How much to take Clexane after surgery. Indications for the appointment of clexane, clinical efficacy, instructions for use and contraindications. Instructions for use

One syringe contains, depending on the dosage: 10000 anti-Xa IU, 2000 anti-Xa IU, 8000 anti-Xa IU, 4000 anti-Xa IU or 6000 anti-Xa IU enoxaparin sodium .

Release form

The drug is a clear solution for injection of a colorless or yellowish color.

1 ml, 0.8 ml, 0.6 ml, 0.4 ml or 0.2 ml of such a solution in a glass syringe, two such syringes in a blister, one or five such blisters in a paper pack.

pharmachologic effect

Clexane (Clexane) has an antithrombotic effect.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Clexane INN (international generic name) enoxaparin . The drug is low molecular weight with a molecular weight of about 4500 daltons. Obtained by alkaline hydrolysis heparin benzyl ether extracted from pig intestinal mucosa.

When used in prophylactic doses, the drug slightly changes APTT , has almost no effect on platelet aggregation and fibrinogen binding. in therapeutic doses enoxaparin increases APTT 1.5-2.2 times.

Pharmacokinetics

After systemic subcutaneous injections enoxaparin sodium 1.5 mg per kilogram of body weight once a day, the equilibrium concentration occurs after 2 days. Bioavailability when administered subcutaneously reaches 100%.

Enoxaparin sodium metabolized in the liver by desulfation and depolymerization . The resulting metabolites have very low activity.

The half-life is 4 hours (single administration) or 7 hours (multiple administration). 40% of the drug is excreted through the kidneys. breeding enoxaparin in elderly patients is delayed as a result of deterioration in renal function.

In individuals with kidney damage, clearance enoxaparin reduced.

Indications for use

This drug has the following indications:

prevention and embolism veins after surgical interventions;
therapy of complicated or uncomplicated;
prevention thrombosis and venous embolism in patients long time on bed rest, due to acute therapeutic pathology (chronic and acute heart failure , heavy infection , respiratory failure , sharp rheumatic diseases );
prevention thrombosis in the system of extracorporeal blood flow at;
therapy and without Q wave;
acute therapy heart attack with an increase in the ST segment in individuals requiring medical treatment.

Contraindications

to the components of the drug, and other low molecular weight.
Diseases with an increased risk of bleeding, such as threatened abortion, bleeding, hemorrhagic .
It is forbidden to use Clexane during pregnancy in women with artificial heart valves.
Age less than 18 years (safety and efficacy not established).

Use with caution in the following cases:

diseases accompanied by impaired hemostasis ( hemophilia , hypocoagulation, thrombocytopenia, von Willebrand disease ), expressed vasculitis ;
stomach or duodenal ulcer, erosive and ulcerative lesions of the digestive tract;
recent ischemic ;
heavy;
hemorrhagic or diabetic retinopathy ;
in severe forms;
recent childbirth;
recent neurological or ophthalmic intervention;
performance epidural or spinal anesthesia,cn inno-cerebral puncture ;
bacterial;
intrauterine contraception;
pericarditis ;
damage to the kidneys or liver;
severe trauma, extensive open wounds;
co-administration with drugs that affect the hemostasis system.

Side effects

As with other anticoagulants, there is a risk of bleeding, especially when invasive procedures or the use of drugs that affect hemostasis. If bleeding is detected, it is necessary to stop the administration of the drug, find the cause of the complication and begin appropriate treatment.

When using the drug against the background epidural or spinal anesthesia, postoperative use of penetrating catheters, cases of the appearance of neuraxial hematomas leading to neurological diseases of varying severity, including irreversible.

Thrombocytopenia in the prevention of veins in surgical patients, treatment and with an increase in the ST segment occurred in 1–10% of cases and in 0.1–1% of cases in prevention thrombosis veins in patients on bed rest and undergoing therapy myocardial infarction and .

After the introduction of Clexane under the skin, the appearance of hematomas at the injection site. In 0.001% of cases, local necrosis skin.

Rarely, skin and systemic reactions have occurred, including.

An asymptomatic transient increase in liver enzymes has also been described.

Instructions for use Clexane

Instructions for use Clexane reports that the drug is injected deeply subcutaneously in the supine position of the patient.

How to inject Clexane?

The drug should be injected into the left and right side of the abdomen alternately. To perform the injection, it is necessary to perform such manipulations as opening the syringe, exposing the needle and inserting it vertically to its full length, into the skin fold previously assembled with the thumb and forefinger. The fold is released after the injection. It is not recommended to massage the injection site.

Video on how to inject Clexane:

The drug is not allowed to be administered intramuscularly.

Introduction scheme. Produce 2 injections per day with an exposure of 12 hours. The dose for one injection should be 100 anti-Xa IU per kilogram of body weight.

Patients with an average risk of occurrence require a dose of 20 mg once a day. The first injection is carried out 2 hours before the operation.

Sick with big risk appearance thrombosis it is recommended to administer 40 mg of Clexane once a day (first injection 12 hours before surgery), or 30 mg of the drug twice a day (first injection 13–24 hours after surgery). The duration of therapy averages a week or 10 days. If necessary, treatment can be continued as long as there is a risk of thrombosis .

Treatment . The drug is administered at the rate of 1.5 mg per kilogram of body weight once a day. The course of therapy usually lasts 10 days.

Prevention thrombosis and embolism veins in patients on bed rest caused by acute therapeutic diseases. The required dose of the drug is 40 mg once a day (duration 6–14 days).

Overdose

Accidental overdose can lead to severe hemorrhagic complications. When taken orally, absorption of the drug into the systemic circulation is unlikely.

Slow administration is indicated as a neutralizing agent. protamine sulfate intravenously. One mg of protamine neutralizes one mg of enoxaparin. If more than 12 hours have passed since the onset of the overdose, then the introduction protamine sulfate not required.

Interaction

Clexane should not be mixed with other drugs. Also, do not alternate the use of Clexane and other low molecular weight heparins.

When applied with weighing 40 kDa, non-steroidal anti-inflammatory drugs , and ticlopidine , thrombolytics or anticoagulants may increase the risk of bleeding.

Terms of sale

Strictly according to the recipe.

Storage conditions

Keep away from children. Store at temperatures up to 25°C.

Shelf life

Three years.

special instructions

When using the drug for the purpose of prevention, there was no tendency to increase the risk of bleeding. When Clexane is used for therapeutic purposes, there is a risk of bleeding in the elderly. In these cases, careful monitoring of the patient is necessary.

Clexane does not affect the ability to drive a car.

Kleksan's analogs

Coincidence in the ATX code of the 4th level:

Kleksan's analogs with identical active substance: Clexane 300 , Novoparin , Enoxarin .

Which is better: Clexane or Fraxiparine?

A frequently asked question by patients about the comparative effectiveness of drugs. and Kleksan belong to the same group and are analogues. There are no studies that reliably confirm the advantage of one drug over another. Therefore, the choice between drugs should be made by the attending physician on the basis of clinical picture disease, the condition of the patient and his own experience.

children

Contraindicated in persons under 18 years of age.

Clexane during pregnancy and lactation

It is forbidden (except in cases where the benefit to the mother is higher than the risk to the fetus) to use Clexane during pregnancy. The consequences can be unpredictable, since there is no exact information about the effect of the use of Clexane during pregnancy on its course.

If necessary, the use of Clexane should be interrupted breast-feeding at the time of treatment.

