Clexane ® injection solution is indicated for use in adults:
prevention of venous thromboembolic complications in surgical patients at moderate and high risk, especially in patients undergoing orthopedic or general surgery, including surgical interventions for oncological diseases; prevention of venous thromboembolic complications in therapeutic patients with acute diseases (such as acute heart failure, respiratory failure, severe infections or rheumatic diseases) and reduced mobility, who are at increased risk of venous thromboembolism; treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), except in cases of PE, which may require thrombolytic therapy or surgery; prevention of thrombus formation in the extracorporeal circulation during hemodialysis; in acute coronary syndrome: for the treatment of unstable angina and non-ST segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid; for the treatment of acute ST segment elevation myocardial infarction (STEMI), including in patients who are scheduled for medical treatment or subsequent percutaneous coronary intervention (PCI).
Composition
The active substance is enoxaparin (1 ml of solution contains 10,000 anti-Xa IU, equivalent to 100 mg of enoxaparin sodium; 1 syringe dose contains 8,000 anti-Xa IU / 0.8 ml, equivalent to 80 mg of enoxaparin sodium).
The excipient is water for injection.
Contraindication
Enoxaparin sodium is contraindicated for use in patients with the following conditions:
Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other LMWH, or to any of the excipients; history of immune-mediated induced thrombocytopenia (HIT) within the last 100 days in the presence of circulating antibodies; active clinically significant bleeding and conditions with a high risk of bleeding, including recent hemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant neoplasm with a high risk of bleeding, recent surgery on the brain, spinal cord or eyes, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or serious malformations of the intraspinal or intracerebral vessels; spinal or epidural anesthesia or locoregional anesthesia if enoxaparin sodium has been used for treatment within the previous 24 hours.
Method of application
Prevention of venous thromboembolic complications in surgical patients at moderate and high risk
Individual thromboembolic risk in patients can be assessed using a validated risk stratification model (scale).
For patients at moderate risk of thromboembolic events: The recommended dose of enoxaparin sodium is 2000 IU (20 mg) once daily administered by subcutaneous (s/c) injection. Preoperative initial administration (2 hours before surgery) of enoxaparin sodium at a dose of 2000 IU (20 mg) has been shown to be effective and safe in moderate-risk surgical procedures. In patients at moderate risk, prophylactic treatment with enoxaparin sodium should be continued for a period of at least 7-10 days, regardless of the state of recovery (e.g., mobility). Prophylaxis should be continued until the patient is no longer significantly impaired in mobility.
For patients at high risk of thromboembolic events, the recommended dose of enoxaparin sodium is 4000 IU (40 mg) once daily, preferably administered 12 hours before surgery by subcutaneous (s/c) injection. If it is necessary to start prophylactic use of enoxaparin sodium more than 12 hours before surgery (for example, a high-risk patient awaiting delayed orthopedic surgery), the last injection should be administered no later than 12 hours before surgery and prophylactic use should be resumed 12 hours after surgery.
For patients undergoing major orthopedic surgery, long-term thromboprophylaxis is recommended - up to 5 weeks.
For patients at high risk of venous thromboembolism (VTE) undergoing abdominal or pelvic surgery for cancer, long-term thromboprophylaxis is recommended - up to 4 weeks.
Prevention of venous thromboembolic complications in therapeutic patients
The recommended dose of enoxaparin sodium is 4000 IU (40 mg) once daily, administered by subcutaneous injection.
Prophylactic treatment with enoxaparin sodium should be given for a period of at least 6-14 days, depending on the state of recovery (e.g. mobility). The benefit of such treatment for a period longer than 14 days has not yet been established.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
The dosage regimen is selected by the physician, taking into account the results of an individual assessment, which should include an assessment of the risk of thromboembolic events and the risk of hemorrhagic events. The dosage regimen of 150 IU / kg (1.5 mg / kg) once daily should be used in uncomplicated patients with a low risk of recurrent VTE. The dosage regimen of 100 IU / kg (1 mg / kg) twice daily should be prescribed for all other patients, such as patients with obesity, symptomatic PE, cancer, recurrent VTE or thrombosis of the proximal veins (iliac vein).
Enoxaparin sodium is used for an average of 10 days. If necessary, oral anticoagulants should be started.
