药品英文名：BeneFix for Injection 500 IU/vial

商品中文名稱：賓凝適第九凝血因子凍晶注射劑
 
藥理分類：VIII. Hematological Agents
6. Agents Used in Hemophilia

常用劑量：Adults, unit required = BW(kg) × 1.2 IU/kg × desired factor IX increase (in % of normal).
Children < 15 yrs, unit required = BW(kg) × 1.4 IU/kg × desired factor IX increase (in % of normal).
 
衛生署許可證適應症：適用於控制與預防Ｂ型血友病（先天性第九凝血因子缺乏症，或稱聖誕節症）之出血，包括接受外科手術時的出血控制與預防出血。

懷孕分級：C

副作用：噁心、輸注部位不適、味覺改變、下頷骨與頭顱骨灼熱感、過敏性鼻炎、頭重腳輕、頭痛等。 

注意事項：Monitoring the factor IX activity (using the factor IX activity assay is advised) and the development of factor IX inhibitors.
 
儲存方法：2-8 °C.

生产厂家：美国惠氏（Wyeth Pharmaceuticals）

 
BeneFIX® Coagulation Factor IX (Recombinant)

Important: BENEFIX has been reformulated with a new, sterile saline diluent. Prescribing Information for this product is different for each formulation. Please contact Global Medical Communications at 1-800-934-5556 if you have a question about the new formulation.

Indication and Usage
BeneFIX is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings. BeneFIX is not indicated for the treatment of other factor deficiencies (eg, factors II, VII, VIII and X), nor the treatment of hemophilia A patients with inhibitors to factor VIII, nor the reversal of coumarin-induced anticoagulation, nor the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Important Safety Information
As with intravenous administration of any protein product, common adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, or tiredness.

BeneFIX may be contraindicated in patients with a known history of hypersensitivity to hamster protein.

Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products.  Patients should be informed of the early symptoms and signs of hypersensitivity reactions.  Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any hypersensitivity reactions occur.

BeneFIX is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.

INDICATIONS AND USAGE
BeneFIX®, Coagulation FactorIX (Recombinant), is indicated for the control and prevention of
hemorrhagic episodes in patients with hemophilia B (congenital factorIX deficiency or Christmas disease), including control andprevention of bleeding in surgical settings.
BeneFIX®, Coagulation FactorIX (Recombinant), is not indicated for the treatment of other factor deficiencies (e.g., factorsII, VII, VIII, andX), nor for the treatment of hemophilia A patients with inhibitors to factor VIII, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.
CONTRAINDICATIONS
Because BeneFIX®, Coagulation FactorIX (Recombinant), is produced in a Chinese hamster ovary cell line, it may be contraindicated in patients with a known history of hypersensitivity to hamster protein.
WARNINGS
The safety and efficacy of BeneFIX® administration by continuous infusion have not been established. There have been post-marketing reports of thrombotic events in patients receiving continuous-infusion BeneFIX® through a central venous catheter, including life- threatening superior vena cava (SVC) syndrome in critically ill neonates Factor IX complex concentrates have historically been associated with thedevelopmentofthromboembolic complications1. The use of factor IX-containing products, including BeneFIX®, may be potentially hazardous in patients at risk of thromboembolic phenomena, including patients with signs of fibrinolysis or disseminated intravascular coagulation (DIC), patients with liver disease or post-surgical patients.
Nephrotic syndrome has been reported following immune tolerance induction with factorIX products in hemophilia B patients with factorIX inhibitors and a history of allergic reactions to factorIX. The safety and efficacy of using BeneFIX® for immune tolerance induction have notbeenestablished.
Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with factorIX products including BeneFIX®. Frequently, these events have occurred in close temporal association with the development of factorIX inhibitors. Patients should be informed of the early symptoms and signs of hypersensitivity reactions including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing,faintness,hypotension, tachycardia, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the type/severity of the reaction, if any of these symptoms occur

Coagulation Factor IX (recombinant) 
藥品名稱： Factor IX Recombinant 500IU Vial 
英商品名： BeneFix* 500IU
中文藥名： 賓凝適第九凝血因子凍晶注射劑
儲存方法： 冰箱保存