Clexan - instructions for use, testimonials, analogs and forms of injection (injections in ampoules for injection 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1 ml) drugs for the treatment and prevention of thrombosis and embolism adults, children and pregnancy

In this article, you can read the instructions for using the drug Clexane. Comments of visitors of the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Kleksana in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Kleksan in the presence of existing structural analogs. Use to treat and prevent thrombosis and embolism in adults, children, as well as during pregnancy and lactation.

Clexane - a preparation of low molecular weight Heparin (molecular weight about 4500 daltons: less than 2000 daltons - about 20%, from 2000 to 8000 daltons - about 68%, more than 8000 daltons - about 18%). Enoxaparin sodium (the active substance of the drug Kleksan) is obtained by alkaline hydrolysis of benzyl ester of heparin isolated from the mucous membrane of the small intestine of the pig. Its structure is characterized by a nonreducing fragment of 2-O-sulfo-4-enapyrazinosuronic acid and a reducing fragment of 2-N, 6-O-disulfo-D-glucopyranoside. The structure of enoxaparin contains about 20% (ranging from 15% to 25%) of the 1,6-anhydro derivative in the reducing fragment of the polysaccharide chain.

In a purified system, Clexane has high anti-10a activity (about 100 IU / ml) and low anti-2a or antithrombin activity (about 28 IU / ml). This anticoagulant activity acts through antithrombin 3 (AT-3), providing anticoagulant activity in humans. In addition to anti-10a / 2a activity, additional anticoagulant and anti-inflammatory properties of sodium enoxaparin have been found both in healthy individuals and patients, and in animal models.This includes the AT-3-dependent inhibition of other clotting factors as factor 7a, the activation of the release of the tissue factor (PTF) inhibitor, as well as the reduction of vWF release from the vascular endothelium into the bloodstream. These factors provide an anticoagulant effect of sodium enoxaparin as a whole.

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

Anti-2a activity in plasma is about 10 times lower than anti-10a activity. The mean maximum anti-2a 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 double administration and 1.5 mg / kg of body weight with single administration respectively .

The average maximum anti-10a plasma activity is observed 3-5 h after the administration of the drug and is approximately 0.2, 0.4, 1.0 and 1.3 anti-10a IU / ml after the sc administration 20, 40 mg and 1 mg / kg and 1.5 mg / kg, respectively.

Composition

Enoxaparin sodium + excipients.

Pharmacokinetics

The pharmacokinetics of enoxaparin in these dosage regimens is linear. Bioavailability of sodium enoxaparin with subcutaneous administration, estimated on the basis of anti-10a activity, is close to 100%. Enoxaparin sodium is mainly biotransformed in the liver by desulfating and / or depolymerizing to form low molecular weight substances with very low biological activity. Excretion of the drug is monophasic. 40% of the administered dose is excreted by the kidneys, 10% being unchanged.

It is possible to delay the excretion of sodium enoxaparin 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 excessive body weight with subcutaneous injection of the drug, the clearance is slightly less.

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 decompensation stage 3 or 4 of the functional class according to 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 thromboembolism or without pulmonary embolism;
• prevention of thrombus formation in the extracorporeal circulation system during hemodialysis (usually, with a duration of the session not more than 4 h);
• treatment of unstable angina and myocardial infarction without Q wave in combination with acetylsalicylic acid;
• treatment of acute myocardial infarction with ST-segment elevation in patients subject to medical treatment or subsequent percutaneous coronary intervention.

Forms of release

Solution for injection 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1 ml (injections in ampoule syringes).

There is no dosage form in the form of tablets.

Instructions for use, dosage and method of use (how to properly stab the drug)

Except for special cases (treatment of myocardial infarction with ST segment elevation,medication or with percutaneous coronary intervention and prevention of thrombus formation in the extracorporeal circulation system during hemodialysis), enoxaparin sodium is administered deep sc. Injections should preferably be performed in the prone position. When using pre-filled syringes for 20 mg and 40 mg to avoid loss of the drug before the injection, do not remove air bubbles from the syringe. Injections should be performed alternately in the left or right anterolateral or posterolateral surface of the abdomen. The needle must be inserted vertically (not sideways) into the entire skin length folded and held until the injection is completed between the thumb and forefinger. Skin fold is released only after the injection is completed. Do not massage the injection site after injection.

The pre-filled disposable syringe is ready for use.

The drug should not be given in / m!

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

Patients with a moderate risk of thrombosis and embolism (general surgical operations) the recommended dose of Kleksanais 20 mg once a day subcutaneously. The first injection is performed 2 hours before surgery.

Patients with a high risk of thrombosis and embolism (general surgical operations and orthopedic operations) the drug is recommended at a dose of 40 mg once a day sc, the first dose is administered 12 hours before surgery, or 30 mg 2 times a day SC with the beginning of the injection 12-24 h after the operation.

