Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
Factor VIII inhibitor bypassing fraction, Quantity: 500 U
Takeda Pharmaceuticals Australia Pty Ltd
Factor VIII inhibitor bypassing fraction
Injection, powder for
Excipient Ingredients: sodium citrate dihydrate; sodium chloride
Intravenous
1 vial powder for injection, 1 x 10mL diluent vial, 1 x 20mL diluent vial
exempt from scheduling - Appendix A; prescription medicine
FEIBA-NF is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia A or B patients with inhibitors.
Visual Identification: White to off-white powder or friable mass, free from foreign particles and visible evidence of contamination.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2007-01-09
FEIBA ® NF _Factor VIII inhibitor bypassing fraction powder for injection with diluent vials (500, 1000, 2500 U/vial)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START USING FEIBA NF. This leaflet answers some common questions about the FEIBA NF. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks against the benefits of using FEIBA NF for you. IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. WHAT FEIBA NF IS USED FOR FEIBA NF is used for the treatment and prevention of bleeding in haemophilia A and B patients who have developed inhibitors (antibodies) against coagulation factor VIII (FVIII), and factor IX (FIX) respectively. It is possible that your doctor may give you FEIBA NF for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY YOU ARE BEING GIVEN FEIBA NF. _HOW DOES FEIBA NF WORK_ Under normal physiological conditions, FVIII and FIX are essential for blood clotting and therefore the control of bleeding. Individuals with haemophilia A have decreased FVIII in their blood circulation, and individuals with haemophilia B have decreased levels of FIX. These deficiencies may lead to heavy bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. Some haemophilia A and haemophilia B patients develop antibodies against FVIII and FIX, respectively, in the course of their treatment, leading to replacement therapy becoming ineffective. In patients with acquired haemophilia (non-haemophiliacs), some of these coagulation factors are not working properly because the patient has developed antibodies to his/her own coagulation factors. FVIII and FIX replacement therapy have been successfully used for the treatment of haemophilia A and haemophilia B as well as non- haemophiliacs. FEIBA Perskaitykite visą dokumentą
FEIBA NF PI V1.0 CCSI20920180202 Page 1 AUSTRALIAN PRODUCT INFORMATION FEIBA NF ® (FACTOR VIII INHIBITOR BYPASSING FRACTION) 1 NAME OF THE MEDICINE Factor VIII inhibitor bypassing fraction 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DESCRIPTION FEIBA NF is a sterile lyophilised powder containing a complex of coagulation Factors. It is intended for intravenous administration after reconstitution. The potency of FEIBA NF is expressed in arbitrary units of factor VIII bypassing activity. One Unit of activity is defined as that amount of FEIBA NF that shortens the activated partial thromboplastin time (aPTT) of a high titre Factor VIII inhibitor reference plasma to 50% of the blank value. FEIBA NF contains Factors II, IX and X, mainly non-activated, and Factor VII mainly in the activated form. In addition, 1-6 units of Factor VIII coagulation antigen (FVIII C: Ag) per mL are present. FEIBA NF is prepared from pooled human plasma. During manufacture, the product is subjected to two dedicated viral inactivation steps – vapour heat treatment and nanofiltration. FEIBA NF is available in three strengths with each vial containing 500 U, 1000 U or 2500 U of factor VIII bypassing activity as contained in human plasma protein. Following reconstitution with the diluent vial provided, the FEIBA activity in each vial is: 50 FEIBA units/mL (2500 U/50 mL, 1000 U/20 mL and 500 U/10 mL) or 25 FEIBA units/mL (500 U/20 mL). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Powder and diluent for injection APPEARANCE FEIBA NF is formulated as a sterile, nonpyrogenic, off-white, lyophilised powder, for intravenous injection. It is supplied in single-dose glass vials. Each FEIBA NF 500 U pack contains: - 1 powder vial of 500 FEIBA-units as contained in 200-600 mg human plasma protein - 1 diluent vial of either 10 mL or 20 mL water for injections - 1 BAXJECT II Hi-Flow – Needleless transfer device intended for transferring and mixing drugs contained in two vials into a syringe. FEIBA NF PI V1.0 Perskaitykite visą dokumentą