Enixum solution for injection 7000 anti-HaIU/0.7ml 0.7ml, syringes 10pcs

Composition

1 syringe (0.7 ml) contains as an Active ingredient eioxaparin sodium 7000 anti-Xa IU (70 mg); excipients: water for injection-up to 0.7 ml

Pharmacological action

Enoxapari sodium is a low-molecular-weight heparin. Average molecular weight about 4500 daltons: less than 2000 daltons – <20%,2000 to 8000 daltons – > 68%, more than 8000 daltons – <20%,2000 to 8000 daltons – > Enoxapari sodium is obtained by alkaline hydrolysis of gasoline ether of heparin isolated from the mucosa of the small intestine of pigs. Its structure is characterized by a non-reducing fragment of 2-0-sulfo-4-enpyrazinosuronic acid and a reducing fragment of 2-14.6-0-disulfo-0-glucopyranoside.

The structure of enoxaparin sodium contains about 20% (ranging from 15% to 25%) of the 1.6-anhydrone derivative in the reducing fragment of the polysaccharide chain.

Pharmacodynamics

In vitro enoxapari sodium has high activity against coagulation factor Xa (anti-Xa activity of approximately 100 IU / ml) and low activity against coagulation factor Na (antp-IIa or anti-thrombin activity of approximately 28 IU / ml). This anticoagulant activity is mediated by antithrombin III (AT-III). In addition to anti-Xa/IIa activity, additional anticoagulant and anti-inflammatory properties of enoxaparpone sodium have also been identified in both human and animal models, which include AT-III-dependent inhibition of other clotting factors, such as Factor Vila, activation of the release of the pu ti inhibitor tissue factor, as well as a decrease in the release of von Willebrand factor from the vascular endothelium into the bloodstream. These factors contribute to the overall anticoagulant effect of enoxaparin sodium.

When used in prophylactic doses, epoxaparin sodium slightly changes the activated partial thromboplasmic time (APTT). It has virtually no effect on platelet aggregation and on the degree of binding of fibrinogen to platelet receptors.

Anti-IIa activity in plasma is approximately 10 times lower than anti-Xa activity.

The average maximum anti-IIa activity is observed approximately 3-4 hours after subcutaneous use and reaches 0.13 IU / ml and 0.19 IU / ml after repeated use of 1 mg/kg of body weight-with a double use and 1.5 mg/kg of body weight – with a single use, respectively. The average maximum anti-Xa plasma activity is observed 3-5 hours after subcutaneous use of the drug and is approximately 0.2; 0.4; 1.0 and 1.3 anti – Xa IU / ml after subcutaneous use of 20 mg,40 mg and 1 mg / kg and 1.5 mg / kg, respectively

Indications

– prevention of venous thrombosis and embolism in surgical interventions, especially in orthopedic and General surgical operations;

– prevention of venous thrombosis and embolism in patients who are on bed rest due to the acute therapeutic disease (including acute heart failure and decompensation of chronic heart failure (III or class IV NYHA), acute respiratory failure; acute infectious diseases; acute stage of rheumatic diseases in combination with one of the risk factors of venous thrombosis (see “Special instructions”));

– treatment of deep vein thrombosis, accompanied or not accompanied by pulmonary thromboembolism;

– treatment of unstable angina and myocardial infarction without Q wave in combination with acetylsalicylic acid;

– prevention of thrombosis in the extracorporeal blood circulation during hemodialysis (usually, if the duration of the session is not more than 4 hours);

– the treatment of acute myocardial infarction with ST-segment elevation in patients subject to medical treatment or subsequent percutaneous coronary intervention.

Contraindications

-Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low-molecular-weight heparins;

– active large bleeding, as well as conditions and diseases in which there is a high risk of bleeding: threatened abortion, cerebral vascular aneurysm or dissecting aortic aneurysm (except in cases of surgical intervention in this regard). recent hemorrhagic stroke, uncontrolled bleeding, thrombocytopenia in combination with positive test in vitro for antiplatelet antibody in the presence of enoxaparin sodium;

not recommended enoxaparin sodium in the prophylaxis of thrombosis in pregnant women with mechanical artificial heart valves (lack of clinical experience);

– age under 18 years (effectiveness and safety not established).

