Clexane injection syringe 20mg 0,2ml N10
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Active ingredients
Enoxaparin Sodium
Release form
Solution
Composition
Enoxaparin sodium 20 mg * (2000 anti-Ha IU). Solvent: water d / and - up to 0.2 ml.
Pharmacological effect
The preparation of low molecular weight heparin (molecular weight of about 4,500 daltons: less than 2,000 daltons - less than 20%, from 2,000 to 8,000 daltons - more than 68%, more than 8,000 daltons - less than 18%). Enoxaparin sodium 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 non-reducing fragment of 2-O-sulfo-4-enepyrazinosuronic acid and a recovering 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 recovering fragment of the polysaccharide chain. In the in vitro purified system, enoxaparin sodium has high anti-Xa activity (approximately 100 IU / ml) and low anti-IIa or antithrombin activity (approximately 28 IU / ml). This anticoagulant activity acts through antithrombin III (AT-III), providing anticoagulant activity in humans. In addition to anti-Xa / IIa activity, additional anticoagulant and anti-inflammatory properties of enoxaparin sodium were also detected in healthy people and patients, and in animal models. This includes AT-III-dependent inhibition of other coagulation factors as factor VIIa, activation of the release of a tissue factor inhibitor pathway (PTF), as well as a reduction in the release of von Willebrand factor from the vascular endothelium into the bloodstream. These factors provide the anticoagulant effect of enoxaparin sodium in general. When using the drug in prophylactic doses, it slightly alters the APTT, has virtually no effect on platelet aggregation and on the level of fibrinogen binding to platelet receptors. Anti-IIa activity in plasma is about 10 times lower than anti-Xa activity. The average maximum anti-IIa activity is observed approximately 3-4 hours after s / c injection and reaches 0.13 IU / ml and 0.19 IU / ml after repeated administration of 1 mg / kg of body weight with double administration and 1.5 mg / kg of body weight with a single dose. introduction respectively. The average maximum anti-Xa plasma activity is observed 3–5 hours after s / c injection and is approximately 0.2, 0.4, 1.0, and 1.3 anti-Xa IU / ml after s / c administration 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.Absorption and distribution: After repeated subcutaneous injections of enoxaparin sodium at a dose of 40 mg and at a dose of 1.5 mg / kg of body weight 1 time / day in healthy volunteers, Css is achieved by 2 days, with an average AUC 15% higher than after a single dose. introduction. After repeated subcutaneous injections of enoxaparin sodium in a daily dose of 1 mg / kg body weight 2 times / day Css is reached in 3-4 days, with AUC on average 65% higher than after a single injection and average values of Cmax are respectively 1.2 IU / ml and 0.52 IU / ml. The bioavailability of enoxaparin sodium in s / c administration, estimated on the basis of anti-Xa activity, is close to 100%. Vd of enoxaparin sodium (for anti-Xa activity) is approximately 5 liters and approaches blood volume. Metabolism: Enoxaparin sodium is mainly biotransformed in the liver by desulfation and / or depolymerization with the formation of low molecular weight substances with very low biological activity. Withdrawal: Enoxaparin sodium is a low clearance drug. After i / v administration for 6 hours at a dose of 1.5 mg / kg body weight, the mean value of anti-Xa clearance in plasma is 0.74 l / h. Removal of the drug is monophasic in nature. T1 / 2 is 4 hours (after a single sc injection) and 7 hours (after repeated administration of the drug). 40% of the administered dose is excreted by the kidneys, with 10% unchanged. Pharmacokinetics in special clinical situations: Possible delay in elimination of enoxaparin sodium in elderly patients as a result of reduced renal function. In patients with impaired renal function, there is a decrease in the clearance of enoxaparin sodium. In patients with lung (CK 50-80 ml / min) and moderate (CK 30-50 ml / min) renal dysfunction after repeated s / c administration of 40 mg of enoxaparin sodium 1 time / day, there is an increase in anti-Xa activity represented by AUC . In patients with severe impaired renal function (CC less than 30 ml / min) with repeated sc injection of the drug at a dose of 40 mg 1 time / day, the AUC in equilibrium is, on average, 65% higher. In patients with overweight when s / to the introduction of the drug clearance is slightly less. If you do not adjust the dose based on the patient’s body weight, then after a single SC injection of enoxaparin sodium at a dose of 40 mg, anti-Xa activity will be 50% higher in women with a body weight less than 45 kg and 27% higher in men with a mass body less than 57 kg, compared with patients with normal average body weight.