The duration of treatment with Clexan is on average 7-10 days. If necessary, therapy can continue as long as there is a risk of developing thrombosis and embolism (for example, in orthopedics, Clexan is prescribed at a dose of 40 mg once a day for 5 weeks).

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

The recommended dose of Clexan is 40 mg once a day for six to 14 days.

Treatment of deep vein thrombosis with pulmonary embolism or without pulmonary arterial thromboembolism

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

The average duration of treatment is 10 days. It is advisable immediately to begin therapy with indirect anticoagulants, while Kleksan therapy should be continued until a sufficient anticoagulant effect is achieved, i.e. MHO should be 2-3.

Prevention of thrombus formation in the extracorporeal circulation system during hemodialysis

The dose of Kleksan is on the average 1 mg / kg of body weight. If the risk of bleeding is high, the dose should be reduced to 0.5 mg / kg of body weight with dual vascular access or 0.75 mg with single vascular access.

When hemodialysis, the drug should be injected into the arterial part of the shunt at the beginning of the hemodialysis session. A single dose, as a rule, is sufficient for a 4-hour session, however, when fibrin rings are detected with a longer hemodialysis, the drug can be additionally administered at the rate of 0.5-1 mg / kg body weight.

Treatment of unstable angina and myocardial infarction without a Q wave

Clexane is administered at a dose of 1 mg / kg body weight every 12 hours, with simultaneous administration of Acetylsalicylic acid in a dose of 100-325 mg once a day. The average duration of therapy is 2-8 days (until the patient's clinical condition is stabilized).

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

Treatment begins with intravenous bolus administration of enoxaparin sodium at a dose of 30 mg and immediately after it (within 15 minutes) is administered subcutaneous administration of Kleksana in a dose of 1 mg / kg (with the first two injections maximal, 100 mg of enoxaparin sodium). Then all subsequent SC doses should be administered every 12 hours at a rate of 1 mg / kg of body weight (ie, with a body weight of more than 100 kg, the dose may exceed 100 mg).

Persons 75 years of age or older do not have an initial intravenous bolus injection. Clexane is administered SC in a dose of 0.75 mg / kg every 12 hours (moreover, with the first two injections, 75 mg of sodium enoxaparin can be administered as much as possible). Then, all subsequent subcutaneous doses should be administered every 12 hours at the rate of 0.75 mg / kg body weight (ie, with a body weight of more than 100 kg, the dose may exceed 75 mg).

When combined with thrombolytics (fibrin-specific and fibrin-nonspecific), sodium enoxaparin should be administered in the range from 15 minutes before the onset of thrombolytic therapy to 30 minutes after it. As soon as possible after the detection of acute myocardial infarction with ST-segment elevation, simultaneous administration of acetylsalicylic acid should be started and,if there are no contraindications, it should continue 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 leaves the hospital if the hospitalization period is less than 8 days.

Bolus administration of sodium enoxaparin should be performed through a venous catheter and sodium enoxaparin should not be mixed or administered together with other medications. In order to avoid the presence of traces of other drugs in the system and their interaction with sodium enoxaparin, the venous catheter should be washed with a sufficient amount of 0.9% sodium chloride solution or Dextrose before and after intravenous bolus administration of sodium enoxaparin. Enoxaparin sodium can be safely administered with 0.9% sodium chloride solution and 5% dextrose solution.

For bolus administration of enoxaparin sodium 30 mg in the treatment of acute myocardial infarction with ST segment elevation 60 mg, 80 mg and 100 mg glass syringes remove excess amount of the drug so that only 30 mg (0.3 ml) remain in them. A dose of 30 mg can be directly administered iv.

To perform IV bolus administration of enoxaparin sodium through a venous catheter, pre-filled syringes for subcutaneous administration of 60 mg, 80 mg and 100 mg can be used. It is recommended to use 60 mg syringes, because this reduces the amount of drug removed from the syringe. 20 mg syringes are not used; in them there is not enough preparation for bolus introduction of 30 mg enoxaparin sodium. 40 mg syringes are not used; on them there are no divisions and it is therefore impossible to accurately measure the amount of 30 mg.

In patients undergoing percutaneous coronary intervention, in the event that the last SC injection of sodium enoxaparin was performed less than 8 hours before the balloon catheter inserted into the site of the narrowing of the coronary artery, additional administration of sodium enoxaparin is not required. If the last penicillin injection of sodium enoxaparin was carried out more than 8 hours before the balloon catheter is inflated, an additional bolus administration of sodium enoxaparin at a dose of 0.3 mg / kg should be performed IV.