With caution:

Conditions where there is a potential risk of bleeding:

– hemostatic disorders (including hemophilia, thrombocytopenia, anticoagulation, von Willebrand disease, etc. ), severe vasculitis;

– ulcer of the stomach or duodenum or others;

– erosive-ulcerative lesions of the gastrointestinal tract in history;

– recent ischemic stroke;

– uncontrolled severe arterial hypertension;

– diabetic or hemorrhagic retinopathy;

– severe diabetes mellitus;

– recently moved or suspected neurological or ophthalmic surgery;

– carrying out spinal or epidural anesthesia (potential risk of bruising), a lumbar puncture (recently moved):

– recent delivery;

– bacterial endocarditis (acute or subacute):

– pericarditis or pericardial effusion;

renal and/or hepatic insufficiency;

intrauterine contraception (IUD);

– severe trauma (especially the Central nervous system (CNS)), open wounds on large surfaces;

– concomitant use of drugs affecting hemostasis;

heparin-induced thrombocytopenia (history) in combination with or without thrombosis.

There are no data on the clinical use of enoxaparin sodium in the following diseases: active tuberculosis, radiation therapy (recently transferred).

Side effects

Side effects were classified by frequency as follows: very frequent (> 1/10), frequent (>>1/100 – >><1/10), infrequent (>1/1000 – <1/10), infrequent (><1/100), rare (>1/10000 – <1/100), rare (><1/1000), very rare (

Bleeding

Bleeding may occur, especially in the presence of concomitant risk factors: organic changes with a tendency to bleed, age, renal failure, low body weight, and certain drug combinations (see “Interactions with other drugs”). If bleeding develops, it is necessary to cancel the drug use, determine the cause of bleeding and start appropriate therapy.

Very frequent – bleeding in the prevention of venous thrombosis, in surgical patients and in the treatment of deep vein thrombosis with or without thromboembolism.

Frequent-bleeding in the prevention of venous thrombosis in patients on bed rest and in the treatment of angina, non-Q-wave myocardial infarction and ST-segment elevation myocardial infarction.

Infrequent-retroperitoneal bleeding and intracranial bleeding in patients treated for deep vein thrombosis with or without thromboembolism, as well as in ST-segment elevation myocardial infarction.

Rare-retroperitoneal bleeding in the prevention of venous thrombosis in surgical patients and in the treatment of angina pectoris, myocardial infarction without Q wave.

When using enoxaparin sodium against the background of spinal/epidural anesthesia and postoperative use of penetrating catheters, rare cases of formation of neuroaxial hematomas have been described, leading to neurological disorders of varying severity, including long-term or irreversible paralysis (see “Special Instructions”).

Thrombocytopenia and platelets

Very frequent – thrombocytosis in the prevention of venous thrombosis in surgical patients and in the treatment of deep vein thrombosis with or without thromboembolism.

Frequent-thrombocytopenia. In the prevention of venous thrombosis in surgical patients and in the treatment of deep vein thrombosis with or without thromboembolism, as well as in ST-segment elevation myocardial infarction.

Infrequent-thrombocytopenia in the prevention of venous thrombosis in patients on bed rest and in the treatment of angina pectoris, myocardial infarction without Q wave.

Very rare – autoimmune thrombocytopenia in ST-segment elevation myocardial infarction.

In rare cases, the development of autoimmune thrombocytopenia in combination with thrombosis has been reported. In some cases, thrombosis was complicated by an organ infarction or limb ischemia (see the section “Special instructions”).

Other services

Very often – increased activity of “hepatic” transaminases.

Often – allergic reactions, hives, itching, redness of the skin, hematoma and pain at the injection site.

Infrequently-skin (bullous rashes), inflammatory reaction at the injection site, skin necrosis at the injection site.