Reviews about Clexane

Since the beginning of the use of the drug in clinical practice Clexane has proven itself well both among doctors and among patients. There are very few reports of allergic reactions to the drug.

Clexane price

It should be noted that the cost this drug does not always correlate with dosage. average price Clexana 0.2 ml (10 pcs.) in Russia is 3600 rubles, Clexana 0.4 ml (10 pcs.) - 2960 rubles, 0.8 ml (10 pcs.) - 4100 rubles, and buying a drug in Moscow in the same dosages will not cost much expensive.

In Ukraine, the price of Clexane 0.2 ml No. 10 is 665 hryvnia, 0.4 ml No. 10 is 1045 hryvnia, and 0.8 ml No. 10 is 323 hryvnia.

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INSTRUCTIONS
by application medicinal product
for medical use Clexane ®

Registration number:

P No. 014462/01.

Tradename:

Clexane ® .

International non-proprietary name:

enoxaparin sodium.

Dosage form:

injection.

Composition per syringe

Dosage 2000 anti-Xa IU/0.2 ml (equivalent to 20 mg/0.2 ml)
Dosage 4000 anti-Xa IU/0.4 ml (equivalent to 40 mg/0.4 ml )
Dosage 6000 anti-Xa IU/0.6 ml (equivalent to 60 mg/0.6 ml)
Dosage 8000 anti-Xa IU/0.8 ml (equivalent to 80 mg/0.8 ml)
Dosage 10,000 anti-Xa/1 ml (equivalent to 100 mg/1 ml)

* - weight calculated based on the content of sodium enoxaparin used (theoretical activity 100 anti-Xa IU/mg).

Description: clear, colorless to pale yellow solution.

Pharmacotherapeutic group:

direct acting anticoagulant.

ATX code- B01AB05.

Pharmacological properties

Characteristic
Enoxaparin sodium - low molecular weight heparin with an average molecular weight of about 4,500 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 тонкой кишки свиньи. Его структура характеризуется невосстанавливающимся фрагментом 2-О-сульфо-4-енпиразиносуроновой кислоты и восстанавливающимся фрагментом 2-N,6-О-дисульфо-D-глюкопиранозида. Структура эноксапарина натрия содержит около 20% (в пределах от 15% до 25%) 1,6-ангидропроизводного в восстанавливающемся фрагменте полисахаридной цепи.

Pharmacodynamics
In a clean system in vitro 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 coagulation 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 circulation. These factors provide the anticoagulant effect of enoxaparin sodium in general. When used in prophylactic doses, it slightly changes the activated partial thromboplastin time (APTT), has virtually no effect on platelet aggregation and the degree 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 subcutaneous administration and reaches 0.13 IU / ml and 0.19 IU / ml after repeated administration of 1 mg / kg of body weight with a double injection and 1.5 mg / kg body weight with a single injection, respectively. The average maximum anti-Xa plasma activity is observed 3-5 hours after subcutaneous administration of the drug and is approximately 0.2; 0.4; 1.0 and 1.3 anti-Xa IU/ml after subcutaneous 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. Variability within and between patient groups is low. After repeated subcutaneous administration of 40 mg of enoxaparin sodium once a day and subcutaneous administration of enoxaparin sodium at a dose of 1.5 mg/kg of body weight once a day in healthy volunteers, the equilibrium concentration is reached by day 2, with an average area under the pharmacokinetic curve of 15 % higher than after a single injection. After repeated subcutaneous injections of enoxaparin sodium at a daily dose of 1 mg / kg of body weight twice a day, the equilibrium concentration is reached after 3-4 days, and the area under the pharmacokinetic curve is on average 65% higher than after a single injection, and the average values of maximum concentrations are respectively 1.2 IU / ml and 0.52 IU / ml. The bioavailability of enoxaparin sodium when administered subcutaneously, estimated on the basis of anti-Xa activity, is close to 100%. The volume of distribution of anti-Xa activity of enoxaparin sodium is approximately 5 liters and approaches the blood volume. 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/hour.
Elimination of the drug is monophasic with half-lives of 4 hours (after a single subcutaneous injection) and 7 hours (after repeated administration of the drug). Enoxaparin sodium is mainly metabolized in the liver by desulfation and / or depolymerization with the formation of low molecular weight substances with very low biological activity. The excretion through the kidneys of the active fragments of the drug is approximately 10% of the administered dose, and the total excretion of active and inactive fragments is approximately 40% of the administered dose. There may be a delay in the excretion of enoxaparin sodium in elderly patients as a result of a decrease in renal function with age. There was a decrease in the clearance of enoxaparin sodium in patients with reduced renal function. After repeated subcutaneous administration of 40 mg of enoxaparin sodium once a day, there is an increase in anti-Xa activity, represented by the area under the pharmacokinetic curve in patients with insignificant (creatinine clearance 50-80 ml / min) and moderate (creatinine clearance 30-50 ml / min) impaired renal function. In patients with severe renal impairment (creatinine clearance less than 30 ml / min), the area under the pharmacokinetic curve at equilibrium is on average 65% higher with repeated subcutaneous administration of 40 mg of the drug once a day. In overweight people with subcutaneous administration of the drug, the clearance is somewhat less. If the dose is not adjusted for the body weight of the patient, then after a single subcutaneous injection of 40 mg of enoxaparin sodium, anti-Xa activity will be 50% higher in women weighing less than 45 kg and 27% higher in men weighing less than 57 kg compared with patients with normal average body weight.

Indications for use

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

Prevention of venous thrombosis and embolism in patients on bed rest due to acute therapeutic diseases, including acute heart failure and decompensation of chronic heart failure (NYHA class III or IV), acute respiratory failure, as well as severe acute infections and acute rheumatic diseases in in combination with one of the risk factors for venous thrombosis (see "Special Instructions").

Treatment of deep vein thrombosis with or without pulmonary embolism.

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 acute infarction ST-segment elevation myocardium in patients undergoing medical treatment or subsequent percutaneous coronary intervention.

Contraindications

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

Conditions and diseases in which there is a high risk of bleeding: threatening abortion, cerebral aneurysm or dissecting aortic aneurysm (with the exception of surgery), hemorrhagic stroke, uncontrolled bleeding, severe enoxaparin- or heparin-induced thrombocytopenia.

The use of Clexane ® in pregnant women with artificial heart valves is not recommended.

Age up to 18 years (efficacy and safety not established).

Carefully use under the following conditions:

hemostasis disorders (including hemophilia, thrombocytopenia, hypocoagulation, von Willebrand disease, etc.), severe vasculitis;

peptic ulcer of the stomach or duodenum or other erosive and ulcerative lesions of the gastrointestinal tract;

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 of the central nervous system), open wounds on large surfaces;

simultaneous administration of drugs that affect the hemostasis system.
The company does not have data on the clinical use of Clexane ® in the following diseases: active tuberculosis, radiation therapy (recently transferred)

Pregnancy and breastfeeding period

There is no evidence that enoxaparin sodium crosses the placental barrier during the second trimester of pregnancy in humans. There is no relevant information regarding the first and third trimesters of pregnancy. Since there are no adequate and well-controlled studies in pregnant women, and animal studies are not always predictive of response to the administration of enoxaparin sodium during human pregnancy, it should be used during pregnancy only when there is an urgent need for its use, determined by a physician. .
It is not known whether unchanged enoxaparin sodium is excreted in human breast milk. Breastfeeding should be discontinued while the mother is being treated with Clexane.

