FLEXBUMIN 20% ALBUMIN (HUMAN) USP20% SOLUTION

Riik: Malaisia

keel: inglise

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

Toimeaine:

Albumin (human), USP

Saadav alates:

Takeda Malaysia Sdn Bhd

INN (Rahvusvaheline Nimetus):

Albumin (human), USP

Ühikuid pakis:

50ml mL; 100ml mL

Valmistatud:

Baxalta US Inc

Infovoldik

Not Applicable

Toote omadused

SHIRETAKEDA
FLEXBUMIN 20%, Albumin (Human), USP, 20% Solution in GALAXY Single
Dose Container
FULL PRESCRIBING INFORMATION
DESCRIPTION
FLEXBUMIN 20% 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 20 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 (0.016 M) and sodium caprylate (0.016 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 20% 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