部份中文贝赋BeneFIX处方资料（仅供参考）
重组人凝血因子IX(贝赋BeneFIX)
商品名：BENEFIX（贝赋）
药品名：COAGULATION FACTOR IX HUMAN RECOMBINANT
通用名：注射用重组人凝血因子IX
适应证
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
性状
本品为白色或浅黄色干粉剂。
主要成份
重组人凝血因子IX，加入了蔗糖、甘氨酸组氨酸等。
用法用量
单位=体重（公斤）×1.2IU/公斤×所需的凝血因子IX的增加（正常％）
儿童，单位=体重（公斤）×1.4IU/公斤×所需的凝血因子IX的增加（正常％）
贮藏
本品需冷藏〖2-8°C〗，遮光保存，禁止冷冻。6个月后重组，应在3小时内使用
有效期
24个月。
日本原处方资料附件：http://www.info.pmda.go.jp/go/pack/6343438D1026_2_05/
High standard formulation of hemophilia B therapeutic agent Benefit
"BENEFIC® for intravenous injection 3000" new release
Pfizer Inc. (Headquarters: Shibuya-ku, Tokyo, President and CEO: Ichiro Umeda) is a high-quality formulation of Genetically Modified Blood Coagulation Factor IX Factor Venex® (generic name: Nonagogu alpha) We will launch "Benfix ® Intravenous 3000" on December 9, 2013. This product was approved by the Ministry of Health, Labor and Welfare on September 2 this year and was listed on the drug price on November 29.
Benefit is an injection that suppresses the bleeding tendency of patients with hemophilia B, and now we have decided to release high-quality formulations that have been highly desired by adult patients. The dosage of this preparation can be determined per body weight considering severity, bleeding site, degree of bleeding, etc. However, in adult patients, high doses exceeding 2000 IU may be required at one time. Since it is urgent to respond to bleeding at home, self-injection at home by a patient is permitted, but when a high dose is required, the patient himself or a guardian dissolves a plurality of drugs and transferred to a syringe I had to do. In order to remedy this situation and to respond to the needs of patients, we obtained approval to manufacture and sell high-quality preparations containing 3000 IU at 5 mL similar to the conventional standards.
Benefice, in addition to formulation design pursuing safety as a recombinant preparation and simplicity of dissolution operation, since the release in January 2010, improvement of size of alcohol cotton wrapped, realization of room temperature preservation, and packaging We are constantly making efforts to improve products based on the patient's perspective, such as reducing the size to about half the size.
Regarding the release of "3000 for intravenous Beneficus", Professor Katsuyuki Fukutake of Tokyo Medical University says, "For rapid treatment of haemophiliacs, rapid drug administration is indispensable. Depending on the patient's weight, bleeding site and degree, it may be necessary to administer a high dose, so 3000 IU A lot of voices wanting formulation were raised.In this time, with the appearance of high-standard formulation, we hope to reduce the burden of the patient's work and help to maintain a better life. "
About hemophilia B
Hemophilia B is a hereditary disorder in which blood is hard to stop. Blood protein (blood coagulation Factor IX) is necessary to consolidate blood and stop bleeding when bleeding, but patients with hemophilia B have this blood protein lowered / deficient. Patients are treated with FX replacement therapy to prevent bleeding tendencies. There are about 1000 patients with hemophilia B in Japan.
About Beneficus
Benefit is a drug approved to suppress the bleeding tendency of patients with hemophilia B (congenital coagulation factor Ⅰ factor deficiency). Benefice is the first genetically modified Factor IX preparation in the world that is manufactured by "Plasma / Albumin Free Process" to reduce the risk of infections such as HIV and hepatitis virus, and is a highly sought-after preparation. Since it was launched in the United States in 1997, it is now widely used all over the world including Japan, and in addition to having released the first high standard (2000 IU) with hemophilia B therapeutic drug, this time a new 3000 IU It has reached release. Also, in all standards of 500, 1000, 2000, 3000 IU, the volume of the solution is set at 5 mL, which is also a formulation considering convenience so that the patient can dissolve and inject in a short time.
Pfizer has a call center that patients can consult about 24 hours a day about the dissolution procedure of Benefit, offers an iPhone application "BeneMobile ™" that can manage the infusion / bleeding record of patients, Through the website "Hemophilia Life" (www.hemophilia-life.jp), we provide information to support treatment of hemophilia B and living.