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Active ingredient: Enoxaparin sodium.
Other names:
Lovenox, Xaparin.
Pharmacological group: Direct-acting anticoagulant - low molecular weight heparin.
Clexane is a unique chemical which belongs to the class of anticoagulation drugs called low molecular weight heparins (LMWH). Clexane, the world's market leader in low-molecular weight heparins, is produced by alkaline decomposition of the benzyl ether of heparin; its molecular weight is about three times less than that of non-fractionated heparin. Clexane is the most widely used LMWH; it has been obtained by 185 million patients in 96 countries over 20 years.
Clexane is the only low-molecular weight heparin that has been shown to be more effective than unfractionated heparin in a large multicenter study, as well as the only low-molecular weight heparin that is approved by the FDA (Food and Drug Administration) in the U.S. for the treatment of unstable angina and myocardial infarction without Q teeth.
Country of manufacture: France.
Manufacturer: Sanofi S.A.
Form of release: Transparent solution for injections from colorless to pale yellow colour.
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Buy Clexane
Clexane is prescribed for:
- prevention of venous thrombosis and embolisms in surgical procedures, especially in orthopedic and general surgery, including oncology;
- prevention of venous thrombosis and embolisms in bed-ridden patients due to acute therapeutic diseases, including acute heart failure and decompensation of chronic heart failure (class III or IV NYHA), respiratory failure, as well as in severe infections and rheumatic diseases with increased risk of venous thrombosis;
- treatment of deep vein thrombosis (DVT) with or without pulmonary artery thromboembolism, except in cases of pulmonary artery thromboembolism requiring thrombolic therapy or surgery;
- prevention of thrombosis in the extracorporeal circulatory system during hemodialysis;
- acute coronary syndrome:
- treatment of unstable angina and myocardial infarction without lifting ST segment in combination with oral administration of acetylsalicylic acid;
- treatment of acute myocardial infarction with ST segment elevation in patients who are subject to medication or subsequent percutaneous coronary surgery.
With the exception of special cases (see below, "Treatment of myocardial infarction with ST segment elevation, medication or percutaneous coronary surgery" and "Prevention of thrombosis in the extracorporeal circulation system during hemodialysis"), sodium enoxaparin is injected deep subcutaneously.
The drug must not be injected intramuscularly.Prevention of venous thrombosis and embolisms in surgical procedures in moderate and high-risk patients
For patients with moderate risk of thrombosis and emboli, the recommended dose of Clexane® is 20 mg once a day subcutaneously. The first injection should be made 2 hours before surgery.
For patients with high risk of thrombosis and embolisms, the drug is recommended in a dose of 40 mg once per day subcutaneously, with the first dose administered 12 hours before surgery.
If earlier preoperative prophylaxis is necessary, the last injection should be given 12 hours before and 12 hours after surgery.
The duration of treatment with Clexane® is 7-10 days in average. If necessary, therapy can be continued until the risk of thrombosis and embolism persists and the patient switches to outpatient mode.
In case of large orthopaedic surgeries it may be advisable to continue treatment after the initial therapy by administration of Clexane® in a dose of 40 mg 1 time per day for 5 weeks.
For patients with high risk of venous thromboembolism, who had surgery, abdominal and pelvic surgery due to oncological disease, it may be advisable to increase the duration of Clexane® administration in a dose of 40 mg 1 time per day for 4 weeks.
Prevention of venous thrombosis and embolisms in bed-ridden patients due to acute therapeutic conditions
The recommended dose of Clexane® is 40 mg once a day, subcutaneously, for 6-14 days. The therapy should be continued until the patient fully switches to outpatient mode (maximum 14 days).
Treatment of DVT with or without PE
The drug is injected subcutaneously at the rate of 1.5 mg/kg once a day or 1 mg/kg twice a day. The dosing regime should be chosen by a doctor based on the assessment of the risk of thromboembolism and the risk of bleeding.
For patients without thromboembolic complications and with low risk of venous thromboelia, the preparation should be administered subcutaneously at the rate of 1.5 mg/kg once a day.
For all other patients, including patients with obesity, symptomatic PE, cancer, repeated enous thromboelia and proximal thrombosis (in the iliac vein), it is recommended to use the drug in a dose of 1 mg/kg 2 times a day.