Rarely – anaphylactic and anaphylactoid reactions, hyperkalemia. Skin necrosis may develop at the injection site, which is preceded by the appearance of purpura or erythematous painful papules. In these cases, therapy with the drug should be discontinued. It is possible to form solid inflammatory nodules-infiltrates at the injection site of the drug, which disappear after a few days and are not a reason for discontinuing the drug.

Interaction

Do not mix Enixum with other medications in the same syringe.

When used concomitantly with other drugs that affect hemostasis (salicylates, including acetylsalicylic acid, nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac, dextran with a molecular weight of 40 kDa. ticlopidine, clopidogrel, and systemic corticosteroids (corticosteroids). thrombolytics or anticoagulants, other antiplatelet drugs, including glycoprotein IIb/IIIa receptor antagonists), increase the risk of bleeding (see “Special instructions”).

How to take, course of use and dosage

Except in special cases (see below “Treatment of ST-segment elevation myocardial infarction, medication or percutaneous coronary intervention” and “Prevention of thrombosis in the extracorporeal circulatory system during hemodialysis”) enoxaparin sodium is administered by deep subcutaneous injection. Injections should preferably be performed in the patient’s “lying down” position. Injections should be performed alternately in the left or right anterolateral or posterolateral surface of the abdomen.

The needle should be inserted vertically (not laterally) into the skin fold for the entire length, collected and held until the injection is completed between the thumb and index finger. The skin fold is released only after the injection is completed. Do not massage the injection site after use of the drug.

The pre-filled disposable syringe is ready for use.

The drug should not be administered intramuscularly!

Prevention of venous thrombosis and embolism in surgical procedures especially in orthopedic and general surgical operations

In patients with a moderate risk of developing thrombosis and embolism (general surgical operations), the recommended dose of the drug is 20 mg once a day subcutaneously. The first injection is made 2 hours before surgery.

In patients with a high risk of developing thrombosis and embolism (general surgical and orthopedic operations), the drug is recommended at a dose of 40 mg once a day subcutaneously; the first dose is administered 12 hours before surgery, or 30 mg 2 times a day with the start of use 12-24 hours after surgery.

The average duration of treatment with the drug is 7-10 days. If necessary, therapy can be continued as long as the risk of thrombosis and embolism persists (for example, in orthopedics, enoxaparin sodium is used 40 mg once a day for 5 weeks).

The specific features of prescribing the drug for spinal / epidural anesthesia, as well as for percutaneous coronary angioplasty, are described in the section “Special instructions”.

Prevention of venous thrombosis and embolism in patients on bed rest due to acute therapeutic diseases

The recommended dose of enoxaparin sodium is 40 mg once daily subcutaneously for 6-14 days.

Treatment of deep vein thrombosis with or without pulmonary embolism

Enixum® is administered subcutaneously at the rate of 1.5 mg / kg once a day or at a dose of 1 mg / kg twice a day. In patients with complicated thromboembolic disorders, the drug is recommended to be used at a dose of 1 mg/kg twice a day.

The average duration of treatment is 10 days. It is advisable to immediately start therapy with oral anticoagulants, while enoxaparin sodium therapy should be continued until a sufficient anticoagulant effect is achieved, i. e. the INR should be 2.0-3.0. If necessary, control of the anticoagulant effect should be evaluated by anti-Xa activity.

Treatment of unstable angina and non-Q wave myocardial infarction in combination with acetylsalicylic acid

Enixum® is administered at the rate of 1 mg/kg of body weight every 12 hours subcutaneously, with simultaneous use of acetylsalicylic acid inside at a dose of 100-325 mg once a day.

The average duration of treatment is 2-8 days (until the patient’s clinical condition stabilizes).

Treatment of ST-segment elevation myocardial infarction, by medication or by percutaneous coronary intervention

Treatment begins with intravenous bolus use of enoxaparin sodium at a dose of 30 mg and immediately after it (within 15 minutes) is administered subcutaneously at a dose of 1 mg/kg (and during the first two subcutaneous injections, a maximum of 100 mg of enoxaparin sodium can be administered). Then all subsequent subcutaneous doses are administered every 12 hours at the rate of 1 mg / kg (i. e., with a body weight of more than 100 kg, the dose may exceed 100 mg).

