Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
Von willebrand factor, Quantity: 1200 IU; Factor VIII, Quantity: 500 IU
CSL Behring Australia Pty Ltd
Factor VIII,Von willebrand factor
Injection, diluent for
Excipient Ingredients:
Intravenous
Glass vial containing 500 IU FVIII, 1200 IU vWF supplied with 1 x 5mL diluent vial
exempt from scheduling - Appendix A; prescription medicine
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.
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
Registered
2009-03-02
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 Läs hela dokumentet
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 Läs hela dokumentet