June 6, 2024 Source: drugdu 98
On May 21st, Weiguang Biological officially obtained the Certificate of Drug Registration of Human Plasminogen Complex approved by the State Drug Administration, adding one new product to its product pipeline! Up to now, Weiguang Bio has 11 products in three categories of blood products, and the comprehensive plasma utilization rate ranks the leading level in the industry.
Prothrombin Complex Concentrate (PCC) approved by Weiguang is a concentrated preparation rich in coagulation factors II, VII, IX and X made from healthy human plasma, separated and purified by gel adsorption, ultrafiltration and other advanced technologies, and lyophilized by S/D and dry heat viral inactivation process. The ratio of Factor II, Factor VII, Factor IX and Factor X in the finished product is 1:1:1:1, all of them are 300IU, which is one of the rare four-factor PCC in the industry, and the quality of the product is at the leading level in the industry. The results of the phase III clinical study of this product show that the infusion of human plasminogen complex can significantly increase the level of factor activity in the patient's body, with obvious improvement of bleeding symptoms and signs, a clinical effective rate of 100%, and good drug safety.
This product is clinically used for the treatment of congenital and acquired coagulation factor II, VII, IX, X deficiency (individual or combined deficiency) including:
1, Coagulation factors II, VII, IX, X deficiency, including hemophilia B;
2, Anticoagulant overdose and vitamin K deficiency;
3, disorders of the coagulation mechanism due to liver disease, when patients with bleeding due to liver disease need to correct coagulation dysfunction;
4, various causes of prolonged prothrombinogen time and the proposed surgical patients; but the coagulation factor V deficiency may not be effective;
5、Treatment of hemophilia A patients who have produced factor VIII inhibitor bleeding symptoms;
6, reversal of coumarin anticoagulant-induced bleeding.
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