In persons 75 years of age and older, the initial intravenous bolus is not used. Enoxaparin sodium is administered subcutaneously at a dose of 0.75 mg / kg every 12 hours (moreover, during the first two subcutaneous injections, a maximum of 75 mg of enoxaparin sodium can be administered). Then, all subsequent subcutaneous doses are administered every 12 hours at the rate of 0.75 mg / kg (i. e., if the body weight is more than 100 kg, the dose may exceed 75 mg). In combination with thrombolytics (fibrin-specific and fibrin – iespecific) enoxaparin sodium should be administered between 15 minutes before the start of thrombolytic therapy and 30 minutes after it. After detection of acute ST-segment elevation myocardial infarction, acetylsalicylic acid should be started simultaneously as soon as possible, which, in the absence of contraindications, should continue for at least 30 days in doses from 75 to 325 mg daily. The recommended duration of treatment with the drug is 8 days or until the patient is discharged from the hospital, if the period of hospitalization is less than 8 days. Bolus use of enoxaparin sodium should be performed through a venous catheter and enoxaparin sodium should not be mixed or administered together with other medications. In order to avoid the presence of traces of other drugs in the system and their interaction with enoxaparin sodium, the venous catheter should be flushed with a sufficient amount of 0.9% sodium chloride solution or dextrose before and after intravenous bolus use of enoxaparin sodium. Enoxaparin sodium is compatible with 0.9% sodium chloride solution and 5% dextrose solution.

For bolus use of 30 mg of enoxaparin sodium in the treatment of acute ST-segment elevation myocardial infarction, an excessive amount of the drug is removed from glass syringes of 60 mg,80 mg and 100 mg so that only 30 mg (0.3 ml) remains in them. A dose of 30 mg can be directly administered intravenously.

For intravenous bolus use of enoxaparin sodium through a venous catheter, pre-filled syringes for subcutaneous use of the drug 60 mg,80 mg and 100 mg can be used. It is recommended to use syringes of 60 mg, as this reduces the amount of drug removed from the syringe. 20 mg syringes are not used, as they do not contain enough preparation for bolus use of 30 mg of enoxaparin sodium. Syringes of 40 mg are not used, as they do not have divisions and therefore it is impossible to accurately measure the amount of 30 mg.

In patients undergoing percutaneous coronary intervention, if the last subcutaneous injection of enoxaparin sodium was performed less than 8 hours before inflating the balloon catheter inserted into the site of narrowing of the coronary artery, additional use of enoxaparin sodium is not required. If the last subcutaneous injection of enoxaparin sodium was administered more than 8 hours before inflating the balloon catheter, an additional intravenous bolus of enoxaparin sodium should be administered at a dose of 0.3 mg/kg.

To increase the accuracy of additional bolus injection of small volumes into the venous catheter during percutaneous coronary interventions, it is recommended to dilute the drug to a concentration of 3 mg / ml. Dilution of the solution is recommended immediately before use.

To obtain a solution of enoxaparin sodium with a concentration of 3 mg / ml using a pre-filled syringe, it is recommended to use a container with an infusion solution, from which part of the solution is extracted to the required volume using a conventional syringe. Enoxaparin sodium (the contents of the hypodermic syringe) is injected into the remaining infusion solution in the container.

The contents of the container with a diluted solution of enoxaparin sodium are carefully mixed. For use with a syringe, the required volume of diluted enoxaparin sodium solution is extracted, which is calculated by the formula:

Volume of diluted solution = Patient’s body weight (kg) x 0.1 or using the table below.

Volumes to be administered intravenously after dilution

Prevention of thrombosis in the extracorporeal circulatory system during hemodialysis (usually, if the session duration is not more than 4 hours)

The average dose of enoxaparin sodium is 1 mg / kg. For patients with a high risk of bleeding, the dose should be reduced to 0.5 mg / kg for double vascular access or to 0.75 mg for single vascular access.

