The information below is relevant in Australia.
Human coagulation factor VIII / von Willebrand factor concentrate (FVIII/VWF concentrate), powder for injection
For more information about BIOSTATE, please visit the
Australian Red Cross Blood Servicewebsite.
For information about haemophilia care in Australia, visit the
Haemophilia Foundation Australia website.
For information on how to prepare BIOSTATE using the Mix2Vial™
BIOSTATE is a freeze-dried preparation containing human coagulation factor VIII / von Willebrand factor complex. Factor VIII (FVIII) and von Willebrand factor (VWF) are essential proteins for normal blood clotting.
BIOSTATE is used to
- replace FVIII in people with haemophilia A, a bleeding disorder in which there are reduced levels of FVIII.
- replace VWF in people with von Willebrand disorder, a bleeding disorder in which there are reduced levels of VWF.
People with low levels of FVIII or VWF may have difficulty forming blood clots, and these clots may take longer to form. Sometimes, people with low levels of FVIII or VWF may bleed spontaneously (e.g. with nose bleeds or bruising) or may be at risk of prolonged bleed after surgery or dental work. Some people with very low level of FVIII or VWF may bleed spontaneously into their joints or muscles.
BIOSTATE is supplied as a freeze-dried powder which is dissolved with Water for Injections and then injected into a vein. Each vial of BIOSTATE is packaged with one vial of Water for Injections and a plastic Mix2Vial™ filter transfer set that is used to transfer the Water for Injections into the BIOSTATE vial.
BIOSTATE is only available with a doctor’s prescription.
Who is this information for?
This information is relevant in Australia and is intended for healthcare professionals or people who have been prescribed this product.
Consumer Medicine Information
The Consumer Medicine Information is a leaflet written for people who have been prescribed this product, and contains information about:
- What BIOSTATE is used for
- How to use BIOSTATE
- Unwanted effects
- Further Information
BIOSTATE Consumer Medicine Information (PDF, 0.141MB)
Product Information contains information to ensure the safe and effective use of a medicine. This document is approved by the Therapeutic Goods Administration (TGA) and made available by CSL for you if you are a:
- qualified healthcare professional; or
- person who has been prescribed this product and who agrees to consult with your healthcare professional if you have any questions in relation to the Product Information.
BIOSTATE Product Information (PDF, 0.161MB)® BIOSTATE is a Registered Trademark of CSL Limited
™ Mix2Vial is a trade mark of West Pharmaceuticals, Inc. or a subsidiary thereof
Date of preparation: February 2013
Last Updated: 02/11/2016