Dosage and administration

Except in special cases (see below "Treatment of myocardial infarction with ST segment elevation, medically or with the help of percutaneous coronary intervention" and "Prevention of thrombus formation in the extracorporeal circulation system during hemodialysis"), enoxaparin sodium is injected deep subcutaneously. 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 vertically (not sideways) into the skin fold to its full length, 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
For patients with a moderate risk of developing thrombosis and embolism (general surgery), the recommended dose of Clexane ® is 20 mg subcutaneously once a day. The first injection is made 2 hours before surgery. For 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 twice a day with the start of administration after 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 (for example, in orthopedics Clexane ® is prescribed at a dose of 40 mg once a day for 5 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 subcutaneously once a day for 6-14 days.
Treatment of deep vein thrombosis with or without pulmonary embolism
The drug is administered subcutaneously at the rate of 1.5 mg/kg of body weight once a day or at a dose of 1 mg/kg of body weight 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 duration of treatment averages 10 days. It is advisable to immediately start therapy with indirect anticoagulants, while Clexane ® therapy should be continued until a sufficient anticoagulant effect is achieved, i.e. international normalized ratio (INR) should be 2.0-3.0.
Prevention of thrombus formation in the extracorporeal circulation system during hemodialysis
The dose of Clexane ® averages 1 mg/kg of body weight. If there is a high risk of bleeding, the dose should be reduced to 0.5 mg/kg body weight with a dual 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 four-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 subcutaneously, while the use of acetylsalicylic acid at a dose of 100-325 mg once a day.
The average duration of therapy is 2-8 days (until the patient's clinical condition stabilizes).
Treatment of ST-segment elevation myocardial infarction, medically or with percutaneous coronary intervention
Treatment begins with an intravenous bolus injection of enoxaparin sodium at a dose of 30 mg and immediately after it (within 15 minutes) enoxaparin sodium is administered subcutaneously at a dose of 1 mg / kg (moreover, 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 of body weight (that is, 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 a rate of 0.75 mg/kg of body weight (that is, with a weight of more than 100 kg, the dose may exceed 75 mg).
When combined with thrombolytics (fibrin-specific and fibrin-non-specific), enoxaparin sodium should be administered in the range of 15 minutes. before the start of thrombolytic therapy up to 30 minutes. after her. As soon as possible after the detection of acute myocardial infarction with ST segment elevation, acetylsalicylic acid should be started simultaneously and, if there are no contraindications, it should be continued for at least 30 days at doses of 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 hospitalization period is less than 8 days. Bolus administration of enoxaparin sodium should be administered through a venous catheter and enoxaparin sodium should not be mixed or co-administered with other medicinal products. In order to avoid the presence in the system of traces of other drugs 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 administration of enoxaparin sodium. Enoxaparin sodium can be safely administered with 0.9% sodium chloride solution and 5% dextrose solution.
To perform a 30 mg bolus of enoxaparin sodium in the treatment of acute ST-segment elevation myocardial infarction, excess drug is removed from 60 mg, 80 mg and 100 mg glass syringes so that only 30 mg (0.3 ml) remain in them. The 30 mg dose may be administered directly intravenously.
For intravenous bolus administration of enoxaparin sodium through a venous catheter, pre-filled syringes for subcutaneous injection of the drug 60 mg, 80 mg and 100 mg can be used. The use of 60 mg syringes is recommended as this reduces the amount of drug removed from the syringe. 20 mg syringes are not used because they do not contain enough drug to deliver a 30 mg bolus of enoxaparin sodium. 40 mg syringes are not used as they are not marked and therefore it is not possible 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 the narrowing of the coronary artery, additional administration of enoxaparin sodium is not required. If the last subcutaneous injection of enoxaparin sodium was carried out more than 8 hours before inflating the balloon catheter, an additional intravenous bolus of enoxaparin sodium at a dose of 0.3 mg / kg should be performed.
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 use. To prepare a 3 mg/ml enoxaparin sodium solution using a 60 mg pre-filled syringe, it is recommended to use a 50 ml infusion bottle (i.e. 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 60 mg hypodermic syringe) 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 administration with a syringe, the required volume of diluted enoxaparin sodium solution is removed, which is calculated by the formula: Volume of diluted solution \u003d Patient body weight (kg) x 0.1 or using the table below.
Volumes to be administered intravenously after dilution

Patient's body weight [kg]	Required dose (0.3 mg/kg) [mg]	Volume of solution required for administration, diluted to a concentration of 3 mg/ml [ml]
45	13,5	4,5
50	15	5
55	16,5	5,5
60	18	6
65	19,5	6,5
70	21	7
75	22,5	7,5
80	24	8
85	25,5	8,5
90	27	9
95	28,5	9,5
100	30	10

Elderly patients
With the exception of treatment of ST-segment elevation myocardial infarction (see above), for all other indications dose reduction of enoxaparin sodium in elderly patients is not required unless they 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 correction of the dosing regimen is recommended:

Usual dosing regimen	Dosing regimen for severe renal failure
1 mg/kg subcutaneously 2 times a day	1 mg/kg subcutaneously once a day
1.5 mg subcutaneously once a day	1 mg/kg subcutaneously once a day
Treatment of acute myocardial infarction with ST segment elevation in patients<75 лет
Single dose: 30 mg intravenous bolus plus 1 mg/kg subcutaneously; followed by subcutaneous injection at a dose of 1 mg/kg twice a day (maximum 100 mg for each of the first two subcutaneous injections)	Single dose: 30 mg intravenous bolus plus 1 mg/kg subcutaneously; followed by subcutaneous administration at a dose of 1 mg/kg once a day (maximum 100 mg for the first subcutaneous injection)
Treatment of acute ST-segment elevation myocardial infarction in patients ≥75 years of age
0.75 mg/kg subcutaneously twice daily without initial bolus (maximum 75 mg for each of the first two subcutaneous injections)	1 mg/kg subcutaneously once daily without initial bolus (maximum 100 mg for first subcutaneous injection)

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

With mild (creatinine clearance 50-80 ml / min) and moderate (creatinine clearance 30-50 ml / min) impaired renal function
Dose adjustment is not required, but laboratory monitoring of therapy should be carried out more carefully.
Patients with liver failure
Due to the lack of clinical studies, caution should be exercised when prescribing enoxaparin sodium to patients with impaired liver function.