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 III or IV functional class NYHA classification, acute respiratory failure, severe acute infection, acute rheumatic diseases in combination with among the risk factors for venous thrombosis) - treatment of deep vein thrombosis with thromboembolism or without pulmonary embolism - prevention of thrombosis in the extracorporeal blood circulation system during hemodialysis (usually with a session duration of not more than 4 hours) - treatment of unstable angina pectoris and infarction (usually with a duration of a session of not more than 4 hours) combination with acetylsalicylic acid — treatment of acute myocardial infarction with ST segment elevation in patients undergoing medical treatment or subsequent percutaneous cortex Narnia intervention.
Contraindications
- hypersensitivity to enoxaparin, heparin and its derivatives, including other low molecular weight heparins — active major bleeding, as well as conditions and diseases for which there is a high risk of bleeding: threatening abortion, cerebral aneurysm or dissecting aortic aneurysm (except in cases of surgical intervention), recent hemorrhagic stroke, uncontrolled bleeding, thrombocytopenia in combination with a positive test in vitro on anti-platelet antibodies in the presence of enoxaparin sodium — up to 18 years of age (efficacy and safety have not been established). The use of Clexan is not recommended; for the prevention of thrombosis in pregnant women with mechanical artificial heart valves (lack of clinical experience). With caution Conditions in which there is a potential risk of bleeding: - impaired hemostasis (including hemophilia, thrombocytopenia, hypocoagulation, von Willebrand disease),severe vasculitis — peptic ulcer of the stomach and duodenum or other erosive and ulcerative lesions of the gastrointestinal tract with a history of recent recent ischemic stroke — uncontrolled severe arterial hypertension — diabetic or hemorrhagic retinopathy — a non-ad hoc pattern that has already been applied to an open dialect or a hemorrhagic retinopathy — you can have a non-activated pattern, you can have a non-activated pattern, you can have a non-activated pattern, you can not change a zone, you can not change a zone, you can not change a zone, you can not change a zone, you can not have a touch, you can not change a zone, you can not change a zone, you will not have any way to make a hole, you will have to open an inscription, you will not have to make a simple case, you will not have an active zone, you will not have, you will not have, you will have to make a simple pattern, you will not have, you will have to make a simple diaphragmatic diabetes or hemorrhagic retinopathy; epidural anesthesia (potential risk of hematoma), lumbar puncture (recently transferred) - neda Delivery - bacterial endocarditis (acute or subacute) - pericarditis or pericardial effusion - renal and / or liver failure — intrauterine contraception (IUD) - severe trauma (especially the central nervous system), open wounds with a large wound surface — simultaneous administration of drugs affecting the system hemostasis — heparin-induced thrombocytopenia (in history) in combination with or without thrombosis. The company does not have data on the clinical use of Clexan; in the following conditions: active tuberculosis, radiation therapy (recently transferred).
Dosage and administration
Except in special cases (treatment of myocardial infarction with ST-segment elevation, medication or with percutaneous coronary intervention and prevention of thrombosis in the extracorporeal circulation system during hemodialysis), enoxaparin sodium is injected deeply into the sc. Injections are preferably carried out in the patient lying down. When using pre-filled syringes for 20 mg and 40 mg in order to avoid loss of the drug before the injection, it is not necessary to remove air bubbles from the syringe. Injections should be carried out alternately in the left or right anterolateral or posterolateral surface of the abdomen. The needle must be inserted at full length vertically (not sideways) into the skin fold, collected and held until the injection is completed between the thumb and index finger. A skin fold is released only after completion of the injection. Do not massage the injection site after the injection. The pre-filled disposable syringe is ready for use. The drug can not be administered in / m! Prevention of venous thrombosis and embolism during surgical interventions, especially in orthopedic and general surgery operations Patients with a moderate risk of developing thrombosis and embolism (for example,abdominal surgery) recommended dose of Clexane; makes 20 mg or 40 mg 1 time / days p / to. The first injection is made 2 hours before surgery. For patients with a high risk of thrombosis and embolism (for example, during orthopedic operations), the drug is recommended at a dose of 40 mg 1 time / day n / a, the first dose is administered 12 hours before surgery, or 30 mg 2 times / day n / a sec the beginning of the introduction after 12-24 h after surgery. Duration of treatment