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【學名】： Coagulation Factor IX (Recombinant)
【商品名】： BeneFix for Injection 500 IU/vial
【製造廠商】 Wyeth
【商品中文名稱】賓凝適第九凝血因子凍晶注射劑
【常用名】 BeneFix
【劑型】 針劑
【常用劑量】 持續靜脈輸注數分鐘，輸注速率約2-3毫升/分鐘。
成人使用劑量，可使用下列公式計算：
實際所需第九凝血因子數（units required）=
體重（kg） × 期望增加第九凝血因子數（%） × 1.2 IU/kg；
小孩（< 15歲）：實際所需第九凝血因子數 =
體重（kg） × 期望增加第九凝血因子數（%） × 1.4 IU /kg。
Adults, unit required = BW(kg) ×1.2 IU/kg × desired factor IX increase (%).
Children < 15 yr, unit required = BW(kg) ×1.4 IU/kg × desired factor IX increase (%).
【建議用法】QD , IV , 每天1次(早晨) 靜脈注射
【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
注意事項 治療期間須監測血中第九凝血因子抗體的濃度。本藥存在血栓栓塞併發症的潛在危險，肝臟疾病患者、接受外科手術者、新生兒、出現栓塞性血栓或瀰漫性血管內凝血患者須經評估後再使用。
Monitoring the factor IX activity (using the factor IX activity assay is advised) and the development of factor IX inhibitors.
【儲存方式】2-8℃冷藏，不可冷凍。有效期內，未開封的BeneFix可儲存於室溫下（≦ 25℃）6個月（需註明開始置放於室溫的日期於外包裝盒上）。
BeneFix Generic Name: Coagulation Factor IX Injection (Recombinant) (ko-ag-yoo-LAY-shun)Brand Name: BeneFix
BeneFix is used for:
Preventing and controlling bleeding in patients with factor IX deficiency (hemophilia B or Christmas disease), including control and prevention of bleeding in surgical settings.
BeneFix is a synthetic protein, clotting factor IX. It works by helping the blood form clots, which stops bleeding.
Do NOT use BeneFix if:
you are allergic to any ingredient in BeneFix or hamster protein
Contact your doctor or health care provider right away if any of these apply to you.
Before using BeneFix :
Some medical conditions may interact with BeneFix . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, plan to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver disease
if you are at risk for developing blood clots
if you have recently had surgery
Some MEDICINES MAY INTERACT with BeneFix . However, no specific interactions with BeneFix are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if BeneFix may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use BeneFix :
Use BeneFix as directed by your doctor. Check the label on the medicine for exact dosing instructions.
BeneFix is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using BeneFix at home, carefully follow the injection procedures taught to you by your health care provider.
If BeneFix contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
If you miss a dose of BeneFix , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use BeneFix .
Important safety information:
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using BeneFix .
LAB TESTS, including factor IX levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using BeneFix during pregnancy. It is unknown if BeneFix is excreted in breast milk. If you are or will be breast-feeding while you are using BeneFix , check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of BeneFix :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Mild chills; nausea; stinging at the injection site.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; faintness; fever; flushing; headache; lethargy; lightheadedness, especially upon standing; nausea; rapid heart rate; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.
Proper storage of BeneFix :
Store the unmixed medicine in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Prior to the expiration date, it may also be stored at room temperature not to exceed 77 degrees F (25 degrees C) for up to 6 months. You should make note of the date the product was placed at room temperature in the space provided on the outer carton. The product does not contain a preservative. After mixing it may be stored between 36 and 46 degrees F (2 and 8 degrees C) and must be used within 3 hours. Do not freeze. Keep BeneFix out of the reach of children and away from pets. | 