Side effect

The study of the side effects of enoxaparin sodium was carried out in more than 15,000 patients participating in clinical trials, of which 1,776 patients were in the prevention of venous thrombosis and embolism during general surgical and orthopedic operations; in 1169 patients - in the prevention of venous thrombosis and embolism in patients 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 10176 patients - in the treatment of 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 was administered subcutaneously once a 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 subcutaneously every 12 hours or 1.5 mg/kg body weight subcutaneously once a day. In the treatment of unstable angina and non-Q wave myocardial infarction, the dose of enoxaparin sodium was 1 mg/kg body weight subcutaneously every 12 hours, and in the case of ST-segment elevation myocardial infarction, an intravenous bolus of 30 mg was administered, followed by the introduction of 1 mg/kg body weight subcutaneously every 12 hours
Adverse reactions were classified by frequency of occurrence as follows: very common (≥1/10), frequent (≥1/100-<1/10), нечастые (≥1/1000-<1/100), редкие (≥1/10000-<1/1000), очень редкие (<1/10000), или частота неизвестна (по имеющимся данным частоту встречаемости нежелательной реакции оценить не представляется возможным). Нежелательные реакции, наблюдавшиеся после выхода препарата на рынок, были отнесены к частоте «частота неизвестна». Vascular disorders
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 the use of other anticoagulants, when using enoxaparin sodium, bleeding may occur, especially if there are risk factors that contribute to the development of bleeding, when performing invasive procedures or using drugs that violate hemostasis (see sections "Special instructions" and "Interaction with other drugs" ).
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 frequent
Bleeding* in the prevention of venous thrombosis in surgical patients and the treatment of deep vein thrombosis with or without pulmonary embolism.
Frequent
Bleeding* in the prevention of venous thrombosis in bed rest patients and in the treatment of unstable angina, non-Q wave myocardial infarction and ST elevation myocardial infarction.
infrequent
Retroperitoneal bleeding and intracranial hemorrhage in patients in the treatment of deep vein thrombosis with or without pulmonary embolism, as well as in the treatment of ST-segment elevation myocardial infarction.
Rare
Retroperitoneal bleeding in the prevention of venous thrombosis in surgical patients and in the treatment of unstable angina and non-Q wave myocardial infarction.
Thrombocytopenia and thrombocytosis
Very frequent
Thrombocytosis (platelet count in peripheral blood more than 400x10 9 /l) in the prevention of venous thrombosis in surgical patients and the treatment of deep vein thrombosis with or without pulmonary embolism.
Frequent
Thrombocytosis in the treatment of patients with acute ST-segment elevation myocardial infarction.
Thrombocytopenia in the prevention of venous thrombosis in surgical patients and the treatment of deep vein thrombosis with or without pulmonary embolism, as well as in acute myocardial infarction with ST segment elevation.
infrequent
Thrombocytopenia in the prevention of venous thrombosis in bed rest patients and in the treatment of unstable angina and non-Q wave myocardial infarction.
Very rare
Immune-allergic thrombocytopenia in the treatment of patients with acute myocardial infarction with ST segment elevation. Other clinically significant adverse reactions regardless of indication - these adverse reactions, presented below, are grouped by system organ classes, given with the frequency of their occurrence defined above and in order of decreasing severity.
Immune System Disorders
Frequent
Allergic reactions.
Rare
Anaphylactic and anaphylactoid reactions (see also the post-marketing data subsection below).
Liver and biliary tract disorders
Very frequent
An increase in the activity of "liver" enzymes, mainly an increase in the activity of transaminases, more than three times the upper limit of normal).
Skin and subcutaneous tissue disorders
Frequent
Urticaria, itching, erythema.
infrequent
bullous dermatitis.
General disorders and disorders at the injection site
Frequent
Hematoma at the injection site, pain at the injection site, swelling at the injection site, bleeding, hypersensitivity reactions, inflammation, induration at the injection site.
infrequent
Irritation at the injection site, skin necrosis at the injection site.
Laboratory and instrumental data
Rare
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 estimated from the available data).
Immune System Disorders
Anaphylactic/anaphylactoid reactions, including shock.
Nervous System Disorders
Headache.
Vascular disorders
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 (see section "Special Instructions").
Blood or lymphatic system disorders
hemorrhagic anemia.
Cases of development of immune-allergic thrombocytopenia with thrombosis; in some cases, thrombosis was complicated by the development of organ infarction or ischemia of the extremities (see section "Special Instructions", subsection "Control of the number of platelets in peripheral blood".
Eosinophilia.
Skin and subcutaneous tissue disorders
Cutaneous vasculitis, skin necrosis, usually preceded by purpura or erythematous papules (infiltrated and painful) may develop at the injection site. In these cases, therapy with Clexane ® should be discontinued. Perhaps the formation of solid inflammatory nodules-infiltrates at the injection site of the drug, which disappear after a few days and are not grounds for discontinuing the drug.
Alopecia.
Liver and biliary tract disorders
Hepatocellular damage to the liver.
Cholestatic liver disease.
Musculoskeletal and connective tissue disorders
Osteoporosis with long-term therapy (more than three months).

Overdose

Accidental overdose of Clexane ® when administered intravenously, extracorporeally or subcutaneously can lead to hemorrhagic complications. When ingesting even large doses, absorption of the drug is unlikely. The anticoagulant effects can, in general, be neutralized by slow intravenous administration of protamine sulfate, the dose of which depends on the dose of Clexane ® administered. One mg (1 mg) of protamine sulfate neutralizes the anticoagulant effect of one mg (1 mg) of Clexane ® ( see information on the use of protamine salts), if enoxaparin sodium 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 more than 8 hours have passed since the administration of the latter or if a second dose of protamine is necessary. If 12 or more hours have passed after the administration of enoxaparin sodium, the administration of protamine is not required. However, even with the introduction of large doses of protamine sulfate, the anti-Xa activity of Clexane ® is not completely neutralized (by a maximum of 60%). Interaction with other drugs
Clexane ® must not be mixed with other drugs! The use of enoxaparin sodium and other low molecular weight heparins should not be alternated, as they differ from each other in the way of production, molecular weight, specific anti-Xa activity, units of measurement and dosage. And, as a consequence, the drugs have different pharmacokinetics and biological activity (anti-IIa activity, interaction with platelets).
With systemic salicylates, acetylsalicylic acid, non-steroidal anti-inflammatory drugs (including ketorolac), 40 kDa dextran, ticlopidine and clopidogrel, systemic glucocorticosteroids, thrombolytics or anticoagulants, other antiplatelet drugs (including glycoprotein IIb / IIIa antagonists) - increased risk of bleeding (see "Special Instructions").

special instructions

General
Low molecular weight heparins are not interchangeable, as they differ in their manufacturing process, molecular weight, specific anti-Xa activity, dosing units and dosing regimen, which are associated with 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 (see section "Side Effects"). 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 tendency to increase 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 the condition of such patients is recommended (see section "Pharmacokinetics" and section "Method of administration and doses", subsection "Elderly patients").
Simultaneous use of other drugs that affect hemostasis
It is recommended that the use of drugs that can disrupt hemostasis (salicylates, including acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, including ketorolac; dextran with a molecular weight of 40 kDa, ticlopidine, clopidogrel; glucocorticosteroid drugs, thrombolytics, anticoagulants, antiplatelet agents, including glycoprotein IIb receptor antagonists /IIIa) was discontinued prior to treatment with enoxaparin sodium, unless their use is strictly indicated. 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 (creatinine clearance less than 30 ml / min), dose adjustment is recommended, both for prophylactic and therapeutic use of the drug. Although dose adjustment is not required in patients with mild to moderate renal impairment (creatinine clearance 30-50 ml / min or 50-80 ml / min), careful monitoring of the condition of such patients is recommended (see sections "Pharmacokinetics" and " Dosage and administration”, subsection “Patients with renal insufficiency”).
Low body weight
An increase in the anti-Xa activity of enoxaparin sodium during its prophylactic use in women weighing less than 45 kg and in men weighing less than 57 kg 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 enoxaparin at prophylactic doses in obese patients (BMI over 30 kg/m2) has not been fully determined and there is no consensus on dose adjustment. These 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. In the event of thrombocytopenia, it usually develops 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 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 neuraxial hematomas have been 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 higher doses of Clexane ®, as well as with the use of indwelling catheters after surgery, or with the simultaneous use of additional drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (see section "Interaction with other drugs"). 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 (see the Pharmacokinetics section). Placement or removal of a catheter is best done when the anticoagulant effect of enoxaparin sodium is low.
Installation or removal of the catheter should be carried out 10-12 hours after the use of prophylactic doses of the drug Clexane ® for the prevention of deep vein thrombosis. In cases where patients receive higher doses of enoxaparin sodium (1 mg/kg twice a day or 1.5 mg/kg once a day), these procedures should be postponed for a longer period of time (24 hours). Subsequent administration of the drug should be carried out no earlier than 2 hours after removal of the catheter.
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, impaired sensory and motor functions (numbness or weakness in the lower extremities), impaired bowel and/or bladder function. The patient should be instructed to immediately inform the doctor if the above symptoms occur. If symptoms consistent with a spinal cord hematoma are suspected, prompt diagnosis and treatment, including, if necessary, spinal cord decompression, is required.
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 tests for platelet aggregation in vitro are of limited value in predicting the risk of its development. The decision to use the drug 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 instrumental interventions should strictly adhere to the recommended intervals between the administration of Clexane ® and these procedures. 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. If manual compression is used, the femoral artery sheath should be removed 6 hours after the last intravenous or subcutaneous 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 thrombus formation. The evaluation of these reports is limited due to the presence of competing factors that contribute to the development of thrombosis of artificial heart valves, including the underlying disease, and due to the lack of clinical data.
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 twice a day to reduce the risk of thrombosis and embolism, 2 out of 8 women developed a blood clot, leading 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.
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 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 history;

