Country: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Factor VIII inhibitor bypassing fraction 500 U; ;
Takeda New Zealand Limited
Factor VIII inhibitor bypassing fraction 500 U
500 U
Powder for injection with diluent
Active: Factor VIII inhibitor bypassing fraction 500 U Excipient: Sodium chloride Sodium citrate dihydrate Water for injection
Combination pack, FEIBA + diluent, 20 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 - 10 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. do not freeze - Vial, glass, diluent - WFI - 10 mL - 48 months from date of manufacture stored at or below 25°C. do not freeze - Vial, glass, FEIBA - 500 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. do not freeze
2000-12-08
FEIBA NF ® F E I B A ® N F v 1 . 0 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING FEIBA NF? FEIBA NF contains the active ingredient factor VIII inhibitor bypassing fraction. FEIBA NF is used to treat and prevent bleeding in patients with haemophilia A and B who have developed inhibitors (antibodies) against coagulation factor VIII and factor IX, respectively. For more information, see Section 1. Why am I using FEIBA NF? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE FEIBA NF? Do not use if you are allergic to FEIBA NF or any of the ingredients listed at the end of the CMI. Do not use if you are suffering from a blood clotting condition called Disseminated Intravascular Coagulation. Talk to your doctor if you have or have had any other medical conditions, if you take any other medicines, if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed. If you are taking a medicine called emicizumab, it is very important you talk to your doctor before using FEIBA NF. For more information, see Section 2. What should I know before I use FEIBA NF? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with FEIBA NF and how it works. Tell your doctor or Haemophilia Treatment Centre if you are taking or using any other medicines including any that you get without a prescription from your pharmacy, supermarket, or health food shop. For more information, see Section 3. What if I am taking other medicines? in the full CMI. 4. HOW WILL I BE GIVEN FEIBA NF? • FEIBA NF injection is prepared and administered by a qualified healthcare professional who is experienced in the care of patients with haemophilia. • Your dose of FEIBA NF is dependent on your condition and body weight, and your dose may change during treatment. • The frequency of your infusions will depend on how well FEIBA NF is working for you. • F Прочитајте комплетан документ
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 Прочитајте комплетан документ