The duration of treatment is about 10 days in average. The therapy with indirect anticoagulants should be started immediately and the treatment with Clexane® should be continued until the therapeutic anticoagulant effect is achieved (MHO values are 2-3).
Prophylaxis of thrombosis in the extracorporeal circulatory system during hemodialysis
The recommended dose of Clexane® is on average 1 mg/kg. In case of high risk of bleeding, the dose should be reduced to 0.5 mg/kg with double vascular access or to 0.75 mg/kg with single vascular access.
In case of hemodialysis Clexane® should be injected into the arterial section of the shunt at the beginning of the hemodialysis session. As a rule, one dose is enough for a 4-hour session, however, if fibrin rings are detected for a longer hemodialysis period, the preparation can be additionally injected at the rate of 0.5-1 mg/kg. There are no data available for patients who use sodium enoxaparin for prophylaxis or treatment and during hemodialysis sessions.
Treatment of unstable angina and myocardial infarction without lifting ST segment
Clexane® is administered at the rate of 1 mg/kg every 12 h, subcutaneously, with simultaneous antithrombocytic therapy. The average duration of therapy is at least 2 days and continues until the patient's clinical condition stabilizes. Usually the administration of the drug lasts from 2 to 8 days.
Acetylsalicylic acid is recommended for all patients without contraindications in an initial dose of 150-300 mg orally followed by a maintenance dose of 75-325 mg once a day.
Treatment of acute myocardial infarction with ST segment elevation, drug or percutaneous coronary intervention
Treatment begins with a single intravenous bolus administration of sodium enoxaparin in a dose of 30 mg.
Immediately after it, sodium enoxaparin is injected subcutaneously in a dose of 1 mg/kg. Then, the drug is administered subcutaneously, 1 mg/kg every 12 h (maximum 100 mg of sodium enoxaparin for each of the first two subcutaneous injections, then - 1 mg/kg for the remaining subcutaneous doses, i.e. if the body weight exceeds 100 kg, a single dose may exceed 100 mg). As soon as possible after acute myocardial infarction with ST segment elevation is detected, patients should be administered acetylsalicylic acid simultaneously, and if no contraindications are given, acetylsalicylic acid (in doses 75-325 mg) should be continued daily for at least 30 days.
Recommended duration of treatment with Clexane® is 8 days or - before discharge from hospital (if the period of hospitalization is less than 8 days)
In combination with thrombolytics (fibrin-specific and fibrin-specific), sodium enoxaparin should be administered between 15 min before and 30 min after thrombolytic therapy.
Patients 75 years of age or older DO NOT have initial intravenous bolus injection. The preparation is administered subcutaneously in a dose of 0.75 mg/kg every 12 hours (maximum 75 mg of sodium enoxaparin for each of the first two subcutaneous injections, then - 0.75 mg/kg for the remaining subcutaneous doses, i.e. with body weight over 100 kg a single dose may exceed 75 mg).
Patients undergoing percutaneous coronary intervention, if the last subcutaneous injection of sodium enoxaparin was given less than 8 hours before inflating the tank catheter injected at the site of the coronary artery narrowing, no additional sodium enoxaparin injection is required. If the last subcutaneous injection of sodium enoxaparin was carried out more than 8 hours before the balloon catheter inflatation, an additional intravenous injection of sodium enoxaparin in the dose of 0.3 mg/kg should be made.
Children under 18.
The safety and effectiveness of sodium enoxaparin use in children has not been established.
Elderly patients (over 75 years of age)
With the exception of the treatment of myocardial infarction with ST segment elevation, all other indications of reduced sodium enoxaparin doses in elderly patients are not required if there is no renal impairment.
Patients with renal impairment
Severe renal impairment (creatinine Cl ≥15 and <30 ml/min).
The use of sodium enoxaparin is not recommended for patients with terminal stage of chronic kidney disease (Cl creatinine <15 ml/min) due to lack of data, except cases of prophylaxis of thrombosis in the extracorporeal circulatory system during hemodialysis.
Renal function disorders of mild (Cl creatinine ≥50 and <80 ml/min) and moderate (Cl creatinine ≥30 and <50 ml/min) severity.
