Enixum 5000 anti-Ha IU/0.5 ml 0.5 ml, 10 pcs.

Name: Enixum 5000 anti-Ha IU/0.5 ml 0.5 ml, 10 pcs.
SKU: 302055
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EAN: 4605964006103 SKU: 302055 Categories: Cardiovascular, Medicine

Description

Enoxaparies sodium is a low molecular weight heparin. The average molecular weight is about 4500 daltons: less than 2000 daltons – < 20%, from 2000 to 8000 daltons – > 68%, more than 8000 daltons – < 18%. Enoxaparies sodium is obtained by alkaline hydrolysis of heparin benzine ester isolated from the mucous membrane of pig small intestine. Its structure is characterized by a nonreducible fragment of 2-0-sulfo-4-enpyrazinosuronic acid and a reducible fragment of 2-14.6-0-disulfo-0-glucopyranoside.

The structure of enoxaparin sodium contains about 20% (ranging from 15% to 25%) of the 1.6- anhydron derivative in the reducing fragment of the polysaccharide chain.

Pharmacodynamics

In vitro enoxaparyl sodium has high activity against factor Ha clotting (anti-Xa activity approximately 100 IU/ml) and low activity against factor Na clotting (antp IIa or anti-thrombin activity approximately 28 IU/ml). This anticoagulant activity is mediated by antithrombin III (AT-III). In addition to anti-Xa/IIa activity, additional anticoagulant and anti-inflammatory properties of enoxaparpene sodium have also been identified in both human and animal models, which include AT-III-dependent inhibition of other clotting factors such as factor Vila, activation of tissue factor pathway inhibitor release, and reduction of Willebrand factor release from the vascular endothelium into the bloodstream. These factors provide the anticoagulant effect of enoxaparin sodium in general.

When used in prophylactic doses, sodium epoxaparin slightly changes the activated partial thromboplastin time (APT). It has almost no effect on platelet aggregation and on the degree of binding of fibrinogen to platelet receptors.

The anti-IIa activity in plasma is about 10 times lower than the anti-Xa activity.

The mean maximum anti-IIa activity is observed about 3-4 h after subcutaneous administration and reaches 0.13 IU/ml and 0.19 IU/ml after repeated administration of 1 mg/kg body weight – when administered twice and 1.5 mg/kg body weight – when administered once, respectively. Mean maximum plasma anti-Xa activity is observed 3-5 h 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 mg, 40 mg and 1 mg/kg and 1.5 mg/kg, respectively

Indications

– prevention of venous thrombosis and embolism in surgical interventions, especially in orthopedic and general surgical operations;

– Prevention of venous thrombosis and embolism in bedridden patients due to acute therapeutic conditions (including acute heart failure and decompensation of chronic heart failure (NYHA class III or IV), acute respiratory failure; acute infectious diseases; acute stages of rheumatic diseases combined with a risk factor for venous thrombosis (see “Special Indications));

– treatment of deep vein thrombosis, which is accompanied or not accompanied by pulmonary embolism;

– treatment of unstable angina and myocardial infarction without Q-wave in combination with acetylsalicylic acid;

– prophylaxis against thrombosis in the extracorporeal circulatory system during hemodialysis (usually with a session duration of 4 hours or less);

The treatment of acute ST-segment elevation myocardial infarction in patients undergoing medication-assisted or subsequent percutaneous coronary intervention.

Active ingredient

Enoxaparin sodium

Composition

1 syringe (0.5 ml) contains enoxaparin sodium 5000 anti-Xa ME (50 mg) as the active ingredient;

How to take, the dosage

Except in special cases (see “Treatment of ST-segment elevation myocardial infarction, medication or by percutaneous coronary intervention” and “Prevention of thrombosis in the extracorporeal circulation system during hemodialysis” below), enoxaparin sodium is injected deep subcutaneously. Injections should preferably be performed in the “supine” position of the patient. Injections should alternate to the left or right anterolateral or posterolateral surface of the abdomen.

