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 Pharmazeutika Produktionsgesellschaft m.b.H.

INN (International Name):

ALBUMIN - UNII:ZIF514RVZR)

Composition:

ALBUMIN (HUMAN) 50 g in 1000 mL

Administration route:

Intravenous

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ALBUMIN (HUMAN) 5% 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] ALBUMIN (HUMAN) 5% should be used when hydration is not adequate. 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) 5% infusions may be indicated.[ 3 ] When albumin deficit is the result of excessive protein loss, the effect of administration of ALBUMIN (HUMAN) 5% will be temporary unless the underlying disorder is reversed. ALBUMIN (HUMAN) 5% may be used to maintain cardiovascular fu

Product summary:

ALBUMIN (HUMAN) 5% is supplied in 5.0 g in 100 mL, 12.5 g in 250 mL or 25.0 g in 500 mL single use bottles. Octapharma Pharmazeutika Produktionsges.m.b.H Octapharma AB 67467-623-01 68209-623-01 100 ml 5.0 67467-623-02 68209-623-02 250 ml 12.5 67467-623-03 68209-623-03 500 ml 25.0 ALBUMIN (HUMAN) 5% 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 PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALBUMIN (HUMAN) 5% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALBUMIN (HUMAN) 5%.
ALBUMIN (HUMAN) 5%
FOR INTRAVENOUS USE ONLY
5% SOLUTION
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
•ALBUMIN (HUMAN) 5% is indicated for the restoration and maintenance
of circulating blood volume for: (1)
•Hypovolemia. (1.1) (1)
•Hypoalbuminemia. (1.2) (1)
•Prevention of central volume depletion after paracentesis due to
cirrhotic ascites. (1.3) (1)
DOSAGE AND ADMINISTRATION
•Intravenous use only. (2)
•Daily dose should not exceed 2 g per kg body weight. (2.1) (2)
• (2)
INDIC ATIO N
DO SE
Hypovolemia (2)
Adults: 25 g (2.1) (2)
Children: (less than 13 years) 2.5 to 1.25 g (2.1) (2)
Hypoalbuminemia (2)
Adults: 50 to 75 g (2.1) (2)
Prevention of volume depletion after paracentesis (2) Adults: 8 g for
every 1,000 mL of ascitic fluid removed (2.1) (2)
•Do not dilute with sterile water for injection as this may cause
hemolysis in recipients. (5.6) (2)
•Store protected from light. (16) (2)
•Do not freeze. (16) (2)
•If large volumes (greater than 1500 ml) are administered, warm the
product to room temperature before use. (2.2) (2)
•Bottles are for single use only. (2.2) (2)
DOSAGE FORMS AND STRENGTHS
• 5.0 g in 100 mL infusion bottle (3) (3)
• 12.5 g in 250 mL infusion bottle (3) (3)
• 25.0 g in 500 mL infusion bottle (3) (3)
• (3)
CONTRAINDICATIONS
• Do not use in individuals who are hypersensitive to albumin
preparations, any ingredient in the formulation, or
components of the container. (4) (4)
WARNINGS AND PRECAUTIONS
•Hypersensitivity or allergic reactions have been observed, and may
in some cases progress to severe anaphylaxis.
Epinephrine should be available immediately to treat any acute
hypersensitivity reaction. (5.1) (5)
•Hypervolemia: Use with caution in patie