During hemodialysis, Enixum® should be inserted into the arterial section of the shunt at the beginning of the hemodialysis session. One dose is usually sufficient for a four-hour session, but if fibrin rings are detected during longer hemodialysis, the drug can be additionally administered at the rate of 0.5-1 mg/kg.

Elderly patients

With the exception of treatment of ST – segment elevation myocardial infarction (see above), no dose reduction of enoxaparin sodium is required for all other indications in elderly patients who do not have impaired renal function.

Patients with renal insufficiency

Severe renal impairment (endogenous creatinine clearance less than 30 ml / min). The dose of enoxaparin sodium is reduced in accordance with the tables below, as these patients accumulate the drug.

When using the drug for therapeutic purposes, the following dosage adjustment is recommended::

When using the drug for preventive purposes, the following dosage adjustment is recommended:

The recommended dosage adjustment is not applicable during hemodialysis.

In mild (creatinine clearance 50-80 ml/min) and moderate (creatinine clearance 30-50 ml/min) renal insufficiency, no dose adjustment is required, but laboratory monitoring of therapy should be carried out more carefully.

Patients with hepatic insufficiency

Due to the lack of clinical studies, caution should be exercised when using enoxaparin sodium in patients with impaired liver function.

Overdose

Symptoms: hemorrhagic complications in case of accidental overdose with subcutaneous use of enoxaparin sodium. With accidental ingestion of even large doses, absorption of the drug is unlikely.

Treatment: neutralize the effect of enoxaparin sodium by slow intravenous (iv) use of protamine sulfate. 1 mg of protamine sulfate neutralizes the anticoagulant effect of 1 mg of enoxaparin sodium, if the drug was administered no more than 8 hours before the use of protamine sulfate.

0.5 mg of protamine sulfate neutralizes the anticoagulant effect of 1 mg of enoxaparin sodium, if it was administered more than 8 hours ago or if a second dose of protamine sulfate is necessary.

If 12 or more hours have elapsed since the introduction of enoxaparin sodium, the introduction of protamine sulfate is not required. However, even with high doses of protamine sulfate, the anti-Xa activity of enoxaparin sodium is not completely neutralized (by a maximum of 60%).

Special instructions

General information

Low-molecular-weight heparins are not interchangeable, as they differ in the production process, molecular weight, specific anti-Xa activity, dosage units and dosage regimen, which are associated with differences in their pharmacokinetics and biological activity (antithrombin activity and platelet interaction). Polom is required to strictly follow the recommendations for the use of each drug belonging to the class of low-molecular-weight heparins.

Bleeding

As with other anticoagulants, the use of Enixum® may cause bleeding of any localization (see “Side effects”). If bleeding develops, it is necessary to find its source and prescribe appropriate treatment.

Bleeding in elderly patients

When using enoxaparin sodium in prophylactic doses in elderly patients, there was no tendency to increase bleeding. When using enoxaparin sodium in therapeutic doses in elderly patients (especially at the age of 80 years and older), there is an increased risk of bleeding. Careful monitoring of these patients is recommended (see “Pharmacokinetics” and “Dosage and use”, subsection “Elderly patients”). Concomitant use of other drugs that affect hemostasis Recommended. to prevent the use of drugs that affect hemostasis (salicylates, including acetylsalicylic acid. NSAIDs, including ketorolac, dextrin with a molecular weight of 40 kDa, ticlopidine, clopidogrel, corticosteroids, thrombolytics, anticoagulants, antiplatelet agents, including glycoprotein antagonists (solutions IIb/IIIa), were discontinued prior to treatment with enoxaparin sodium, except when their use is necessary. If combinations of enoxaparin sodium with these drugs are indicated, then careful clinical monitoring and monitoring of appropriate laboratory parameters should be carried out.

