Index of drugs

Patients with haemophilia A with moderate or severe deficiency of factor VIII. Patients with a low titre of factor VIII inhibitor not exceeding 10 U Bethesda / ml. The product is used prophylactically and in case of haemorrhage, bleeding and surgical procedures. In the case of treatment of patients with factor VIII inhibitor, a physician experienced in this area should be consulted prior to the transfusion of the preparation.

1 vial with lyophilisate contains 250 IU, 500 IU. or 1000 IU factor VIII.

Highly purified factor VIII concentrate (antihemophilic factor or factor VIII: C), prepared from human plasma derived from multiple donors, obtained by the M method using affinity chromatography using mouse monoclonal antibodies directed to factor VIII. The preparation is purified by ion-exchange chromatography and fully tested for the carriage of HbsAg, anti-HCV antibodies, anti-HIV1 antibodies. Method M also includes virus inactivation steps to reduce the risk of transmission of viral hepatitis and other viral diseases. Factor VIII is a protein - a physiological plasma component necessary for proper clotting. Administration of the preparation increases the procoagulant activity of factor VIII in plasma and may temporarily correct coagulation disorders in patients with haemophilia A. T_0,5 is about 14.8. +/- 3 hours.

Hypersensitivity to mouse protein.

During pregnancy and breast-feeding, the potential risks and benefits for the mother, fetus and child should be considered. The drug should only be given for clinical indications.

Feeling broken, fever, nausea and chills. Hypersensitivity reactions (urticaria, anaphylactic shock), tightness in the chest, drop in blood pressure may occur. In 10% of patients with haemophilia treated with factor VIII preparations, antibodies against factor VIII (factor VIII inhibitor) are produced. This makes it impossible in most cases to continue to effectively treat the patient using factor VIII preparations. None of the inactivation technologies used does not completely exclude the risk of transmission of viral diseases.

The preparation is administered intravenously, setting the dose individually depending on the level of factor VIII deficiency in the plasma, the location and type of bleeding, and the clinical condition of the patient. Expected increase in factor VIIIin vivo, expressed in IU / ml of plasma or as a% of normal, can be calculated by dividing the dose administered by weight in kg and multiplying by 2. Administration of 1 IU. factor VIII / kg m.c. increases its plasma concentration by about 2 IU / day (or 2% of normal). Although there are different ways to calculate the dose in an approximate way, it is recommended that during the administration of factor VIII, its serum concentration should be monitored at least once a day. Due to the short half-life of factor VIII, it is necessary to repeat injections every 12 hours to maintain the desired plasma concentration in the patient. In the case of small intra-articular bleeding and bleeding, an increase in procoagulant activity of factor VIII in plasma is required up to 20-40 IU / dl after transfusion of the dose for 1-3 days until the bleeding stops. In massive outflow attacks, the level of procoagulant activity should be maintained at 30-60 IU / dl, usually for 3 days. In the treatment of life-threatening bleeding, after trauma to the abdomen, chest or head, it is required to maintain procoagulant activity at a level not lower than 60-100 IU / day for a few to several days. Tooth extraction in 70% of patients is sufficient by a single transfusion of the preparation with an increase in procoagulant activity to 60-80 IU / dl and oral anti-fibrinolytic therapy. In the case of surgical procedures in patients with a stroke to o.u.n. it is necessary to maintain the level of procoagulant activity above 40-50 IU / dl (during the procedure 80-110 IU / dl) for a few to several days. Patients with massive haemorrhages, life-threatening bleeds and patients undergoing surgery should be treated in centers with experience in the treatment of haemophilia and able to frequently determine the procoagulant activity of factor VIII in the patient's plasma. When preparing the preparation for use, follow the instructions in the instructions provided with each package.