory Distress Syndrome (1.7), Prevention of Central Volume Depletion after Paracentesis Due to Cirrhotic Ascites (1.8) 04/2012
Dosage and Administration, Hypovolemia, Cardiopulmonary Bypass, Acute Nephrosis, Hypoalbuminemia, Ovarian Hyperstimulation Syndrome, Neonatal Hyperbilirubinemia, Adult Respiratory Distress Syndrome, Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites (2.1) 04/2012
Warnings and Precautions, Hypersensitivity (5.1), Hypervolemia/Hemodilution (5.2), Dehydration (5.3), Electrolyte Imbalance (5.4), Coagulation Abnormalities (5.5), Laboratory Monitoring (5.6), Application Precautions (5.7) 04/2012
INDICATIONS AND USAGE
Human Albumin Grifols 20% is an albumin solution indicated for:
-
Hypovolemia. (1.1)
-
Cardiopulmonary bypass procedures. (1.2)
-
Acute nephrosis. (1.3)
-
Hypoalbuminemia. (1.4)
-
Ovarian hyperstimulation syndrome. (1.5)
-
Neonatal hyperbilirubinemia. (1.6)
-
Adult respiratory distress syndrome (ARDS). (1.7)
-
Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.8)
DOSAGE AND ADMINISTRATION
For Intravenous Use Only
Dosage and infusion rate should be adjusted to the patient's individual requirements.
|
Indication |
Dose |
|
Hypovolemia |
Adults: Initial dose of 20 g (including renal dialysis).
For acute liver failure: initial dose of 12 to 25 g (2.1) |
|
Cardiopulmonary bypass procedures |
Adults: Initial dose of 25 g (2.1) |
|
Acute nephrosis |
Adults: 25 g together with diuretic once a day for 7 - 10 days (2.1) |
|
Hypoalbuminemia |
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) |
|