The needle should be inserted vertically (not laterally) into the full length skin fold, gathered and held between the thumb and forefinger until the injection is complete. The skin fold, release only after the injection is completed. The injection site should not be massaged after the injection.

The pre-filled disposable syringe is ready for use.

The product must not be injected intramuscularly!

Prevention of venous thrombosis and embolism in surgical procedures, especially orthopedic and general surgical procedures

In patients with a moderate risk of thrombosis and embolism (general surgical procedures), the recommended dose is 20 mg once daily subcutaneously. The first injection is given 2 hours before the surgical intervention.

In patients with high risk of thrombosis and embolism (general surgical and orthopedic operations), the drug is recommended in a dose of 40 mg once daily subcutaneously; the first dose is given 12 hours before the surgical intervention, or 30 mg 2 times daily with the beginning of the injection 12-24 hours after surgery.

The duration of treatment with the drug is on average 7-10 days. If necessary the therapy can be continued until the risk of thrombosis and embolism remains (for example, in orthopedics Enoxaparin sodium is used 40 mg once a day for 5 weeks).

The peculiarities of the drug administration during spinal/epidural anesthesia as well as during percutaneous coronary angioplasty are described in section “Special Precautions”.

Prevention of venous thrombosis and embolism in bedridden patients due to acute medical conditions

The recommended dose of enoxaparin sodium is 40 mg once daily subcutaneously for 6 to 14 days.

The treatment of deep vein thrombosis with or without pulmonary embolism

Enixum® is administered subcutaneously at a rate of 1.5 mg/kg once daily or at a dose of 1 mg/kg twice daily. In patients with complicated thromboembolic disorders the drug is recommended in a dose of 1 mg/kg twice daily.

The duration of treatment is on average 10 days. It is advisable to initiate therapy with oral anticoagulants immediately, while therapy with sodium enoxaparin should be continued until sufficient anticoagulant effect is achieved, i.e. INR should be 2.0-3.0. If necessary, control of anticoagulant effect should be assessed by anti-Xa activity.

The treatment of unstable angina and myocardial infarction without Q-wave in combination with acetylsalicylic acid

Enixum® is administered at a rate of 1 mg/kg body weight every 12 h subcutaneously, while acetylsalicylic acid is given simultaneously in an oral dose of 100-325 mg once daily.

The average duration of treatment is 2-8 days (until the patient’s clinical condition stabilizes).

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

. Treatment begins with an intravenous bolus injection of 30 mg of enoxaparin sodium and is immediately followed (within 15 minutes) by a subcutaneous dose of 1 mg/kg (with a maximum of 100 mg of enoxaparin sodium in the first two subcutaneous injections). Thereafter, all subsequent subcutaneous doses are administered every 12 hours at a rate of 1 mg/kg (i.e., if body weight exceeds 100 kg, the dose may exceed 100 mg).

In persons 75 years of age and older, an initial intravenous bolus injection is not used. Enoxaparin sodium is administered subcutaneously at a dose of 0.75 mg/kg every 12 hours (with a maximum of 75 mg of enoxaparin sodium being administered for the first two subcutaneous injections). Thereafter, all subsequent subcutaneous doses are administered every 12 hours at a rate of 0.75 mg/kg (i.e., if the body weight exceeds 100 kg, the dose may exceed 75 mg).
When combined with thrombolytics (fibrin-specific and fibrin- and non-fibrin-specific), enoxaparin sodium should be administered between 15 minutes before thrombolytic therapy and 30 minutes after it. After detection of acute myocardial infarction with ST-segment elevation, acetylsalicylic acid should be started as soon as possible, which, in the absence of contraindications, should be continued for at least 30 days in 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 injection of sodium enoxaparin should be performed through a venous catheter and sodium enoxaparin should not be mixed or administered 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 flushed with sufficient amounts of 0.9% sodium chloride solution or dextrose before and after intravenous bolus injection of sodium enoxaparin. Enoxaparin sodium is compatible with 0.9% sodium chloride solution and 5% dextrose solution.

