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Human coagulation factor VIII

Function and Efficacy

In the process of endogenous blood coagulation, activated coagulation factor VIII acts as a cofactor and, in the presence of Ca2 and phospholipids, activates coagulation factor X together with activated coagulation factor IX, 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%.

Ingredients

Human coagulation factor VIII.

Appearance

Milky white loose body, the solution becomes clear or slightly opalescent after re-dissolution.

Indication

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.

Usage and Dosage

(I) Usage: Warm the preparation bottle containing freeze-dried human coagulation factor VIII and sterile water for injection to 25-37℃. Open the aluminum-plastic combination cover to expose the rubber stopper. Disinfect the exposed part of the rubber stopper with a disinfectant such as alcohol. Do not leave any disinfectant residue on the stopper. Remove the plastic cover on one end of the preparation needle. Insert the short end of the preparation needle into the center of the stopper of the diluent bottle. Remove the plastic cover on the other end of the preparation needle. Invert the diluent bottle and the preparation needle and insert the long end of the preparation needle into the center of the stopper of the factor VIII preparation bottle. Wait until the diluent completely flows into the factor VIII preparation bottle. Remove the diluent bottle, vent and remove the preparation needle. Gently turn the bottle to completely dissolve the product. Do not shake it violently to avoid foaming and protein denaturation. The method for intravenous injection with a syringe is as follows: Install the filter needle on the syringe and draw the human coagulation factor VIII solution into the syringe through the filter needle. Occasionally, there will be trace amounts of fine protein particles in the solution, which can be filtered out without affecting the potency of the preparation. Remove the filter needle and replace it with an infusion set. The prepared preparation must be infused immediately and used up within one hour. The administration rate should be slow, not exceeding 10 ml/min. If the patient's dosage exceeds one bottle, the same infusion set can be used for one venous puncture. The prepared solution cannot be refrigerated. Discard all infusion sets after use. (II) Dosage: The dosage must be based on 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 the first dose of 15-25 IU/kg body weight. If necessary, give a maintenance dose of 10-15 IU/kg body weight every 8-12 hours; 3. Major bleeding: life-threatening bleeding such as bleeding in the oral cavity, urinary system 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. At the beginning of the operation, the concentration of factor VIII in the blood must reach 60-120% of the normal level. Usually 30-40 IU/kg body weight is administered before surgery. Within 4 days after surgery, the minimum level of factor VIII should be maintained at 60% of the normal level, 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

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

Precautions

It is contraindicated for those who are allergic to this product.

Drug Interactions

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

Storage

Store below 8℃ away from light and do not freeze.

Packaging Specification

200 International Units

Manufacturer

Shanghai RAAS Blood Products Co., Ltd.

  • Founded in:

    1988-10-29
  • Address:

    No. 2009, Wangyuan Road, Fengxian District, Shanghai
  • Tax NO.:

    913100006072419512
  • Registered Funds:

    6,637,984,837 yuan
  • Website:

  • Email:

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