ALBUTEIN (albumin- human injection, 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 10 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. ALBUTEIN® 20% can be used in such cases.1 ALBUTEIN 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 ALBUTEIN 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 ALBUTEIN 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 lo

Product summary:

ALBUTEIN 20% is supplied in single-use, individually laser etched vials. The following vial sizes of ALBUTEIN 20% are available: NDC Number      Fill Size     Grams Protein 68516-5215-1       50 mL            10 g 68516-5215-2       100 mL          20 g Each vial size label incorporates integrated hangers. Each label has a peel-off strip showing the product name and lot number. ALBUTEIN 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

ALBUTEIN- ALBUMIN (HUMAN) INJECTION, SOLUTION
GRIFOLS USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALBUTEIN 20% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALBUTEIN 20%.
ALBUTEIN 20% (ALBUMIN [HUMAN] U.S.P.)
20% SOLUTION
INITIAL U.S. APPROVAL: 1978
INDICATIONS AND USAGE
ALBUTEIN 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)
Ovarian hyperstimulation syndrome
Adults: 50 g to 100 g over 4 hours and repeated at 4-12
hour intervals as necessary. (2.1)
Neonatal hyperbilirubinemia
1 g per kilogram body weight prior to or during exchange
transfusion. (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)
Prevention of central volume depletion after
paracentesis due to cirrhotic ascites
Adults: 8 g for every 1000 mL of ascitic fluid removed. (2.1)
Do not dilute with sterile water for injection as this ma