Hemapaksan - instructions for use, dose, side effects, contraindications

Active substanceSodium EnoxaparinSodium Enoxaparin

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Dosage form: & nbsphypodermic solution

Composition:

in one syringe contains:

Active substance: Enoxaparin sodium - 2000 IU / 0.2 ml (20 mg); 4000 IU / 0.4 mL (40 mg); 6000 IU / 0.6 ml (60 mg).

Excipients: water for injections

Description:Transparent, colorless or light yellow solution.

Pharmacotherapeutic group:Anticoagulant means of direct action

ATX: & nbsp

B.01.A.B.05 Enoxaparin

Pharmacodynamics:

Enoxaparin sodium is low molecular weight heparin with high anti-Xa activity (100 IU / mg) and low anti-HA or antithrombin activity (28 IU / mg). At doses required for different indications, sodium enoxaparin does not increase bleeding time. With preventive doses, sodium enoxaparin does not cause a marked change in activated partial thromboplastin time (APTT).It does not affect the aggregation of platelets, nor the binding of fibrinogen to platelets.

Pharmacokinetics:

Pharmacokinetic parameters were studied using the anti-Xa activity time of plasma activity, as well as anti-Na activity in the recommended dose ranges. The absolute bioavailability of enoxaparin sodium after subcutaneous administration is close to 100%. The mean maximum anti-Xa plasma activity was observed between 3 and 5 hours after subcutaneous injection. The pharmacokinetics of sodium enoxaparin is likely to be linear in the recommended dose ranges. Even if the difference in pharmacokinetic parameters in the equilibrium between the single and repeated administration is reported, this difference is expected and is within the therapeutic ranges. The mean maximum anti-Na activity of plasma was observed in the period from 3 to 4 hours after subcutaneous administration. Sodium Enoxaparin Primarily metabolized in the liver. The half-life for anti-Xa activity is approximately 4 hours after a single administration and up to 7 hours after repeated administration. Renal clearance of active metabolites is approximately 10% of the administered dose, and total renal excretion is 40% of the dose.In elderly people, since renal function decreases with age, excretion can be reduced. In patients with severe renal failure (creatinine clearance <30 mL / min) AUC markedly increased after repeated subcutaneous administration of 4000 anti-Xa ME 1 time at day.

Indications:

Solution for injection containing 2000 ME anti-Xa / 0.2 ml and 4000 ME anti-Xa / 0.4 ml is shown for the following cases:

- Prevention of venous thrombosis and thromboembolism (especially in orthopedic and surgical operations);

- Prevention of venous thrombosis and thromboembolism in patients on bed rest (CHF III or IV class NYHA, acute respiratory failure, acute infections or acute rheumatic diseases in combination with one of the risk factors for venous thrombosis: age over 75 years, cancer, thrombosis and history of thromboembolism, obesity, hormone therapy, chronic heart failure, chronic respiratory failure).

Solution for injection containing 6000 ME anti-Xa / 0.6 ml shown for:

- Treatment of deep vein thrombosis, with embolism and without pulmonary embolism;

- Treatment of unstable angina and myocardial infarction without a tooth Q on ECG, when taken together with acetylsalicylic acid;

- Prevention of hypercoagulation in the system of extracorporeal circulation during hemodialysis.

Contraindications:

The drug can not be used:

- with a known hypersensitivity (allergy) to sodium enoxaparin, heparin or other low molecular weight heparins;

- aneurysm of cerebral vessels or exfoliating aortic aneurysm (with the exception of surgical intervention);

- with hemorrhagic stroke (established or suspected) and with a high risk of uncontrolled bleeding;

- with severe uncontrolled arterial hypertension;

- with severe enoxaparin or heparin-induced thrombocytopenia (during the last months);

- in childhood (due to the lack of safety data and the effectiveness of the drug in this category of patients).

Carefully:Spinal or epidural anesthesia (potential risk of hematoma); conditions associated with the risk of bleeding - violations in the blood coagulation system (including hemophilia, thrombocytopenia, hypocoagulation, Willebrand disease, etc.); recent childbirth,severe diabetes mellitus, endocarditis bacterial (acute or subacute), stomach ulcer or duodenal ulcer or other erosive and ulcerative lesions of the gastrointestinal tract, intrauterine contraception, neurologic or ophthalmic surgery (recently transferred or suspected), pericarditis or pericardial effusion, radiation therapy (recently transferred), renal and / or hepatic insufficiency, diabetic or hemorrhagic retinopathy, spinal puncture (recently transferred), severe trauma (especially CNS), active tube rkulez, respiratory disease or urinary tract (acute phase), severe vasculitis, open wounds on large surfaces, hypertension.

Pregnancy and lactation:

There is no evidence that sodium enoxaparin penetrates the placental barrier. However, it should be used during pregnancy only in case of emergency. Sodium Enoxaparin is not recommended for use in pregnant women with artificial heart valves (see section "Special instructions").

As a precautionary measure, nursing mothers receiving sodium enoxaparin, it is recommended to avoid breastfeeding.

Dosing and Administration:

Subcutaneously and into the arterial contour during the hemodialysis session.

Prevention of venous thrombosis and thromboembolism in surgical patients

In patients with an average risk of thromboembolism (eg, abdominal surgery), the recommended dose of enoxaparin sodium is 2000 IU / 0.2 mL or 4000 IU / 0.4 mL once daily. In general surgery, the first injection should be done 2 hours before surgery.

In patients with a high risk of developing thrombosis and thromboembolism (eg, in orthopedic surgery), the recommended dose of enoxaparin sodium is 4000 IU / 0.4 mL once a day, starting 12 hours before surgery, or 3000 ME (30 mg) 2 times a day after 12-24 hours after the operation. For specific recommendations regarding injection intervals for spinal / epidural anesthesia and procedures for percutaneous coronary revascularization, see "Specific guidance". Duration of treatment with enoxaparin sodium is usually from 7 to 10 days. Some patients may require longer treatment,and it should be continued until there is a risk of developing thrombosis and thromboembolism (in orthopedics used at a dose of 4000 IU / 0.4 ml once a day for 5 weeks).

Prevention of venous thrombosis and thromboembolism in therapeutic patients on bed

The recommended dose of enoxaparin sodium is 4000 IU / 0.4 ml once a day for 6-14 days.

Treatment of deep vein thrombosis, with thromboembolism and without pulmonary embolism

Enoxaparin sodium is administered at a dose of 150 IU / kg body weight (1.5 mg / kg) once a day or 100 IU / kg (1 mg / kg) 2 times a day. For patients with complicated thromboembolic disorders, a dose of 100 IU / kg is recommended twice a day. Duration of treatment is 10 days. It is advisable to immediately begin therapy with oral anticoagulants, while therapy with enoxaparin should be continued until a sufficient anticoagulant effect is achieved (International Normalized Ratio 2-3).

Treatment of unstable angina and myocardial infarction without a Q wave

The recommended dose of enoxaparin sodium is 100 IU / kg body weight every 12 hours with simultaneous administration of acetylsalicylic acid in a dose of 100-32: 5 mg once a day.The average duration of therapy is 2-8 days (until the patient's clinical condition is stabilized).

Prevention of hypercoagulation in the extracorporeal circulation system during hemodialysis

The recommended dose of enoxaparin sodium is 100 IU / kg body weight. For patients with a high risk of bleeding, the dose should be reduced to 50 IU / kg with dual vascular access or up to 75 IU / kg with single vascular access. During hemodialysis sodium enoxaparin should be entered into the arterial contour at the beginning of the hemodialysis session. A single dose, as a rule, is sufficient for a 4-hour session. However, when fibrin rings are detected with prolonged hemodialysis, 50-100 IU / kg body weight may be added.

Special categories of patients

- Patients of advanced age: dose adjustment is not required, unless renal function is impaired.

- In severe renal failure, the dose is adjusted depending on the amount of creatinine clearance: for creatinine clearance less than 30 ml / min, prophylactic the dose is 2000 ME 1 time in day; therapeutic dose - 100 IU / kg body weight once a day.

- With mild and moderate renal disease Insufficiency: dose adjustment is not it takes.

Method of administration

Hemapaxan is injected by deep subcutaneous injection with preventive and therapeutic treatment and into the arterial contour during the hemodialysis session. INTENDED USE INGENTIONALLY INGENTIONAL PREPARATION. Before the injection should not appear air bubble. Subcutaneous injection is preferable when the patient is in the "lying" position. Hemapaksan is injected alternately into the left or right anterolateral and posterolateral parts of the anterior abdominal wall. When the needle is injected, the needle should be inserted perpendicularly, not under an incline, over its entire length into the thickness of the skin, squeezed into the crease between the thumb and forefinger. Skin fold should be retained until the end of the injection. After injection, the injection site can not be ground.

Instructions for using a syringe with an automatic needle guard system

1. Remove the cap from the needle of the syringe by moving strictly in a straight line, so as not to bend it.

If it is necessary to adjust the dose, this should be done before the dose prescribed to the patient is administered.

2. To make an injection by the usual method by pushing the syringe piston up to the stop

3.Remove the syringe from the injection site while continuing to hold the piston rod with your finger.

4. By directing the needle away from yourself and other people, activate the protection system by strongly pressing the piston rod. The protective cover will close the needle, and a "click" will be heard, which serves to confirm the activation of the protective device.

5. Immediately discard the used syringe in the nearest container for disposal of sharp objects.

NOTES:

- The protective system can only be activated once after using the syringe.

- The protective system should be actuated !, only after the needle has been removed from the patient's skin.

- Do not remove the protective cap from the needle after the injection.

- The protective system is not sterilizable.

- The activation of the protective system can lead to a slight extrusion of liquid from the syringe. To ensure optimum safety, the protection system should be activated by directing the syringe away from yourself and each other's people (down).

Side effects:

Point hemorrhages (petechiae), ecchymosis, rarely - hemorrhagic syndrome (incl.retroperitoneal and intracranial hemorrhages, up to a lethal outcome), hyperemia and soreness at the site of injection, rarely - hematoma, the appearance of dense inflammatory nodes (resolved within a few days, cessation of treatment is not required); rarely - necrosis of the skin at the injection site, which is preceded by purpura or erythematous plaques (infiltrated and painful); asymptomatic thrombocytopenia (in the first days of treatment), rarely - immunoallergic thrombocytopenia (on days 5-21 of treatment) with the development of ricochetous thrombosis (heparin thrombotic thrombocytopenia), which can be complicated by an organ infarction or limb ischemia; asymptomatic reversible increase in the activity of "liver" transaminases.

Rarely - systemic and skin allergic reactions. In case of traumatic spinal / epidural anesthesia (the probability increases with the use of a permanent postoperative epidural catheter) - intra-abdominal hematoma (rarely), which can lead to temporary or permanent paralysis.

Overdose:

Symptoms: bleeding.

Treatment: Protamine sulfate (1 mg protamine sulphate neutralizes anti-Na activity caused by 1 mg enoxaparin sodium); high doses neutralize the anti-Xa activity of enoxaparin sodium by 60%.

Interaction:

In order to avoid possible interactions with other drugs, inform your doctor about other drugs that you are currently using. It is recommended to interrupt the use of drugs that affect hemostasis before starting treatment with sodium enoxaparin, unless there is a strict indication for this. It is not recommended combination with antagonists of vitamin K, antiplatelet agents (including acetylsalicylic acid and its derivatives, blockers of glycoprotein receptors IIb / IIIa), sulfhydrazone, valproic acid, ketorolac and other NSAIDs (nonsteroidal anti-inflammatory drugs), high molecular weight dextrans, clopidogrel, ticlopidine, glucocorticosteroids (systemic action), thrombolytics. As with other low molecular weight heparins, when combined with these drugs is required, careful monitoring of the patient's condition andindicators of hemostasis.

Do not mix the drug in one syringe with other medicines!

Special instructions:

- Heparins with low molecular weight should not be used on an interchangeable basis, as they differ in the process of their manufacture, molecular weight, specific anti-Xa activity, units of action and dosage. Clear adherence to specific instructions for each drug is required.

- Spinal / epidural anesthesia

When prescribing anticoagulant therapy during spinal / epidural anesthesia, careful, constant monitoring of patients to detect any neurological symptoms (median pain in the back, violation of sensory and motor functions, including numbness or weakness in the lower extremities, a disruption of function gastrointestinal tract and / or urinary bladder). When identifying symptoms that are characteristic of hematoma of the brain stem, urgent diagnosis and treatment is needed, including if necessary spinal decompression.

Rare cases of spinal cord hematoma are described in the treatment with sodium enoxaparin against the background of spinal / epidural anesthesia with the development of persistentparalysis. The risk of occurrence of these phenomena decreases with the use of the drug in a dose of up to 4000 ME. The risk increases with an increase in the dose of the drug, as well as with the use of penetrating epidural catheters after surgery or with the concomitant use of additional drugs that affect hemostasis (including NSAIDs). The risk also increases with traumatic or repeated spinal puncture. During epidural or spinal anesthesia, the introduction and removal of the catheter is best done when the anticoagulant effect of sodium enoxaparin is low: 10-12 hours after the use of prophylactic doses of the drug or 24 hours after the administration of higher doses (100 anti-Ha IU / kg of body weight body 2 times a day or 150 anti-Ha IU / kg body weight 1 time per day). The subsequent administration of the drug should be carried out no earlier than 2 hours after removal of the catheter.

- Thrombocytopenia caused by the use of heparin

With a decrease in the number of platelets below the norm by 30-50%, as well as when there are signs of internal bleeding (melena or the detection of fresh blood in feces, vomiting of blood, hypochromic anemia) sodium enoxaparin cancel.With thrombocytopenia, a history of heparin, sodium enoxaparin appoint in exceptional cases because of the risk of immunoallergic thrombotic thrombocytopenia, manifested on days 5-21 after administration. The risk of thrombocytopenia caused by heparin can persist for several years.

- Procedures for percutaneous coronary revascularization

To reduce the risk of bleeding in the treatment of acute coronary syndrome, suggesting surgical invasive treatment with violation of the integrity of the vessel wall, administration of sodium enoxaparin should not be performed less than for 6-8 hours before manipulation or 6-8 hours after the manipulation.

- Artificial heart valves

There is insufficient data on the efficacy and safety of the drug for the prevention of thromboembolic complications in patients with artificial heart valves.

- Laboratory tests

At doses used to prevent venous thrombosis and thromboembolism, sodium enoxaparin does not significantly affect the time of bleeding and the total blood coagulation, as well as the aggregation of platelets or their binding to fibrinogen.At higher doses, an increase in APTT and activated clotting time can occur.

Form release / dosage:Solution for subcutaneous administration.

Packaging:By 2000 IU / 0.2 ml, 4000 IU / 0.4 ml, 6000 IU / 0.6 ml in single dose syringes, consisting of the body of a Type I syringe with an attached stainless steel needle; The syringes are closed by pressing the plug-piston, after which the piston rod occupies a certain position. The needle protection system is alternative and can be inserted, or not inserted into the syringe; rigid protective cap of a needle made of natural rubber and styrene-butadiene-rubber compound or synthetic polyisoprene rubber; elastomer piston stopper (chlorobutyl rubber); Piston: blue (for dosage of 2000 IU / 0.2 ml); red (for a dosage of 4000 IU / 0.4 ml); white transparent color (for a dosage of 6000 IU / 0.6 ml). The syringe (for a dosage of 6000 IU / 0.6 ml) additionally has a calibration, each division corresponds to 0.025 ml. The syringe (for a dosage of 6000 IU / 0.6 ml) with a needle guard system has a black piston. Two filled syringes are packed in a contour G1VX package, sealed with paper foil or transparent film.3 contour PVC packaging along with instructions for use in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C. Do not freeze!

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-010223/08

Date of registration:19.12.2008 / 14.09.2016

Expiration Date:Unlimited

The owner of the registration certificate:Italfarmaco SpAItalfarmaco SpA Italy

Manufacturer: & nbsp

ITALFARMACO, S.p.A. Italy