Kidney failure

Patients with impaired renal function are at risk of developing bleeding as a result of increased systemic exposure to enoxaparin sodium

In patients with severe renal impairment (creatinine clearance less than 30 ml / min), there is a significant increase in exposure to enoxaparin sodium, so it is recommended to adjust the dose. as with preventive, hac and therapeutic use of the drug. Although no dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance 30-50 ml / min or 50-80 ml / min), careful monitoring of these patients is recommended (see “Pharmacokinetics” and “Dosage and use”, subsection “Patients with renal insufficiency”).

Low body weight

There was an increase in exposure to enoxaparin sodium with its preventive use in women with a body weight of less than 45 kg and in men with a body weight of less than 57 kg, which may lead to an increased risk of bleeding. Careful monitoring of these patients is recommended.

Obese patients

Obese patients have an increased risk of developing thrombosis and embolism.The safety and efficacy of enoxaparin sodium in prophylactic doses in obese patients (body mass index greater than 30 kg / m2) is not fully defined, and there is no consensus on dose adjustment. These patients should be closely monitored for signs and symptoms of thrombosis and embolism.

Controlling the number of platelets in peripheral blood

The risk of developing antibody-mediated heparin-induced thrombocytopenin also exists with the use of low-molecular-weight genarins. If thrombosis develops, it is usually detected between 5 and 21 days after the start of enoxaparin sodium therapy. In this regard, it is recommended to regularly monitor the number of platelets in the peripheral blood before starting treatment with Enixum® and during its use. If there is a confirmed significant decrease in platelet count (by 30-50% compared to baseline), it is necessary to immediately cancel enoxaparin sodium and transfer the patient to another therapy. Spinal / epidural anesthesia

Cases of occurrence of neuroaxial hematomas with enoxaparin sodium and simultaneous spinal/epidural anesthesia with the development of long-term or irreversible paralysis are described. The risk of these events is reduced when enoxaparin sodium is administered at a dose of 40 mg or lower.

The risk increases with higher doses of enoxaparin sodium, as well as with the use of permanent catheters after surgery, or with the simultaneous use of additional drugs that affect hemostasis, such as NSAIDs (see “Interaction”). The risk is also increased with traumatic or repeated spinal puncture, or in patients with a history of spinal surgery or spinal deformity. To reduce the possible risk of bleeding associated with the use of enoxaparin sodium and epidural or spinal anesthesia/analgesia. The pharmacokinetic profile of the drug should be taken into account (see “Pharmacokinetics”). Catheter insertion or removal is best performed when the anticoagulant effect of enoxanarin sodium is low, but the exact time to achieve a sufficient reduction in the anticoagulant effect in different patients is unknown.

Insertion or removal of the catheter should be performed at least 12 hours after the introduction of lower doses of Enixum® (20 mg once a day,30 mg once or twice a day. 40 mg once daily) and at least 24 hours after use of higher doses of Enixum® (0.75 mg / kg body weight twice daily. 1 mg/kg of body weight twice a day. 1.5 mg / kg once a day). At these time points, the anti – Xa activity of enoxanarin sodium still continues to be detected, and delaying this time is not a guarantee of that. that the development of a neuroaxial hematoma can be avoided.

Patients receiving enoxaparin sodium at doses of 0.75 mg / kg of body weight twice a day or 1 mg/kg of body weight twice a day, with this (twice a day) dosage regimen, should not be given a second dose in order to increase the interval before installing or replacing the catheter. Similarly, consideration should be given to delaying the next dose of enokeaparin sodium for at least 4 hours based on the benefit/risk ratio (risk of thrombosis and bleeding during the procedure, taking into account the presence of risk factors in patients). However, it is not possible to give clear recommendations on the time of use of the next dose of enokeaparin sodium after catheter removal. It should be noted that in patients with a creatinine clearance of less than 30 ml/min, the elimination of enokeaparin sodium slows down. Therefore, in this category of patients, doubling the time from catheter removal should be considered: at least 24 hours for lower doses of enoxaparin sodium (30 mg once daily) and at least 48 hours for higher doses (1 mg/kg body weight per day).

