BUMINATE 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:

Baxalta US Inc.

INN (International Name):

ALBUMIN HUMAN

Composition:

ALBUMIN HUMAN 0.25 g in 1 mL

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

BUMINATE- ALBUMIN HUMAN INJECTION, SOLUTION
BAXALTA US INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUMINATE 25% SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR BUMINATE 25%.
BUMINATE 25% ALBUMIN (HUMAN), USP, 25% SOLUTION
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
BUMINATE 25%, Albumin (Human) Solution is indicated for:
Hypovolemia (1.1)
Hypoalbuminemia: Burns, Adult Respiratory Distress Syndrome (ARDS) and
Nephrosis (1.2)
Cardiopulmonary Bypass Surgery (1.3)
Hemolytic Disease of the Newborn (HDN) (1.4)
Limitations of Use: Albumin is not indicated as an intravenous
nutrient.(1.5)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY
Adjust dose and rate of infusion based on the patient's clinical
status. (2.1)
Do not exceed 2 g of albumin per kg body weight for the daily dose.
(2.1)
Do not exceed 1 mL/min for patients with normal blood volume. (2.1)
Do not dilute with Sterile Water for Injection. (2.2)
INDIC ATIO N
DO SE
Hypovolemic Shock
Infants and young children: 2.5 to 5 mL per kg body weight.
Older children and adults: initial dose 100 to 200 mL.
Repeat after 15 to 30 minutes if the response is not adequate.
Hypoalbumine mia
Calculate the body albumin compartment to be 80 to 100 mL per kg body
weight. Do not exceed a daily dose of 2 g of albumin per kg of body
weight.
Burns:
The dosage should be determined according to the patient's condition
and
response to treatment after the first 24 hours.
Hemolytic Disease of the
Newborn
1 g per kg body weight prior to or during exchange transfusion.
DOSAGE FORMS AND STRENGTHS
BUMINATE 25% is a solution containing 25 g of albumin per each 100 mL.
(3)
CONTRAINDICATIONS
History of hypersensitivity reaction to albumin preparations or to any
of the excipients (N-acetyltryptophan and sodium
caprylate). (4)
Severe anemia or cardiac failure with normal or increased
intravascular volume. (4)
Do not administer to patients with chronic renal insufficiencies due
to the