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

To obtain a solution of enoxaparin sodium at a concentration of 3 mg / ml with a pre-filled 60 mg syringe, it is recommended to use a container with an infusion solution of 50 ml (ie with 0.9% sodium chloride solution or 5% dextrose solution). 30 ml of the solution is removed from the container with the infusion solution using a conventional syringe. Enoxaparin sodium (the contents of the syringe for infusion to 60 mg) is introduced into the remaining 20 ml of the infusion solution. The contents of the container with diluted sodium enoxaparin solution are gently mixed.

Side effect

• bleeding;
• retroperitoneal bleeding;
• intracranial hemorrhages;
• neuroaxial hematomas;
• thrombocytopenia (including autoimmune thrombocytopenia);
• thrombocytosis;
• increased activity of hepatic transaminases;
• allergic reactions;
• hives;
• itching;
• redness of the skin;
• hematoma and pain at the injection site;
• cutaneous (bullous) rashes;
• inflammatory reaction at the site of administration;
• necrosis of the skin at the injection site;
• anaphylactic and anaphylactoid reactions;
• hyperkalemia.

Contraindications

• conditions and diseases in which there is a high risk of bleeding (threatening abortion, cerebral aneurysms or exfoliating aortic aneurysm (with the exception of surgery), hemorrhagic stroke, uncontrolled bleeding, severe enoxaparin or heparin-induced thrombocytopenia);
• age under 18 years (effectiveness and safety not established);
• increased sensitivity to enoxaparin, heparin and its derivatives, including other low molecular weight heparins.

Application in pregnancy and lactation

Clexane should not be used during pregnancy, except when the intended benefit to the mother exceeds the potential risk to the fetus. The information that sodium enoxaparin penetrates through the placental barrier in the 2nd trimester, no, there is no information on the 1 and 3 trimesters of pregnancy.

It is not recommended to use the drug in pregnant women with artificial heart valves.

When Kleksana is used during lactation, breastfeeding should be stopped.

Application in elderly patients

Persons 75 years of age or older do not have an initial intravenous bolus injection.Enoxaparin sodium is administered SC at a dose of 0.75 mg / kg every 12 hours (moreover, with the first two injections, 75 mg of sodium enoxaparin can be administered as often as possible). Then, all subsequent subcutaneous doses are administered every 12 hours at a rate of 0.75 mg / kg body weight (ie, with a body weight of more than 100 kg, the dose may exceed 75 mg).

Use in children

Contraindicated in children and adolescents under the age of 18 years (efficacy and safety not established).

special instructions

When prescribing the drug for the purpose of prevention, there was no tendency to increase bleeding. When prescribing a drug for medical purposes, there is a risk of bleeding in older patients (especially in persons older than 80 years). It is recommended that the patient be closely monitored.

It is recommended that the use of drugs capable of disrupting hemostasis (salicylates, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac, dextran with a molecular mass of 40 kDa, ticlopidine, clopidogrel, glucocorticosteroids (GCS), thrombolytic agents, anticoagulants, antiplatelet agents, including glycoprotein antagonists receptors 2b / 3a) was discontinued before treatment with enoxaparin sodium, except in cases when their use is strictly shown.If combinations of sodium enoxaparin with these drugs are shown, careful clinical observation and monitoring of relevant laboratory parameters should be carried out.

In patients with impaired renal function, there is a risk of bleeding as a result of an increase in anti-10a activity of enoxaparin sodium. In patients with severe renal dysfunction (CK <30 mL / min), it is recommended that dose adjustments be made for both prophylactic and therapeutic purposes of the drug. Although dose adjustment is not required in patients with mild to moderate renal impairment (QA 30-50 ml / min or KK 50-80 ml / min), careful monitoring of the condition of such patients is recommended.

An increase in the anti-10a activity of sodium enoxaparin for its prophylactic use in women with a body weight of less than 45 kg and in men weighing less than 57 kg may lead to an increased risk of bleeding.

The risk of autoimmune thrombocytopenia caused by heparin also exists when low molecular weight heparins are used. If thrombocytopenia develops, it is usually detected between the 5th and 21st days after initiation of sodium enoxaparin therapy.In this regard, it is recommended that the number of platelets be monitored regularly before and during drug administration. In the presence of a confirmed significant decrease in the number of platelets (by 30-50% compared with the initial index), it is necessary to immediately cancel enoxaparin sodium and transfer the patient to another therapy.

Spinal / epidural anesthesia

As with the use of other anticoagulants, the occurrence of neuroaxial hematomas with the use of Clexan against spinal / epidural anesthesia with the development of persistent or irreversible paralysis is described. The risk of occurrence of these phenomena decreases with the use of the drug in a dose of 40 mg or lower. The risk increases with an increase in the dose of the drug, as well as with the use of penetrating epidural catheters after surgery, or with the concomitant use of additional drugs that have the same effect on hemostasis as NSAIDs. The risk also increases with traumatic exposure or repeated cerebrospinal puncture or in patients who have a history of referring to the transferred operations in the region of the spine or deformity of the spine.

