FLEXBUMIN- 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:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

ALBUMIN HUMAN

Composition:

ALBUMIN HUMAN 0.05 g in 1 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

FLEXBUMIN 5% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia and cardiopulmonary bypass surgery. FLEXBUMIN 5% [Albumin (Human)] is indicated for reversing hypovolemia. When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 25% albumin should be used.4,6 FLEXBUMIN 5% is indicated for patients with hypoalbuminemia resulting from one or more of the following:5 FLEXBUMIN 5% is indicated for patients with hypoalbuminemia accompanying severe injuries, infections or severe pancreatitis that cannot be quickly reversed and nutritional supplements fail to restore serum albumin levels. Burns After the first 24 hours, FLEXBUMIN 5% is indicated in conjunction with appropriate crystalloid therapy, for the treatment of oncotic deficits following extensive burns and to replace protein loss which accompanies any severe burn.4,6 Preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass surgery. FLEXBUMIN 5% is indicated a

Product summary:

FLEXBUMIN 5% is supplied in a single-dose plastic container: Storage Room temperature: not to exceed 25°C (77°F). Protect from freezing.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FLEXBUMIN- ALBUMIN HUMAN INJECTION, SOLUTION
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLEXBUMIN 5% SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLEXBUMIN 5%.
FLEXBUMIN 5% ALBUMIN (HUMAN), USP, 5% SOLUTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
FLEXBUMIN 5%, Albumin (Human) Solution is indicated for:
Hypovolemia (1.1)
Hypoalbuminemia: Burns (1.2)
Cardiopulmonary Bypass Surgery (1.3)
Limitations of Use: Albumin is not indicated as an intravenous
nutrient. (1.4)
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)
INDICATION
DOSE
Hypovolemic Shock
Infants and young children: 12 to 20 mL per kg body weight.
Older children and adults: initial dose 250 to 500 mL.
Repeat after 15 to 30 minutes if the response is not adequate.
Hypoalbuminemia
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.
DOSAGE FORMS AND STRENGTHS
FLEXBUMIN 5% is a solution containing 5 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)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions (including anaphylactic reactions) have
been observed. If hypersensitivity
reaction is suspected, discontinue use and implement appropriate
standard medical treatment. (5.1)
Under conditions where hypervol