HUMAN ALBUMIN GRIFOLS (albumin- human solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Albumin Human (UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR)

Available from:

GRIFOLS USA, LLC

Administration route:

INTRAVENOUS

Therapeutic indications:

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.

Product summary:

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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

HUMAN ALBUMIN GRIFOLS - ALBUMIN (HUMAN) SOLUTION
GRIFOLS USA, LLC
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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