To reduce the risk of bleeding from the spinal canal with epidural or spinal anesthesia, it is necessary to take into account the pharmacokinetic profile of the preparation. It is better to install or remove a catheter with a low anticoagulant effect of sodium enoxaparin.

The installation or removal of the catheter should be performed 10-12 hours after the use of Clexane in preventive doses for the prevention of deep vein thrombosis. In those cases where patients receive higher doses of enoxaparin sodium (1 mg / kg 2 times a day or 1.5 mg / kg once daily), these procedures should be postponed for a longer period of time (24 hours). The subsequent administration of the drug should be carried out no earlier than 2 hours after removal of the catheter.

If the doctor prescribes anticoagulant therapy during epidural / spinal anesthesia, careful monitoring of the patient is necessary to identify any neurological signs and symptoms, such as: back pain, sensory and motor function disorders (numbness or weakness in the lower extremities), disorders function of the intestine and / or bladder.The patient should be instructed about the need to inform the doctor immediately if any of the above symptoms occur. If signs or symptoms characteristic of the spinal cord hematoma are found, urgent diagnosis and treatment is necessary, including if necessary spinal decompression.

Heparin-induced thrombocytopenia

With extreme caution, Clexane should be prescribed to patients who have a history of thrombocytopenia caused by heparin, in combination with or without thrombosis.

The risk of thrombocytopenia caused by heparin can persist for several years. If, based on the history of the patient, heparin-induced thrombocytopenia is suspected, then platelet aggregation tests are of limited importance in predicting the risk of developing it. The decision to prescribe Clexan in this case can be taken only after consultation with the appropriate specialist.

Percutaneous coronary angioplasty

In order to reduce the risk of bleeding associated with invasive vascular manipulation in the treatment of unstable angina and myocardial infarction without Q wave, the catheter should not be removed within 6-8 hours after the administration of Kleksan.The next calculated dose should be administered no earlier than 6-8 hours after removal of the introductory femoral artery. It is necessary to monitor the site of infestation in time to identify signs of bleeding and the formation of a hematoma.

Artificial heart valves

There have been no studies that have made it possible to reliably assess the efficacy and safety of Kleksan in preventing thromboembolic complications in patients with artificial heart valves. For this purpose, the use of the drug is not recommended.

Laboratory Tests

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

When the dose is raised, the APTT and the clotting time may be prolonged. The increase in APTT and clotting time are not in direct linear dependence on the increase in antithrombotic activity of the drug, so there is no need for monitoring them.

Prevention of venous thrombosis and embolism in patients with acute therapeutic illnesses on bed

In the case of acute infection, acute rheumatic conditions, the prophylactic administration of sodium enoxaparin is justified only if the above conditions are combined with one of the listed risk factors for venous thrombus formation: age over 75 years, malignant neoplasm, thrombosis and embolism in the history, obesity, hormone therapy, heart failure , chronic respiratory failure.

Impact on the ability to drive vehicles and manage mechanisms

Clexane has no influence on the ability to drive vehicles and mechanisms.

Drug Interactions

Clexane can not be mixed with other drugs!

Do not alternate the use of enoxaparin sodium and other low molecular weight heparins, t. they differ from each other in the way of production, molecular weight, specific anti-10a activity, units of measurement and dosage. And, as a consequence, the drugs have different pharmacokinetics and biological activity (anti-2a activity, interaction with platelets).

With systemic salicylates, acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) (including ketorolac),dextran with a molecular mass of 40 kDa, ticlopidine and clopidogrel, systemic glucocorticosteroids (GCS), thrombolytics or anticoagulants, other antiplatelet drugs (including glycoprotein 2b / 3a antagonists) increase the risk of bleeding.

Analogues of the drug Clexane

Structural analogs for the active substance:

• Anfiber;
• Hemapaksan;
• Enoxaparin sodium.

Analogues for the pharmacological group (anticoagulants):

• Angioks;
• Angioflux;
• Antithrombin 3 human;
• Arikstra;
• Warfarex;
• Warfarin;
• Venabos;
• Venolife;
• Viatrom;
• Hemapaksan;
• Gepalpan;
• Heparin;
• Heparin ointment;
• Heparoid;
• Hepatrombin;
• Dolobien;
• Yellon gel;
• Calciparin;
• Cleaver;
• Xarelto;
• Lavenum;
• Lyoton 1000;
• Marewan;
• Nigepan;
• Pelentan;
• Piyavit;
• Pradax;
• Seprotin;
• Cincumar;
• Skinlight;
• Troxevasin Neo;
• Trombleuss;
• Thrombogel;
• Thrombophobia;
• Troparin;
• Phenylin;
• Fragmin;
• Fraksiparin;
• Fraksiparin Forte;
• Cibor;
• Exent;
• Eliwis;
• Emeran;
• Enoxaparin sodium;
• Essaven.

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