To perform a 30 mg bolus injection of enoxaparin sodium in the treatment of acute ST-segment elevation myocardial infarction, the 60 mg, 80 mg and 100 mg glass syringes should be discarded so that only 30 mg (0.3 ml) remains. The 30 mg dose can be given directly intravenously.

Pre-filled 60 mg, 80 mg and 100 mg hypodermic syringes may be used for intravenous bolus injection of enoxaparin sodium via a venous catheter. The 60 mg syringe is recommended because it reduces the amount of drug removed from the syringe. The 20 mg syringe is not used because it does not contain enough preparation for a 30 mg bolus of enoxaparin sodium. The 40 mg syringe is not used because it has no graduations and therefore cannot accurately measure the 30 mg.

In patients undergoing percutaneous coronary intervention, if the last subcutaneous injection of sodium enoxaparin was given less than 8 hours before the balloon catheter inserted into the coronary artery constriction was inflated, no additional injection of sodium enoxaparin is required. If the last subcutaneous injection of sodium enoxaparin was given more than 8 hours before the balloon catheter was inflated, an intravenous additional bolus injection of sodium enoxaparin at a dose of 0.3 mg/kg should be given.

In order to improve 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. Dilution of the solution is recommended immediately prior to administration.

To obtain a 3 mg/ml solution of enoxaparin sodium using a pre-filled syringe, it is recommended to use a container with infusion solution from which a portion of the solution is extracted to the desired volume using a normal syringe. Enoxaparin sodium (contents of the hypodermic syringe) is injected into the remaining infusion solution in the container.

The volume of the pre-filled syringe	The amount of infusion solution left in the container
	0.3 ml	10 ml
0.6 ml		20 ml

The contents of the container with the diluted enoxaparin sodium solution are mixed gently. The required volume of the diluted enoxaparin sodium solution is extracted for injection using a syringe, which is calculated according to the formula:

Volume of diluted solution = Patient body weight (kg) x 0.1 or using the table below.

Volumes to be administered intravenously after dilution

Patient body weight (kg)	Required dose (0.3 mg/kg) [mg] <	Volume of solution diluted to a concentration of 3 mg/ml [ml/p>
	45	13.5	4.5
	50	15	5
55	16.5	5.5

	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
	28.5	9.5
100	30	10

Prevention of thrombosis in the extracorporeal circulatory system during hemodialysis (usually with a session duration of 4 hours or less)

The dose of enoxaparin sodium averages 1 mg/kg. For patients at high risk of bleeding, the dose should be reduced to 0.5 mg/kg for double vascular access or 0.75 mg for single vascular access.

In hemodialysis, Enixum® should be administered to the arterial shunt site 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, an additional dose of 0.5-1 mg/kg may be administered.

Patients in the elderly

With the exception of treatment of ST-segment elevation myocardial infarction (see above) for all other indications, no dose reduction of enoxaparin sodium is required in elderly patients if they do not have renal impairment.

Patients with renal impairment

Severe renal impairment (endogenous creatinine clearance less than 30 mL/min). The dose of enoxaparin sodium is reduced according to the tables below because the drug accumulates in these patients.

The following dosing regimen adjustments are recommended when using the drug for therapeutic purposes:

The usual dosing regimen			Dosing regimen for severe renal failure
1 mg/kg subcutaneously 2 times daily			1 mg/kg subcutaneously 1 time daily /p>
1.5 mg subcutaneously once daily			1 mg/kg subcutaneously once daily
Treatment of acute ST-segment elevation myocardial infarction in patients < 75 years old
	Once: 30 mg bolus intravenous injection plus 1 mg/kg subcutaneously; followed by a subcutaneous injection of 1 mg/kg twice daily (maximum 100 mg for each of the first two subcutaneous injections)	Once: 30 mg bolus intravenous plus 1 mg/kg subcutaneously; followed by 1 mg/kg subcutaneously once daily (maximum 100 mg for the first subcutaneous injection) /p>
Treatment of acute myocardial infarction with ST-segment elevation in patients >75 years old
0.75 mg/kg subcutaneously 1 mg/kg subcutaneously twice daily without initial bolus injection (maximum 75 mg for each of the first two subcutaneous injections)	1 mg/kg subcutaneously once daily without initial bolus injection (maximum 100 mg for the first subcutaneous injection)
		br>

The following dosing regimen adjustment is recommended when using the drug for prophylactic purposes

The usual dosing regimen

The dosing regimen for severe renal failure

40 mg subcutaneously once daily

20 mg subcutaneously once daily

/td>

20 mg subcutaneously once daily

In mild (creatinine clearance 50-80 mL/min) and moderate (creatinine clearance 30-50 mL/min) renal failure, no dose adjustment is required, but more careful laboratory monitoring of therapy should be performed.