There is no dose correction required, but patients should be carefully monitored by a doctor.
Patients with liver function disorders.
Due to the lack of clinical trials, it is necessary to be careful when prescribing sodium enoxaparin to patients with impaired liver function.
Patients with low body weight
There was an increase in the exposure of sodium enoxaparin in its preventive use in women with body weight less than 45 kg and in men with body weight less than 57 kg, which may lead to increased risk of bleeding. Close monitoring of the condition is recommended.
Patients with obesity
Patients with obesity are at increased risk of thrombosis and embolism. The safety and effectiveness of the use of enoxaparin in prophylactic doses in obese patients (BMI over 30 kg/m2) has not been fully determined and there is no consensus on dose correction. These patients should be closely monitored for symptoms and signs of thrombosis and embolisms.
Patients with mechanical artificial heart valves
The use of sodium enoxaparin to prevent thrombosis in patients with mechanical artificial heart valves has not been sufficiently studied. There are separate reports on the development of cardiac valve thrombosis in patients with mechanical artificial heart valves in the background of sodium enoxaparin therapy for the prevention of thrombosis. Due to insufficiency of clinical data and presence of ambiguous factors, including the underlying disease, it is difficult to assess such reports.
Pregnant women with mechanical artificial heart valves
The use of sodium enoxaparin to prevent thrombosis in pregnant women with mechanical artificial heart valves has not been sufficiently studied.Pregnant women with mechanical artificial heart valves have a high risk of thrombosis and embolism.
The pre-filled disposable syringe is ready for use.
The drug must not be injected intramuscularly!
Subcutaneous injection
Injections should preferably be done in the patient's lying position.
When using pre-filled syringes for 20 and 40 mg, it is not necessary to remove air bubbles from the syringe before the injection to avoid loss of preparation.
Injections should be given alternately on the left or right anterolateral or posterolateral abdominal surface.
The needle must be injected vertically (not sideways) over the entire length into the skin fold collected and held until the injection is complete between the thumb and index finger.
The skin fold is only released when the injection is complete.
The injection site should not be massaged after injection.
Intravenous bolus injection
Intravenous bolus injection of sodium enoxaparin should be done through a venous catheter.
Sodium enoxaparin should not be mixed or injected with other drugs.
In order to avoid traces of other drugs in the infusion system and their interaction with sodium enoxaparin, venous catheter should be washed with sufficient amount of 0.9% sodium chloride solution or 5% dextrose solution before and after intravenous bolus administration of sodium enoxaparin.
Sodium enoxaparin can be safely injected with 0.9% sodium chloride solution and 5% dextrose solution.
For the bolus administration of 30 mg of sodium enoxaparin in the treatment of acute myocardial infarction with lifting of ST segment from 60, 80 and 100 mg glass syringes, the excess of the preparation is removed so that only 30 mg (0.3 ml) remains in them. The dose of 30 mg can be directly injected intravenously.
For intravenous bolus administration of sodium enoxaparin through a venous catheter, pre-filled syringes for subcutaneous administration of 60, 80 and 100 mg can be used.
It is recommended to use 60 mg syringes, as this reduces the amount of the drug to be removed from the syringe.
20 mg syringes should not be used, as there is not enough preparation for bolus administration of 30 mg of sodium enoxaparin.
40 mg syringes are not used, as they are not divided and therefore it is impossible to measure the amount of 30 mg accurately.
To increase the accuracy of the additional intravenous bolus injection of small amounts into the venous catheter, it is recommended to dilute the preparation to the concentration of 3 mg/ml during PSC.
It is recommended to dilute the solution immediately before administration.
To obtain a solution of sodium enoxaparin with a concentration of 3 mg/ml using a pre-filled 60 mg syringe, it is recommended to use a container with 50 ml infusion solution (i.e. with 0.9% sodium chloride solution or 5% dextrose solution).
A 30 ml solution is extracted and removed from the infusion solution container with a conventional syringe.
Sodium enoxaparin (content of 60 mg hypodermic syringe) is injected into the remaining 20 ml of infusion solution in the container.
The content of the container with diluted solution of sodium enoxaparin is gently mixed.
