ReFacto® Manufacturer: Wyeth Pharmaceuticals Generic Name: Antihemophilic Factor VIII (Recombinant) Indications: ReFacto® Antihemophlic Factor (Recombinant) is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congential factor VIII deficiency or classic hemophilia) ReFacto® is indicated for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes. The effect of regular routine prophylaxis on long term morbidity and mortality is unknown. ReFacto® can be of significant therapeutic value for treatment of hemophilia A in certain patients with inhibitors to factor VIII. In clinical studies of ReFacto, study subjects who developed inhibitors on study continued to manifest a clinicqal response when inhibitor titers were < 10BU. When an inhibitor is present, the dosage requirement of factor VIII is variable. The dosage can be determined only by a clinical response and by monitoring of circulating factor VIII levels after treatment. Refacto® does not contain von Willebrand factor and is therefore not indicated in von Willebran's Disease. ReFacto® Product Insert How Supplied: Factor products are supplied in vials sizes of varying International Units (iu). Vial sizes (iu sizes) may change with each new lot of product manufactured. Vial sizes may range from approximately 200 - 1500 iu per vial. 美国FDA批准惠氏公司的ReFacto因子Ⅷ（重组）新释药系统上市 美国FDA批准惠氏公司的重组抗血友病因子Ⅷ（antihemophilic factor，ReFacto）R2用具包用于治疗血友病。本品是首个获准的配有预填充稀释剂注射器的无针头复溶注射器。 本品系一重组抗血友病因子Ⅷ，在最终成品中不含人血清白蛋白。 与以往的复溶方法相比，R2用具包提供了更快速简便的输注方法。此用具包配有预填充稀释剂的注射器、小瓶结合器和装有250，500，1000或2000 IU ReFacto单次使用的小瓶。将小瓶结合器置ReFacto小瓶上，此结合器与预填充注射器使ReFacto复溶，无针头暴露的危险。此R2用具包以较小的包装供应，组分少，减少了所需的储存空间。本品用具包提供了较为简便、快速的输注的方法以及组分较少，大大缩短使用R2用具包患者的输注时间。