Patients with hepatic impairment

In the absence of clinical studies, caution should be exercised when using enoxaparin sodium in patients with hepatic impairment.

Interaction

Enixum should not be mixed with other drugs in the same syringe.

When concomitant use with other drugs affecting hemostasis (salicylates. including acetylsalicylic acid, nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac, dextran with a molecular weight of 40 kDa. ticlopidine, clopidogrel, systemic glucocorticosteroids (GCS), thrombolytics or anticoagulants, other antiplatelet agents, including glycoprotein IIb/IIIa receptor antagonists), the risk of bleeding increases (see “Indications”).

Special Instructions

General

Low molecular weight heparins are not interchangeable, since they differ in 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 necessary to strictly follow the recommendations for the use of each drug belonging to the class of low molecular weight heparins.

Bleeding

As with the use of other anticoagulants, the use of Enixum® may cause bleeding of any localization (see “Side effects”). In case of bleeding it is necessary to find its source and prescribe an appropriate treatment.

When using enoxaparin sodium in prophylactic doses in elderly patients no tendency to increase bleeding has been found. There is an increased risk of bleeding when using enoxaparin sodium at therapeutic doses in elderly patients (especially those aged 80 years or older). It is recommended to closely monitor the condition of such patients (see “Pharmacokinetics” and “Dosage method”, subsection “Elderly patients”). Simultaneous use of other drugs affecting hemostasis It is recommended that the use of drugs affecting hemostasis (salicylates. including acetylsalicylic acid. NSAIDs including ketorolac, 40 kDa dextrin, ticlopidine, clopidogrel, GCS, thrombolytics, anticoagulants, antiaggregants including glycoprotein IIb/IIIa antagonists) should be stopped before treatment with enoxaparin sodium unless their use is necessary. If combinations of enoxaparin sodium with these drugs are indicated, close clinical observation and monitoring of relevant laboratory parameters should be performed.

Renal failure

In patients with impaired renal function, there is a risk of bleeding due to increased systemic exposure to sodium enoxaparin

In patients with severe renal impairment (creatinine clearance less than 30 ml/min), a significant increase in sodium enoxaparin exposure is noted, so dose adjustments are recommended. both in prophylactic and therapeutic use of the drug. Although dose adjustment is not required in patients with mild to moderate renal dysfunction (creatinine clearance 30-50 ml/min or 50-80 ml/min), it is recommended to closely monitor these patients (see “Pharmacokinetics” and “Dosage and administration”, subsection “Patients with renal impairment”).

Low body weight

An increased exposure of enoxaparin sodium has been noted with prophylactic administration in women with a body weight less than 45 kg and in men with a body weight less than 57 kg, which may lead to an increased risk of bleeding. Close monitoring of such patients is recommended.

Patients with obesity

Patients with obesity have an increased risk of thrombosis and embolism. The safety and efficacy of enoxaparin sodium in prophylactic doses in obese patients (body mass index greater than 30 kg/m2) is not fully defined, and there is no general consensus on dose adjustment. These patients should be closely monitored for symptoms and signs of thrombosis and embolism.

