FLEXBUMIN- albumin human solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ALBUMIN HUMAN (UNII: ZIF514RVZR) (ALBUMIN HUMAN - UNII:ZIF514RVZR)

Tersedia dari:

Takeda Pharmaceuticals America, Inc.

Rute administrasi :

INTRAVENOUS

Indikasi Terapi:

FLEXBUMIN 25% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia, cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN). FLEXBUMIN 25% [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 25% is indicated for patients with hypoalbuminemia resulting from one or more of the following:5 FLEXBUMIN 25% 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 25% is indicated, in conjunction with appropriate crystalloid therapy, for the treatment of oncotic deficits following extensive burns and to replace the protein loss which accompanies any severe burn.4,6 Adult Respiratory Distress Syndrome (ARDS) FLEXBUMIN 25% is indicated, in conjunctio

Ringkasan produk:

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

Status otorisasi:

Biologic Licensing Application

Karakteristik produk

FLEXBUMIN- ALBUMIN HUMAN 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 25% SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLEXBUMIN 25%.
FLEXBUMIN 25% ALBUMIN (HUMAN), USP, 25% SOLUTION,
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
FLEXBUMIN 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)
INDICATION
DOSE
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.
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.
Hemolytic Disease of the
Newborn
1 g per kg body weight prior to or during exchange transfusion.
DOSAGE FORMS AND STRENGTHS
FLEXBUMIN 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)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions (includin