Supply : 5000 IU(Factor IX) / vial <<IVKNR>>
Description: BeneFIX® is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized and shown to be free of infectious agents. It is a purified protein produced by recombinant DNA technology for use in therapy of factor IX deficiency, known as hemophilia B.
Action: Factor IX is activated by factor VII/tissue factor complex in the extrinsic coagulation pathway as well as by factor XIa in the intrinsic coagulation pathway. Activated factor IX, in combination with activated factor VIII, activates factor X. This results ultimately in the conversion of prothrombin to thrombin. Thrombin then converts fibrinogen to fibrin, and a clot can be formed.
Indication: 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。
Dosage and Administration: IV infusion,
Teatment and prevention of bleeding in hemophilia B：
Adult, IU required (IU) = BW (kg) x desired increase (% or IU/dL) x 1.2 (IU/kg per IU/dL)
Pediatric (<15 years), IU required (IU) = BW (kg) x desired increase (% or IU/dL) x 1.4 (IU/kg per IU/dL)
|
Type of Hemorrhage |
Factor IX Activity Required |
Dosing Interval |
Duration of Therapy |
|
Minor Uncomplicated hemarthroses, superficial muscle, or soft tissue |
20 - 30 [% or (IU/dL)] |
12 - 24 hrs |
1 - 2 days |
|
Moderate Intramuscle or soft tissue with dissection,mucous membranes, dental extractions, or hematuria |
25 - 50 [% or (IU/dL)] |
12 - 24 hrs |
Treat until bleeding stops and healing begins; about 2 - 7 days |
|
Major Pharynx, retropharynx, retroperitoneum, CNS, surgery |
50 - 100 [% or (IU/dL)] |
12 - 24 hrs |
7 - 10 days |
Adverse drug reaction:
Rare : headache, fever, chills, flushing, nausea, vomiting, lethargy, or manifestations of allergic reactions
Contraindication: Contraindicated use in patient with known history of hypersensitivity to hamster protein.
Caution: Caution use in patient with factor IX inhibitors, thrombosis, disseminated intravascular coagulation.
Note: Do NOT inject air into the BeneFIX® vial. This may cause partial loss of product.
Preparation of dosage form: Slowly inject the solution intravenously with an infusion kit or with a suitable injection needle. Warm both diluent and Benefix® in unopened vials to room temperature.
Storage & Stability: 2~
Pregnancy Category: C
Reference:
1. MICROMEDEX(R) Healthcare Series.2008.
2. Drug package Insert.
