Kleksan: instructions for use of the injection solution. Kleksan: instructions for use, analogues and reviews, prices in Russian pharmacies

Clexane is a direct anticoagulant produced at the facilities of the world famous French pharmaceutical company Sanofi-Aventis. The active substance of Clexane - enoxaparin sodium (which is nothing more than low molecular weight heparin) is obtained from animal raw materials: for these purposes, the mucous membrane of the small intestine of a pig is used. The mechanism of action of the drug lies in its ability to activate antithrombin III, and, therefore, create all conditions for suppressing the activity of the blood coagulation system. In addition, Clexane is endowed with mild anti-inflammatory properties, which has been fully demonstrated in preclinical studies in laboratory animals and clinical trials in healthy volunteers. The scope of the drug in clinical practice is the prevention and treatment of thrombosis and thromboembolism.

The main "competitor" of Clexane is unfractionated injectable heparin (which is called "heparin, injection solution"). As shown by numerous clinical studies, clexane is in many ways superior to its "colleague" in the clinical and pharmacological subgroup. Thus, in a comparative study of clexane and heparin in the prevention of deep vein thrombosis after surgical interventions on the hip joint, the former showed an almost twofold advantage in reducing the incidence of thrombosis (25% versus 12.5% ​​for heparin). In a comparative study of the efficacy and safety of clexane and heparin in patients with proximal venous thrombosis, clot regression was 43% in the clexane group and only 27% in the heparin group. The number of thromboembolic complications in the first group was 7 times less than in the second.

To summarize, the advantages of clexane compared to unfractionated heparins are, first of all, in a longer therapeutic effect, in reducing the frequency of drug administration (1-2 times a day), the absence of the need for constant laboratory monitoring, less effect on platelets and less frequent development negative side effects and complications. To complete the picture, it should be added that the studies were conducted on the basis of the Clinic of Faculty Surgery of the Russian State University.

The use of clexane, as, in fact, of any anticoagulant, should be carried out under close medical supervision. So, if the appointment of the drug for prophylactic purposes does not entail an increase in the risk of bleeding, then in the case of using Clexane as a therapeutic agent, such a risk exists, especially for elderly patients. Clexane is not recommended to be taken together with drugs that can affect blood clotting (salicylates, non-steroidal anti-inflammatory drugs, glucocorticosteroids, antiplatelet agents, anticoagulants). Since Clexane has not been clinically tested in people with liver failure, special care is required when using the drug in this category of patients. The latter is also required for patients with a history of thrombocytopenia (a decrease in the number of platelets) that has developed under the influence of heparin. And in conclusion - two very important "no": Clexane should not be administered intramuscularly and should not be mixed with other drugs.

Pharmacology

Low molecular weight heparin preparation (molecular weight about 4500 daltons: less than 2000 daltons -< 20%, от 2000 до 8000 дальтон - >68%, more than 8000 daltons -< 18%). Эноксапарин натрия получают щелочным гидролизом бензилового эфира гепарина, выделенного из слизистой оболочки тонкого отдела кишечника свиньи. Его структура характеризуется невосстанавливающимся фрагментом 2-O-сульфо-4-енпиразиносуроновой кислоты и восстанавливающимся фрагментом 2-N,6-O-дисульфо-D-глюкопиранозида. Структура эноксапарина содержит около 20% (в пределах от 15% до 25%) 1,6-ангидропроизводного в восстанавливающемся фрагменте полисахаридной цепи.

In a purified in vitro system, enoxaparin sodium has high anti-Xa activity (about 100 IU/ml) and low anti-IIa or antithrombin activity (about 28 IU/ml). This anticoagulant activity acts through antithrombin III (AT-III) to provide anticoagulant activity in humans. In addition to anti-Xa/IIa activity, additional anticoagulant and anti-inflammatory properties of enoxaparin sodium have also been identified both in healthy people and patients, and in animal models. This includes AT-III-dependent inhibition of other clotting factors such as factor VIIa, activation of tissue factor pathway inhibitor (PTF) release, and reduced release of von Willebrand factor from the vascular endothelium into the bloodstream. These factors provide the anticoagulant effect of enoxaparin sodium in general.

When using the drug in prophylactic doses, it slightly changes the APTT, has virtually no effect on platelet aggregation and the level of fibrinogen binding to platelet receptors.

Plasma anti-IIa activity is approximately 10 times lower than anti-Xa activity. The average maximum anti-IIa activity is observed approximately 3-4 hours after s / c injection and reaches 0.13 IU / ml and 0.19 IU / ml after repeated administration of 1 mg / kg body weight with a double injection and 1.5 mg / kg body weight with a single dose introduction, respectively.

The average maximum plasma anti-Xa activity is observed 3-5 hours after s / c administration of the drug and is approximately 0.2, 0.4, 1.0 and 1.3 anti-Xa IU / ml after s / c administration of 20, 40 mg and 1 mg / kg and 1.5 mg/kg, respectively.

Pharmacokinetics

The pharmacokinetics of enoxaparin in these dosing regimens is linear.

Suction and distribution

After repeated s / c injections of enoxaparin sodium at a dose of 40 mg and at a dose of 1.5 mg / kg of body weight 1 time / day in healthy volunteers, C ss is reached by day 2, and AUC is on average 15% higher than after a single injection. After repeated s / c injections of enoxaparin sodium at a daily dose of 1 mg / kg of body weight 2 times / day, C ss is achieved in 3-4 days, and AUC is on average 65% higher than after a single injection and the average values ​​of C max are respectively 1.2 IU/ml and 0.52 IU/ml.

The bioavailability of enoxaparin sodium with s / c administration, estimated on the basis of anti-Xa activity, is close to 100%. V d of enoxaparin sodium (by anti-Xa activity) is approximately 5 liters and approaches the volume of blood.

Metabolism

Enoxaparin sodium is mainly biotransformed in the liver by desulfation and / or depolymerization with the formation of low molecular weight substances with very low biological activity.

breeding

Enoxaparin sodium is a low clearance drug. After intravenous administration for 6 hours at a dose of 1.5 mg/kg of body weight, the average clearance of anti-Xa in plasma is 0.74 l/h.

Excretion of the drug is monophasic. T 1/2 is 4 hours (after a single s / c injection) and 7 hours (after repeated administration of the drug). 40% of the administered dose is excreted by the kidneys, with 10% being unchanged.

Pharmacokinetics in special clinical situations

There may be a delay in the excretion of enoxaparin sodium in elderly patients as a result of a decrease in renal function.

In patients with impaired renal function, there is a decrease in the clearance of enoxaparin sodium. In patients with mild (CC 50-80 ml / min) and moderate (CC 30-50 ml / min) impaired renal function, after repeated s / c administration of 40 mg of enoxaparin sodium 1 time / day, there is an increase in anti-Xa activity, represented by AUC . In patients with severe renal impairment (CC less than 30 ml / min), with repeated subcutaneous administration of the drug at a dose of 40 mg 1 time / day, AUC in the equilibrium state is on average 65% higher.

In overweight patients with s / c administration of the drug, the clearance is somewhat less. If the dose is not adjusted for the patient's body weight, then after a single s / c administration of enoxaparin sodium at a dose of 40 mg, anti-Xa activity will be 50% higher in women weighing less than 45 kg and 27% higher in men weighing less than 45 kg. body weight less than 57 kg, compared with patients with normal average body weight.

Release form

The solution for injection is clear, colorless to pale yellow.

1 ml of solution for injection contains 100 mg (10,000 anti-Xa IU) enoxaparin sodium.

Solvent: water for injection - up to 0.2 ml.

0.2 ml - glass syringes (type I) (2) - blisters (1) - cardboard packs.
0.2 ml - glass syringes (type I) (2) - blisters (5) - cardboard packs.
0.2 ml - glass syringes (type I) with needle protection system (2) - blisters (1) - cardboard packs.
0.2 ml - glass syringes (type I) with needle protection system (2) - blisters (5) - cardboard packs.

