通用名称和剂型: 重组凝血因子VIIa ( rFVIIa的)房间温度稳定毫克, 2毫克, 5毫克, 8毫克,每小瓶冻干PWD静脉注射后重建;不含防腐剂。 公司名称: 诺和诺德 诺其RT的功能主治为: 治疗出血和手术预防血友病A和B抑制剂因子VIII和IX ,在获得性血友病,先天性FVII缺乏。 成人和儿童剂量: 给静脉推注。个体化治疗基地对止血时间表。血友病A和B抑制剂:出血: 90micrograms/kg有每2小时后止血剂量:持续严重出血,3 - 6小时间隔;长时间给药慎用。手术:最初90micrograms/kg手术前,在2小时的时间间隔重复在手术过程中,未成年人(手术后给药) :每2小时为1日48小时,然后每隔2 - 6小时,直至痊愈;主要(手术后给药) :每2小时5天,然后每4小时,直至痊愈。先天性凝血因子VII缺乏症: 15-30micrograms/kg每4 - 6小时直到止血acheived 。获得性血友病患者:每2-3小时70-90micrograms/kg直到止血acheived 。 药理类别: 凝血因子。 警告/注意事项: 目前批准的适应症外给药时,动脉栓塞的不良事件的风险增加。弥散性血管内凝血,先进的动脉粥样硬化性疾病,挤压伤,败血病,心血管疾病史,肝脏疾病,术后固定,老人,新生儿血栓事件的风险增加。监测/活化凝血或血栓形成的症状体征,停止或减少剂量,如果出现。监测凝血酶原时间和FVII混凝剂活动前及给药后在FVII缺乏。监测抗体形成。小鼠,仓鼠或牛蛋白过敏症。怀孕( Cat.C ) 。哺乳母亲:不推荐。 相互作用: 避免伴随活化或非活化凝血酶原复合物浓缩剂,可能会增加血栓事件的风险。切勿与输液。
不良反应: 发热,出血,注射部位反应,关节痛,头痛,高血压,心绞痛,低血压,胃肠不适,疼痛,水肿,皮疹,血栓形成,增加纤维蛋白降解产物,弥漫性血管内凝血的水平, D-二聚体升高和AT-Ⅲ水平,血栓性静脉炎。
如何提供: 单剂量小瓶- 1 (稀释剂)
Generic Name and Formulations: Recombinant Coagulation Factor VIIa (rFVIIa) Room Temperature Stable 1mg, 2mg, 5mg, 8mg; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Company: Novo Nordisk Indications for NOVOSEVEN RT: Treatment of bleeding and for surgical prophylaxis in Hemophilia A and B with inhibitors to Factors VIII and IX, in acquired hemophilia, and in congenital FVII deficiency.
Adults and Children's Dose: Give by IV bolus. Individualize; base treatment schedule on hemostasis. Hemophilia A and B with inhibitors: Bleeding: 90micrograms/kg every 2hrs; post-hemostatic dosing: continue at 3–6hrs intervals for severe bleeds; caution with prolonged dosing. Surgery: initially 90micrograms/kg prior to surgery, repeat at 2hr intervals during surgery; minor (post-surgical dosing): every 2hrs for 1st 48hrs, then every 2–6hrs until healed; major (post-surgical dosing): every 2hrs for 5 days, then every 4hrs until healed. Congenital Factor VII deficiency: 15–30micrograms/kg every 4–6hrs until hemostasis acheived. Acquired hemophilia: 70–90micrograms/kg every 2–3hrs until hemostasis acheived.
Pharmacological Class: Clotting factors.
Warnings/Precautions: Increased risk of arterial thromboembolic adverse events when administered outside the current approved indications. Disseminated intravascular coagulation, advanced atherosclerotic disease, crush injury, septicemia, history of cardiovascular disease, hepatic disease, post-op immobilization, elderly, neonates; increased risk of thrombotic events. Monitor for signs/symptoms of coagulation activation or thrombosis; discontinue or reduce dose if occur. Monitor prothrombin time and FVII coagulant activity before and after dosing in FVII deficiency. Monitor for antibody formation. Mouse, hamster, or bovine protein hypersensitivity. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions: Avoid concomitant activated or non-activated prothrombin complex concentrates; may increase risk of thrombotic events. Do not mix with infusion solutions.
Adverse Reactions: Pyrexia, hemorrhage, inj site reactions, arthralgia, headache, hypertension, angina, hypotension, GI upset, pain, edema, rash; thrombosis, increased levels of fibrin degradation products, disseminated intravascular coagulation, elevated D-dimer and AT-III levels, thrombophlebitis.
How Supplied: Single-dose vials—1 (with diluent) |