Flexbumin 25% Albumin (Human) USP 25% Solution

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Albumin (Human)

Available from:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC code:

B05AA01

Dosage:

25 g/100 mL

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Albumin (Human) 25 g/100 mL

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Baxalta US Inc. (Bulk Production)

Authorization status:

ACTIVE

Authorization date:

2008-12-15

Patient Information leaflet

1
BAXTER 

FLEXBUMIN, ALBUMIN (HUMAN), USP SOLUTION 
in GALAXY SINGLE-DOSE CONTAINER 

DESCRIPTION 

FLEXBUMIN 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 (FLEXBUMIN 20%) or 25 g of albumin
(FLEXBUMIN 25%) 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 and sodium caprylate.  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, Albumin (Human), USP Solution 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.
1-3 

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 s

Summary of Product characteristics

1
SHIRE
FLEXBUMIN, ALBUMIN (HUMAN), USP SOLUTION
in
SINGLE-DOSE CONTAINER
DESCRIPTION
FLEXBUMIN in 50 and 100 mL 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 (FLEXBUMIN 20%) or 25 g of albumin (FLEXBUMIN 25%) 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 and sodium caprylate. 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, Albumin (Human), USP Solution 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.
1-3
The 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 regulati