with Clexane; on average is 7-10 days. If necessary, therapy can be continued as long as the risk of thrombosis and embolism persists, and until the patient switches to an outpatient regimen. For orthopedic operations, it may be advisable to continue treatment by administering Clexan after initial therapy; at a dose of 40 mg 1 time / day for 3 weeks. Features of the drug Clexane; for spinal / epidural anesthesia, as well as for procedures of coronary revascularization 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 Clexan; makes 40 mg 1 time / days p / to, at least, within 6 days. Therapy should be continued until the patient is fully transferred to the outpatient mode (maximum for 14 days). Treatment of deep vein thrombosis with pulmonary thromboembolism or without pulmonary artery thromboembolism The drug is injected s / c at a rate of 1.5 mg / kg body weight 1 time / day or at a dose of 1 mg / kg body weight 2 times / day. In patients with complicated thromboembolic disorders, the drug is recommended to be used at a dose of 1 mg / kg 2 times / day. The average duration of treatment is 10 days. It should immediately begin therapy with indirect anticoagulants, while therapy with Clexane; it is necessary to continue until a therapeutic anticoagulant effect is achieved, i.e. MHO should be 2-3. Prevention of thrombosis in the extracorporeal circulation during hemodialysis The recommended dose of Clexane; averages 1 mg / kg body weight. With a high risk of bleeding, the dose should be reduced to 0.5 mg / kg of body weight with a double vascular approach or 0.75 mg with a single vascular approach.In hemodialysis, the drug should be injected into the arterial area of the shunt at the beginning of the hemodialysis session. A single dose is usually sufficient for a 4-hour session, however, if fibrin rings are detected during longer hemodialysis, the drug can be additionally administered at a rate of 0.5–1 mg / kg body weight. Treatment of unstable stenocardia and myocardial infarction without C wave Qleksan; administered at the rate of 1 mg / kg body weight every 12 hours of the s / c, with simultaneous use of acetylsalicylic acid in a dose of 100-325 mg 1 time / day. The average duration of therapy is at least 2 days (until the patient’s clinical condition stabilizes). Usually the administration of the drug lasts from 2 to 8 days. Treatment of acute myocardial infarction with ST-segment elevation, medication or with percutaneous coronary intervention. Treatment begins with a single IV bolus administration of enoxaparin sodium at a dose of 30 mg. Immediately after it, enoxaparin sodium is administered in a dose of 1 mg / kg. Next, the drug is prescribed s / c at 1 mg / kg body weight every 12 hours (maximum 100 mg of enoxaparin sodium for each of the first two s / c injections, then 1 mg / kg body weight for the remaining subcutaneous doses, i.e. with a body weight of more than 100 kg, a single dose may exceed 100 mg). In patients aged 75 years and older, the initial IV bolus is not used. Sodium enoxaparin is injected s / c at a dose of 0.75 mg / kg every 12 hours (moreover, during the first two s / c injections, 75 mg of enoxaparin sodium can be administered as much as possible for each injection, then all subsequent doses of 0.75 mg / kg of body weight, i.e., with a body weight of more than 100 kg, the dose may exceed 75 mg). When combined with thrombolytic agents (fibrin-specific and fibrin-nonspecific), enoxaparin sodium should be administered in the range from 15 minutes before the start of thrombolytic therapy to 30 minutes after it. As soon as possible after the detection of acute myocardial infarction with ST segment elevation, acetylsalicylic acid should be started at the same time (in doses of 75 to 325 mg) and, if there are no contraindications, it should last for at least 30 days. The recommended duration of drug treatment is 8 days or until the patient is discharged from the hospital if the period of hospitalization is less than 8 days. In / into the bolus administration of enoxaparin sodium should be carried out through the venous catheter and sodium enoxaparin should not be mixed or administered with other drugs.In order to avoid the presence of traces of other medicinal substances in the infusion system and their interaction with sodium enoxaparin, the venous catheter should be flushed with a sufficient amount of 0.9% sodium chloride or dextrose solution before and after the IV bolus injection of sodium enoxaparin. Enoxaparin sodium can be administered safely with a 0.9% sodium chloride solution and a 5% dextrose solution. For bolus administration of enoxaparin sodium at a dose of 30 mg for the treatment of acute myocardial infarction with ST segment elevation from glass syringes 60 mg, 80 mg and 100 mg, remove the excess amount of the drug so that only 30 mg (0.3 ml) remains in them. A dose of 30 mg can be directly administered IV. For IV bolus administration of enoxaparin sodium through a venous catheter, you can use prefilled syringes for s / c administration of the drug 60 mg, 80 mg and 100 mg. It is recommended to use 60 mg syringes, because This reduces the amount of drug removed from the syringe. Syringes 20 mg are not used, because they are not enough drug for the bolus of 30 mg of enoxaparin sodium. 