Dosage

With the exception of special cases (treatment of ST-segment elevation myocardial infarction, medical or percutaneous coronary intervention and prevention of thrombus formation in the extracorporeal circulation system during hemodialysis), enoxaparin sodium is injected deeply SC. It is desirable to carry out injections in the position of the patient lying down. When using pre-filled 20 mg and 40 mg syringes, do not remove air bubbles from the syringe before injection to avoid loss of drug. Injections should be carried out alternately in the left or right anterolateral or posterolateral surface of the abdomen. The needle must be inserted to its full length vertically (not laterally) into the skin fold, collected and held until the injection is completed between the thumb and forefinger. The skin fold is released only after the injection is completed. Do not massage the injection site after drug administration.

The pre-filled disposable syringe is ready to use.

The drug must not be administered intramuscularly!

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

In patients with a moderate risk of developing thrombosis and embolism (for example, abdominal surgery), the recommended dose of Clexane ® is 20 mg or 40 mg 1 time / day s / c. The first injection is given 2 hours before surgery.

In patients with a high risk of thrombosis and embolism (for example, during orthopedic operations), the drug is recommended at a dose of 40 mg 1 time / day s / c, the first dose is administered 12 hours before surgery, or 30 mg 2 times / day s / c start of administration 12-24 hours after surgery.

The duration of treatment with Clexane ® averages 7-10 days. If necessary, therapy can be continued as long as the risk of thrombosis and embolism persists, and until the patient switches to an outpatient regimen.

In orthopedic surgery, it may be advisable to continue treatment after initial therapy by administering Clexane ® at a dose of 40 mg 1 time / day for 3 weeks.

Features of the appointment of Clexane for spinal / epidural anesthesia, as well as for coronary revascularization procedures, are described in the "Special Instructions" section.

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

The recommended dose of Clexane ® is 40 mg 1 time/day s.c. for at least 6 days. Therapy should be continued until the patient is completely transferred to the outpatient regimen (maximum within 14 days).

Treatment of deep vein thrombosis with or without pulmonary embolism

The drug is administered s / c at the rate of 1.5 mg / kg body weight 1 time / day or at a dose of 1 mg / kg body weight 2 times / day. In patients with complicated thromboembolic disorders, the drug is recommended to be used at a dose of 1 mg / kg 2 times / day.

The duration of treatment averages 10 days. Treatment with indirect anticoagulants should be started immediately, while therapy with Clexane ® should be continued until a therapeutic anticoagulant effect is achieved, i.e. MHO should be 2-3.

Prevention of thrombus formation in the extracorporeal circulation system during hemodialysis

The recommended dose of Clexane ® is on average 1 mg/kg of body weight. With a high risk of bleeding, the dose should be reduced to 0.5 mg / kg body weight with a double vascular access or 0.75 mg with a single vascular access.

In hemodialysis, the drug should be injected into the arterial site of the shunt at the beginning of the hemodialysis session. One dose is usually sufficient for a 4-hour session, however, if fibrin rings are detected during longer hemodialysis, the drug can be additionally administered at the rate of 0.5-1 mg/kg of body weight.

Treatment of unstable angina and non-Q wave myocardial infarction

Clexane ® is administered at the rate of 1 mg/kg of body weight every 12 hours s / c, while the use of acetylsalicylic acid at a dose of 100-325 mg 1 time / day.

The average duration of therapy is at least 2 days (until the patient's clinical condition stabilizes). Usually the administration of the drug lasts from 2 to 8 days.

Treatment of acute ST-segment elevation myocardial infarction, medically or with percutaneous coronary intervention

Treatment begins with a single intravenous bolus of enoxaparin sodium at a dose of 30 mg. Immediately after it, enoxaparin sodium is administered s.c. at a dose of 1 mg/kg. Further, the drug is prescribed s / c at 1 mg / kg body weight every 12 hours (maximum 100 mg enoxaparin sodium for each of the first two s / c injections, then 1 mg / kg body weight for the remaining subcutaneous doses, i.e. with a body weight of more than 100 kg, a single dose may exceed 100 mg).

In patients aged 75 years and older, the initial IV bolus is not used. Enoxaparin sodium is administered sc at a dose of 0.75 mg/kg every 12 hours (moreover, during the first two sc injections, a maximum of 75 mg of enoxaparin sodium can be administered per injection, then all subsequent sc doses of 0.75 mg/kg kg of body weight, i.e. with a body weight of more than 100 kg, the dose may exceed 75 mg).

When combined with thrombolytics (fibrin-specific and fibrin-nonspecific), enoxaparin sodium should be administered in the range from 15 minutes before the start of thrombolytic therapy to 30 minutes after it. As soon as possible after the detection of acute myocardial infarction with ST segment elevation, acetylsalicylic acid should be started simultaneously (in doses from 75 to 325 mg) and, if there are no contraindications, it should be continued for at least 30 days.

In / in the bolus of enoxaparin sodium should be carried out through a venous catheter and enoxaparin sodium should not be mixed or administered together with other drugs. In order to avoid the presence of traces of other drugs in the infusion 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 the intravenous bolus administration of enoxaparin sodium. Enoxaparin sodium can be safely administered with 0.9% sodium chloride solution and 5% dextrose solution.

For bolus administration of enoxaparin sodium at a dose of 30 mg in the treatment of acute myocardial infarction with ST segment elevation, excess amount of the drug is removed from glass syringes 60 mg, 80 mg and 100 mg so that only 30 mg (0.3 ml) remain in them. A dose of 30 mg can be directly injected into / in.

For intravenous bolus administration of enoxaparin sodium through a venous catheter, pre-filled syringes for s / c administration of the drug 60 mg, 80 mg and 100 mg can be used. It is recommended to use 60 mg syringes, as this reduces the amount of drug removed from the syringe. Syringes 20 mg are not used, because. they do not have enough drug for a 30 mg bolus of enoxaparin sodium. 40 mg syringes are not used because there are no divisions on them 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 inflation of the balloon catheter inserted into the narrowing of the coronary artery, additional administration of enoxaparin sodium is not required. If the last s / c injection of enoxaparin sodium was carried out more than 8 hours before the inflation of the balloon catheter, an additional bolus of enoxaparin sodium at a dose of 0.3 mg / kg should be performed intravenously.

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

To prepare a solution of enoxaparin sodium with a concentration of 3 mg / ml using a pre-filled syringe of 60 mg, it is recommended to use a container with an infusion solution of 50 ml (i.e. with 0.9% sodium chloride solution or 5% dextrose solution). From the container with the infusion solution using a conventional syringe, 30 ml of the solution is removed and removed. Enoxaparin sodium (the contents of a syringe for s / c injection of 60 mg) is injected into the remaining 20 ml of the infusion solution in the container. The contents of the container with a diluted solution of enoxaparin sodium are gently mixed. For injection with a syringe, the required volume of a diluted solution of enoxaparin sodium is removed, which is calculated by the formula:

Volume of diluted solution = body weight of the patient (kg) × 0.1 or using the table below.

Elderly patients. With the exception of the treatment of ST-elevation myocardial infarction (see above), for all other indications, dose reduction of enoxaparin sodium in elderly patients is not required if they do not have impaired renal function.

For patients with severely impaired renal function (CC less than 30 ml / min), the dose of enoxaparin sodium is reduced in accordance with the tables below, because. in these patients, there is an increase in systemic exposure (duration of action) of the drug.

When using the drug for therapeutic purposes, the following correction of the dosing regimen is recommended:

When using the drug for prophylactic purposes, the following correction of the dosing regimen is recommended:

With mild (CC 50-80 ml / min) and moderate (CC 30-50 ml / min) impaired renal function, dose adjustment is not required, but patients should be under close medical supervision.

