部分中文拜科奇信息资料（仅供参考） 【商品名】拜科奇 【通用名】注射用重组人凝血因子VIII 【成  份】主要组成成份：人凝血因子Ⅷ 【药理作用】 人凝血因子VIII是正常血浆的组成成分，在血液凝固过程中起着必不可少的作用。拜科奇对纠正和预防因因子VIII缺乏而致的严重出血有疗效。输用每公斤体重1个单位的人凝血因子VIII可使循环血液中的因子VIII水平增加2%到25%。对血友病患者的临床研究显示因子VIII的生物半衰期在6-14小时之间。用TNBP和Tween80进行的有机溶剂清洁剂(SD)灭活病毒处理对人类致病病毒如HIV-1、HBV、HCV等有高度的灭活作用，同时又不影响因子VIII和其他血浆蛋白的活性。SD处理灭活病毒的效果经用指示病毒如疱疹性口炎病毒，Sindbis病毒和乙脑病毒，以及艾滋病毒(HIV)得到验证。 【适应症】 拜科奇用于预防和控制因凝血因子VIII缺乏或因患获得性因子VIII抑制物增多症而致的出血。拜科奇不适用于血管性假血友病(von Willebrand病)的治疗。 【临床疗效】： 拜科奇用于预防和控制因凝血因子VIII缺乏或因患获得性因子VIII抑制物增多症而致的出血。拜科奇不适用于血管性假血友病(von Willebrand病)的治疗。 【用法用量】 用法： 将装有冻干人凝血因子 VIII和灭菌注射用水的制剂瓶加温至25-37℃。 开启铝塑组合盖， 露出橡皮塞。用消毒剂如酒精消毒橡皮塞的暴露部分。瓶塞上勿残留消毒剂。取下配制用针一端的塑料套。将配制用针短的一端插入稀释液瓶的瓶塞中央。去掉配制用针另一端长针的塑料外套。倒转稀释液瓶和配制用针并将配制用针的长针一端插入因子Ⅷ制剂瓶的瓶塞中央。待稀释液完全流入因子Ⅷ制剂瓶内。取下稀释液瓶，排气后拔去配制用针。轻轻转动瓶子使产品完全溶解。不得剧烈摇动以免产生泡沫及引起蛋白变性。 用注射器进行静脉注射用法如下：将过滤针头装在注射器上，通过过滤针将人凝血因子Ⅷ溶液吸入注射器。偶尔溶液中会有微量细小蛋白颗粒，可被滤去而不影响制剂的效价。拔去过滤针，代之以输注装置。配制好的制剂需立即输用，并在一小时内用完。给药速度宜慢，不要超过10mL/分。如果病人的用药量超过一瓶，可用同一套输注装置经一次静脉穿刺给药。配制好的溶液不可再冷藏。使用完毕后丢弃一切输液用装置。  用量： 给药剂量必须参照体重、是否存在抑制物，出血的严重程度等因素。下列公式可用于计算剂量：  所需因子Ⅷ单位（ IU ） / 次＝ 0.5× 患者体重（ kg ） × 需提升的因子 Ⅷ 活性水平（正常的％）例：所需因子Ⅷ单位（ IU ） / 次＝ 0.5×50 （ kg ） ×30 （％）＝ 750 IU一般推荐剂量如下：  1. 轻度至中度出血： 单一剂量 10 ～ 15 IU/kg 体重，将因子 Ⅷ 水平提高到正常人水平的 20 ～ 30 ％。  2. 较严重出血或小手术： 需将因子 Ⅷ 水平提高到正常人水平的 30 ～ 50 ％，通常首次剂量 15 ～ 25 IU/kg体重。如需要，每隔 8 ～ 12 小时给予维持剂量 10 ～ 15 IU/kg 体重。  3. 大出血： 危急生命的出血如口腔、泌尿系统及中枢神经系统出血或重要器官如颈、喉、腹膜后，骼腰肌附近的出血：首次剂量 40IU/kg 体重，然后每隔 8 ～ 12 小时给予维持剂量 20 ～ 25 IU/kg 体重。疗程需由医生决定。  4. 手术： 只有当凝血因子 Ⅷ 抑制物水平无异常增高时，方可考虑择期手术。手术开始时血液中因子Ⅷ浓度需达到正常人水平的 60～ 120 ％。通常在术前按 30 ～ 40 IU/kg 体重给药。术后 4 天内因子 Ⅷ 最低应保持在正常人水平的 60％，接下去的 4 天减至 40 ％。  5. 获得性因子 Ⅷ 抑制物增多症： 应给予大剂量的凝血因子 Ⅷ ，一般超过治疗血友病患者所需剂量一倍以上。 【不良反应】 不良反应包括寒颤、恶心、头晕或头痛，这些症状通常是暂时的。有可能发生过敏反应。 【禁    忌】 对本品过敏者禁用。 【注意事项】 1.大量反复输入本品时，应注意出现过敏反应、溶血反应及肺水肿的可能性，对有心脏病的患者尤应注意。  2.本品溶解后，一般为澄清略带乳光的溶液，允许微量细小蛋白颗粒存在。但如发现有大块不溶物时，则不可使用。  3.本品对于因缺乏因子Ⅸ所致的乙型血友病，或因缺乏因子Ⅺ所致的丙型血友病均无疗效，故在用前应确诊患者系属因子Ⅷ缺乏，方可使用本品。 4.本品不得用于静脉以外的注射途径。  5.本品被溶解后应立即使用， 并在一小时内用完 。未用完部分必须弃去。 6.请勿使用超过有效期限的产品。如在配制时发现制剂瓶已失去真空度，不得使用。 【孕妇及哺乳期妇女用药】 目前尚无凝血因子Ⅷ对动物生殖影响的研究，也不清楚因子Ⅷ用于孕妇是否会对胎儿造成损害或影响生育能力。人凝血因子Ⅷ制剂仅在十分必须的情况下才给孕妇使用。 【药物相互作用】 应单独输注，不可与其他药物合用。 【药代动力学】 生物半衰期为8～12小时。生物半衰期为8～12小时. 【药理毒理】 在内源性血凝过程中，凝血因子Ⅷ作为一种辅助因子，在Ca …  ［详细］在内源性血凝过程中，凝血因子Ⅷ作为一种辅助因子，在Ca 2+和磷脂存在下，与活化的凝血因子Ⅸ激活凝血因子Ⅹ，形成凝血酶原酶，从而激活凝血酶原，形成凝血酶，使凝血过程正常进行。输用每公斤体重1 IU的人凝血因子Ⅷ，可使循环血液中的因子Ⅷ水平增加2%～2.5%。［隐藏］ 【贮    藏】8℃以下避光保存。不得冰冻。 【有 效 期】2年 Kogenate FS IV Uses This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein(clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop. This medication should not be used to treat von Willebrand disease. How to use Kogenate FS IV This medication is given by injection into a vein, usually over 5 to 10 minutes or as directed by your doctor. The medication may need to be given more slowly over a longer time depending on your dose and how you respond to it. After first receiving this medication in a hemophilia treatment center or hospital, some patients may be able to give this medication to themselves at home. If your doctor directs you to give this medication at home, read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. Learn how to store and discard needles and medical supplies safely. If you have any questions, ask your health care professional. If the medication and the solution used to mix it were refrigerated, bring both to room temperature before combining. After adding the solution to the powder, gently swirl the mixture to completely dissolve the powder. Do not shake. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. Use immediately according to the product instructions. The dosage is based on your medical condition, weight, blood test results, and response to treatment. Follow your doctor's instructions closely. Tell your doctor if your condition does not improve or if it worsens. Kogenate FS IV Side Effects Flushing of the face, headache, nausea, and fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, and chills may also occur. If any of these effects persist or worsen, tell your doctororpharmacistpromptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/tightness. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Kogenate FS IV Precautions Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal. Consult your doctor for more details. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding. Kogenate FS IV Interactions Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Kogenate FS IV Overdose If overdose is suspected, contact your local poison control center or emergency room immediately. Canada residents can call a provincial poison control center. NOTES: Do not share this medication with others. Laboratory blood tests (e.g., factor VIII levels) should be performed frequently to determine your dosage and to check how well this medication is working. Consult your doctor for more details. MISSED DOSE: It is important to follow the dosing schedule as directed by your doctor. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up. STORAGE: Store the medication according to the manufacturer's instructions. Ask your pharmacist if you have any questions. Do not freeze this product or store it in the bathroom. Protect the product from light. After mixing, use the product within the time frame stated in the manufacturer's instructions and throw away any unused portion. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details. 附件: 201112121303425.PDF --------------------------------------------------------------- 注：以下产品不同规格和不同价格，购买时以咨询为准！ --------------------------------------------------------------- 原产地英文商品名: KOGENATE FS 2000IU/VIAL 原产地英文药品名: ANTIHEMOPHILIC FACTOR,HUM REC 中文参考商品译名: 拜科奇 2000单位/瓶 中文参考药品译名: 人基因重组抗血友病因子 生产厂家中文参考译名: 辉瑞 生产厂家英文名: pfizer -------------------------------------------------------------- 原产地英文商品名: KOGENATE FS 3000IU/VIAL 原产地英文药品名: ANTIHEMOPHILIC FACTOR,HUM REC 中文参考商品译名: 拜科奇 3000单位/瓶 中文参考药品译名: 人基因重组抗血友病因子 生产厂家中文参考译名: 辉瑞 生产厂家英文名: pfizer -------------------------------------------------------------- 原产地英文商品名: KOGENATE FS 1000IU/VIAL 原产地英文药品名: ANTIHEMOPHILIC FACTOR,HUM REC 中文参考商品译名: 拜科奇 1000单位/瓶 中文参考药品译名: 人基因重组抗血友病因子 生产厂家中文参考译名: 辉瑞 生产厂家英文名: pfizer -------------------------------------------------------------- 原产地英文商品名: KOGENATE FS 500IU/VIAL 原产地英文药品名: ANTIHEMOPHILIC FACTOR,HUM REC 中文参考商品译名: 拜科奇 500单位/瓶 中文参考药品译名: 人基因重组抗血友病因子 生产厂家中文参考译名: 辉瑞 生产厂家英文名: pfizer -------------------------------------------------------------- 原产地英文商品名: KOGENATE FS 250IU/VIAL 原产地英文药品名: ANTIHEMOPHILIC FACTOR,HUM REC 中文参考商品译名: 拜科奇 250单位/瓶 中文参考药品译名: 人基因重组抗血友病因子 生产厂家中文参考译名: 辉瑞 生产厂家英文名: pfizer 该药品相关信息网址1: http://www.kogenate.com/ 该药品相关信息网址2: http://www.kogenatefs.com/ 该药品相关信息网址3: http://www.rxlist.com/kogenate_fs-drug.htm