Prevention of blood clots during hemodialysis
The recommended dose of enoxaparin sodium is 100 IU/kg (1 mg/kg). In patients at high risk of hemorrhagic events, the dose should be reduced to 50 IU/kg (0.5 mg/kg) if dual vascular access is available or to 75 IU/kg (0.75 mg/kg) if single vascular access is available.
During hemodialysis, enoxaparin sodium should be administered into the arterial part of the circuit at the beginning of the dialysis session. This dose is usually sufficient to perform dialysis for 4 hours. However, if fibrin rings occur, for example, when the session lasts longer than usual, an additional dose of 50 IU to 100 IU / kg (0.5 to 1 mg / kg) can be administered.
There are no data on the use of enoxaparin sodium in patients for prophylaxis or treatment and during hemodialysis sessions.
Acute coronary syndrome: treatment of unstable angina and non-ST segment elevation myocardial infarction (NSTEMI) and acute ST segment elevation myocardial infarction (STEMI)
For the treatment of unstable angina and NSTEMI, the recommended dose of enoxaparin sodium is 100 IU/kg (1 mg/kg) administered every 12 hours by subcutaneous injection and administered in combination with antiplatelet therapy. Treatment should be administered for a minimum of 2 days and continued until the patient is clinically stabilized. The usual duration of treatment is 2 to 8 days.
For all patients who do not have complications, the use of acetylsalicylic acid orally is recommended in an initial loading dose of 150-300 mg (patients who have not yet received acetylsalicylic acid) and a maintenance dose of 75-325 mg/day continuously, regardless of the treatment strategy.
For the treatment of acute STEMI, the recommended dose of enoxaparin sodium is a single intravenous (IV) bolus of 3000 IU (30 mg) plus a dose of 100 IU/kg (1 mg/kg) SC followed by 100 IU/kg (1 mg/kg) SC every 12 hours (maximum 10,000 IU (100 mg) for each of the first two SC doses). Appropriate antiplatelet therapy, such as oral acetylsalicylic acid (75-325 mg once daily), should be administered concurrently unless contraindicated. The recommended duration of treatment is 8 days or until the patient is discharged from the hospital, whichever comes first. When used with thrombolytic therapy (fibrin-specific or non-fibrin-specific), enoxaparin sodium should be administered between 15 minutes before the start of fibrinolytic therapy and 30 minutes after the start of fibrinolytic therapy.
In patients undergoing PCI, if the last dose of enoxaparin sodium was administered subcutaneously less than 8 hours before balloon inflation, additional doses are no longer required. If the last subcutaneous administration of the drug was more than 8 hours before balloon inflation, an intravenous bolus of 30 IU/kg (0.3 mg/kg) of enoxaparin sodium should be administered.
Method of use
The drug "Clexane ®" cannot be administered intramuscularly.
For the prevention of venous thromboembolic complications after surgical interventions, treatment of DVT and PE, treatment of unstable angina and NSTEMI, enoxaparin sodium should be administered by subcutaneous injection.
For the treatment of acute STEMI, the drug should be started with a single IV bolus injection followed by immediate SC administration. To prevent thrombus formation in the extracorporeal circulation during hemodialysis, the drug is administered into the arterial line of the dialysis circuit.
An introductory part of the instructions is provided, read the full instructions inside the package.
Application features
Pregnant women
Enoxaparin sodium should be prescribed to pregnant women only if the doctor determines a clear need for such treatment.
It is not known whether enoxaparin is excreted in human milk. Absorption of enoxaparin sodium when administered orally is unlikely, so it can be used during breastfeeding.
There are no clinical data on the effect of enoxaparin sodium on fertility. Animal studies have not shown any effect of the drug on fertility.
Children
The safety and efficacy of enoxaparin sodium in pediatric patients have not yet been established.
Drivers
The effect of enoxaparin sodium on the ability to drive vehicles and operate other mechanisms is absent or insignificant.
Overdose
Symptoms
Unintentional overdose of enoxaparin sodium as a result of intravenous, extracorporeal or subcutaneous administration may lead to hemorrhagic complications. After taking even fairly high doses, absorption of enoxaparin sodium is unlikely.
Treatment
However, even with high doses of protamine, the anti-Xa activity of enoxaparin sodium is never completely neutralized (maximum by approximately 60%).
Side effects
In clinical trials, the most frequently reported adverse reactions were haemorrhagic events, thrombocytopenia and thrombocytosis.
Storage conditions
Store at a temperature not exceeding 25 °C, out of the reach of children. Do not freeze.
Shelf life - 3 years.