Due to the lack of clinical studies, Clexane should be used with caution in patients with impaired liver function.

Overdose

Symptoms: accidental overdose with intravenous, extracorporeal or s / c administration can lead to hemorrhagic complications. When taken orally, even in large doses, absorption of the drug is unlikely.

Treatment: as a neutralizing agent, slow intravenous administration of protamine sulfate is indicated, the dose of which depends on the dose of Clexane administered. It should be taken into account that 1 mg of protamine neutralizes the anticoagulant effect of 1 mg of enoxaparin if Clexane ® was administered no more than 8 hours before the administration of protamine. 0.5 mg of protamine neutralizes the anticoagulant effect of 1 mg of Clexane if it was administered more than 8 hours ago or if a second dose of protamine is required. If more than 12 hours have passed after the administration of Clexane, then the administration of protamine is not required. However, even with the introduction of protamine sulfate in high doses, the anti-Xa activity of Clexane is not completely neutralized (by a maximum of 60%).

Interaction

Clexane ® must not be mixed with other drugs!

With simultaneous use with drugs that affect hemostasis (systemic salicylates, acetylsalicylic acid, NSAIDs (including ketorolac), dextran with a molecular weight of 40 kDa, ticlopidine and clopidogrel, systemic corticosteroids, thrombolytics or anticoagulants, other antiplatelet drugs (including glycoprotein IIb antagonists / IIIa) increases the risk of bleeding.

Side effects

The study of side effects of enoxaparin sodium was carried out in more than 15,000 patients participating in clinical trials, of which 1776 patients - in the prevention of venous thrombosis and embolism in general surgical and orthopedic operations, in 1169 patients - in the prevention of venous thrombosis and embolism in patients who are on bed rest, due to acute therapeutic diseases, in 559 patients - in the treatment of deep vein thrombosis with pulmonary embolism or without pulmonary embolism, in 1578 patients - in the treatment of unstable angina and myocardial infarction without a Q wave, in 10,176 patients - in the treatment myocardial infarction with ST segment elevation. The mode of administration of enoxaparin sodium differed depending on the indications. In the prevention of venous thrombosis and embolism during general surgical and orthopedic operations or in patients on bed rest, 40 mg s / c was administered 1 time / day. In the treatment of deep vein thrombosis with or without pulmonary embolism, patients received enoxaparin sodium at the rate of 1 mg/kg body weight s/c every 12 hours or 1.5 mg/kg body weight s/c 1 time/day. In the treatment of unstable angina and non-Q wave myocardial infarction, the dose of enoxaparin sodium was 1 mg/kg body weight s.c. every 12 hours, and in the case of myocardial infarction with ST segment elevation, a bolus dose of 30 mg was administered followed by a dose of 1 mg / kg of body weight s / c every 12 hours.

Adverse reactions were classified according to the frequency of occurrence as follows: very often (≥1/10), often (≥1/100 -<1/10), нечасто (≥1/1000 - <1/100), редко (≥1/10 000 - <1/1000), очень редко (<1/10 000), частота неизвестна (по имеющимся данным частоту встречаемости нежелательной реакции оценить не представляется возможным). Нежелательные реакции, наблюдавшиеся после выхода препарата на рынок, были отнесены к группе "частота неизвестна".

From the blood coagulation system

Bleeding

In clinical studies, bleeding was the most commonly reported adverse reaction. These included major bleeding, observed in 4.2% of patients (bleeding was considered major if it was accompanied by a decrease in hemoglobin by 2 g / l or more, required transfusion of 2 or more doses of blood components, and also if it was retroperitoneal or intracranial). Some of these cases have been fatal.

As with other anticoagulants, bleeding may occur with the use of enoxaparin sodium, especially in the presence of risk factors that contribute to the development of bleeding, during invasive procedures or when using drugs that disrupt hemostasis.

When describing bleeding below, the "*" sign means an indication of the following types of bleeding: hematoma, ecchymosis (except for those that developed at the injection site), wound hematomas, hematuria, epistaxis, gastrointestinal bleeding.

Very common - bleeding * in the prevention of venous thrombosis in surgical patients and the treatment of deep vein thrombosis with or without thromboembolism.

Often - bleeding * in the prevention of venous thrombosis in patients on bed rest, and in the treatment of unstable angina, myocardial infarction without Q wave and myocardial infarction with ST segment elevation.

Infrequently - retroperitoneal bleeding and intracranial hemorrhage in patients in the treatment of deep vein thrombosis with or without pulmonary embolism, as well as myocardial infarction with ST segment elevation.

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

Thrombocytopenia and thrombocytosis

Very often - thrombocytosis (the number of platelets in the peripheral blood is more than 400×10 9 / l) in the prevention of venous thrombosis in surgical patients and the treatment of deep vein thrombosis with or without thromboembolism.

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

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

Very rarely - immune-allergic thrombocytopenia in the treatment of patients with acute myocardial infarction with ST segment elevation.

Other clinically significant adverse reactions regardless of indication

The adverse reactions presented below are grouped by system organ class, given with the frequency of their occurrence as defined above, and in order of decreasing severity.

From the immune system: often - allergic reactions; rarely - anaphylactic and anaphylactoid reactions.

On the part of the liver and biliary tract: very often - an increase in the activity of liver enzymes, mainly an increase in the activity of transaminases more than 3 times the upper limit of the norm.

From the skin and subcutaneous tissues: often - urticaria, itching, erythema; infrequently - bullous dermatitis.

General disorders and disorders at the injection site: often - hematoma, pain, swelling at the injection site, bleeding, hypersensitivity reactions, inflammation, formation of seals at the injection site; infrequently - irritation at the injection site, skin necrosis at the injection site.

Laboratory and instrumental data: rarely - hyperkalemia.

Post-launch data

The following adverse reactions have been observed during post-marketing use of Clexane ® . There were spontaneous reports of these adverse reactions and their frequency was defined as "frequency unknown" (cannot be determined from the available data).

From the immune system: anaphylactic / anaphylactoid reactions, including shock.

From the nervous system: headache.

On the part of the blood coagulation system: when using enoxaparin sodium against the background of spinal / epidural anesthesia or spinal puncture, there have been cases of spinal hematoma (or neuraxial hematoma). These reactions led to the development of neurological disorders of varying severity, including persistent or irreversible paralysis.

From the hemopoietic system: hemorrhagic anemia; cases of development of immune-allergic thrombocytopenia with thrombosis; in some cases, thrombosis was complicated by the development of organ infarction or limb ischemia; eosinophilia.

From the skin of the subcutaneous tissues: at the injection site, skin vasculitis, skin necrosis, which is usually preceded by the appearance of purpura or erythematous papules (infiltrated and painful), may develop; in these cases, therapy with Clexane ® should be discontinued; the formation of solid inflammatory nodules-infiltrates at the injection site of the drug is possible, which disappear after a few days and are not grounds for discontinuing the drug; alopecia.

From the side of the liver and biliary tract: hepatocellular damage to the liver; cholestatic liver disease.

From the musculoskeletal system: osteoporosis with long-term therapy (more than 3 months).

Indications

• prevention of venous thrombosis and embolism during surgical interventions, especially orthopedic and general surgical operations;
• prevention of venous thrombosis and thromboembolism in patients on bed rest due to acute therapeutic diseases (acute heart failure, chronic heart failure in the stage of decompensation of III or IV functional class according to the NYHA classification, acute respiratory failure, severe acute infection, acute rheumatic diseases in combination with one of the risk factors for venous thrombosis);
• treatment of deep vein thrombosis with or without thromboembolism of the pulmonary artery;
• prevention of thrombus formation in the extracorporeal circulation system during hemodialysis (usually with a session duration of not more than 4 hours);
• treatment of unstable angina and non-Q wave myocardial infarction in combination with acetylsalicylic acid;
• treatment of acute ST-segment elevation myocardial infarction in patients undergoing medical treatment or subsequent percutaneous coronary intervention.

