Active substanceStreptokinaseStreptokinase
Similar drugsTo uncover
  • Streptokinase
    lyophilizate in / in 
    BELMEDPREPARATY, RUP     Republic of Belarus
  • Thromboflue
    lyophilizate in / in 
  • Eber Biotech SA     Cuba
  • Dosage form: & nbsplyophilizate for solution for intravenous and intraarterial administration
    Composition:
    1 vial contains: active substance - recombinant streptokinase 750 000 ME or 1 500 000 MB; Excipients - sodium hydrogenphosphate, sodium dihydrogenphosphate digydrat, natryya glutamate monohydrate, human albumin serum.

    Description:
    Lyophilized powder or mass packed in a tablet, white, without any visible particles.

    Pharmacotherapeutic group:fibrinolytic agent.
    ATX: & nbsp

    B.01.A.D.   Enzyme preparations

    B.01.A.D.01   Streptokinase

    Pharmacodynamics:
    When the compound of streptokinase with plasminogen (plasminogen) complex is formed, activating its transition in the blood or a blood clot in fibrinolizin (plasmin) - a proteolytic enzyme that dissolves the fibers of fibrin in blood clots and thrombi, causing degradation of fibrinogen and other plasma proteins, including factors folding of V and VII. Dissolves thrombi, acting both on their surface and from the inside.The most effective for fresh clots of fibrin (before retraction).
    With IV injection, the fibrinolytic effect peaks at 45 minutes. After the end of the infusion, the effect of the drug continues for several hours, the elongation of the thrombin time lasts up to 24 hours due to a simultaneous decrease in fibrinogen and an increase in the number of circulating degradation products of fibrin and fibrinogen. With intracoronary injection, thrombolysis occurs after 1 hour.
    Restores the patency of thrombosed blood vessels, allowing you to reduce the frequency of deaths and / or avoid urgent surgical intervention. With intravenous administration reduces blood pressure (BP) and the overall peripheral resistance of blood vessels with subsequent reduction in the minute volume of blood (IOC), in patients with chronic heart failure improves left ventricular function.
    The use of EKERKINASIS in acute myocardial infarction restores coronary blood flow, reduces the size of the infarction, reduces the likelihood of developing heart failure and cardiogenic Schock.
    In thrombosis of the deep veins of the extremities, the administration of Eberkinase allows the lysis of thrombi to be achieved in less than 72 hours, preventing the development of post-phlebitis syndrome for a long time.
    The drug restores blood flow in the arteriovenous anastomosis, eliminating the thrombosis of vascular access, observed in .70% of patients with terminal stage, chronic renal failure (ESRD) on program hemodialysis.
    Streptokinase activates not only tissue fibrinolysis (the action is aimed at dissolving the thrombus - thrombolysis), but also systemic fibrinolysis (cleavage of the fibrinogen of the blood), which can lead to bleeding (due to hypofibrinogenemia).
    Streptokinase - streptococcal protein with antigenic properties, so it is possible to neutralize it in the body with appropriate antibodies. In this situation, the acceleration of fibrinolysis is achieved by the introduction of excess (necessary for neutralizing antibodies) amounts of streptokinase.

    Pharmacokinetics:
    The half-life after intravenous administration of 1 500 000 ME is 1 hour, and the streptokinase-profibrinolysin complex is 23 minutes. The complex is partially inactivated by anti-streptococcal antibodies.The resulting fibrinolysin is inactivated by alpha2-antiplasmin and alpha2-microglobulin. Biotransformiruetsya in the liver by hydrolysis. It is excreted in a small amount by the kidneys. With liver diseases, excretion of the drug is delayed, renal failure does not affect excretion.

    Indications:
    • . Acute myocardial infarction (prescription up to 12 hours).
    • Deep vein thrombosis (prescription less than 14 days old).
    • . Thrombosis of permanent vascular access in patients with ESRD in program hemodialysis.
    • Thrombosis with prosthetic heart valves.
    • . Pulmonary embolism.
    • Acute and subacute thrombosis and thromboembolism of peripheral arteries.
    • Retrombosis after operations on the vessels.

    Contraindications:
    Hypersensitivity to the drug, bleeding, hemorrhagic diathesis, erosive-ulcerative lesions of the gastrointestinal tract, tumors with a tendency to bleeding, brain tumors or metastases in the CNS, traumatic brain injury, postoperative period (8 weeks for neurosurgery, 3 weeks for the remaining operations), up to 3 weeks after a biopsy of the internal organs, up to 4 weeks after the translumbral arteriography,3 months after intracranial hemorrhages and acute hemorrhagic stroke, uncontrolled arterial hypertension (BP more than 200/110 mmHg), aneurysm, diabetic hemorrhagic retinopathy, acute pancreatitis, bacterial endocarditis, pericarditis, recent multiple injuries, infection of thrombus and adherent tissues, hepatic or renal insufficiency (creatinine> 200 micromol / l), tuberculosis (active form).

    Carefully:
    Postponed streptococcal infection (including rheumatism), bronchiectasis with hemoptysis, esophageal veins, recent appointment of anticoagulants, conditions after cardiopulmonary resuscitation (including indirect cardiac massage), artificial lung ventilation, nephrourolythiasis, menorrhagia, menstrual period, presence intravesical catheter, prior treatment with streptokinase (from 5 days to 1 year), elderly age (over 75 years).

    Pregnancy and lactation:
    Pregnancy and lactation
    It is not recommended to use the drug during pregnancy and lactation, in the first 10 days after childbirth or abortion.

    Dosing and Administration:
    Doses of the drug should not exceed recommended. Dosing should be without adjustments to body weight.
    Preparation of the drug solution for intravenous, intraarterial and intracoronary injection.
    In a bottle with Eberkinase slowly 5 ml of water for injections is slowly added along the wall. To dissolve the preparation, the bottle is gently rotated, not shaking to avoid the formation of foam. The resulting concentrated solution is aseptically transferred to a vial for infusion of a suitable volume, according to the needs of the patient. The most suitable solvents are 0.9% sodium chloride solution or 5% dextrose solution.
    Do not add to the drug other components and medicines. The finished solutions should be used within 12 hours.
    Acute myocardial infarction.
    Treatment should be started as soon as possible, but no later than 12 hours after the occurrence of a heart attack. The drug is administered in one of two ways: intravenously - once in a dose of 1,500,000 IU for 60 minutes; or intracoronary (via a catheter) - bolus in a dose of 20,000 IU, and then intravenously as an infusion of 2,000-4,000 IU per minute for 30-90 minutes.
    Deep vein thrombosis.
    Intravenously through a catheter in the subclavian region or lower leg. If thrombosis affects several areas, the drug is injected into the most affected one. The initial dose of 250 000 ME of EKERKINASIS diluted in 100 ml of a 5% solution of dextrose or 0.9% sodium chloride solution is injected for 30 minutes, then transferred to a maintenance infusion of 100,000 IU per hour, lasting 24-72 hours depending on the time lysis of the clot.
    Thrombosis of permanent vascular access in patents with ESRD. who are on program hemodialysis.
    Eberkinase is injected directly into the arterial part of the vascular access at a dose of 1 000 000 ME; the maximum duration of infusion is 1 hour.
    Thromboembolism of the pulmonary artery and thrombosis with prosthetic heart valves.
    Via the peripheral vein of the upper limbs, 250 000 ME of EBERKINASIS are injected in 100 ml of a 5% dextrose solution or 0.9% sodium chloride solution for 30 minutes. Then continue infusion of 100,000 IU per hour before the onset of thrombus lysis, but no more than 72 hours.
    Acute and subacute thrombosis and thromboembolism of peripheral arteries. Retrombosis after operations on the vessels.
    Via the peripheral vein of the upper limbs, an initial dose of 250,000 IU of EKERKINASIS is administered,diluted in 100 ml of a 5% dextrose solution or 0.9% sodium chloride solution for 30 minutes, then maintaining a dose of 100,000 IU / h before lysis of the thrombus, but no more than 5 days.
    Application in pediatrics.
    Special studies on the use of Eberkina in children have not been conducted. However, there are separate observations on the use of the drug in children aged 1 month to 16 years, indicating the efficacy and safety of its use in pediatrics at a dose of 1,000 to 5,000 IU / kg in the form of an intravenous infusion lasting from 5 to 30 minutes, with followed by continuous infusion at a dose of 1,000 to 5,000 IU / kg before the onset of thrombus lysis, with strict monitoring of possible side effects.
    Side effect
    'Bleeding, as a rule, is limited to the place of administration, recent punctures, incisions, bleeding gums are possible in some cases; hemorrhages in the skin, periomyocardium, in the brain, hematoma; internal bleeding (gastrointestinal tract, urogenital, retroperitoneal, etc.); rupture of the spleen. Severe bleeding with the use of Eberkinase i was noted in 0.3% of patients, moderate bleeding at 0.6% and minor at 2.2%.
    g From the side of the cardiovascular system are possible Reduced blood pressure, reperfusion arrhythmia, brady or tachycardia,non-cardiogenic pulmonary edema (with intracoronary administration), thromboembolism (due to thrombus mobilization or fragmentation), incl. pulmonary artery (with deep vein thrombosis), distal artery (cholesterol embolus with local thrombolysis), embolic stroke.
    Allergic reactions can account for up to 3% of all side effects,
    including anaphylactic reactions (1-2%) and angioedema (0.2%), less often such manifestations as dyspnea, bronchospasm, skin rashes, urticaria, pruritus, hemorrhagic vasculitis (Shenlaine-Henoch syndrome) and serum sickness.
    | | Other reactions: fever, chills, tremor, vomiting, nausea and pain in the lumbar region, arthralgia, increased ESR, acute renal failure (up to 6-16 days after streptokinase administration); with repeated administration - increased activity of liver transaminases and alkaline phosphatase, gamma-glutamyl transpeptidase and creatine phosphokinase; hyperbilirubinemia, decreased activity of cholinesterase.