A syringe is used to extract the required volume of diluted sodium enoxaparin solution, which is calculated by the formula:
Diluted solution volume = patient body weight (kg) × 0.1
1. Wash hands and the area of skin (place for injection) in which the patient will inject the drug, water and soap. Dry it out.
2. Take a comfortable sitting or lying position and relax. Make sure that you can clearly see the place where the drug will be injected. Optimal use of a relaxation chair, a lounge chair or a bed covered with support cushions.
3. Choose a place for the injection on the right or left side of the abdomen. This place should be at least 5 cm from the navel towards the sides. Do not give your own injection at a distance of 5 cm from the navel or around existing scars or bruises. Alter the injection sites on the right and left side of the abdomen depending on where the drug was injected the previous time.
4. Wipe the injection area with a tampon moistened with alcohol.
5. Carefully remove the cap from the needle of the syringe with Clexane®. Put the cap away. Syringe is pre-filled and ready for use. Do not press the piston to displace air bubbles until the needle has been injected at the injection site. Doing so may result in loss of medication. After removing the cap, do not allow the needle to touch any objects. This is necessary to preserve the sterility of the needle.
6. Hold the syringe in the patient's hand as he holds a pencil and gently squeeze the alcohol-wiped area of the drug with the other hand to form a fold of the skin between thumb and index finger. Hold the skin fold while the medicine is being injected.
7. Hold the syringe so that the needle points down (vertically at 90°). Insert the full length of the needle into the skin fold.
8. Push the piston with your finger. This will inject the drug into the abdominal subcutaneous adipose tissue. Hold the skin fold while the patient is injecting the medication.
9. Remove the needle by pulling it back without deviating from the axis. The safety mechanism will automatically close the needle. Now you can stop holding the skin fold. The safety system for starting the protective mechanism will only be activated when the entire contents of the syringe have been injected by pressing the piston for the entire length of its stroke.
10. In order to prevent bruising, do not rub the injection site after injection.
11. Place the used syringe with the protective mechanism in the container for sharp objects. Close the container tightly with the lid and keep it out of the reach of children.
Symptoms:
An accidental overdose of Clexane® (when used intravenously, subcutaneously or extracorporeally) may lead to hemorrhagic complications. Even large doses of Clexane® are unlikely to be absorbed when taken orally.
Treatment:
Anticoagulant effects can be largely neutralized by slow intravenous administration of protamine sulfate, the dose of which depends on the dose of injected Clexane®. 1 mg of protamine sulfate will neutralize anticoagulant activity of 1 mg of Clexane®, if sodium enoxaparin was administered not more than 8 hours before protamine administration. 0.5 mg of protamine will neutralize the anticoagulant effect of 1 mg of Clexane® if sodium enoxaparin is administered not more than 8 hours before protamine administration. 0.5 mg of protamine will neutralize the anticoagulant effect of 1 mg of the preparation if more than 8 hours have elapsed since the last dose or if the second dose of protamine is necessary. If 12 hours or more have elapsed since the administration of sodium enoxaparin, no protamine administration is required. However, even with large doses of protamine anti-Xa sulfate, the activity of Clexane® is not completely neutralized (by 60% maximum).
- Hypersensitivity to sodium enoxaparin, heparin or its derivatives, including other low molecular weight heparins;
- active, clinically significant bleeding, and conditions and diseases with a high risk of bleeding, including recent hemorrhagic stroke, acute gastrointestinal ulcer, and the presence of malignant tumours with a high risk of bleeding, Recent brain and spinal cord surgeries, ophthalmic surgeries, known or suspected esophageal varicose veins, arteriovenous malformations, vascular aneurysms, spinal and brain vascular abnormalities;
- spinal or epidural anesthesia or loco regional anesthesia when sodium enoxaparin was used for treatment in the previous 24 hours;
- immuno-mediated heparin-induced thrombocytopenia (in history) during the last 100 days or the presence of circulating antithrombocytic antibodies in the blood;
- children under 18 years of age, as no efficiency or safety has been established for this category of patients.
With Caution:
conditions in which there is a potential risk of bleeding:
- Hemostasis disorders, severe vasculitis;
- gastric or duodenal ulcer or other gastrointestinal erosive lesions in the history; recent ischemic stroke;
- uncontrolled severe arterial hypertension;
- diabetic or hemorrhagic retinopathy;
- severe diabetes;
- recent or suspected neurological or ophthalmic surgery;
- spinal or epidural anesthesia (potential hematoma risk), spinal puncture (recent);
- recent dchildbirth;
- bacterial endocarditis (acute or subacute);
- pericarditis or pericardial effusion;
- renal and/or liver failure;
- intrauterine contraception severe trauma (especially CNS), open wounds on large surfaces;
- simultaneous administration of drugs affecting the hemostasis system;
- heparin-induced thrombocytopenia without circulating antibodies in the history (more than 100 days).
The frequency of unwanted reactions was determined according to the WHO classification: very often (≥1/10); often (≥1/100 - <1/10); not often (≥1/1000 - <1/100); rarely (≥1 /10000 - <1/1000); very rarely (<1/10000), the frequency is unknown (cannot be calculated from available data).
- Vessels
Bleedings
In clinical studies, bleeding was the most common unwanted reaction. These included large bleedings in 4.2% of patients (haemorrhage was considered large if accompanied by a Hb reduction of 2 g/l or more, required 2 or more doses of blood components; and if it was retroperitoneal or intracranial). Some of these cases were fatal.
As with other anticoagulants, sodium enoxaparin may cause bleeding, especially if there are risk factors for bleeding, invasive procedures or the use of drugs that disrupt hemostasis.
In description of bleedings, an "*" indicates the following types of bleedings: hematoma, ecchymosis (except for those developed at the injection site), wound hematoma, hematuria, nasal bleeding, gastrointestinal bleeding.
Very often - bleeding* in the prevention of venous thrombosis in surgical patients and the treatment of DVT with or without PE.
Often - bleeding* in the prevention of venous thrombosis in patients on bed rest and the treatment of unstable angina, myocardial infarction without a tooth Q and myocardial infarction with lifting ST segment.
Not often - retroperitoneal bleeding and intracranial hemorrhage in patients treated for DVT with or without PE and myocardial infarction with ST segment elevation.
Rarely - retroperitoneal bleeding in the prevention of venous thrombosis in surgical patients and in the treatment of unstable angina and myocardial infarction without Q-teeth
- Thrombocytopenia and thrombocytosis
Very often - thrombocytosis (number of platelets in peripheral blood - > 400*109/l) in the prevention of venous thrombosis in surgical patients and treatment of DVT with or without PE.
Often - thrombocytosis in the treatment of patients with acute myocardial infarction with lifting of ST segment.
Thrombocytopenia in the prevention of venous thrombosis in surgical patients and the treatment of DVT with PE or without it, as well as in acute myocardial infarction with ST segment elevation.
Not often - thrombocytopenia in the prevention of venous thrombosis in patients on bed rest, and in the treatment of unstable angina and myocardial infarction without a tooth Q.
Very rarely - autoimmune thrombocytopenia in the treatment of patients with acute myocardial infarction with lifting of ST segment.
- Blood and lymphatic system
Often - bleeding, thrombocytopenia, thrombocytosis;
Rarely - cases of autoimmune thrombocytopenia with thrombosis;
in some cases thrombosis has been complicated by organ infarction or limb ischemia.
- Immune system
Often - allergic reactions.
- Liver and biliary tract
Very often - increased activity of liver enzymes
- Skin and hypodermis
Often - hives, itching, erythema;
Not often - bullous dermatitis.
- General disorders and disorders at the injection site
Often - hematoma at the injection site, swelling at the injection site, bleeding, hypersensitivity reactions, inflammation, seal formation at the injection site;
Not often - irritation at the injection site, skin necrosis at the injection site.
Simultaneous use of other drugs that affect hemostasis
The use of drugs affecting hemostasis (salicylates of systemic action, including acetylsalicylic acid in doses with anti-inflammatory effect, non-steroidal anti-inflammatory drugs, including ketorolac, other thrombolitics (alteplase, repelase, streptokinase, tekteplase, urokinase) is recommended to be cancelled before treatment with sodium enoxaparin, unless their use is necessary. If their simultaneous use with sodium enoxaparin is shown, careful clinical observation and monitoring of relevant laboratory parameters should be carried out.