Contraindications

• active major bleeding, as well as conditions and diseases in which there is a high risk of bleeding: threatened abortion, cerebral aneurysm or dissecting aortic aneurysm (except in cases of surgical intervention for this reason), recent hemorrhagic stroke, uncontrolled bleeding, thrombocytopenia in in combination with a positive in vitro test for antiplatelet antibodies in the presence of enoxaparin sodium;
• age up to 18 years (efficacy and safety have not been established);
• hypersensitivity to enoxaparin, heparin and its derivatives, including other low molecular weight heparins.

Carefully

Conditions in which there is a potential risk of bleeding:

• hemostasis disorders (including hemophilia, thrombocytopenia, hypocoagulation, von Willebrand disease), severe vasculitis;
• peptic ulcer of the stomach and duodenum or other erosive and ulcerative lesions of the gastrointestinal tract in history;
• recent ischemic stroke;
• uncontrolled severe arterial hypertension;
• diabetic or hemorrhagic retinopathy;
• severe diabetes mellitus;
• recent or proposed neurological or ophthalmic surgery;
• spinal or epidural anesthesia (potential risk of developing a hematoma), spinal puncture (recently transferred);
• recent childbirth;
• bacterial endocarditis (acute or subacute);
• pericarditis or pericardial effusion;
• renal and / or liver failure;
• intrauterine contraception (IUD);
• severe trauma (especially the central nervous system), open wounds with a large wound surface;
• simultaneous administration of drugs that affect the hemostasis system;
• heparin-induced thrombocytopenia (history) with or without thrombosis.

The company does not have data on the clinical use of Clexane ® in the following conditions: active tuberculosis, radiation therapy (recently transferred).

Application features

Use during pregnancy and lactation

There is no information that enoxaparin sodium crosses the placental barrier in the II trimester, there is no relevant information regarding the I and III trimesters of pregnancy.

Because there are no adequate and well-controlled studies in pregnant women, and animal studies do not always predict the response to the administration of enoxaparin sodium in human pregnancy, Clexane ® should be used during pregnancy only in cases where there is an urgent need for its use, established by the doctor.

It is not known whether unchanged enoxaparin sodium is excreted in breast milk. Breastfeeding should be discontinued while the mother is being treated with Clexane.

Pregnant women with mechanical artificial heart valves

The use of the drug Clexane ® for the prevention of thrombosis in pregnant women with mechanical prosthetic heart valves has not been studied enough. In a clinical study of pregnant women with mechanical prosthetic heart valves, when using enoxaparin sodium at a dose of 1 mg/kg body weight 2 times 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 valvular thrombosis in pregnant women with mechanical prosthetic heart valves treated with enoxaparin to prevent thrombosis.

Pregnant women with mechanical prosthetic heart valves are at high risk of developing thrombosis and embolism.

Application for violations of liver function

Application for violations of kidney function

Use in children

special instructions

Low molecular weight heparins are not interchangeable, because they differ in their manufacturing process, molecular weight, specific anti-Xa activity, dosing units and dosing regimen, resulting in differences in their pharmacokinetics and biological activity (antithrombin activity and interaction with platelets). Therefore, it is required to strictly follow the recommendations for use for each drug belonging to the class of low molecular weight heparins.

Bleeding

As with the use of other anticoagulants, the use of the drug Clexane ® may develop bleeding of any localization. With the development of bleeding, it is necessary to find its source and carry out appropriate treatment.

Bleeding in elderly patients

When using the drug Clexane ® in prophylactic doses in elderly patients, there was no risk of bleeding.

When using the drug in therapeutic doses in elderly patients (especially aged ≥80 years), there is an increased risk of bleeding. Careful monitoring of these patients is recommended.

Simultaneous use of other drugs that affect hemostasis

It is recommended that the use of drugs that can disrupt hemostasis (salicylates, including acetylsalicylic acid, NSAIDs, including ketorolac; dextran with a molecular weight of 40 kDa, ticlopidine, clopidogrel; corticosteroids, thrombolytics, anticoagulants, antiplatelet agents, including glycoprotein receptor antagonists IIb / IIIa) was discontinued prior to initiation of enoxaparin sodium treatment, unless their use is necessary. If combinations of enoxaparin sodium with these drugs are indicated, then careful clinical observation and monitoring of relevant laboratory parameters should be carried out.

kidney failure

In patients with impaired renal function, there is a risk of bleeding as a result of increased systemic exposure to enoxaparin sodium.

In patients with severely impaired renal function (CK<30 мл/мин) рекомендуется проводить коррекцию дозы как при профилактическом, так и терапевтическом применении препарата. Хотя не требуется проводить коррекцию дозы у пациентов с легким и умеренным нарушением функции почек (КК 30-50 мл/мин или КК 50-80 мл/мин), рекомендуется проведение тщательного контроля состояния таких пациентов.

Low body weight

There has been an increase in the exposure of enoxaparin sodium during its prophylactic use in women weighing less than 45 kg and in men weighing less than 57 kg, which may lead to an increased risk of bleeding. Careful monitoring of the condition of such patients is recommended.

Obese patients

Obese patients have an increased risk of thrombosis and embolism. The safety and efficacy of prophylactic doses of enoxaparin in obese patients (BMI >30 kg/m 2 ) have not been fully determined, and there is no consensus on dose adjustments. Such patients should be closely monitored for the development of symptoms and signs of thrombosis and embolism.

Monitoring the number of platelets in peripheral blood

The risk of developing antibody-mediated heparin-induced thrombocytopenia also exists with the use of low molecular weight heparins. Thrombocytopenia usually develops between days 5 and 21 after initiation of enoxaparin sodium therapy. In this regard, it is recommended to regularly monitor the number of platelets in peripheral blood before starting treatment with Clexane ® and during its use. In the presence of a confirmed significant decrease in the number of platelets (by 30-50% compared with baseline), it is necessary to immediately stop enoxaparin sodium and transfer the patient to another therapy.

Spinal/epidural anesthesia

As with the use of other anticoagulants, cases of the occurrence of neuraxial hematomas are described when using the drug Clexane ® with simultaneous spinal / epidural anesthesia with the development of persistent or irreversible paralysis. The risk of these phenomena is reduced when using the drug at a dose of 40 mg or lower. The risk increases with the use of the drug Clexane ® in higher doses, as well as with the use of indwelling catheters after surgery, or with the simultaneous use of additional drugs that affect hemostasis, such as NSAIDs. The risk also increases with traumatic or repeated lumbar puncture or in patients with a history of previous 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 must be taken into account. Insertion or removal of a catheter is best done when the anticoagulant effect of enoxaparin sodium is low, but the exact time to achieve a sufficient decrease in anticoagulant effect in different patients is unknown.

The installation or removal of the catheter should be carried out 10-12 hours after the use of the drug Clexane ® at lower doses (20 mg 1 time / day, 30 mg 1-2 times / day, 40 mg 1 time / day) and at least after 24 hours after administration of Clexane ® at higher doses (0.75 mg/kg body weight 2 times/day, 1 mg/kg body weight 2 times/day, 1.5 mg/kg body weight 1 time/day). At these time points, anti-Xa activity of the drug still continues to be detected, and delays in time are not a guarantee that the development of neuraxial hematoma can be avoided.

Patients receiving enoxaparin sodium at doses of 0.75 mg / kg body weight 2 times / day or 1 mg / kg body weight 2 times / day, with this (twice a day) dosing regimen, should not administer a second dose in order to increase interval before insertion or replacement of the catheter. Similarly, the possibility of delaying the next dose of the drug by at least 4 hours should be considered, based on an assessment of the benefit / risk ratio (the 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 timing of the next dose of enoxaparin sodium after removal of the catheter. It should be borne in mind that in patients with CC less than 30 ml / min, the excretion of enoxaparin sodium slows down. Therefore, in this category of patients, consideration should be given to doubling the time from catheter removal: at least 24 hours for lower doses of enoxaparin sodium (30 mg 1 time / day) and at least 48 hours for higher doses (1 mg / kg body weight per day).

