BIOSTATE human coagulation factor VIII 1000IU/ von Willebrand factor 2400IU powder for injection vial with diluent vial

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

Factor VIII, Quantity: 1000 IU; Von willebrand factor, Quantity: 2400 IU

Boleh didapati daripada:

CSL Behring Australia Pty Ltd

INN (Nama Antarabangsa):

Factor VIII,Von willebrand factor

Borang farmaseutikal:

Injection, diluent for

Komposisi:

Excipient Ingredients:

Laluan pentadbiran:

Intravenous

Unit dalam pakej:

Glass vial containing 1000 IU FVIII, 2400 IU vWF supplied with 1 x 10 mL diluent vial

Jenis preskripsi:

exempt from scheduling - Appendix A; prescription medicine

Tanda-tanda terapeutik:

The prophylaxis and treatment of non-surgical and surgical bleeding in patients with von Willebrand disease when desmopressin (DDAVP) treatment is ineffective or contraindicated. The prophylaxis and treatment of non-surgical and surgical bleeding associated with factor VIII deficiency due to haemophilia A.

Ringkasan produk:

Visual Identification: Clear and colourless; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2009-03-02

Risalah maklumat

Biostate AU CMI 26.00
Page 1 of 6
BIOSTATE
®
Human coagulation factor VIII (FVIII) and human von Willebrand factor
(VWF) complex,
powder and diluent for solution for injection.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Biostate
®
. It does not contain
complete information about
Biostate
®
.
It does not take the place of
talking to your doctor.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
PLEASE TALK TO YOUR DOCTOR.
FOLLOW YOUR DOCTOR’S ADVICE
EVEN IF IT IS DIFFERENT FROM
WHAT THIS LEAFLET SAYS.
PLEASE READ THIS LEAFLET
CAREFULLY AND KEEP IT FOR
FUTURE REFERENCE.
The information in this leaflet is
subject to change. Please check
with your Haemophilia
Treatment Centre if there is any
new information about this
medicine that you should know
since you were last treated.
WHAT BIOSTATE
®
IS
USED FOR
Biostate
®
contains FVIII and
VWF in a purified and
concentrated form. Both FVIII
and VWF are blood proteins that
are essential for normal blood
clotting.
Biostate
®
is used in patients
with von Willebrand Disease
(VWD), a bleeding disorder
resulting from low levels of
VWF or abnormal VWF.
Individuals with VWD tend to
take longer than normal to form
blood clots, and tend to bleed
from the skin and mucous
membranes such as the nose,
mouth and intestines. Because
VWF provides stability for the
fragile FVIII protein in the
blood, patients with VWD may
also have low FVIII levels.
Biostate
®
is also used in patients
with haemophilia A, a bleeding
disorder, in which there are low
levels of FVIII or abnormal
FVIII. Individuals with low
levels or abnormal FVIII have
difficulty in forming blood clots,
with these clots often taking
longer than normal to be made.
Sometimes the individual may
bleed unexpectedly into their
joints, muscles or internal
organs.
ASK YOUR HAEMOPHILIA
TREATMENT CENTRE IF YOU HAVE
ANY QUESTIONS ABOUT WHY
BIOSTATE
®
HAS BEEN PRESCRIBED
FOR YOU.
BEFORE YOU ARE GIVEN
BIOSTATE
®
TELL YOUR DOCTOR IF YOU:

have allergies to any
medicin

Ciri produk

Biostate AU PI 30.00
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
BIOSTATE
®
(HUMAN COAGULATION FACTOR VIII AND HUMAN VON WILLEBRAND FACTOR
COMPLEX)
POWDER AND DILUENT FOR SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Human coagulation factor VIII and human von Willebrand factor complex.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 human plasma collected by Australian Red Cross Lifeblood. The
FVIII/VWF complex
in Biostate
®
is purified from cryoprecipitate using selective precipitation and
size exclusion
chromatography steps.
VON WILLEBRAND FACTOR (VWF)
Following reconstitution, 1 mL of Biostate
®
contains:

Biostate
®
50 IU FVIII/mL: approximately 120 IU of human plasma derived VWF

Biostate
®
100 IU FVIII/mL: approximately 240 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.
FACTOR VIII (FVIII)
Following reconstitution, 1 mL of Biostate
®
contains:

Biostate
®
50 IU FVIII/mL: approximately 50 IU of human plasma-derived
coagulation
FVIII

Biostate
®
100 IU FVIII/mL: approximately 100 IU of human plasma-derived
coagulation
FVIII.
The FVIII potency (IU) is determined using the European Pharmacopoeia
chromogenic assay.
The activity of FVIII is measured as FVIII coagulation activity
(FVIII:C). The specific FVIII
activity of Biostate
®
prior to the addition of human albumin as a stabiliser is
approximately
50 IU of FVIII/mg protein.
Biostate AU PI 30.00
Page 2 of 20
Biostate
®
contains other proteins such as fi