40 mg syringes are not used because there are no divisions on them and therefore it is impossible to accurately measure the amount of 30 mg. In patients undergoing percutaneous coronary intervention, if the last s / c injection of enoxaparin sodium was performed less than 8 hours before the balloon catheter introduced into the place of the coronary artery was inflated, additional administration of enoxaparin sodium is not required. If the last s / c injection of enoxaparin sodium was carried out more than 8 hours before the balloon catheter is inflated, an additional bolus of enoxaparin sodium should be given IV at a dose of 0.3 mg / kg. To improve the accuracy of the additional bolus 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. Dilution of the solution is recommended immediately before the introduction. To obtain a solution of enoxaparin sodium with a concentration of 3 mg / ml using a pre-filled syringe of 60 mg, it is recommended to use a 50 ml infusion solution (i.e., a 0.9% solution of sodium chloride or 5% dextrose).From the container with the infusion solution using a conventional syringe is removed and removed 30 ml of solution. Enoxaparin sodium (contents of syringe for sc administration of 60 mg) is injected into the remaining 20 ml of infusion solution in the vessel. The contents of the container with the diluted solution of enoxaparin sodium are gently mixed. Elderly patients. Except for the treatment of myocardial infarction with ST segment elevation (see above), for all other indications of reducing doses of enoxaparin sodium in elderly patients, if they do not have impaired renal function, is not required. In patients with severely impaired renal function (CC less than 30 ml / min), the dose of enoxaparin sodium is reduced in accordance with the tables presented below, since these patients have an increase in systemic exposure (duration of action) of the drug. With a light (CK 50-80 ml / min) and moderate (CK 30-50 ml / min) impaired renal function, dose adjustment is not required, but patients should be under the careful supervision of a physician. In connection with the absence of clinical studies, the drug Clexane; should be used with caution in patients with impaired liver function. Instructions for self-injection of the drug Clexane; (a pre-filled syringe with a needle protection system) 1. Wash your hands and a skin area (injection site) into which you will inject the drug with soap and water. Dry them. 2. Take a comfortable sitting or lying position and relax. Make sure that you see well the place where you are going to inject the drug. Optimal use of a lounge chair, a chaise longue, or a bed lined with pillows for support. 3. Select a location for the injection in the right or left side of the abdomen. This place should be at a distance of at least 5 cm from the navel towards the sides. Do not perform self-injection at a distance of 5 cm from the navel or around existing scars or bruises. Alternate the injection site in the right and left parts of the abdomen, depending on where you injected the drug the previous time. 4. Wipe the injection site with an alcohol swab. 5. Carefully remove the cap from the needle of the syringe with Clexane ;. Put the cap back. The syringe is pre-filled and ready to use. Do not press the plunger to expel air bubbles before inserting the needle at the injection site.This can lead to a loss of the drug. After removing the cap, do not allow the needle to touch any objects. This is necessary to maintain the sterility of the needle. 6. Hold the syringe in the hand with which you write, as you hold the pencil, and with the other hand, gently squeeze the rubbed area with alcohol between your thumb and index finger so that it forms a fold of skin. Hold the skin fold as you enter the drug. 7. Hold the syringe so that the needle is pointing down (vertically at a 90 ° angle). Insert the needle all the way into the skin fold. 8. Press a finger on the piston. This will ensure the introduction of the drug in the subcutaneous fatty tissue of the abdomen. Hold the skin fold as you enter the drug. 9. Remove the needle by pulling it back without deviating from the axis. The protective mechanism will automatically close the needle. Now you can stop retaining the skin fold. The security system that ensures the start of the protective mechanism is activated only after the entire contents of the syringe have been inserted by pressing the piston the entire length of its stroke. 10. In order to prevent the formation of a bruise, do not rub the injection site after the injection. 11. Place the used syringe with a protective mechanism in a container for sharp objects. Close the container tightly with the lid and keep it out of the reach of children. When using the drug strictly adhere to the recommendations provided in the instructions, as well as the instructions of the doctor or pharmacist. If you have any questions, consult your doctor or pharmacist.