If, as directed by a doctor, anticoagulant therapy is used during epidural / spinal anesthesia, the patient must be especially carefully monitored continuously to identify any neurological symptoms, such as: back pain, sensory and motor dysfunctions (numbness or weakness in the lower extremities), disorders bowel and/or bladder function. The patient should be instructed to immediately inform the doctor if the above symptoms occur. If symptoms characteristic of a spinal cord hematoma are suspected, urgent diagnosis and treatment are necessary, including, if necessary, decompression of the spinal cord.

Heparin-induced thrombocytopenia

Clexane should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia with or without thrombosis.

The risk of heparin-induced thrombocytopenia may persist for several years. If the history suggests the presence of heparin-induced thrombocytopenia, then in vitro platelet aggregation tests are of limited value in predicting the risk of its development. The decision to prescribe Clexane ® in this case can only be taken after consultation with the appropriate specialist.

Percutaneous coronary angioplasty

In order to minimize the risk of bleeding associated with invasive vascular instrumentation 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 the administration of Clexane ® . This is necessary in order to achieve hemostasis after percutaneous coronary intervention. When using a closure device, the femoral artery sheath can be removed immediately. When using manual compression, the femoral artery sheath should be removed 6 hours after the last IV or SC injection of enoxaparin sodium. If treatment with enoxaparin sodium is continued, then the next dose should be administered no earlier than 6-8 hours after removal of the femoral artery sheath. It is necessary to monitor the insertion site of the sheath in order to detect signs of bleeding and hematoma formation in a timely manner.

Patients with mechanical prosthetic heart valves

The use of the drug Clexane ® for the prevention of thrombosis in patients with mechanical prosthetic heart valves has not been studied enough. There are isolated reports of valvular thrombosis in patients with mechanical prosthetic heart valves treated with enoxaparin sodium to prevent thrombosis. The evaluation of these reports is limited due to the presence of competing factors that contribute to the development of prosthetic heart valve thrombosis, including the underlying disease, and due to insufficient clinical data.

Laboratory tests

At doses used to prevent thromboembolic complications, Clexane ® does not significantly affect bleeding time and blood coagulation, as well as platelet aggregation or their binding to fibrinogen.

With increasing doses, aPTT and activated clotting time may be prolonged. The increase in APTT and activated clotting time are not in a direct linear relationship with the increase in the 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 the event of an acute infection, acute rheumatic conditions, the prophylactic administration 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, history of thrombosis and embolism, obesity, hormonal therapy , heart failure, chronic respiratory failure.

Influence on the ability to drive vehicles and control mechanisms

The drug Clexane ® does not affect the ability to drive vehicles and mechanisms.

Among the drugs - anticoagulants include Clexane. This medicinal solution(color from transparent to pale yellow), reduces the likelihood of blood clots and helps to stop the growth of existing ones. Below is a brief description of the drug Clexane 0.4, instructions for use of which are provided with the delivery of the drug itself.

In contact with

General information

The main pharmacological action of the drug is considered prevention of blood clots. The main component of this drug is enoxaparin sodium. Without going into pharmacological terms, we note that this substance allows you to achieve a decrease in blood density, and helps to improve its general condition.

Storage conditions

Recommended storage temperature medication is 25°C. If the form of application has already been made in a syringe, then storage in a dark place protected from sunlight and moisture is recommended.
This condition is caused by the following factors:

• direct exposure to sunlight (and ultraviolet included) reduces the shelf life;
• if purchased in powder form, then excess moisture can reduce the effect of the necessary medicine and affect its quality;
• in the case of using a syringe with a medicinal substance, in no case open it, to avoid air oxidation or evaporation.

Kleksan 0.4 instructions for use

Usually, the most acceptable storage place is a sideboard, or a closet. In extreme cases, storage in the refrigerator is acceptable (both dark and the temperature is suitable). Storage of this drug should be out of reach of children. Best before date is 3 years.

How to take medicine

Before injecting Clexane, we hasten to pay attention - the medicine is intended only for injection under the skin. It is strictly forbidden to administer it intramuscularly. Depending on the purpose for which this tool is used, there are differences in approaches to its use.
The injection of the drug is carried out strictly in the abdominal cavity.

The approximate injection site is usually located in the navel (radius from 10 to 15 cm, or the width of the palm).
The injection procedure is as follows:

• the position of the patient (preferably) should be horizontal;
• wash your hands thoroughly with soap;
• treat the planned injection site (cotton wool or sponge in combination with medical alcohol, or boric acid);
• prepare a syringe with Clexane solution (if there are air bubbles, you do not need to remove them);
• on the stomach we form a fold (not very large);
• insert the syringe for the entire length of the syringe needle (no more than 2 cm), make an injection;
• hold a fold of skin on the abdomen until the drug is completely injected;
• after the needle is pulled out, we again disinfect the injection site.

It may seem strange to many that the bubbles are not removed from the syringe.

In fact, this is an indicator that the medical substance has been completely introduced, and no damage will be caused to the body.

However, it is allowed bubble removal, the result will be the same.

The procedure itself is not painful, and is not something complicated, thereby giving an answer to the question: "Clexane, where to inject?".

The main thing to remember is that the drug is administered only in the abdominal cavity.

And if there are difficulties with understanding, we will inform you that for each package of Clexane 0.4, the instruction contains graphic tips on how to do it correctly.

Depending on the prescribed dosage, there are such forms of solution for injection: a glass syringe with a volume of 0.2, 0.4, 0.6, 0.8 and 1 ml. The drug is released in a package of 2 syringes, protected by a blister.

Important! Note the fact that the use of a solution of the drug with an expired release date is strictly prohibited!

More descriptive instructions for use are supplied with the drug.

Depending on the condition of the patient, and the purpose of the drug, there are different dosages.

If the injection is given for prophylactic purposes, then depending on the weight, solutions from 20 to 40 mg can be prescribed once a day.

If severe renal insufficiency is observed, then the maximum volume will not exceed 0.2 ml 1 time per 24 hours.

Adjustment of the volume of the administered Clexane solution is mandatory carried out by the attending doctor.

If diseases such as myocardial infarction, angina pectoris, deep vein thrombosis, etc. are observed.

Strictly do not use solution with hemodialysis.

Attention! If there was an overdose of the treatment solution Clexane 0.4, then protamine sulfate will be required to neutralize. The total amount of "antidote" is calculated from 1 mg of Clexane = 1 mg of sulfate (the ratio is valid in the first 8 hours). After more than 8 hours, the following ratio is based on: for each mg of the drug - 0.5 mg of protamine sulfate. If more than 12 hours have passed, no "antidote" is required.

Use during pregnancy

There are no solid data prohibiting the use of this drug in women during pregnancy yet. However, from the essence of its purpose, it is clear why they are prescribed - prevention of blood clots.

If the pregnancy proceeds with IVF, then the reasons for its appointment may be:

1. Decreased blood density (thinning).
2. As a preventive measure against blood clots.
3. Providing the fetus with normal blood flow (during pregnancy, the blood becomes “thicker” in order to reduce the volume of blood that will be lost during childbirth).

But we also note the peculiarity that the effect of the drug on a woman and a child during the 1st to 3rd trimester has not been fully studied.

In fact, the justified use of this substance is rational in the event that it will bring more benefit to the mother and child than harm.

If the medicine is necessary for pregnant women, then before injecting Clexane, it is imperative to consult a doctor.

If during the period of feeding the child into breast milk enoxaparin will be released- Stop using it immediately. Looking ahead, we will inform you that Clexane medicine and alcohol during pregnancy are strictly incompatible!

Possible consequences

One possible side effect may be bleeding. With this outcome, the medication should be stopped immediately. Then immediately required to undergo an examination and find out the reasons for such a result, only after the recommendation of the doctor to continue the use.

In rare cases, a hemorrhagic syndrome develops (i.e. a rash all over the body with dots up to 3 mm in diameter, bruises on the skin and mucous membranes, low blood clotting, bleeding, etc.), which subsequently appears as a hemorrhage in the skull, body damage is possible, incompatible with life.
In the event that the drug is administered to the patient during the use of a catheter or when using spinal anesthesia, neurological damage (disorders) may occur, which will subsequently manifest themselves in the form of paresis or paralysis.

In the first days of admission, the total number of platelets in the blood may be reduced, which will manifest itself in the form of reduced blood clotting.

However, this indicator is not a strong argument for discontinuing the use of the drug, and is considered temporary, even in the context of the use of Clexane during pregnancy.

During application, an erythematous rash in the form of plaques may be caused in the patient (may be pink in appearance with scaly skin).

Such a side effect eventually "transforms" into necrosis of living tissue.

If the first "banks" are found, the drug should be stopped. Therefore, Clexane, the side effects of which can cause serious harm should be taken with extreme caution and vigilance.

Clexane can cause an allergic reaction expressed in the form of a violation of the skin. In advanced cases, the formation of vasculitis is possible. If such an effect is detected, it is necessary to see a doctor in the near future.

Similar drugs of the same direction

Among the most "related" in properties include the following substitutes:

• Flenox,
• Novoparin,
• Gizende,
• Heparin
• Aksparin,
• Fraxiparine
• and others.

In all medicines contain enoxaparin sodium itself. These drugs are available in powder form, for the subsequent manufacture of a solution and injection.

In terms of price, the “run-up” of the price tag depends on the country of origin (domestic and imported), as well as on the dosage.

For example, the same Flenox, at a dosage of 0.4, will cost about 980 rubles, and Ukrainian-made Novoparin can cost no more than 567 rubles.

Fraxiparine from the same family can reach the astronomical price (price difference ranging from 1800 to 2500 rubles).

Imported analogues differ significantly in price. On the example of Novoparin, after a brief monitoring, you can find out that an English-made product (dosage 0.4) will cost about 800 rubles. The easiest way to find Novoparin, due to its lower price and prevalence. Those. Clexane, whose analogues were presented above, is a rather specific remedy for which you can pick up a cheaper replacement.

closest Fraxiparine is considered an analogue as an equivalent substitute. Due to the similarity of medications, many have a reasonable question: “Fraxiparine or Clexane, which is better?”

In essence, these two drugs are equivalent. As pharmacists and doctors note, the main difference lies in the amount (percentage) of the active substance - enoxaparin sodium.

Important! Obviously, they do not save on health. But the high cost of the necessary medicines sometimes makes you think about possible analogues of the drug, and sometimes even stop the treatment process.

Before you buy a "substitute" in any case, you should consult with your doctor. Because an incorrectly selected “double” of the drug Clexane can lead to the following consequences:

• allergic reactions with possible consequences;
• deterioration of the patient's condition due to unacceptable substances in the composition;
• side effects of the analog, which can correct the treatment in the wrong direction;
• zero effect is possible, etc.

The essence of these drugs is that they, as it were, thin the blood, relieving it of excess "density".

Otherwise, the drugs are quite similar and can be used to prevent blood clots. In the price issue, the Clexane medicine syringe will vary within 2,700 rubles, and the price of its “double” will range from 2,900 to 3,400 rubles.

Both drugs are sold in sufficient quantities, and there are no problems with their supply.

Those. the risk of replacement is quite high, and the desire to save will result in additional costs at best. Therefore, if you want to buy an effective substitute for the drug, first specify its name, dosage and cost, and then consult a doctor about its possible use.

Clexane and booze

especially acute compatibility contraindications these two do not exist. But their simultaneous entry into the human body is unacceptable if:

• if an alcoholic drink and medicine are used at the same time;
• it is unacceptable to use Clexane during pregnancy at any time;
• during the course of treatment it is strictly forbidden to take alcohol.

In other cases, these two substances are compatible if at least 24 hours have passed between their introduction into the body. If these substances were consumed with a difference of less than 20 hours, try to drink as much water as possible in the next 4 hours (namely, pure, not soda or something like that), while completely eliminating the use of strong drinks.

As a consolation, we can say that if such an accident happened for the first time, then there will be no serious consequences. Obvious side effects can be: nausea, vomiting, headaches, redness, cramps of the limbs, and so on.

Video: how to put Clexane correctly

Clexane, despite its narrow specialty, is quite strong remedy capable of harming a person. Its use is permissible only on the recommendation of the attending physician. Otherwise, negative consequences are possible, which in turn can bring new health problems.

The syringe contains 20, 40, 60, 80 or 100 mg of Clexane (enoxaparin), respectively, in 0.2; 0.4; 0.6; 0.8 or in 1.0 ml of an aqueous solution. 1 mg of Clexane contains 100 anti-Xa units.

PHARMACOLOGICAL PROPERTIES

Clexane is a low molecular weight heparin with high activity against coagulation factor Xa (thrombokinase) and low activity against factor IIa (thrombin). In doses used for the prevention of venous thrombosis, it has practically no effect on bleeding time, clotting time, APTT, platelet aggregation.

When s/to the introduction quickly and almost completely absorbed. The peak of anti-Xa activity in plasma is reached after 3-5 hours. Clexane is excreted mainly in the urine. The half-life is about 4 hours. Anti-Xa activity in blood plasma is determined within 24 hours after a single injection. In renal failure in the elderly, the half-life may increase to 5-7 hours, but dose adjustment is not required. During hemodialysis, the elimination of enoxaparin does not change.

INDICATIONS FOR USE

• Prevention of venous thrombosis and thromboembolism, especially in orthopedic and general surgical operations and in cancer patients.
• Treatment of deep vein thrombosis with or without pulmonary embolism.
• Treatment of unstable angina and non-Q wave myocardial infarction (in combination with aspirin).
• Prevention of thrombus formation in the extracorporeal circulation during hemodialysis.

CONTRAINDICATIONS

Allergic reactions to Clexane (enoxaparin), heparin and other low molecular weight heparins. High risk of bleeding, including acute gastric and duodenal ulcers.

PRECAUTIONARY MEASURES

Do not enter in / m! Strictly follow the instructions. With a history of thrombocytopenia caused by heparin, Clexane is used only in exceptional cases, after consultation with a specialist. Before and during treatment, platelet counts should be checked regularly, and if they decrease by 30-50%, the administration of enoxaparin is immediately stopped.

Clexane is prescribed with caution at the risk of bleeding: hypocoagulation, a history of peptic ulcer, recurrent ischemic strokes, severe arterial hypertension, diabetic retinopathy, repeated neurological or ophthalmic operations, severe liver disease. Rare cases of spinal cord hematoma have been described with the use of Clexanan on the background of spinal and epidural anesthesia with the development of persistent or irreversible paralysis. During pregnancy, the drug is prescribed only for strict indications.

SIDE EFFECTS

At observance of the recommended dosages hemorrhagic manifestations are extremely rare. In the first days of treatment, moderate asymptomatic thrombocytopenia may appear. Perhaps an asymptomatic reversible increase in the number of platelets, occasionally - immune thrombocytopenia. A reversible increase in the level of liver enzymes is possible. At the injection site, there may be moderate redness and hematoma, occasionally there are dense inflammatory nodes that resolve after a few days, and it is not necessary to stop treatment. Extremely rarely, necrosis occurs at the injection site. In such cases, the administration of the drug should be stopped immediately. Occasionally, skin or systemic allergic reactions to the drug were observed.

