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

INN (International Name):

Albumin Human

Composition:

Albumin Human 12.5 g in 50 mL

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® 25% can be used in such cases.1 Human Albumin Grifols 25% 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 25% 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 25% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. When

Product summary:

Human Albumin Grifols 25% is supplied in single-use, individually laser etched vials. The following vial sizes of Human Albumin Grifols 25% are available: 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 25% is stable for three years provided the storage temperature does not exceed 30 ºC. 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
25% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HUMAN
ALBUMIN GRIFOLS 25%.
HUMAN ALBUMIN GRIFOLS 25%
ALBUMIN (HUMAN) U.S.P.
25% SOLUTION
INITIAL U.S. APPROVAL: 2003
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 25% 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 25 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 hypop