If the doctor prescribes anticoagulant therapy during epidural / spinal anesthesia or lumbar puncture, the patient should be constantly monitored for any neurological symptoms, such as pain in the blue eyes, impaired sensory and motor functions (numbness or weakness in the lower extremities), impaired bowel and/or bladder function. The patient should be instructed to inform the doctor immediately if the symptoms described above occur. If symptoms that are characteristic of a spinal hematoma are suspected, urgent diagnosis and treatment are required, including, if necessary, spinal cord decompression.

Heparin-induced thrombocytopenia

Enixum® should be used with extreme caution in patients who have a history of heparin-induced thrombocytonepia, with or without thrombosis.

The risk of developing heparin-induced thrombocytopenia may persist for several years. If a history of heparin-induced thrombocytopenia is suspected, then in vitro platelet aggregation tests are of limited importance in predicting the risk of its development. The decision on the use of Enixum in this case can be made only after consultation with the appropriate specialist.

Percutaneous coronary angioplasty

To minimize the risk of bleeding associated with invasive vascular instrumental manipulation in the treatment of unstable angina and non-Q-wave myocardial infarction and acute ST-segment elevation myocardial infarction. These procedures should be performed in the intervals between use of Enixum. This is necessary in order to achieve hemostat after percutaneous coronary intervention. If a closure device is used, the femoral artery introducer can be removed immediately. When applying manual compression, the femoral artery ne introducer should be removed 6 hours after the last intravenous or subcutaneous injection of znoxaparin sodium. If treatment with epoxaparin sodium continues, the next dose should be administered no earlier than 6-8 hours after removal of the femoral artery introducer. It is necessary to monitor the place of introduction of the introducer. to detect signs of bleeding and hematoma formation in a timely manner.

Patients with mechanical artificial heart valves The use of enoxaparin sodium for the prevention of thrombosis in patients with mechanical artificial heart valves has not been sufficiently studied. There are separate reports of the development of cardiac valve thrombosis in patients with mechanical artificial heart valves during therapy with epoxaparin sodium for the prevention of thrombosis. Evaluation of these reports is limited due to the presence of competing factors contributing to the development of artificial heart valve thrombosis, including the underlying disease, and due to insufficient clinical data. In women with mechanical artificial heart valves, the use of eioxaparin sodium for the prevention of thrombosis in pregnant women with mechanical artificial heart valves has not been sufficiently studied. In a clinical study of pregnant women with mechanical artificial heart valves using enoxaparin sodium and a dose of 1 mg / kg twice a day to reduce the risk of thrombosis and embolism,2 out of 8 women developed a blood clot, which led to blockage of the heart valves and death of the mother and fetus.

There are isolated post-marketing reports of heart valve thrombosis in pregnant women with mechanical artificial heart valves treated with enoxaparin sodium to prevent thrombosis. Pregnant women with mechanical artificial heart valves have a high risk of developing thrombosis and embolism. Laboratory tests

In doses used for the prevention of thromboembolic complications, enoxaparin sodium does not significantly affect the bleeding time and blood clotting parameters, as well as platelet aggregation or their binding to fibrinogen.

When the dose is increased, the APTT and activated blood clotting time may be prolonged. The increase in APTT and activated clotting time are not directly linearly related to the increase in anticoagulant activity of the drug, so there is no need to monitor them.

Prevention of venous thrombosis and embolism in patients with acute therapeutic diseases who are on bed rest

In case of acute infection or acute rheumatic conditions, prophylactic use of enoxaparin sodium is justified only if the above conditions are combined with one of the following risk factors for venous thrombosis: age over 75 years; malignant neoplasms: thrombosis and embolism in the anamnesis; obesity; hormone therapy; heart failure; chronic respiratory failure.

Influence on the ability to drive vehicles and fur. :

There are no data indicating a negative effect of enoxaparin sodium on the ability to drive vehicles and engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

At a temperature not exceeding 25 °C. Do not freeze it.

Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Enoxaparin sodium

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection