药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(200822801003032.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文賓凝適处方资料(仅供参考)
學名:Coagulation Factor IX (recombinant)
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. 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.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(200822801003032.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |