Active substanceStreptokinaseStreptokinase
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  • Streptokinase
    lyophilizate in / in 
    BELMEDPREPARATY, RUP     Republic of Belarus
  • Thromboflue
    lyophilizate in / in 
  • Eber Biotech SA     Cuba
  • Dosage form: & nbsp
    Lyophilizate for preparation of solution for intravenous or intraarterial administration.

    Composition:
    1 bottle contains:
    active substance: streptokinase 1 500 000ME
    auxiliary substances: human serum albumin,
    polygelin.

    Description:
    Description white powder or loose solid mass; hygroscopic.

    Pharmacotherapeutic group:fibrinolytic agent
    ATX: & nbsp

    B.01.A.D.   Enzyme preparations

    B.01.A.D.01   Streptokinase

    Pharmacodynamics:
    In conjunction with plasminogen (plasminogen) forms a complex, activating the last 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. . coagulation factors V and VII. Dissolves thrombi, acting both on their surface and from the inside.
    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.
    Restores the patency of thrombosed blood vessels. With intravenous infusion reduces blood pressure (BP) and general peripheral resistance of blood vessels (OPSS), followed by a decrease in the minute volume of circulation (IOC), in patients with chronic heart failure (CHF) improves left ventricular function. Reduces the frequency of deaths with myocardial infarction. It improves the functional parameters of the heart. Reduces the number of thrombotic complications in diseases of the cardiovascular system (CVS) and deaths from pulmonary embolism.
    The maximum effect is observed after 45 minutes. After the infusion is over, the fibrinolytic effect is observed for several hours, the elongation of the thrombin time persists to 24 hours due to a simultaneous decrease in fibrinogen and an increase in the number of circulating degradation products of fibrin and fibrinogen. Activates not only tissue fibrinolysis (the action is aimed at dissolving thrombus - thrombolysis),but also systemic fibrinolysis (cleavage of the fibrinogen of the blood), in connection with this, bleeding may develop (due to hypofibrinogenemia). The most effective for fresh clots of fibrin (before retraction). With intracoronary injection, thrombolysis occurs after 1 hour.

    Pharmacokinetics:
    Metabol is made from hydrolysis. The half-life period after intravenous administration of 1.5 million ME - 1 h, and the complex
    streptokinase-profibrinolysin - 23 min. The complex is partially inactivated by anti-streptococcal antibodies. The resulting fibrinolysin is inactivated by alpha2-antiplasmin and alpha2-microglobulin.
    It is excreted in a small amount by the kidneys. With diseases, liver clearance is slowed.

    Indications:
    Acute myocardial infarction (up to 24 h), thromboembolism of the pulmonary artery and its branches.
    Thrombosis and thromboembolism of arteries (acute, subacute, chronic thrombosis of peripheral arteries, chronic obliterating endarteritis, obliteration of arteriovenous shunt), occlusion of central retinal vessels with a prescription of less than 6-8 hours (arteries), less than 10 days (veins); arterial thrombosis
    diagnostic or therapeutic procedures in children, vascular thrombosis during catheterization in newborns.
    Thrombosis of the veins of the internal organs, thrombosis of the deep veins of the extremities (with the prescription of less than 14 days) and the pelvis.
    Retrombosis after operations on the vessels.
    Thrombosis of hemodialysis shunt. Thrombosis with prosthetic heart valves. Washing of intravenous catheters (including for hemodialysis). Mono- or combined therapy of rest stenocardia with acute myocardial infarction.

    Contraindications:
    Hypersensitivity, bleeding, hemorrhagic diathesis, erosive-ulcerative lesions of the gastrointestinal tract (GI tract), inflammatory bowel disease, recent multiple injuries, aneurysm, tumors with a tendency to bleeding, brain tumors or metastases in the central nervous system (CNS), arterial hypertension (blood pressure more than 200/110 mmHg), diabetic retinopathy, acute pancreatitis, endocarditis, pericarditis, mitral heart defects with atrial fibrillation, tuberculosis (active form), pulmonary caverns, sepsis ischemia, septic thrombosis, postoperative period (8-12 postoperative days, 3-6 weeks after advanced surgical interventions, 8 weeks after neurosurgical operations), recent biopsy of internal organs, 4 weeks after translumbral arteriography,3 months after an acute hemorrhagic stroke; permanent bladder catheter; childhood.

    Carefully:
    With caution - Hepatic / renal failure, bronchial asthma, streptococcal infection (including rheumatism), bronchiectasis with hemoptysis, esophageal veins, recent appointment of anticoagulants, post-cardiopulmonary resuscitation (including indirect cardiac massage), artificial ventilation of the lungs, nefrourolitiaz, menorrhagia, menstrual period, previous treatment with streptokinase (from 5 days to 1 year), elderly age (over 75 years).

    Pregnancy and lactation:
    The use of the drug is contraindicated in the first 18 weeks of pregnancy; in the pathology of pregnancy associated with an increased risk of bleeding, recent childbirth (within 10 days) or the artificial termination of pregnancy.

    Dosing and Administration:
    Intravenously drip, intraarterially, intracoronary. Intravenously (to dissolve the powder, gently mix, avoiding foaming, with 5 ml of a 0.9% solution of sodium chloride or water for injection, with Ringer's solution).
    For short-term lysis in thrombosis of peripheral arteries or veins, an initial dose of 250,000 IU is intravenously dripped for 30 minutes, followed by maintenance doses of 1.5 million ME each hour for 6 hours, the maximum dose per cycle is 9 million ME. It is possible to repeat the 6 hour introduction on the next day, which takes place no later than 5 days after the first course. In the case of prolonged thrombolysis - 250 thousand ME intravenously drip for 30 minutes, then 1 million IU / h in the form of infusion lasting from 12 hours to 3-5 days (no more). If necessary, continue therapy after a break and with a possible replacement for another homologous thrombolytic.
    For coronary thrombosis, 1.5 million IU for 60 minutes, followed by the administration of heparin at a dose of 1,000 IU / h.
    The effect is monitored by determining thrombin or partial thrombollastine time. For long-term lysis in peripheral vascular thrombosis 250,000 IU are administered for 30 minutes. The maintenance dose is 100 thousand IU / h. This achieves a 2-4-fold increase in thrombin time 6-8 hours after the onset of lysis. The concentration of fibrinogen in the plasma should not be less than 1 g / l. If after a few hours the thrombin time increases more than 4 times, the maintenance dose should be reduced by a factor of 2 and applied until,The thrombin time index again does not stabilize in the above interval.
    For lysis of the intracoronary thrombus, intracoronary injection is introduced, with the help of a catheter 20,000 ME, then 2-4 thousand IU / mi, a total dose of 140,000 IU, 30-40 minutes or 250-300 thousand ME for 30-60 min. The administration does not stop earlier than 1 hour, although recanalization may develop more rapidly.
    For the prevention of retrombosis appoint heparin. Duration of treatment should not exceed 5 days.
    Patients with acute, subacute, chronic peripheral thrombosis and thromboembolism are administered 1-2 thousand IU at intervals of 3-5 minutes. Duration and quantity depend on the localization and depth of occlusion of the vessel, maximal - 120 thousand ME for 3 hours. It is possible to perform simultaneous angioplasty.
    Local thrombolysis in acute, subacute and chronic thrombosis and thromboembolism of peripheral arteries intraarterially, at a dose of 1-2 thousand ME at intervals of 3-5 minutes until the effect is achieved. The total dose should not exceed 120 thousand, ME.
    For deep vein thrombosis and pulmonary embolism, intravenous drip, 250,000 IU for 30 minutes, then 100,000 IU / h for 24-72 hours in accordance with pathology.
    To restore the patency of the cannula - 100-250 thousand.ME in 2 ml of sodium chloride solution, slowly into each occluded end. The procedure is carried out for 2 hours, followed by aspiration of contents from the cannula.

    Side effects:Bleeding from the injection site, gums; hemorrhages in the skin, peri- and myocardium, in the brain, hematoma; internal bleeding (gastrointestinal tract, urogenital, retroperitoneal, etc.); rupture of the spleen; reperfusion arrhythmia, 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; capillarotoxicosis (Schönlein-Henoch syndrome); increased ESR, with repeated administration - increased activity of "liver" transaminases and alkaline phosphatase (APF), gamma-glutamintranspeptidase (GGT), creatine phosphate kinase (CKF); hyperbilirubinemia, decreased activity of cholinesterase. Allergic reactions (especially with repeated injections): skin hyperemia, urticaria, generalized exanthema, dyspnea, bronchospasm, hyperthermia, chills, headache, myalgia, pain in the spine, lowering blood pressure, brad and-or tachycardia, arthritis, vasculitis .h.hemorrhagic), nephritis, polyneuropathy, angioedema, anaphylactic shock.
    Overdose:
    Symptoms: massive bleeding.
    Treatment: antifibrinolptic medicines (LS) (tranexamic acid or PABA, inhibitors of kallikrein and other proteases, for example, intravenously 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 dextran and
    hydroxyethyl starch). Symptomatic treatment. All activities are conducted against the background of the cancellation of streptokinase.

    Interaction:
    Heparin, coumarin derivatives, dipyridamole, acetylsalicylic, valproic acid increase the effect and increase the risk of bleeding; antifibrinolytic drugs - weaken. Incompatible with plasma-substitute drugs - hydroxyethyl starch or dextran (can not be used as a solvent).

    Special instructions:
    Ready solutions should be used within 12 hours. Periodic (with an interval of 4 hours) blood coagulability monitoring is necessary: thrombin or partial
    thromboplastin time (avoiding reocclusion of blood vessels allows an increase in thrombin time by 2-4 times, and partial thromboplastin time by 1.5-2.5 times, taking into account that it is necessary to inject an appropriate amount of heparin - 0.5-1 thousand IU / h, followed by oral coumarin).
    Before administration, patients with a history of elevated titer of anti-streptokinase antibodies are tested for sensitivity to streptokinase.
    At the beginning of 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 antihistamine drugs and 100-200 mg of methylprednisolone. Repeated administration may increase the likelihood of allergic reactions.
    During treatment with deep vein thrombosis, patients should not stop taking contraceptives in order to avoid the development of menorrhagia.
    After 5 days of treatment and for 1 year after the end of therapy, after the streptococcal infection, the probability of development of resistance is high due to the appearance of 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, in view of possible bleeding (do not enter within 10 days after arterial punctures and / m injections).
    Effect on the ability to drive transp. cf. and fur:Not detected
    Form release / dosage:
    Lyophilizate, for the preparation of a solution for intravenous and intra-arterial administration of 1 500 000 ME, in a bottle of transparent colorless neutral borosilicate tubular glass 5 ml in volume, with a rubber stopper and a snap-in aluminum cap.
    One bottle with the drug in a cardboard box together with the Instruction for Use.

    Packaging:

    Lyophilizate, for the preparation of a solution for intravenous and intra-arterial administration of 1 500 000 ME, in a bottle of transparent colorless neutral borosilicate tubular glass 5 ml in volume, with a rubber stopper and a snap-in aluminum cap.
    One bottle with the drug in a cardboard box together with the Instruction for Use.
    Storage conditions:In the dark place at a temperature of 2 ° C to 8 ° C. Keep out of the reach of children.
    Shelf life:
    2 years.
    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009717/08
    Date of registration:05.12.2008
    The owner of the registration certificate:Bharat Searms & Waxings LimitedBharat Searms & Waxings Limited India
    Manufacturer: & nbsp
    Representation: & nbspMEDINTORG, ZAOMEDINTORG, ZAO
    Information update date: & nbsp20.08.2015
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