    Side effects:
    Bleeding.
    You should avoid intramuscular or subcutaneous injections, which are not justified to the fullest.Arterial punctures or punctures of the central veins, especially the femoral, are performed only in patients with absolute indications. At the end of the procedure, a pressure bandage is applied and the puncture site is regularly checked to detect hemorrhages. Strict measures are taken to prevent injuries, especially for patients who are on bed rest.
    Nasogastric and bubble probes are used only in inevitable cases.
    Special care should be taken when shaving the hair for the purpose of applying electrodes to electrocardiography.
    In extracerebral hemorrhage.
    Minor or superficial: manual compression or application of a pressure bandage.
    Significant-, the use of the drug is canceled, if it is not finished. The need to use freshly frozen plasma or antifibrial drugs should be considered.
    With intra-cerebral bleeding.
    The use of the drug is canceled if it is not finished. The diagnosis is confirmed as soon as possible by means of a computer tomography. The threat of squeezing the medulla oblongata requires appropriate medical measures.The need for antifibrinolytic drugs is determined individually.
    Arterial hypotension during intravenous infusion
    a) Reduction of systolic blood pressure (SBP) compared to baseline by 10 mm pm, cm.
    Position the patient's head horizontally. Reduce the speed of intravenous Eberkinase.
    b) If the SBP value is between 50 and 89 mm pm. cm.
    Discard intravenous administration. Arrange the patient in the Trendelenburg position. If there is no obvious congestion (congestion) or pulmonary edema, after 20 to 30 minutes, add 100 to 200 ml of a 0.9% solution of sodium chloride.
    at) If the SBP value is below 50 mm pm. cm. (state of shock):
    Discard the intravenous infusion. Monitor the hemodynamics of the patient. Carry out the procedure in accordance with b).
    Allergic Reagents
    Stop the intravenous infusion of Eberkinase. If necessary, the use of epinephrine (adrenaline), antihistamines or corticosteroids, as well as tracheal intubation.
    Heat
    At the beginning of therapy, an increase in temperature to 39 ° C, which usually spontaneously disappears after the first day of treatment, can be observed.If necessary, the use of antipyretics in normal doses is recommended. Sometimes the preventive use of antipyretic agents is permitted.