obesity;

hormone therapy;

heart failure;

chronic respiratory failure.

Influence on the ability to drive vehicles and engage in other potentially hazardous activities
The drug Clexane ® does not affect the ability to drive vehicles and mechanisms.

Release forms

Solution for injection 2000 anti-Xa IU / 0.2 ml; 4000 anti-Xa IU/0.4 ml; 6000 anti-Xa IU/0.6 ml; 8000 anti-Xa IU/0.8 ml; 10000 anti-Xa IU/1 ml.
1 type of packaging
0.2 ml or 0.4 ml or 0.6 ml or 0.8 ml or 1.0 ml of the drug solution in a glass syringe (type I), respectively. 2 syringes in a blister. On 1 or 5 blisters together with the application instruction in a cardboard pack.
2 type of packaging
0.2 ml or 0.4 ml or 0.6 ml or 0.8 ml or 1.0 ml of the drug solution in a glass syringe (type I) with a needle protection system, respectively. 2 syringes in a blister. On 1 or 5 blisters together with the application instruction in a cardboard pack.

Storage conditions

At a temperature not higher than +25°С. Keep out of the reach of children!

Shelf life

3 years.
After the expiration date, the drug can not be used.

Holiday conditions

On prescription.

Registration certificate holder
SANOFI-AVENTIS FRANCE, France.

Manufacturer

1) Sanofi Winthrop Industry, France.
Manufacturer's address: 180, rue Jean Jaurès, 94702 Maison Elfort Sedex, France.
2) Sanofi Winthrop Industry, France.
Manufacturer's address: Boulevard Industrial, Zon Industrial, 76580 Le Trais, France.

Consumer claims should be sent to:
125009, Moscow, st. Tverskaya, 22.

- These are common diseases that almost everyone faces. If appropriate treatment is not provided in time, then serious consequences, including death, may result.

Modern pharmacological firms provide a huge selection of drugs for the treatment of these diseases. Each of them can not only relieve pain, but also the inflammatory process.

These drugs include the drug Clexane. It has not only anti-inflammatory properties, but also a tonic effect, so it is often prescribed during prophylaxis before and after operations.

general information

Clexane is a drug that belongs to the group. The drug is used for and, thrombosis, embolism. The active ingredient of the drug is enoxaparin sodium.

This component is also called heparin, which is in a low molecular weight state, obtained by hydrolysis of heparin with alkali (in the form of an ether in benzyl form).

The main raw material for enoxaparin sodium is heparin, which is obtained from the intestinal mucosa of thin-looking pigs.

The composition of Clexane includes the active substance - sodium enexoparin and a clear liquid with a yellow tint for injection.

Produced in the form of syringes, which are filled with a clear liquid for injection under the skin. Syringes are available with different volumes - 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1 ml, which contain 20 mg, 40 mg, 60 mg, 80 mg and 1 gram of the main component - enexoparin and water for injection as a solvent. 1 blister contains 2 syringes.

Pharmacological properties and pharmacodynamics

Clexane has antithrombotic properties. It is used as injections under the skin during the treatment of acute coronary syndrome, deep vein thrombosis, and also as a preventive treatment for various pathologies of the veins.

The second international non-proprietary name for this drug is enoxaparin. The drug is heparin in low molecular weight form, the molecular weight of which is approximately 4500 daltons.

During the use of the agent for prophylactic treatment, it has a slight change in the activated partial thromboplastin time. It also has almost no effect on the state of platelets and binding to fibrogen. Also, during the treatment of various diseases with this drug, the APTT is increased by almost 1.5-2 times.

After prolonged subcutaneous injections of a systematic nature in the amount of 1.5 mg per 1 kilogram of body weight, the maximum level of enoxaparin sodium in the body is reached after two days. Bioavailability during subcutaneous administration is 100%.

Metabolization of enoxaparin in the liver is achieved by desulfation and depolymerization. The metabolites that are formed during this process are of low activity.

The half-life of the drug lasts from 4 hours to 5 hours during a single dose. If the medicine is taken repeatedly - 7 hours. About 40% of the drug is excreted through the kidneys. The excretion of the active substance enexoparin in the elderly is slower, this is due to the deterioration of kidney function.

Indications for use

The main purpose of Clexane is to use it during prophylactic treatment for venous thrombosis, embolism, thromboembolism.

Also, Clexane injections are prescribed for the following indications:

recommended for patients who observe bed rest, who have undergone therapeutic diseases in an acute form - infectious diseases in severe form, the presence of respiratory and heart failure, heart failure in a chronic form, rheumatic diseases in an acute form with the presence of risk factors for thrombus formation;
during surgical interventions;
prescribed for hemodialysis, but provided that the procedure lasts no more than 4 hours;
during deep vein varicose veins which may or may not be accompanied by pulmonary embolism;
prescribed for unstable rhythm of angina pectoris and myocardial infarction. And also during acute myocardial infarction in patients who receive medical treatment procedures with coronary intervention.

Assignment restrictions

According to the instructions, the drug is not recommended for use in the following indications:

in the presence of increased sensitivity of the body to the main component- enoxaparin sodium, as well as to heparin and its derivatives;
should not be taken under the age of 18;
all kinds of diseases and conditions that are accompanied by an increased risk of severe bleeding - these include a hemorrhagic stroke, aneurysm of the aorta or vessels of the brain of the head, as well as in the presence of enoxaparin- and heparin-induced thrombocytopenia in severe form, uncontrolled bleeding.

It is also worth paying attention to the fact that the drug should be used with extreme caution in the following conditions:

in the presence of renal or hepatic insufficiency;
if there is a peptic ulcer of the stomach or duodenum, as well as any other erosive and ulcerative lesions of the gastrointestinal tract;
with severe diabetes mellitus;
with retinopathy of hemorrhagic or diabetic type;
severe vasculitis;
problems with hemostasis;
bacterial type endocarditis;
with uncontrolled hypertension of the arterial type of severe type;
when performing epidural or spinal anesthesia;
if there are severe injuries associated with the central nervous system;
if there is intrauterine contraception;
in the presence of extensive wounds with severe bleeding;
when taken simultaneously with drugs that affect the homeostasis system.

