Human Prothrombin Complex

[Composition]

Active ingredients: Human coagulation factor Ⅱ, Ⅶ, Ⅸ, Ⅹ

Excipients: heparin sodium, glycine, arginine, Lysine hydrochloride.

 [Characters]

It is a white or gray-green loose powder. After redissolution it turns into colorless, light yellow, light blue or yellow-green color clear liquid, with a slight opalescence.

 [Indications]

The product is used to treat congenital and acquired deficiency diseases of coagulation factors II, VII, Ⅸ, Ⅹ(alone or combined deficiency), include:

1. Coagulation factor IX deficiency (hemophilia B), and Ⅱ, VII, Ⅹ coagulation factor deficiency;

2. Anticoagulant overdose, Vitamin K deficiency;

3. Bleeding patients caused by liver disease need to correct coagulation disorders;

4. Prolonged prothrombin time due to various reasons and intended for surgical patients; deficiency of coagulation factor Ⅴ may be invalid;

5. Hemophilia A patients with bleeding symptoms who have produced the factor VIII inhibitor;

6. Reversal of hemorrhage caused by coumarin anticoagulant;

 [Strengths]

100IU per vial, each vial contains factor IX 100IU, factor II 100IU, factor VII 25IU, factor X 100IU, filling quantity of 1.5 ml. After redissolution the volume is 10ml.

 [Administration and Dosage]

Administration:

1. This product is for intravenous infusion, should be used under the strict supervision of clinician.

2. Before using, the product and its diluent should be pre-heating to 20-25℃, pour the pre-heating diluent into container according to the labeled amount, shake gently until the product completely redissolved (pay attention to avoid a lot of foam).

3. After redissolution use the blood transfusion set with filter for intravenous infusion. The infusion rate should be slow at beginning, about 15 drops / min, after 15 min the infusion rate could be slightly accelerated to 40 ～60 drops/min, generally finish the infusion in 30 to 60 minutes.

4. The physician should pay attention to the infusion at any time, if found the clinical symptoms and signs of disseminated intravascular coagulation or thrombosis, should stop infusion immediately. Then use the heparin antagonists.

Dosage: Should determine the dosage according to the condition and the results of clinical test result including coagulation test indicators.

1. The dosage used varies with the deficiency degree of factors, generally inject 10 ～ 20IU per kgBW, patients who lack of coagulation factor IX are injected every 24h; lack of coagulation factor II and X every 24-48h; lack of coagulation factor VII every 6-8h. The dose may be decreased appropriately after 2~3days.

2. The dose may be increased appropriately in excessive bleeding or major surgery.

3. The patients with prolonged prothrombin time, if proposed to do splenectomy,  should be injected the product before surgery. It depends on the circumstances to decide whether to inject in the intraoperative or postoperative time.