SPECIAL MARKS

In case of overdose, hemorrhagic complications are possible. In case of an overdose, slow intravenous administration of protamine is indicated. 1 mg of protamine neutralizes the anticoagulant activity caused by 1 mg of Clexane. However, even high doses of protamine do not completely neutralize the anti-Xa activity of Clexane (maximum - 60%).

Prior to the appointment of Clexane, drugs that affect hemostasis, such as aspirin, non-steroidal anti-inflammatory drugs, dextran, ticlopidine, glucocorticoids, thrombolytics and anticoagulants, should be discontinued. If this is not possible, Clexane should be used under close clinical and laboratory control. DO NOT MIX WITH OTHER DRUGS IN THE SAME SYRINGE!

APPLICATION AND DOSAGE

Mode of application

Clexane is administered s / c in the supine position, in the antero- or posterolateral region of the abdominal wall at the level of the belt. The needle is inserted vertically for its entire length into the thickness of the skin, clamped into the fold; the skin fold is not straightened until the end of the injection. After the injection, the injection site should not be rubbed. During hemodialysis, Clexane should be injected into the arterial line.

Prevention of venous thrombosis and thromboembolism

At moderately high risk Clexane is prescribed 20 mg (0.2 ml) s / c once a day. The drug is started 2 hours before surgery and continued until there is a risk of thromboembolic complications (usually 7 days). At very high risk Clexane is given 40 mg (0.4 ml) s.c. once daily, with the first dose given 12 hours before surgery and continued as long as there is a risk of thromboembolic complications (usually for 10 days).

Treatment of deep vein thrombosis

1 mg/kg s.c. every 12 hours for 10 days. At the same time, treatment with oral anticoagulants is started, and the administration of Clexane is continued until the effect is achieved (INR from 2 to 3).

Treatment of unstable angina and non-Q wave myocardial infarction

The recommended dose of Clexane is 1 mg/kg every 12 hours s.c., along with aspirin (100-325 mg 1 time per day). Clexane is prescribed for at least 2 days and continues treatment until the condition stabilizes. The usual duration of treatment is 2-8 days.

Prevention of coagulation in the extracorporeal circulation system during hemodialysis

Clexane is injected into the arterial line at the beginning of hemodialysis at a dose of 1 mg/kg for a 4-hour procedure. With a high risk of bleeding, the dose is reduced to 0.5 mg / kg with double access to the vessels or to 0.75 mg / kg with a single access. But with the deposition of fibrin rings, you can enter an additional 0.5-1 mg / kg.

Release form

Syringes ready for use: 20 mg/0.2 ml, 40 mg/0.4 ml, 60 mg/0.6 ml, 80 mg/0.8 ml, 100 mg/1.0 ml 2 syringes per pack .

Storage

Shelf life 24 months. Store at a temperature not exceeding 25°C. Do not freeze.

Pregnancy is a very important time in every woman's life. It would seem that nature has calculated all the nuances and features of the work of the organs during the period of expectation of the baby, but in some cases a well-functioning system can fail. It is at these moments that it is important to quickly determine the diagnosis and help the body cope with the problem. Pharmacology offers a large selection of medicines, including Clexane. Why would a doctor recommend its use?

Clexane is a drug that has an antithrombotic effect. The therapeutic effect in the course of treatment is achieved due to the active substance - enoxaparin sodium. On the shelves of pharmacy chains, the drug arrives in disposable syringes, inside which contains liquid for injection. The doctor selects only the dosage. Manufacturers produce Clexane in 1.0 ml, 0.8 ml, 0.6 ml, 0.4 ml or 0.2 ml of a clear or yellowish solution.

It is worth noting that syringes are for single use only. You can not use them for the introduction of other drugs or Clexane repeatedly. After the procedure, the system must be disposed of.

Clexane comes in syringes that can't be reused.

Getting into the body by subcutaneous injection, the active substance reaches its full concentration in the blood after three, a maximum of five hours. Enoxaparin sodium is excreted, including by the kidneys.

During the period of expectation of a baby, women are forbidden to independently begin treatment with Clexane. This is due to the fact that a sufficient number of studies have not been conducted, so doctors cannot say with certainty whether the active ingredient penetrates the placental barrier. However, doctors, based on clinical observations of pregnant women who used the drug, do not note its negative impact on the development and health of the fetus.

Indications for the use of Clexane during pregnancy

From the moment of conception, significant changes occur in the body of a pregnant woman. First of all, it concerns blood formation. Many women know that blood volume increases, because it should be enough for a growing fetus. But not everyone knows about the increase in its coagulability: this is a kind of insurance for a woman in labor, preventing bleeding during childbirth. Nature has carefully planned everything. However, these factors increase the load on the circulatory system, which in some cases leads to the expansion of the walls of blood vessels, the beginning of the inflammatory process, and in the future - to the development of thrombosis.

Fatigue, swelling of the legs, pain - all these are the first signs of varicose veins, which can provoke the formation of blood clots in the vessels

During the period of gestation, women must pass tests. If, according to the results of the study, hypercoagulability (a strong increase in blood clotting) is determined in the expectant mother, she is prescribed medications that help thin the vital fluid and prevent the formation of blood clots.

Blood clots are dangerous not only for the health of the mother. They can also form in the vessels of the placenta, which leads to impaired blood circulation between the body of the woman and the fetus: the blood flow slows down or stops altogether. Because of this, the child lacks oxygen and nutrients. This situation is extremely dangerous, because it negatively affects the development of the crumbs, and can also cause its intrauterine death.

Doctors prescribe treatment for expectant mothers with Clexane injections in the following cases:

• prevention and treatment of thrombosis (including to prevent the formation of blood clots in women who have been in bed for a long time);
• thrombosis after surgery;
• angina pectoris - acute chest pain that occurs due to insufficient blood supply to the heart;
• heart attack - a pathological condition due to circulatory disorders.

How long can a doctor prescribe Clexane

The decision on the possibility of including Clexane in the treatment regimen is made only by the doctor. In the first three months of pregnancy, doctors try not to prescribe injections to expectant mothers. This is due to the fact that there is no data on the effect of the active substance on the embryo. In the early stages, it is extremely important to minimize the risks of developing baby pathologies, because it is during this period that the formation of all organs and systems of the child takes place.

According to the instructions, the drug is undesirable for pregnant women. However, in practice, doctors often prescribe it starting from the second trimester. But the treatment takes place under the supervision of a doctor who carefully monitors the mother's health and studies changes in blood counts.

The growing uterus not only compresses the woman's internal organs, but also increases the pressure on the veins. As a result, inflammation of the walls of blood vessels and the formation of blood clots occur. Clexane is intended to prevent thrombus formation in the pelvic area and lower extremities.

How to give injections

The method of administration of Clexane differs from the usual. The fact is that the drug is forbidden to inject intramuscularly or intravenously. According to the instructions, the injection is made deep under the skin in the left and right abdomen in turn. The dosage is determined only by the doctor, depending on the diagnosis of the expectant mother and the individual characteristics of the course of pregnancy. Most often, women in anticipation of a baby are prescribed a daily dose, which is equal to 0.2–0.4 ml of a solution.

Instructions for insertion under the skin on the abdomen

To correctly introduce the drug into the body, you must adhere to the following recommendations.

For convenience, doctors advise performing the procedure in the supine position. The course of treatment is also determined by the attending physician. On average, it is 7-14 days.

How to cancel the drug: stop abruptly or gradually

Cancellation of Clexane before childbirth has its own characteristics. In some situations, they throw it abruptly (for example, with a threat of miscarriage and bleeding). But in most cases, this should be done gradually and under the supervision of a doctor, slowly reducing the dosage and conducting regular blood tests. Before a planned cesarean section, the use of the drug is usually stopped the day before the operation, and after that several more injections are made to prevent the formation of blood clots.

A specialist will tell you about all the intricacies of Clexane cancellation.