During pregnancy and lactation

The drug Clexane during pregnancy is prescribed in rare cases. It is usually prescribed when the expected therapeutic effect for the mother is higher than the potential rice for the child.

In addition, there is no information on whether enoxaparin sodium crosses the placental barrier during pregnancy.

If treatment with the drug is necessary during lactation, then feeding should be stopped for the period of treatment.

Rules for use and dosage

The solution is administered using the injection method, while the patient should be in the supine position. The drug is injected into the anterior or posterolateral abdominal region of the wall at the site of the belt.

The needle should be inserted vertically completely, into the skin layer, which is clamped in the form of a fold. After the introduction of the fold is not straightened. It should be borne in mind that after the injection, the place does not need to be rubbed.

With venous thrombosis, varicose veins and thromboembolism

If the disease has an average form of development with a slightly pronounced risk, Clexane is used at 20 mg (0.2 g) for subcutaneous administration 1 time per day.

The injection of the drug is made 2 hours before the operation, and continues as long as there is a possibility of complications of a thromboembolic nature. The duration of the injections lasts about a week.

If the disease is severe, then the drug is used at 40 mg (0.4 g) for subcutaneous administration 1 time per day. The first injection is carried out 12 hours before the operation, and continues in the subsequent period, while there is a possibility of complications of a thromboembolic nature. Injections are made for about 10 days.

How to inject Clexane yourself - a visual video:

Treatment of deep vein thrombosis

During deep vein thrombosis, a drug is prescribed at a dosage of 1 gram for injection under the skin. Injections are administered every up to 2 times a day after 12 hours.

Simultaneously with Clexane, treatment with oral anticoagulants is prescribed. The course of injection is 10 days.

Side effects

The instructions indicate the side effects that may occur when using the drug:

bleeding;
the occurrence of thrombocytopenia;
skin rashes;
the occurrence of allergies, which may be systemic.

In addition, after the administration of the drug, local reactions may occur - pain at the injection site, the appearance of hematomas, in rare cases, necrosis.

Also, many reviews of experts note that with long-term treatment with this drug, there may be a risk of developing osteoporosis.

Opinion of experts of different profiles

From the reviews of doctors about the drug Clexane.

In my opinion, Clexane is a good remedy for the treatment of thrombosis, embolism and thromboembolism.

In all my practice of using this drug, I can say with confidence that this remedy has a positive effect and leads to a quick recovery. But still, it should be used only according to indications and only after a doctor's prescription.

Vascular surgeon

The drug Clexane performs well both in the treatment of heart failure, myocardial infarction, and various vein diseases - varicose veins, thrombosis, embolism, thromboembolism. This remedy has passed clinical trials and has proven its effectiveness. However, do not forget about side effects and contraindications, it is not advisable to use this remedy for hemorrhagic diseases and other conditions indicated in the instructions.

Cardiologist

The voice of the people

Patients' thoughts.

The drug Clexane was prescribed to me by my doctor for the treatment of vein thrombosis. I did it in accordance with the instructions before the operation and further in the subsequent period. The whole course of treatment I had a week.

After the treatment, I noticed relief, pain disappeared, inflammation and heaviness disappeared. However, there are still many contraindications and side effects of this remedy, and it is so effective!

Lyudmila, 48 years old

I was prescribed Clexane for the treatment of deep vein varicose veins and thrombosis. I have a high risk disease.

I was given it at a dosage of 40 mg, first before the operation, then in the subsequent period. I received 10 injections in total. Of course, the situation has improved, but not by much. Perhaps I have a severe lesion and advanced disease. And there are too many contraindications.

Mikhail, 52 years old

Issue price

The cost of the drug Clexane depends on the form of release and the volume of the syringe:

0.2 grams 10 pieces - from 1750 rubles;
0.4 grams 10 pieces - from 2900 rubles;
0.6 grams 2 pieces - from 880 rubles;
0.8 grams 10 pieces - from 5000 rubles.

Fragmin;
Cibor;
Ostohont;
Gepalpan;
Troparin lmv.

Content

For the prevention of thrombosis, vascular accidents and other cardiovascular problems, Clexane injections are prescribed. The drug belongs to the group of low molecular weight heparins, has multiple contraindications, should be used only under medical supervision.

Composition and form of release

Clexane is produced in the form of solutions for injection: from a completely clear to pale yellow liquid in glass syringes. One carton contains from 1 to 5 blisters of 2 syringes each. The official international name of Clexane is Enoxaparin, the Latin name is clexane.

As an auxiliary component, the composition of the solution includes water for injection. The active ingredient is the low molecular weight sodium enoxaparin. The dosage of 1 syringe is measured in international units of anti-XA ME and is:

Syringe volume	Dose of anti-HA ME

Properties of the drug components

The drug belongs to the group of low molecular weight anticoagulants of the heparin class. Clexane has a high anti-Xa activity and a relatively low ability to inhibit thrombin. The mechanism of the pharmacological action of the drug is the activation of protein antithrombin, which slows down the activity of factor X, while not having a significant effect on platelet synthesis.

Under the influence of enoxaparin, APTT (activated partial thromboplastin time, the interval during which a blood clot forms after calcium chloride or other reagents are added to it) may slightly change. The bioavailability of the active ingredient when administered subcutaneously is 100%. Enoxaparin is completely metabolized by the liver, 40% is excreted by the kidneys. The half-life is 4 hours (with a single use) and 7 hours (with repeated administration).

Why is Clexane prescribed?

The drug is used for the treatment and prevention of cardiovascular diseases. According to the instructions, the main indications for the appointment of injections are:

prevention of venous embolism or thrombosis after surgery;
treatment of deep vein thrombosis uncomplicated by pulmonary embolism;
prevention of thrombosis in patients who are forced to stay in bed for a long time - heart failure, severe infections, respiratory failure, rheumatic diseases;
treatment of angina pectoris;
therapy of myocardial infarction without Q wave;
treatment of acute infarction in individuals with ST segment enlargement.

How to inject Clexane

Instructions for use of the drug informs that the solution must be injected deep subcutaneously into the left or right side of the abdomen when the patient is in a supine position. After the injection, it is not recommended to massage or rub the injection site. The dosage regimen and frequency of injection depends on the diagnosis:

	Dosage	Multiplicity of introduction	Duration of treatment
Treatment of deep vein thrombosis	1.5 mg per 1 kg of patient's body weight	1 time / day
Prevention of thrombosis, embolism		1 time / day
Patients with an average risk of blood clots		1 time / day
Patients at high risk of blood clots		1-2 times / day

special instructions

Clexane is forbidden to be administered intramuscularly to pregnant and lactating women and children. In addition, the instructions contain the following instructions regarding treatment:

