商品名：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.

【原产地英文商品名】BENEFIX 1000IU/Vial
【原产地英文药品名】COAGULATION FACTOR IX HUMAN RECOMBINANT
【中文参考商品译名】
注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
·宾凝适 250单位/瓶
·宾凝适 500单位/瓶
·宾凝适 1000单位/瓶
·宾凝适 2000单位/瓶
【中文参考药品译名】基因重组人凝血因子IX
【生产厂家中文参考译名】美国惠氏
【生产厂家英文名】Wyeth Pharmaceuticals

-------------------------------------------------------------------------------

【临床试验期】完成
【中文适应病症参考翻译1】Ｂ型血友病
【中文适应病症参考翻译2】Ｂ型血友病之出血
【中文适应病症参考翻译3】外科手術時的出血控制與預防出血

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.