BIOSTATE FOR INJECTION 50 iuml

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

COAGULATION FACTOR VIII (HUMAN) (FREEZE-DRIED); VON WILLEBRAND FACTOR

Beschikbaar vanaf:

BLOOD SERVICES GROUP, HEALTH SCIENCES AUTHORITY

ATC-code:

B02BD02

Dosering:

50 iu/mL

farmaceutische vorm:

INJECTION, POWDER, FOR SOLUTION

Samenstelling:

COAGULATION FACTOR VIII (HUMAN) (FREEZE-DRIED) 50 iu/mL; VON WILLEBRAND FACTOR 100 iu/mL

Toedieningsweg:

INTRAVENOUS

Prescription-type:

Prescription Only

Geproduceerd door:

CSL Behring (Australia) Pty Ltd

Autorisatie-status:

ACTIVE

Autorisatie datum:

2003-01-31

Bijsluiter

BIOSTATE_SG_PI_8.03  
PAGE 
1 OF 9 

BIOSTATE
® 

SINGAPORE 

NAME OF THE MEDICINE 

Human coagulation factor VIII and human von Willebrand factor complex,
powder for injection. 

DESCRIPTION 
Biostate
®
 is a high purity, sterile, powder for injection containing a human
coagulation factor VIII 
(FVIII) and human von Willebrand factor (VWF) complex.  Biostate
®
 is manufactured from plasma 
donated by Singapore’s voluntary and non-remunerated donors.
 It is intended for intravenous 
administration.  The FVIII/VWF complex in Biostate
®
 is purified from cryoprecipitate using selective 
precipitation and size exclusion chromatography steps.  The Biostate
®
 manufacturing process includes 
solvent detergent (tributyl phosphate and polysorbate 80) and
dry heat treatment (80°C for 72 hours) 
steps to reduce the potential for viral transmission.  The solvent
detergent, dry heat treatment, and 
partitioning steps used in the manufacture of Biostate
®
 have been demonstrated to be effective virus 
inactivation/removal steps _in vitro_ for the relevant viruses,
human immunodeficiency virus (HIV) and 
hepatitis A virus (HAV), and also with model viruses for hepatitis B
(HBV) and hepatitis C viruses 
(HCV).  The manufacturing process also contributes to
inactivation/removal of human parvovirus B19 
(B19). 
Human albumin is added to Biostate
®
 as a stabiliser.  Measured prior to the addition of albumin, the 
specific activity of Biostate
®
 is nominally 50 FVIII:C IU/mg of total protein.  Biostate
®
 contains other 
proteins such as fibrinogen, fibronectin, immunoglobulins (IgA, IgM,
IgG) and transforming growth 
factor β (TGF-β), 
all of which are present at significantly lower levels than in normal
plasma.  
When expressed as per mg clottable protein (fibrinogen), the specific
activity of the final product is 
nominally 300 IU VWF:RCo/mg and 150 IU FVIII:C/mg, based on the
Biostate
®
 VWF to FVIII ratio of 
2:1. 
Biostate
®
 i

Productkenmerken

Biostate SG PI 10.05b
Page 1 of 15
BIOSTATE
®
SINGAPORE
NAME OF THE MEDICINE
Human coagulation factor VIII and human von Willebrand factor complex,
powder for
injection.
DESCRIPTION
Biostate
®
is a high purity, sterile, powder for injection containing a human
coagulation factor
VIII (FVIII) and human von Willebrand factor (VWF) complex. Biostate
®
is manufactured
from plasma donated by Singapore’s voluntary and non-remunerated
donors. It is intended
for intravenous administration. The FVIII/VWF complex in Biostate
®
is purified from
cryoprecipitate using selective precipitation and size exclusion
chromatography steps. The
Biostate
®
manufacturing process includes solvent detergent (tributyl phosphate
and
polysorbate 80) and dry heat treatment (80°C for 72 hours) steps to
reduce the potential for
viral transmission. The solvent detergent, dry heat treatment, and
partitioning steps used in
the manufacture of Biostate
®
have been demonstrated to be effective virus
inactivation/removal steps
_in vitro_
for the relevant viruses, human immunodeficiency virus
(HIV) and hepatitis A virus (HAV), and also with model viruses for
hepatitis B (HBV) and
hepatitis C viruses (HCV). The manufacturing process also contributes
to
inactivation/removal of human parvovirus B19 (B19).
VON WILLEBRAND FACTOR (VWF)
Following reconstitution, 1 mL of Biostate
®
contains:
•
Biostate
®
50 IU FVIII/mL: approximately 100 IU of human plasma derived VWF
The VWF activity of Biostate
®
is determined using a VWF to platelet glycoprotein Ib binding
activity assay (VWF:Ac). The VWF activity is expressed as
international units (IU) and 1 IU
VWF:Ac is equivalent to 1 IU VWF ristocetin cofactor (VWF:RCo) in
accordance with the
WHO standard. The specific VWF activity of the product prior to the
addition of human
albumin as a stabiliser is approximately 100 IU of VWF/mg protein.
Biostate SG PI 10.05b
Page 2 of 15
FACTOR VIII (FVIII)
Following reconstitution, 1 mL of Biostate
®
contains:
•
Biostate
®
50 IU FVIII/mL: approximately 50 IU of