Country: United States
Language: English
Source: NLM (National Library of Medicine)
Albumin Human (UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR)
GRIFOLS USA, LLC
INTRAVENOUS
For restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3 Acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. Human Albumin Grifols® 20% can be used in such cases.1 Human Albumin Grifols 20% may be of value in the treatment of shock or hypotension in renal dialysis patients.1 Preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. Albumin also may be used in the priming fluid.4,5,6 Human Albumin Grifols 20% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.1,2,7 Human Albumin Grifols 20% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. When albumin deficit is the result of excessive protein loss, the effect of Human Albumin Grifols 20% administration will be temporary unless the underlying disorder is reversed.8,9,10 Septic patients and patients undergoing major surgery may lose more than half of their circulating plasma volume.1,11 Treatment with Human Albumin Grifols 20% may be of value in such cases, especially when plasma colloid oncotic pressure is abnormally low.1 In the first 24 hours after thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, Human Albumin Grifols 20% can be used to maintain plasma colloid osmotic pressure.2,12,13 Protein loss from the third space due to infection (acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis) may require treatment with an infusion of albumin.14,15 Human Albumin Grifols 20% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.16,17 Human Albumin Grifols 20% is indicated for the treatment of neonatal hyperbilirubinemia. It may be used prior to or during an exchange procedure in an attempt to bind free bilirubin and enhance its excretion.18,19,20 Human Albumin Grifols 20% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ARDS.6,21 Human Albumin Grifols 20% may be used to maintain cardiovascular function following removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites.2,22,23,24 - Hypersensitivity to albumin preparations or to any of the excipients. - Severe anemia or cardiac failure with normal or increased intravascular volume. Pregnancy Category C. Animal reproduction studies have not been conducted with Human Albumin Grifols 20%. It is also not known whether Human Albumin Grifols 20% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Human Albumin Grifols 20% should be given to a pregnant woman only if clearly needed. No human or animal data. Use only if clearly needed. No human or animal data. Use only if clearly needed. No human or animal data. Use only if clearly needed. No human or animal data. Use only if clearly needed.
Human Albumin Grifols 20% is supplied in single-use, individually laser etched vials. The following vial sizes of Human Albumin Grifols 20% are available: NDC Number Fill Size Grams Protein 61953-0001-1 50 mL 10 g 61953-0001-2 100 mL 20 g Each vial has an integral suspension band and a label with a peel-off strip showing the product name and lot number. Human Albumin Grifols 20% is stable for three years provided the storage temperature does not exceed 30 °C. Protect from freezing.
Biologic Licensing Application
HUMAN ALBUMIN GRIFOLS - ALBUMIN (HUMAN) SOLUTION GRIFOLS USA, LLC ---------- 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 hypopr Read the complete document