Included in the formulation
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):VED
АТХ:B.02.B.X Other haemostatic drugs for systemic use
Pharmacodynamics:It is an enzyme that is derived from snake venom Bothrops atrox, Bothrops moojeni or Bothrops jararaca. Under the action of this enzyme, fibrin monomers are cleaved from fibrinogen. In small doses, this enzyme can be used to stimulate the formation of a thrombus, and in large doses leads to a thrombolytic effect.
Pharmacokinetics:The highest concentration in the blood is observed a few minutes after intravenous administration of the drug. Distribution: more determined in the kidney and liver, less in the blood, spleen, lungs, small amounts are determined in the brain, fat and muscle tissue. Half-Elimination (half-life) is 3-4 hours; after 24 hours, 2-3% of its concentration in the blood remains, 30% of metabolites in the urine are released per day. After intravenous infusion, hypofibrinogenemia is observed for 12 hours.
Indications:Ischemic stroke.
Sudden hearing loss.
Violations peripheral circulation, microcirculation (in t.ch. acute sensorineural hearing loss, vibration disease).
Acute stroke.
Myocardial infarction.
Ischemic syndrome in the background of obliterating atherosclerosis.
Chronic arterial insufficiency of the lower extremities.
With pulmonary hemorrhage in newborns (in combination with hemocoagulase and mechanical ventilation of the lungs).
IX.I60-I69.I63 Cerebral infarction
Contraindications:Hypersensitivity.
Concomitant therapy with anticoagulants and / or thrombolytic agents.
Multiple organ failure.
Invasive operations and methods of diagnosis, surgical interventions.
Propensity to bleeding.
Hemorrhagic stroke.
Rupture of papillary muscles and perforation of the interventricular septum of the heart.
Severe renal / hepatic insufficiency.
Postoperative period.
Stomach ulcer and duodenal ulcer (exacerbation).
Cardiogenic shock.
Childhood (safety and efficacy not studied).
Carefully:Stomach ulcer and duodenal ulcer.
Cerebrovascular diseases.
Propensity to allergic reactions.
Elderly age.
Pregnancy.
TObreast-feeding.
Pregnancy and lactation:Category Food and Drug Administration (US Food and Drug Administration) not determined.
Dosing and Administration:Intravenously drip. Stroke: 20 units for the first day or 10 units a day later, then a maintenance dose of 5-10 units every other day, 3 injections per course. If necessary, repeat the course.
Ischemic syndrome on the background of obliterating atherosclerosis, disturbance of circulation / microcirculation: initial dose - 10 units, supporting - 5 units, 3-6 courses.
Disturbance of microcirculation in a vibration disease: 10 units in 250 ml of saline every day (13 procedures).
With acute cerebral infarction - 20 YE within the first 24 hours or 10 YE 24 hours after the onset of the disease, the maintenance dose (according to the patient's condition) is usually 5-10 YE In a day, only 3 injections per course. If necessary, the course can be repeated.
Side effects:Bleeding various localization, including intracranial.
Headaches, tinnitus, dizziness.
Fever, skin rash, anaphylactic shock.
Nausea, vomiting, unpleasant sensations in the field of epigastrium.
Increased activity "hepatic" transaminases, increased urea concentration / C-reactive protein in the blood, a positive reaction to latent blood in the urine.
Overdose:Not described, symptomatic treatment.
Interaction:Not described.
Special instructions:During the reception, monitoring of fibrinogen in the blood and close monitoring of the patient's physician is necessary.
If, after a single injection of the drug, the concentration of fibrinogen is below 1 g / l or during treatment bleeding or suspicion appears, the drug is canceled and haemostatic measures are performed.
At the puncture site, a tight bandage should be applied.