Control of peripheral blood platelet counts

The risk of antibody-mediated heparin-induced thrombocytopenin also exists with the use of low-molecular-weight genarins. If thrombostaining develops, it is usually detected between days 5 and 21 after the start of therapy with enoxaparin sodium. Therefore, it is recommended to monitor the peripheral blood platelet count regularly before and during treatment with Enixum®. In case of confirmed significant decrease of platelet count (by 30-50 % compared to baseline value), Enoxaparin sodium should be immediately stopped and the patient should be transferred to another therapy. Spinal/epidural anesthesia

There have been described cases of neuroaxial hematomas when using enoxaparin sodium simultaneously with spinal/epidural anesthesia with development of long-lasting or irreversible paralysis. The risk of these phenomena is reduced when enoxaparin sodium is used at a dose of 40 mg or lower.

The risk increases with higher doses of enoxaparin sodium and with the use of permanent catheters after surgery or with the simultaneous use of additional drugs that affect hemostasis, such as NSAIDs (see “Interactions”). The risk also increases with traumatic or repeated spinal tap or in patients with a history of 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 should be considered (see “Pharmacokinetics”). Catheter placement or removal is best performed when the anticoagulant effect of enoxanarine sodium is low, but the exact time to achieve sufficient reduction in anticoagulant effect in different patients is unknown.

The insertion or removal of a catheter should be performed at least 12 h after lower doses of Enixum® (20 mg once daily, 30 mg once or twice daily. 40 mg once daily) and at least 24 hours after administration of higher doses of Enixum® (0.75 mg/kg body weight twice daily. 1 mg/kg body weight twice daily. 1.5 mg/kg body weight once daily). At these time points, the anti-HA activity of enoxanarine sodium is still detectable, and time delays are no guarantee that neuroaxial hematoma development will be avoided.

Patients receiving enoxaparin sodium at doses of 0.75 mg/kg body weight twice daily or 1 mg/kg body weight twice daily on this (twice daily) dosing regimen should not administer a second dose in order to increase the interval before inserting or replacing the catheter. Similarly, consideration should be given to delaying the next dose of sodium enoceaparin by at least 4 hours based on a benefit/risk assessment (risk of thrombosis and bleeding during the procedure, taking into account patients’ risk factors). However, it is not possible to give a clear recommendation on the timing of the next dose of sodium enoceaparin after catheter removal. Note that in patients with a creatinine clearance of less than 30 ml/min the excretion of sodium enoceparin is slower. Therefore, in this category of patients, consideration should be given to doubling the time from catheter removal: at least 24 h for lower doses of sodium enoxaparin (30 mg once daily) and at least 48 h for higher doses (1 mg/kg body weight daily).

If anticoagulant therapy is prescribed by a physician during epidural/spinal anesthesia or lumbar puncture, the patient should be monitored continuously for any neurologic symptoms such as blue pain, impaired sensory n motor function (numbness or weakness in the lower extremities), impaired bowel and/or bladder function. The patient should be instructed to inform the physician immediately if the symptoms described above occur. If symptoms characteristic of a spinal cord hematoma are suspected, prompt diagnosis and treatment, including decompression of the spinal cord if necessary, are necessary.

Heparin-induced thrombocytopenia

Enixum® should be used with particular 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 heparin-induced thrombocytopenia is suspected anamnesthetically, in vitro platelet aggregation tests are of limited value in predicting the risk of its development. The decision to use Enixum in such a case should only be made after consultation with an appropriate specialist.

Prescapular coronary angioplasty

To minimize the risk of bleeding associated with invasive vascular instrumentation in the treatment of unstable angina and myocardial infarction without Q-wave and acute myocardial infarction with ST-segment elevation. these procedures should be performed in intervals between the administration of Enixum. This is necessary in order to achieve hemostasis after percutaneous coronary intervention. If a femoral artery intraductor device is used, the femoral artery intraductor can be removed immediately. If manual compression is used, the femoral artery intromedullary tube should be removed 6 h after the last intravenous or subcutaneous injection of znoxaparin sodium. If treatment with sodium epoxaparin is ongoing, the next dose should not be administered before 6-8 h after removal of the femoral artery intraductor. The insertion site of the intraductor should be monitored to detect timely signs of bleeding and hematoma formation.

