ALBUMIN (HUMAN)- 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:

Octapharma USA Inc

INN (International Name):

ALBUMIN - UNII:ZIF514RVZR)

Composition:

ALBUMIN (HUMAN) 200 g in 1000 mL

Administration route:

Intravenous

Therapeutic indications:

ALBUMIN (HUMAN) 20% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [ 1 , 2 ] When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [ 1 ] For subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, ALBUMIN (HUMAN) 20% infusions may be indicated. [ 3 ] When albumin deficit is the result of excessive protein loss, the effect of administration of ALBUMIN (HUMAN) 20% will be temporary unless the underlying disorder is reversed. ALBUMIN (HUMAN) 20% may be used to maintain cardiovascular function following the removal of large volumes of ascitic f

Product summary:

ALBUMIN (HUMAN) 20% is supplied in 10 g in 50 mL or 20 g in 100 mL single use bottles. ALBUMIN (HUMAN) 20% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Store protected from light. Do not freeze. Do not use after expiration date. Do not use if turbid.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ALBUMIN (HUMAN)- ALBUMIN HUMAN SOLUTION
OCTAPHARMA USA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALBUMIN (HUMAN) 20% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALBUMIN (HUMAN) 20%.
ALBUMIN (HUMAN) 20% FOR INFUSION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
ALBUMIN (HUMAN) 20% is indicated for the restoration and maintenance
of circulating blood volume for:
• Hypovolemia. ( 1.1 )
• Hypoalbuminemia. ( 1.2 )
• Prevention of central volume depletion after paracentesis due to
cirrhotic ascites. ( 1.3 )
• Ovarian hyperstimulation syndrome (OHSS). ( 1.4 )
• Adult respiratory distress syndrome (ARDS). ( 1.5 )
• Acute nephrosis. ( 1.6 )
• Hemolytic Disease of the Newborn (HDN). ( 1.7 )
DOSAGE AND ADMINISTRATION
• Intravenous use only.
• Daily dose should not exceed 2 g per kg body weight. ( 2.1 )
INDIC ATIO N
DO SE
Hypovole mia
Adults: 25 g (2.1)
Children (less than 13 years): 2.5 to 1.25 g (2.1)
Hypoalbumine mia
Adults: 50 to 75 g (2.1)
Prevention of volume depletion after
parace nte sis
Adults: 8 g for every 1,000 mL of ascitic fluid removed (2.1)
Ovarian hyperstimulation syndrome
Adults: 50 to 100 g over 4 hours and repeated at 4-12 hour intervals
as
necessary (2.1)
Adult respiratory distress syndrome
Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if
necessary
(2.1)
Acute nephrosis
Adults: 25 g together with diuretic once a day for 7-10 days (2.1)
Hemolytic Disease of the Newborn
1 g per kilogram body weight prior or during exchange transfusion
(2.1)
• Do not dilute with sterile water for injection as this may cause
hemolysis in recipients. ( 5.6 )
• Store protected from light. ( 16 )
• Do not freeze. ( 16 )
• If large volumes (> 1500 ml) are administered, warm the product to
room temperature before use. ( 2.2 )
• Bottles are for single use only. ( 2.2 )
DOSAGE FORMS AND STRENGTHS
• 10 g in 50 mL infusion bottle ( 3 )
• 20 g in 100 mL infusion bottl