    Overdose:
    Symptoms: massive bleeding.
    Treatment: antifibrinolytic agents (tranexamic acid or
    aminomethylbenzoic acid, inhibitors of kallikrein and other proteases, for example, in / in the drip, aprotinin in the initial dose of 500 thousand KIE, then in a maintenance dose of 50-100 thousand KIE / h). Aminocaproic acid - 5 g for 1 h, then 1 g / h for 4-8 h until the effect is achieved with internal bleeding; restoration of blood loss (except for dextran and hydroxyethyl starch). Symptomatic treatment. All activities are conducted against the background of the cancellation of streptokinase.

    Interaction:
    Pharmacodynamic.
    Drugs that have anticoagulant and / or antiplatelet effects (heparin, coumarin derivatives, dipyridamole, dextran, acetylsalicylic acid, non-steroidal anti-inflammatory drugs, valproic acid and others) intensify the effect and increase the risk of bleeding, antifibrinolytic drugs - weaken.
    Pharmaceutical.
    Incompatible with plasma substitutes - hydroxyethyl starch or dextrin (can not be used as a solvent).
    Pregnancy and lactation
    It is not recommended to use the drug during pregnancy and lactation, in the first 10 days after childbirth or abortion.

    Special instructions:
    The diluted solution can be stored at 2-8 ° C for 24 hours without losing its activity. After this period, the solution should not be used!
    The resistance to lysis of the thrombus increases with its age, so therapy should be performed as soon as possible after the appearance of clinical symptoms. To minimize the risk of bleeding during thrombolytic therapy, the patient should be in bed in absolute rest, any movement, invasion (biopsy) or intramuscular injection should be ruled out. If therapy with heparin was given, it should be canceled.
    Periodic (with an interval of 4 hours) blood clotting is necessary: ​​thrombin or partial thromboplastin time (avoiding reocclusion of blood vessels allows the increase of thrombin time by 2-4 times,and partial thromboplastin - in 1,5-2,5 times; with this in mind, it is necessary to administer an appropriate amount of heparin - 0.5-1 thousand IU / h, and then oral coumarin derivatives).
    Before administration, patients with a history of elevated titer of anti-streptokinase antibodies are tested for sensitivity to streptokinase.
    At the beginning of the treatment infusion should be carried out at a low rate, 10 minutes before the start of infusion with the prophylactic purpose it is possible to administer antihistamines and 100-200 mg of methylprednisolone. Repeated administration may increase the likelihood of allergic reactions.
    During treatment with deep vein thrombosis, patients should not be interrupted Reception of contraceptives in order to avoid the development of menorrhagia.
    After 5 days of treatment and for 1 year after the termination of therapy, after the transferred streptococcal infection, the probability of development of resistance is high
    due to the appearance of a high titer of anti-streptococcal antibodies. If it is necessary to conduct thrombolytic therapy in this case, you can use other fibrinolytics (urokinase and etc.).
    For intravenous administration, vessels of the upper limbs are preferred; after the procedure - applying a pressure bandage for 30 minutes, with subsequent monitoring,because of possible bleeding (do not administer within 10 days after arterial punctures and / or injections).
    In all cases where there is a high probability of bleeding, including difficult to control due to localization, an assessment of the risk-benefit ratio is necessary.

    Form release / dosage:
    Liofilizate for the preparation of solution for intravenous or intra-arterial administration.

    Packaging:
    Liofilizate for the preparation of solution for intravenous or intra-arterial administration. By 750,000 ME or 1500,000 ME of the preparation into glass bottles sealed with a chlorobutyl gray stopper and closed by an aluminum flap of a natural color flip off, at the top with a closed polypropylene plastic cover, an aluminum ring that is not pulled together with the plastic button after opening the cap.
    For 1 bottle with instructions for use in a cardboard bundle.

    Storage conditions:
    At a temperature of 2 to 8 ° C.
    Keep out of the reach of children!

    Shelf life:
    3 years.
    Do not use after expiry date.

    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-006593/09
    Date of registration:18.08.2009
    The owner of the registration certificate:Eber Biotech SAEber Biotech SA Cuba
    Manufacturer: & nbsp
    Information update date: & nbsp20.08.2015
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