מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Factor VIII inhibitor bypassing fraction 2500 U; ;
Takeda New Zealand Limited
Factor VIII inhibitor bypassing fraction 2500 U
2500 U
Powder for injection with diluent
Active: Factor VIII inhibitor bypassing fraction 2500 U Excipient: Sodium chloride Sodium citrate dihydrate Water for injection
Combination pack, FEIBA + diluent, 50 mL
General sale
General sale
Baxter Manufacturing SpA
FEIBA NF is indicated for treatment of haemorrhage and to cover surgical interventions in: · Haemophilia A patients with Factor VIII inhibitors · Haemophilia B patients with Factor IX inhibitors. FEIBA NF is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia A subjects with inhibitors experiencing >/= 12 bleeding episodes per year. Prophylaxis with FEIBA NF is recommended for patients with high titer (>5BU) inhibitor or low titer (<5 BU) inhibitor, refractory to increased dosing with FVIII or FIX.
Package - Contents - Shelf Life: Combination pack, FEIBA + diluent - 50 mL - 24 months from date of manufacture stored at or below 25°C protect from light. do not freeze 3 hours reconstituted stored at or below 25°C - Vial, glass, Diluent WFI - 50 mL - 36 months from date of manufacture stored at or below 25°C. do not freeze - Vial, glass, FEIBA - 2500 U - 24 months from date of manufacture stored at or below 25°C protect from light 3 hours reconstituted stored at or below 25°C
2010-07-20
FEIBA-NF V2.0 1 FEIBA ® NF _Factor VIII inhibitor bypassing fraction powder for injection with diluent vials (500, 1000, 2500 U/vial) _ NEW ZEALAND 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 of bleeding in haemophilia A and B patients who have developed inhibitors (antibodies) against coagulation factor VIII (FVIII), and factor IX (FIX) respectively. FEIBA NF may also be used for treating non-haemophiliacs with acquired inhibitors to factors VIII, XI and XII in case of severe or life threatening haemorrhages. FEIBA NF is also used to prevent or reduce the frequency of bleeding episodes in haemophilia A patients who have developed inhibitors and who experience 12 or more bleeding episodes per year. 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 beco קרא את המסמך השלם
NEW ZEALAND DATA SHEET FEIBA NF Data Sheet V3.0 CCDSv3 Page 1 1 PRODUCT NAME FEIBA NF 500 U injection with diluent FEIBA NF 1000 U injection with diluent FEIBA NF 2500 U injection with diluent 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Factor VIII inhibitor bypassing fraction 500 U, 1000 U and 2500 U. FEIBA NF contains a complex of coagulation factors. The potency of FEIBA NF is expressed in arbitrary units of factor FVIII 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 (FVIII) inhibitor reference plasma to 50% of the blank value. 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). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Injection with diluent. FEIBA NF is formulated as a sterile, nonpyrogenic, off-white, lyophilised powder, for intravenous injection after reconstitution with the water for injection diluent provided. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications On-demand and surgery indication FEIBA NF is indicated for treatment of haemorrhage and to cover surgical interventions in: • Haemophilia A patients with FVIII inhibitor • Haemophilia B patients with FIX inhibitor FEIBA NF was also used in combination with Factor VIII concentrate for a continual long term therapy to achieve a complete and permanent elimination of the FVIII inhibitor so as to allow for regular treatment with FVIII concentrate as in patients without inhibitor. In addition, FEIBA NF may be used for treating non-haemophiliacs with acquired inhi קרא את המסמך השלם