Control of peripheral blood platelet count
In the presence of a confirmed significant decrease in the number of platelets (30-50% compared to the initial indicator) it is necessary to immediately cancel sodium enoxaparin and transfer the patient to another anticoagulant therapy without heparin.
Cerebral coronary angioplasty
In order to minimize the risk of bleeding associated with invasive vascular instrumental manipulation in the treatment of unstable angina and myocardial infarction without the Q tooth and acute myocardial infarction with ST segment elevation, these procedures should be carried out in the intervals between administration of the drug. This is necessary to achieve hemostasis at the site of the catheter injection after the CHF. If a closing device is used, the femoral artery intruder may be removed immediately. When using manual compression, the femoral artery intruder should be removed 6 hours after the last intravenous or subcutaneous injection of sodium enoxaparin. If treatment with sodium enoxaparin continues, the next dose should be administered no earlier than 6-8 hours after the removal of the femoral artery intruder. The site of the intruder should be monitored to detect signs of bleeding and hematoma in time.
Skin necrosis / Skin vasculitis
In case of development of skin necrosis / skin vasculitis, use of the drug should be stopped.
Laboratory tests
In doses used for prophylaxis of thromboembolic complications, Clexane® does not significantly affect the time of bleeding and blood clotting, as well as the aggregation of platelets or their binding to fibrinogen. If the dose is increased, the APTT (activated partial thromboplastin time) and the activated time of blood clotting can be prolonged. The increase in APTT and activated clotting time are not directly linearly dependent on the increase in anticoagulant activity of the drug, so there is no need to monitor them.
Hyperkalemia
Heparins can inhibit aldosterone secretion in the adrenal glands, resulting in hyperkalemia, especially in patients with diabetes mellitus, chronic renal failure, prior to metabolic acidosis, taking drugs that increase potassium content. Potassium in plasma should be monitored regularly, especially in risk group patients.
Impact on the ability to drive vehicles
Clexane has no effect on the ability to drive vehicles.
Active ingredient: Sodium Enoxaparin
Solvent: Water for injections
Effectiveness: surpasses non-fractionated heparin in reducing the risk of coronary heart disease complications.
Safety: out of 8.2 million patients receiving Clexane, only 279 had side effects.
Easy to use: 1 mg/kg subcutaneous weight every 12 hours, ready to use syringes.
Other benefits of Clexane:
- predictable and long-lasting anticoagulation effect;
- no cancellation syndrome;
- no drug resistance;
- no need for laboratory control;
- less pronounced effect on platelet function;
- lower incidence of side effects and complications.
SYNERGY RESEARCH RESULTS
SYNERGY is a prospective randomized open study that assesses the efficacy and safety of Clexane compared to unfractionated heparin in severe patients with acute coronary syndrome without ST segment elevation, who are scheduled for surgical intervention (angioplasty or stenting). The SYNERGY study was performed in about 400 centers in the USA, Canada, Europe and South America.
The results obtained in the SYNERGY study demonstrate the advantages of sodium enoxaparin in the operative tactics of management of patients at high risk of acute coronary syndrome development.
In the secondary analysis, conducted with 5673 patients participating in the SYNERGY study, it was noted that patients who received CLEXANE before randomization and continued to receive it throughout the course of treatment significantly (by 18%) reduced the relative risk of death and myocardial infarction within 30 days after surgery, compared to patients who were initially and subsequently injected with unfractionated heparin (12.8 and 15.6%, respectively, p=0.0029).
The results of the SYNERGY study are fully consistent with the meta-analysis data of all studies, which compared the clinical effectiveness and safety of CLEXANE and non-fractionated heparin in patients with acute coronary syndrome both in conservative and surgical patients. They demonstrate:
the use of CLEXANE significantly reduces the mortality and incidence of myocardial infarction without threatening a significant increase in hemorrhagic complications.
At temperatures not exceeding 25 °C.
Keep out of the reach of children.
Shelf life: 3 years.
Do not use after the expiration date indicated on the package.
There is no prescription required!
You can legally buy Clexane on our website without prescription!
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