Contraindications and side effects, as well as possible consequences for the child

Clexane is a serious medicine that has a fairly extensive list of contraindications. It is forbidden to inject the solution into the body of a woman if she has one or more conditions:

• allergic reactions to the components of the drug, which is a manifestation of individual intolerance to the active substances;
• risk of bleeding: threatened miscarriage, hemorrhagic stroke (rupture of a cerebral vessel followed by hemorrhage), aneurysm (protrusion of the artery wall due to its thinning or stretching);
• hemophilia is a hereditary disease characterized by a violation of the blood coagulation process;
• the presence of an artificial valve in the heart.

In addition to these contraindications, there are a number of diseases in which Clexane must be used with great care:

• stomach ulcer or erosive mucosal lesions;
• severe forms of diabetes;
• disruption of the kidneys or liver;
• extensive open wounds (to avoid the development of serious bleeding).

Treatment with Clexane takes place under the supervision of a doctor in order to assess the condition of the woman and the fetus

During or after administration, the solution may cause unpleasant symptoms. Women should know that when they occur, you should not do another injection. It is necessary to seek advice from your doctor in order to change the drug or adjust the dose of the drug. The expectant mother may experience the following side effects:

• headaches, dizziness;
• allergic reactions: irritation, rash, itching;
• with prolonged use of Clexane, the development of cirrhosis of the liver is possible;
• hematomas at the injection site.

Simultaneous use with other drugs

It is forbidden to use Clexane together with other drugs that affect blood clotting processes, for example, with Curantyl or Dipyridamole. With some groups of medicines, for example, non-steroidal anti-inflammatory drugs, anticoagulants (inhibit blood clotting) and thrombolytics (dissolve blood clots), Clexane is not used so as not to provoke bleeding.

What are the analogues and other options for replacing Clexane

There are other medications based on enoxaparin sodium on the pharmacological market, so pharmacists can offer a replacement. Full analogues of Kseksan are:

If, as a result of treatment with Clexane, a woman experiences unpleasant symptoms or she has contraindications to its use, the attending physician will select another drug. Have a similar therapeutic effect:

• Fraxiparine - the active substance is effective for the treatment and prevention of blood clots;
• Warfarin - is available in the form of blue tablets and is used while waiting for a child only in the second and third trimesters;
• Fragmin - solution for injection has an antithrombotic effect.

Gallery: Fraxiparine, Warfarin, Gemapaksan and other drugs used to treat blood clots

Fragmin is prescribed to pregnant women for the treatment of thrombosis.
Warfarin is forbidden to use in the first trimester of pregnancy Fraxiparine is available as a solution for injection.

Anfibra is available in several dosages. Gemapaksan is used to thin the blood and fight thrombus formation.

Table: characteristics of drugs that can be prescribed to pregnant women to replace Clexane

Clexane is a drug whose main action is designed to prevent blood clotting. It is actively used in traumatological, surgical, orthopedic medical fields for the prevention and treatment of blood clots in deep veins.

The use of Clexane helps to prevent the occurrence of blood clots in the extracorporeal circulation. The introduction of the drug occurs subcutaneously for the treatment of acute coronary syndrome.

Clexane is not recommended during pregnancy. However, many doctors prescribe this drug for indications and in cases where the positive effect on the woman's body is much higher than the potential risk of fetal development. In addition, this medicine should be completely abandoned during breastfeeding.

The drug can only be used to prevent the appearance of blood clots and in myocardial infarction.

Contraindications to the use of Clexane during pregnancy

During pregnancy, the use of Clexane is prohibited in the presence of the following diseases and conditions:

• ischemic stroke;
• peptic ulcers of the gastrointestinal tract and erosive lesions;
• arterial hypertension;
• recent surgery;
• problems with the retina;
• liver and kidney failure;
• severe traumatic lesions;
• intrauterine device;
• inflammatory process localized in the inner lining of the heart;
• diabetes mellitus at any stage;
• homeostasis disorders.

The consequences of using Clexane in these conditions are catastrophically dangerous. Prescribe this drug during pregnancy can only be an experienced and qualified doctor, who must at the same time monitor the treatment.

In addition, the use of the drug is highly not recommended for malignant neoplasms, overweight, heart failure.

At the same time, you should not combine the drug during pregnancy with other potent drugs.

Technology of drug administration

There is a certain technique for introducing Clexane into the body of a pregnant woman, which provides for compliance with the following rules:

1. The drug must be injected as deep as possible under the skin.
2. The introduction is possible in the supine position.
3. Intramuscular administration is prohibited.
4. If the administered dose does not exceed 20 mg, then the air should not be removed from the syringe in order to exclude the “loss” of the drug.
5. It is necessary to inject the medicine into the left or right region of the peritoneum: the skin fold is clamped with fingers and the needle is inserted vertically into it for the entire length. The skin can be released only after the complete administration of the drug.
6. It is forbidden to comb and massage the injection site.

Clexane is a clear, colorless solution that is available as a solution. The main active ingredient of the drug is enoxaparin sodium.

If there is a risk of blood clots or during surgery, 20-40 mg of the drug is administered daily. If an operation is expected, then Clexane must be administered 100-120 minutes before the start of the operation.

If there is a risk of blood clots that occur against the background of surgical intervention, Clexane should be administered 1 time 12 hours before the operation.

Diseases of the respiratory system - a contraindication to the use of Clexane

The duration of treatment with this drug is 7-10 days. If at the end of the therapeutic course there are risks for the development of pathologies, then the treatment continues until the main manifestations of the ailments disappear.

In order to prevent thrombosis and embolism in pregnant women, Clexane is used once a day. The duration of treatment in this way is 1-2 weeks (no more).

Indications for use

The drug is used to treat a number of diseases, including during pregnancy, the main of which are:

• acute form of respiratory or heart failure;
• thrombosis;
• myocardial infarction;
• infectious and rheumatic diseases;
• unstable angina.

During pregnancy, it is recommended to inject Clexane in smaller and reduced dosages. Only a doctor can determine the exact dose. Given the complexity of the injection procedure, only a qualified specialist should perform it. Self-treatment with this drug is prohibited.

Side effects from using Clexane during pregnancy

When treated with this drug, there is a relatively high risk of bleeding. In such situations, the use of the drug in the future is strictly prohibited. Treatment is symptomatic.

In rare cases, there is the appearance of hemorrhoidal syndrome, against which hemorrhages appear in the cranial region and the space behind the peritoneum. There is a possibility of death.

In those situations when the drug is used for catheterization of the patient or spinal anesthesia, the appearance of a hematoma of the spinal space with various neurological disorders is likely.

Often at the very beginning of treatment, thrombocytopenia may develop. In this case, it is not clinically significant, because it has a transient character.

Most often, all kinds of local reactions are observed in the area of ​​​​subcutaneous administration of the drug:

• soreness of the injection site;
• the appearance of a small hematoma;
• the formation of a dense infiltrate;
• formation of erythematous plaques.

All allergic reactions associated with the use of this medicinal product are limited to skin manifestations. In exceptional cases, systemic reactions develop. The most dangerous effect is vasculitis.

drug overdose

Cases of overdose of Clexane are possible only when the drug is administered in large volumes intravenously or subcutaneously. Oral medication reduces the chance of overdose to a minimum.

Clexane's antidote is protamine sulfate. To neutralize 1 mg of the drug, the introduction of 1 mg of the substance is required. In this case, it is possible to neutralize the drug only when the drug was administered less than 8 hours ago. If it was introduced earlier, then 0.5 mg of protamine sulfate is enough.

Clexane should not be mixed with other potent drugs. Also, simultaneous use with low molecular weight heparins is not allowed.

Clexane during pregnancy can only be prescribed by the attending physician, after studying the patient's history, assessing her condition, the presence of contraindications for use and other factors that may adversely affect a person's health after the start of treatment.

It has already been noted above that Clexane during pregnancy is used in reduced dosages. During breastfeeding, the use of the drug is excluded.