In the event of a feeling of numbness or tingling of the limbs, impaired tactile sensations, bowel disorder or bladder dysfunction, you must stop using Clexane and immediately consult a doctor.
The drug does not have a significant effect on the psychomotor abilities of a person. You can drive a car or take part in work with increased concentration of attention throughout the course of therapy.
Subject to the dosages and frequency of use indicated in the instructions, the drug does not affect the synthesis of platelets and the time of hematopoiesis.
During therapy, it is necessary to regularly take a blood test in order to monitor and detect possible bleeding in time.
From days 15 to 21 of therapy, the patient has an increased chance of developing thrombocytopenia (a condition characterized by a decrease in the number of platelets). If the treatment was prescribed for a course of more than 10 days, it is necessary to monitor the blood counts and compare them with the initial data of the laboratory examination.
Patients with problems of the liver, kidneys, elderly people should consult a doctor to adjust the treatment regimen.

drug interaction

Instructions for use Clexane warns that the drug is strictly forbidden to combine or alternate with other low molecular weight heparins. During treatment, it is important to consider the following ability of the injection solution to interact with other medicines:

The therapeutic effect of enoxaparin increases when combined with acetylsalicylic acid, warfarin derivatives, clopidogrel, dipyridamole, fibrinolytics ticlopidine.
Plasma substitutes, gout medications, loop diuretics, and penicillins increase the effectiveness of Clexane.
The simultaneous use of low molecular weight heparins and non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of hemorrhage (bleeding).
Antihistamines, cardiac glycosides, smoking, tetracycline antibiotics reduce the effectiveness of Clexane.
Simultaneous use of low molecular weight heparins and anticonvulsants, antiarrhythmic drugs or beta-blockers leads to a decrease in the effectiveness of the latter.

Clexane and alcohol

The simultaneous use of the solution with alcoholic or alcohol-containing drinks is strictly prohibited. Ignoring this instruction can lead to increased side effects, liver failure, hemorrhagic apoplexy (sudden paralysis due to rupture of the arteries and bleeding in the brain).

Side effects

The drug Clexane increases the risk of bleeding, especially when taking other drugs that affect hemostasis at the same time. If blood flow disorders are detected, the medication should be stopped immediately. Other side effects of Clexane include:

Organ or system
		Headache.
Hematopoiesis	Hematoma, epistaxis, thrombocytopenia.	Intracranial hemorrhage, retroperitoneal bleeding.
immune	Allergy (erythema, itching).	Anaphylactic shock.
Liver and bile ducts	Increased activity of transaminases (liver enzymes).	Cholestatic liver disease.
Musculoskeletal		Osteoporosis (when taking the drug for more than 3 months).
Skin and soft subcutaneous tissue	Inflammation, swelling at the injection site, soft tissue hardening.	Skin necrosis.

Overdose

Cases of drug overdose are extremely rare. Clinically, this manifests itself in increased side effects and an increased risk of bleeding. In case of an overdose, the patient is shown the slow introduction of a neutralizing substance - protamine sulfate. One milligram of this drug completely inhibits the effect of 1 mg of enoxaparin. The introduction of protamine sulfate is not required if more than 12 hours have passed since the onset of the overdose.

Contraindications

Clexane is used only according to the instructions and under the supervision of a physician. The medicine has a number of categorical contraindications that should be taken into account before starting treatment. These include:

individual intolerance to Clexane;
conditions accompanied by an increased risk of bleeding - abortion, threatened miscarriage, aortic aneurysm, hemorrhagic stroke;
children's age (up to 18 years);
the presence of artificial heart valves in the patient's body.

With caution, injections are prescribed to elderly patients, people with liver or kidney disease. Other relative contraindications include:

pathologies that are accompanied by a violation of hemostasis - hemophilia, severe vasculitis, thrombocytopenia, hypocoagulation;
erosive and ulcerative lesions of the gastrointestinal tract;
recent ischemic stroke;
complicated diabetes mellitus;
recent childbirth, ophthalmic or neurological surgery;
performance of spinal, epidural anesthesia;
performing a spinal puncture;
use of intrauterine contraception;
pericarditis;
bacterial endocarditis;
severe arterial hypertension (high blood pressure).

Terms of sale and storage

The drug is released strictly according to the prescription. Store Clexane, according to the instructions, at temperatures up to 25 ° C. Shelf life - 3 years.

Analogues

In the absence of Clexane in the pharmacy, the doctor may prescribe other drugs with an identical principle of action. Analogues with the same active ingredient are:

Clexane 300 - available in 3 ml bottles. It has completely similar indications and contraindications as Clexane. Released by prescription only.
Novoparin - solution for injection. Available in glass syringes of 1 or 2 pcs. on the package with instructions. It is used for the prevention and treatment of thrombosis.
Enoxarin - low molecular weight heparin is available in dosing syringes of 2, 4, 8 thousand anti-Xa IU. It is prescribed for the treatment of deep vein thrombosis.

Clexane contains the active ingredient enoxaparin. It is used to prevent vascular accidents, thrombosis and other pathological conditions of the cardiovascular system.

Clexane is available in four different concentrations: IU/0.2, IU/0.4, IU/0.6, IU/0.8 ml solutions. The official international non-proprietary name for clexane is enoxaparin. In the pharmacological classification of ATX, the drug is indicated by Latin letters and numbers B01AB05.

Clexane

Description of the mechanism of action of clexane

Clexane is used to prevent the formation of blood clots, which can lead to thrombosis of the lower extremities or pelvic veins, during and after surgery. It is used to prevent vascular occlusion in patients. In clinical studies, Clexane has been shown to be highly effective in the treatment of early bed rest-induced thrombosis.

Clexane is used to treat existing deep venous occlusions with and without pulmonary embolism. It is indicated for patients with refractory angina pectoris, in case of imminent myocardial infarction and in so-called non-Q wave myocardial infarction (reflected on the ECG).

Pharmacodynamics of Clexane

During dialysis, when blood is being cleansed outside the body on a dialysis machine, the addition of clexane helps prevent clotting in the tubing system.

Another area of use for Clexane is the treatment of a certain form of myocardial infarction, in which ST segment elevation is detected on the ECG. This ST segment elevation indicates blockage of the coronary artery leading directly to the heart.

Why and for what diseases is Clexane prescribed?

Indications for prescribing the drug:

Perioperative and postoperative prevention of deep vein thrombosis (venous occlusion) in general surgery and orthopedics;
Prevention of deep vein thrombosis in patients with an average or high risk of blood clots in the veins, with acute severe internal diseases (heart failure III or IV degree, respiratory diseases), which leads to prolonged bed rest (40 milligrams);
During dialysis;
With circulatory disorders, difficult to treat unstable angina and certain forms of myocardial infarction.

It should be noted that the drug in pharmacies is dispensed strictly by prescription. Only a treating cardiologist can write a prescription for a medication.

Dosage of Clexane

Under the direction of a doctor, patients without a serious risk of vascular occlusion (thromboembolism) are prescribed a weekly course of 2000 IU of clexane per day. The treatment regimen varies depending on the parameters of the coagulogram.

Patients at high risk of thromboembolism, especially those who have had arm or leg surgery, should receive an injection containing 4,000 IU of Clexane daily.

In general surgery, the first Clexane injection is given approximately two hours before the intervention; in orthopedic surgery and in patients with an increased risk of thromboembolism in about twelve hours.

Patients with moderate or high risk of thrombosis, severe, acute diseases of the internal organs, which bring the patient to complete immobility (immobilization), should take once a day an ampoule with a solution containing 4000 units of clexane.

To treat ST-segment elevation myocardial infarction, the doctor initially gives a bolus injection of the drug (30 mg). The duration of treatment with Clexane does not exceed a week. In the treatment of myocardial infarction without a Q-wave, clexane is used in combination with acetylsalicylic acid. In case of intolerance to clexane, it should be replaced with analogues.

