Included in the formulation
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):VED
7 nosologies
АТХ:B.02.B.D.04 Coagulation factor IX
Pharmacodynamics:Coagulation factor IX has a hemostatic effect; increases the concentration of the factor IX in plasma, restores hemostasis in patients with deficiency. Active form of the factor IX factor IXa - in combination with a factor VIII activates factor X, which promotes the transition of prothrombin into thrombin and the formation of a fibrin clot. Increases concentration in plasma vitamin K-dependent coagulation factors (II, VII, IX and X). With a decrease in the plasma factor IX Below 5% of the norm, the risk of spontaneous hemorrhages increases sharply, and a content above 20% of the norm ensures satisfactory hemostasis.
Pharmacokinetics:About 30-50% of the factor IX is detected in the blood immediately after intravenous infusion; then the haemostatic activity gradually decreases. The half-life is 24 hours
Indications:Bleeding caused by factor IX deficiency (treatment, prevention); hemophilia; bleeding caused by coumarin anticoagulants (before an emergency surgery, with trauma).
III.D65-D69.D67 Hereditary deficiency of factor IX
XVIII.R50-R69.R58 Bleeding, not elsewhere classified
Contraindications:Hypersensitivity, DIC-syndrome, acute thrombosis, acute myocardial infarction, factor VII deficiency, acute renal failure, pregnancy, lactation.
Carefully:Elderly and children's age, liver and kidney disease.
Pregnancy and lactation:The category of recommendations for the FDA is C.
Contraindicated in pregnancy and lactation.
Dosing and Administration:Intravenously (struino or drip), no more than 2 ml / min. The dosage regimen is set individually at the control of the factor IX in blood. In emergency cases, please note that the first dose of 1 IU / kg increases the factor IX by 0.5-1%, and subsequent administration of the same dose by 1-1.5%.With the removal of teeth and small operations, the concentration of the factor IX should not be below 30% of the norm, with gastrointestinal bleeding - below 30-50%, and with intracranial hemorrhages or extensive operations - below 60%. If the patient undergoes surgery or is injured, an additional amount of factor IX, maintaining a dose of 10-20 IU / kg per day.
For long-term prophylaxis of bleeding (severe hemophilia B) - 18-30 IU / kg once a week or 9-15 IU / kg 2 times a week. To treat bleeding in patients with hemophilia A - 75 IU / kg; if necessary, a second dose is given after 12 hours. The rate of intravenous infusion is 100 IU / min.
To calculate the number of units of factor activity IX, which should be administered to the patient to achieve the required concentration factor IX in the bloodstream, the following formula can be recommended: the required dose = Φ (%) × body weight (kg) × 0.8, where Φ (%) is the required increase in activity.
Side effects:Heat, chills, headache, nausea, tachycardia, tingling sensations in the body, back pain, postoperative thrombosis, allergic reactions (urticaria, anaphylactic reaction), decreased resistance to infectious diseases.
Interaction:Incompatible with other hemostatic drugs (contact activation or inactivation possible).
Special instructions:The diluted drug should be used no later than 1 hour after preparation and not added to other transfused liquids (plasma, solutions).
It should be borne in mind that the antibodies produced to factor IX can partially or completely inactivate the drug. In this case, an increase in the dose and the use of activated factors of the prothrombin complex and / or immunosuppressants are recommended.
With a significant increase in heart rate, the injection is slowed or stopped.