Patients with mechanical artificial heart valves The use of enoxaparin sodium for thrombosis prophylaxis in patients with mechanical artificial heart valves has not been well studied. There are isolated reports of the development of heart valve thrombosis in patients with mechanical artificial heart valves on therapy with sodium epoxaparin for thrombosis prophylaxis. The evaluation of these reports is limited because of competing factors contributing to the development of artificial heart valve thrombosis, including underlying disease, and because of insufficient clinical data. Variable Women with Mechanical Artificial Heart Valves The use of sodium eioxaparin for the prevention of thrombosis in pregnant women with mechanical artificial heart valves has been poorly studied. In a clinical study of pregnant women with mechanical artificial heart valves, when enoxaparin sodium was used at a dose of 1 mg/kg twice daily to reduce the risk of thrombosis and embolism, 2 of 8 women developed thrombus, resulting in heart valve block and maternal and fetal death.

There have been anecdotal postmarketing reports of heart valve thrombosis in pregnant women with mechanical artificial heart valves treated with enoxaparin sodium to prevent thrombosis. Pregnant women with mechanical heart valves have a high risk of thrombosis and embolism. Laboratory tests

At doses used for the prevention of thromboembolic complications, sodium enoxaparin has no significant effect on bleeding time and clotting rates or on platelet aggregation or binding to fibrinogen.

Additional doses may lengthen the ACTV and activated clotting time. Increase of ACTV and activated clotting time are not in direct linear relation to increase of anticoagulant activity of the drug, so there is no need to monitor them.

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

In case of acute infection, acute rheumatic conditions, 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 greater than 75 years; malignancy: history of thrombosis and embolism; obesity; hormone therapy; heart failure; chronic respiratory failure.

Impact on ability to drive motor vehicles:

There are no data indicating adverse effects of enoxaparin sodium on ability to drive motor vehicles and engage in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.

Contraindications

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

– active major bleeding, as well as conditions and diseases with a high risk of bleeding: threatened abortion, cerebral vascular aneurysm, or dissecting aortic aneurysm (unless surgery is performed for this reason). Recent hemorrhagic stroke, uncontrolled bleeding, thrombocytopenia in combination with a positive in vitro test for antiplatelet antibodies in the presence of enoxaparin sodium;

– it is not recommended to use sodium enoxaparin to prevent thrombosis in pregnant women with mechanical artificial heart valves (insufficient clinical experience of use);

– age under 18 years (effectiveness and safety not established).

Cautions:

Conditions in which there is a potential risk of bleeding:

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

– gastric or duodenal ulcer or other

– gastrointestinal erosive-ulcerative lesions in the anamnesis;

– recent ischemic stroke;

– uncontrolled severe arterial hypertension;

– diabetic or hemorrhagic retinopathy;

– severe diabetes mellitus;

– recent or suspected neurologic or ophthalmic surgery;

– performing spinal or epidural anesthesia (potential risk of hematoma), spinal tap (recent):

– recent childbirth;

– bacterial endocarditis (acute or subacute):

– pericarditis or pericardial effusion;

– renal and/or liver failure;

– intrauterine contraception (IUD);

– severe trauma (especially central nervous system (CNS)), open wounds on large surfaces;

– concomitant administration of drugs that affect the hemostatic system;

– heparin-induced thrombocytopenia (history) in combination with or without thrombosis.

There are no data on the clinical use of enoxaparin sodium in the following diseases: active tuberculosis, radiation therapy (recent).

Side effects

Side effects were classified by frequency as follows: very frequent (>1/10), frequent (>1/100 to < 1/10), infrequent (>1/1000 to < 1/100), rare (>1/10000 to < 1/1000), very rare (< 1/10000).

Bleeding

Bleeding may occur, especially in the presence of associated risk factors: organic changes with propensity for bleeding, age, renal insufficiency, low body weight, and some combinations of drugs (see “Interactions with other drugs”). If bleeding develops, the drug administration should be stopped, the cause of bleeding should be determined and an appropriate therapy should be started.

Very common are bleeding during prophylaxis of venous thrombosis, in surgical patients and treatment of deep vein thrombosis with or without thromboembolism.

