Human coagulation factor VIII

In the process of endogenous blood coagulation, coagulation factor VIII acts as a cofactor, and in the presence of Ca2 and phospholipids, it participates in the activation of prothrombin by coagulation factor X with activated coagulation factor IX to form thrombin, thereby allowing the coagulation process to proceed normally. Infusion of 1 unit of human coagulation factor VIII per kilogram of body weight can increase the level of factor VIII in the circulating blood by 2% to 2.5%.

Main components: human coagulation factor VIII.

This product has a corrective effect on coagulation dysfunction caused by lack of human coagulation factor VIII. It is mainly used to prevent and treat bleeding symptoms caused by hemophilia A and acquired coagulation factor VIII deficiency and to treat surgical bleeding in such patients.

This product is designed for intravenous infusion and should be used under the strict supervision of a clinical physician. Before use, sterile water for injection at 25-37°C or 5% glucose injection should be injected into the bottle according to the amount indicated on the bottle label (when the product has just been taken out of the refrigerator or when the temperature is low in winter, special attention should be paid to raising the temperature of the product to 25-37°C before dissolving, otherwise precipitation is easy to precipitate), gently shake the product to completely dissolve it (be careful not to produce foam), and then use a blood transfusion device with a filter device for intravenous drip. The drip rate is generally about 60 drops per minute. The product should be used immediately after dissolution and should be infused within 1 hour. It should not be left standing. Dosage: The dosage must refer to factors such as body weight, the presence of inhibitors, and the severity of bleeding. The following formula can be used to calculate the dose: Required Factor VIII Units (IU)/time = 0.5 Patient weight (kg) Factor VIII activity level to be increased (% of normal) Example: Required Factor VIII Units (IU)/time = 0.550 (kg) 30 (%) = 750 IU The generally recommended doses are as follows: 1 Mild to moderate bleeding: a single dose of 10-15 IU/kg body weight to increase factor VIII levels to 20-30% of normal levels. 2 More severe bleeding or minor surgery: Factor VIII levels need to be increased to 30-50% of normal levels, usually with a first dose of 15-25 IU/kg body weight. If necessary, a maintenance dose of 10-15 IU/kg body weight is given every 8-12 hours. 3 Major bleeding: life-threatening bleeding such as bleeding in the mouth, urinary tract and central nervous system or bleeding in important organs such as the neck, larynx, retroperitoneum, and near the iliopsoas muscle: the first dose is 40 IU/kg body weight, and then a maintenance dose of 20-25 IU/kg body weight is given every 8-12 hours. The course of treatment must be determined by the doctor. 4 Surgery: Elective surgery can only be considered when there is no abnormal increase in the level of coagulation factor VIII inhibitors. The concentration of factor VIII in the blood must reach 60-120% of the normal level at the beginning of the operation. Usually 30-40 IU/kg body weight is administered before surgery. Factor VIII should be maintained at a minimum of 60% of the normal level within 4 days after surgery, and then reduced to 40% in the next 4 days. 5 Acquired factor VIII inhibitor syndrome: A large dose of coagulation factor VIII should be given, generally more than double the dose required to treat hemophiliacs.

Adverse reactions include chills, nausea, dizziness, or headache, which are usually temporary. Allergic reactions may occur.

Not yet clear.

It should be infused alone and not used in combination with other drugs.

Strictly store below 8°C and away from light.

100IU/10ml/bottle Each bottle contains 100IU of human coagulation factor VIII, and the volume after reconstitution is 10ml

Hualan Biological Engineering,Inc.

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  1992-03-30

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