FLEXBUMIN 25% ALBUMIN (HUMAN) USP 25% SOLUTION

Negara: Malaysia

Bahasa: Inggris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Albumin (human), USP

Tersedia dari:

Takeda Malaysia Sdn Bhd

INN (Nama Internasional):

Albumin (human), USP

Unit dalam paket:

50ml mL; 100ml mL

Diproduksi oleh:

Baxalta US Inc

Selebaran informasi

Not Applicable

Karakteristik produk

SHIRE TAKEDA
FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution in GALAXY Single
Dose Container
FULL PRESCRIBING INFORMATION
DESCRIPTION
FLEXBUMIN 25% in 50 and 100 mL GALAXY plastic container is a sterile,
nonpyrogenic preparation
of albumin in a single dosage form for intravenous administration.
Each 100 ml contains 25 g of albumin
and was prepared from human venous plasma using the Cohn cold ethanol
fractionation process. Source
material for fractionation may be obtained from another U.S. licensed
manufacturer. It has been adjusted
to physiological pH with sodium bicarbonate and/or sodium hydroxide
and stabilized with N-
acetyltryptophan (0.02 M) and sodium caprylate (0.02 M). The sodium
content is 145 ± 15 mEq/L. This
solution contains no preservative and none of the coagulation factors
found in fresh whole blood or
plasma. FLEXBUMIN 25% is a transparent or slightly opalescent solution
which may have a greenish
tint or may vary from a pale straw to an amber color.
The likelihood of the presence of viable hepatitis viruses has been
minimized by testing the plasma at
three stages for the presence of hepatitis viruses, by fractionation
steps with demonstrated virus removal
capacity and by heating the product for 10 hours at 60°C.
This procedure has been shown to be an effective method of
inactivating hepatitis virus in albumin
solutions even when those solutions were prepared from plasma known to
be infective.
The GALAXY plastic container is fabricated from a specially designed
multilayered plastic (PL 2501).
Solutions are in contact with the polyethylene layer of the container
and can leach out certain chemical
components of the plastic in very small amounts within the expiration
period. The suitability and safety
of the plastic have been confirmed in tests in animals according to
the USP biological tests for plastic
containers, as well as by tissue culture toxicity studies.
CLINICAL PHARMACOLOGY
Albumin is responsible for 70-80% of the colloid osmotic pressure of
normal plasma, thus making it
useful in regula