Frequent – Bleeding in prophylaxis of venous thrombosis in bed-ridden patients and in treatment of angina pectoris, myocardial infarction without Q wave and myocardial infarction with ST-segment elevation.

Infrequent – retroperitoneal bleeding and intracranial bleeding in patients treated for deep vein thrombosis with or without thromboembolism and ST-segment elevation myocardial infarction.

Rarely, retroperitoneal bleeding in the prevention of venous thrombosis in surgical patients and in the treatment of angina, myocardial infarction without the Q-wave.

When using enoxaparin sodium against the background of spinal/epidural anesthesia and postoperative use of penetrating catheters, rare cases of neuroaxial hematomas resulting in neurological disorders of varying severity, including long-term persistent or irreversible paralysis, have been described (see “Special Precautions”).

Thrombocytopenia and thrombocytopenia are very common in the prevention of venous thrombosis in surgical patients and in the treatment of deep vein thrombosis with or without thromboembolism.

Frequent – thrombocytopenia. In prophylaxis of venous thrombosis in surgical patients and treatment of deep vein thrombosis with or without thromboembolism, and in ST-segment elevation myocardial infarction.

Infrequent – thrombocytopenia in prophylaxis of venous thrombosis in bed-ridden patients and in treatment of angina pectoris, myocardial infarction without Q-wave.

Very rare – autoimmune thrombocytopenia in ST-segment elevation myocardial infarction.

In rare cases, the development of autoimmune thrombocytopenia in combination with thrombosis has been reported. In some of them, thrombosis has been complicated by organ infarction or limb ischemia (see section “Special Indications”).

Other

Very often – increased activity of “hepatic” transaminases.

Often – allergic reactions, urticaria, itching, redness of the skin, bruising and pain at the injection site.

Infrequent – skin (bullous rashes), inflammatory reaction at the injection site, skin necrosis at the injection site.

Rarely – anaphylactic and anaphylactoid reactions, hyperkalemia. Necrosis of the skin may develop at the injection site preceded by purpura or erythematous painful papules. In these cases the drug therapy should be discontinued. Solid inflammatory nodules-infiltrates may form at the injection site of the drug, which disappear after a few days and are not a reason for discontinuation of the drug.

Overdose

Symptoms: hemorrhagic complications of accidental overdose during subcutaneous injection of enoxaparin sodium. In case of accidental ingestion of even large doses, absorption of the drug is unlikely.

Treatment: neutralize the effect of enoxaparin sodium by slow intravenous (IV) administration of protamine sulfate. 1 mg of protamine sulfate will neutralize the anticoagulant effect of 1 mg of enoxaparin sodium if the drug is administered no more than 8 hours before administration of protamine sulfate.

The 0.5 mg of protamine sulfate will neutralize the anticoagulant effect of 1 mg of enoxaparin sodium if administered more than 8 h before or if a second dose of protamine sulfate must be administered.

If, however, 12 hours or more have elapsed since the administration of enoxaparin sodium, administration of protamine sulfate is not necessary. However, even when large doses of protamine sulfate are administered, the anti-Xa activity of sodium enoxaparin is not completely neutralized (maximum 60%).

Pregnancy use

There are currently insufficient clinical data to determine the possible teratogenic or fetotoxic effects of enoxaparin sodium when administered prophylactically during pregnancy. Enixum® should not be used during pregnancy unless the potential benefit to the mother outweighs the possible risk to the fetus.

A spinal or epidural anesthesia should not be performed during treatment with the drug.

If epidural anesthesia is planned, preventive treatment with Enoxaparin sodium should be discontinued, if possible, at least 12 hours before the anesthesia. Enoxaparin sodium is not recommended for use in pregnant women with prosthetic heart valves.

Breastfeeding should be discontinued during treatment with Enoxaparin sodium.

Similarities

Clexane

Additional information

Weight	0.044 kg
Shelf life	2 years. Do not use after the expiration date printed on the package.
Conditions of storage	At a temperature not exceeding 25 ° C. Do not freeze. Store out of the reach of children.
Manufacturer	PharmFirm Sotex, Russia
Medication form	solution for injection
Brand	PharmFirm Sotex