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

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 loss, the effect of ALBUTEIN 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 ALBUTEIN 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, ALBUTEIN 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 ALBUTEIN 20% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.16,17 ALBUTEIN 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 ALBUTEIN 20% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ARDS.6,21 ALBUTEIN 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. Risk Summary   There is no data with ALBUTEIN 20% use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ALBUTEIN 20%. It is not known whether ALBUTEIN 20% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ALBUTEIN 20% should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary There is no information regarding the presence of ALBUTEIN 20% in human milk, the effect on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ALBUTEIN 20% and any potential adverse effects on the breastfed infant from ALBUTEIN 20%. No human or animal data.  Use only if clearly needed.  No human or animal data.  Use only if clearly needed. 

Product summary:

ALBUTEIN FlexBag 20% is supplied in single-dose, latex-free, flexible container, free of polyvinyl chloride (PVC), diethylhexyl phthalate (DEHP), or other plasticizers. The protective overwrap is also latex-free, and contains no chloride, PVC or plasticizers.  Each unit is individually laser-etched with at least the lot number and expiration date. ALBUTEIN FlexBag 20% is available in a singlepack of 1 FlexBag/carton: Storage ALBUTEIN FlexBag 20%, in flexible container, is stable for two years provided the storage temperature does not exceed 30 °C.  Protect from freezing. Keep the overwrap intact.

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 FLEXBAG 20%
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALBUTEIN
FLEXBAG 20%.
ALBUTEIN FLEXBAG 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