Kleksan's analogs

Trade names for Clexane substitutes:

Enoxaparin sodium (from the Russian pharmaceutical company Pharmstandard);
Aksparin (producing country - Ukraine);
Novoparin;
Flenox.

Novoparin - the most famous analogue of Clexane

The shelf life of Clexane, like other drugs, should not exceed 5 years.

Side Effects of Clexane

Depending on the method of administration of the drug (injection or tablet), the concentration of the active substance and the general health of the patient, the profile of side effects differs.

Common side effects of clexane:

Temporary increase in liver enzymes (transaminases).

Unusual side effects of Clexane:

Open or hidden bleeding, especially on the skin, mucous membranes, wounds, gastrointestinal tract, urinary tract and genitals;
Decrease in the total number of platelets (type I thrombocytopenia at the beginning of therapy).

Rare side effects of clexane:

Decrease in the number of platelets (thrombocytopenia type II), which may be associated with vascular occlusion, dehydration of the skin (skin necrosis), bleeding, and severe coagulation disorders;
Allergic reactions (itching, rash, redness, urticaria);
Swelling of the skin and mucous membranes (angioneurotic edema);
Nausea and vomiting;
Increase in body temperature;
Stomach ache;
Diarrhea;
drop in blood pressure;
Severe cerebral hemorrhage
stomach bleeding;
Bleeding from the intestines (possibly fatal);
Increased bleeding during surgical interventions;
Worsening of the course of existing leukopenia.

Very rare and isolated side effects of the drug:

Allergic (anaphylactic) reaction with rash, skin lesions, vasospasm, shortness of breath, drop in blood pressure;
Bleeding with fatal outcome;
hemorrhages;
Necrosis of the epidermis at the injection site;
Irritation;
Violations of the sensitivity of the tongue;
Chest pain;
Hair loss;
Headache;
bone loss (osteoporosis);
Priapism;
Spasm of blood vessels;
Cystitis;
Lethal decrease in blood pressure;
Slow heart rate;
Increased blood acidity (metabolic acidosis);
Decrease in the amount of aldosterone (hypoaldosteronism);
Increased potassium levels (hyperkalemia).

With concomitant anesthesia of the spinal cord (spinal or epidural), serious complications can occur, leading to death.

Contraindications to the use of clexane

In medicine, there are absolute and relative contraindications to the prescription of medicines. With an absolute contraindication to the use of clexane, it should not be prescribed even in extreme cases. With a relative contraindication, an exception can be made for some patients, but the doctor must correctly prescribe the dosage of clexane. Injecting too much of the drug can cause life-threatening adverse reactions.

Absolute contraindications to the use of clexane:

Hypersensitivity to clexane, heparin and other derivatives of these drugs;
Allergy-related or heparin-induced platelet deficiency that has occurred either within the last 100 days or with the appearance of appropriate antibodies;
Acute cerebral hemorrhage, myocardial infarction, kidney, lung, hemorrhage in the gastrointestinal tract, malformations of arteries or veins, aortic aneurysms, cerebral vessels;
Epidural, spinal or local anesthesia administered within the last 24 hours.

Relative contraindications to the appointment of clexane:

Platelet dysfunction;
mild to moderate liver or pancreas dysfunction;
Impaired kidney function as it increases the effect of clexane. Here, the physician must adjust the dose according to the patient's body weight;
older people who are overweight or underweight, as clexane may be less or more effective in these cases;
Patients with an artificial heart valve;
Myocarditis, endocarditis.

In microinvasive vascular surgery, the clinician must follow the prescribed interval for administering Clexane to minimize the risk of bleeding.

Vascular stenting

Clexane: instructions for use during pregnancy

Clexane should be used when planning or during pregnancy and breastfeeding only after a thorough medical risk assessment. There is not enough information about the possible passage of the active substance into breast milk, but the effect of anticoagulants on the child is considered unlikely.

However, the use of Clexane in pregnant women with prosthetic heart valves is not recommended due to possible fetal and maternal death from thromboembolism.

Several months of use of Clexane (as with all heparins) during pregnancy increases the risk of bone loss (osteoporosis).

Osteoporosis due to long-term use of clexane

During childbirth in pregnant women who are treated with clexane, an injection into the spinal cord (epidural anesthesia) is absolutely prohibited. In the event of an imminent miscarriage, the use of this drug is strictly prohibited.

The use of Clexane in children

The use of Clexane in children and adolescents under 18 years of age has not yet been adequately studied. Therefore, the use of the active ingredient in this age group is generally not recommended by the manufacturers. In case of doubt, it is necessary to observe the age restrictions for therapy with clexane.

Interaction and compatibility of drugs with Clexane

The action of enoxaparin is enhanced by substances that also affect blood clotting. These include acetylsalicylic acid, warfarin derivatives, fibrinolytics, dipyridamole, ticlopidine, clopidogrel, or GPIIb/IIIa receptor antagonists.

Dextrins (plasma substitutes), probenecid (an anti-gout drug), ethacrynic acid (loop diuretics), cytotoxic drugs (for cancer), or a high dose of penicillin (an antibiotic) may increase the effectiveness of Clexane.

Non-steroidal (NSAID) and steroidal anti-inflammatory drugs (phenylbutazone, indomethacin or sulfinpyrazone) lead to an increased risk of hemorrhage when taken with clexane.

NSAIDs

Concomitant administration of H1 antihistamines (anti-allergic agents), cardiac glycosides (cardiotonic agents), tetracycline (antibiotics) and ascorbic acid (vitamin C), smoking leads to a decrease in the overall effect of clexane.

With the simultaneous use of clexane with phenytoin (an anticonvulsant drug), quinidine (an antiarrhythmic drug), propranolol (a beta-blocker) and benzodiazepines (hypnotics), its therapeutic effect is reduced. Together, this can lead to a change in the medicinal efficacy of these substances.

The simultaneous administration of clexane with alcoholic beverages (alcohol) is strictly prohibited, as the risk of developing hemorrhagic apoplexy increases. The use of clexane is prohibited in conjunction with tricyclic antidepressants. In some cases, the simultaneous administration of clexane and barbiturates caused cardiac arrhythmias.

In contrast, the effect of intravenous administration of glycerol trinitrate (a nitro-based vasodilator) is attenuated by concomitant treatment with clexane. The effect of quinine (an antimalarial drug) is weakened.

Quinine

Medicinal products that increase potassium levels (such as ACE inhibitors) should be used with extreme caution with Clexane.

Mixing Clexane with other medicinal products may result in their insolubility. In addition, clexane can falsify many laboratory tests.

Precautions while using Clexane

There are precautions to help prevent the development of life-threatening consequences. Main list of recommendations:

Clexane cannot be administered intramuscularly;
Before starting treatment with this drug, any pre-existing bleeding disorders must be diagnosed by a physician and appropriate laboratory control tests;
Platelet counts need to be monitored regularly during treatment with Clexane;
The chance of bleeding increases during treatment with Clexane;
Clexane should not be stored in a place that is too warm or too cold. It is recommended to store the drug at room temperature.

Clexane can cause serious allergic reactions. Signs of this may be hyperemia, vasomotor rhinitis, swelling of the mucous membrane, conjunctivitis, severe asthma attack. In rare cases, Clexane causes anaphylactic shock, which is often fatal.