Novoparin solution for infection. 60 mg syringe of 0.6 ml No. 10

Solution for injections "Novoparin ^® " is shown for use by the adult:

• for prevention of venous tromboembolic episodes at surgical patients with moderate and high risk, especially at the patients who are subject to orthopedic or all-surgical surgeries, including surgeries concerning oncological diseases;
• for prevention of venous tromboembolic episodes at therapeutic patients with acute diseases (such as acute heart failure, respiratory insufficiency, heavy infections or rheumatic diseases) and the lowered mobility which have the increased risk of developing of a venous thrombembolia;
• for treatment of the deep vein thrombosis (DVT) and a pulmonary embolism (TELA), except for cases of TELA at which performing thrombolytic therapy or surgical intervention can be required;
• for prevention of formation of blood clots in extracorporal blood circulation during a hemodialysis;
• at a sharp coronary syndrome:
  • for treatment of unstable stenocardia and a myocardial infarction without raising of a ST (NSTEMI) segment, in combination with oral administration of acetylsalicylic acid;
  • for treatment of an acute myocardial infarction with raising of a ST (STEMI) segment, including at patients to whom medicament treatment or the further percutaneous coronary intervention (PCI) is planned.

Structure

Active ingredient - enoksaparin sodium (1 ml of solution supports an enoksaparin of sodium about an anti-factor Ha activity 10000 ME that is equivalent an enoksaparina of sodium of 100 mg; The 6000th anti-factor Ha ml ME/0.6 that is equivalent an enoksaparina of sodium of 60 mg).

Excipient - water for injections.

Contraindication

Enoksaparin of sodium is contraindicated to use to patients with such states:

• hypersensitivity to a sodium enoksaparin, heparin or its derivatives, including other low-molecular heparins;
• existence in the anamnesis of the immunomediated geparinindutsirovanny thrombocytopenia (GIT) within the last 100 days in the presence of the circulating antibodies;
• active clinically significant bleeding and states with high risk of developing of bleeding, including recently had hemorrhagic stroke, a digestive tract ulcer, presence of a malignant new growth with high risk of bleeding, recently postponed surgery on a brain, a spinal cord or eyes, the known or suspected gullet varicosity, arteriovenous malformation, vascular aneurysms or serious malformations of intraspinal or intratserebralny vessels;
• spinal or epidural anesthesia or lokoregionarny anesthesia if enoksaparin sodium it was used for treatment within the last 24 hours.

Prevention of venous tromboembolic episodes at surgical patients with moderate and high risk

Individual thromboembolic risk at patients can be estimated by

by means of validirovanny model (scale) of stratification of risks.

to Patients with moderate risk of thromboembolic events the recommended dose of an enoksaparin of sodium makes

2000 ME (20 mg) once a day which is entered by hypodermic (p / j) by injections. It was shown that preoperative initial introduction (in 2 hours prior to surgery) an enoksaparina of sodium in a dose 2000 ME (20 mg) is effective and safe at surgeries with moderate risk. Patients have groups of moderate risk preventive treatment enoksapariny sodium should be continued during the period lasting not less than 7-10 days, irrespective of a condition of restoration (for example mobility). Prevention needs to be continued until at the patient the reduced mobility significantly is not noted any more.

to Patients with high risk of thromboembolic events the recommended dose of an enoksaparin of sodium makes

4000 ME (40 mg) once a day which is desirable for entering in 12 hours prior to surgery by hypodermic (p / j) injections. If there is a need for the beginning of preventive use of an enoksaparin of sodium more than 12 hours prior to surgery (for example, the patient of high risk who expects orthopedic surgical intervention is delayed), the last injection should be applied not later than 12 hours before surgery and to restore preventive use in 12 hours after surgery.

to

For patients who are subject to big orthopedic surgical intervention recommends a long tromboprofilaktika - up to 5 weeks.

to

For patients with high risk of a venous thrombembolia (VTE) which carry out surgeries on abdominal organs or a basin concerning oncological diseases recommends a long tromboprofilaktika - up to 4 weeks.

Prevention of venous tromboembolic episodes at therapeutic patients

Recommended dose of an enoksaparin of sodium makes

4000 ME (40 mg) once a day which is entered by p / to an injection. Preventive treatment enoksapariny sodium needs to be performed during the period lasting not less than 6-14 days, depending on a condition of restoration (for example mobility). The advantage of such treatment during the period lasting more than 14 days is not defined yet.

Treatment of the deep vein thrombosis (DVT) and pulmonary embolism (TELA)

Enoksaparin of sodium needs to be entered p / to in the form of an injection of 150 ME/kg (1.5 mg/kg) once a day or in the form of injections of 100 ME/kg (1 mg/kg) twice a day. The scheme of dosing is chosen by the doctor, considering results of individual assessment which has to include assessment of risk of thromboembolic events and risk of hemorrhagic events. The scheme of dosing on 150 ME/kg (1.5 mg/kg) should be used to patients without complications with low risk of a recurrence of VTE once a day. Twice a day should appoint the scheme of dosing on 100 ME/kg (1 mg/kg) all other patients, such as patients with obesity, simptomny TELA, oncological diseases, recurrent VTE or thrombosis of proximal veins (ileal vein). Enoksaparin of sodium apply on average within 10 days. If necessary it is necessary to begin intake of oral anticoagulants.

Prevention of formation of blood clots during a hemodialysis

Recommended dose of an enoksaparin of sodium makes 100 ME/kg (1 mg/kg). Patients with high risk of hemorrhagic events should lower a dose to 50 ME/kg (0.5 mg/kg) in the presence of double vascular access or to 75 ME/kg (0.75 mg/kg) in the presence of uniform vascular access. During a hemodialysis enoksaparin sodium it is necessary to enter into an arterial part of a contour at the beginning of dialysis session. This dose, as a rule, is enough for carrying out dialysis within 4 hours. However at emergence of fibrinous rings, for example, when the session lasts longer, than usually, it is possible to enter an additional dose from 50 ME to 100 ME/kg (from 0.5 to some mg/kg). Patients do not have data on use of an enoksaparin of sodium for prevention or treatment and during the hemodialysis sessions.

Sharp coronary syndrome: treatment of unstable stenocardia and myocardial infarction without raising of a ST (NSTEMI) segment and an acute myocardial infarction with raising of a ST (STEMI) segment

For treatment of unstable stenocardia and NSTEMI the recommended dose of an enoksaparin of sodium makes 100 ME/kg (1 mg/kg) which is entered by each 12 hours by p / to an injection and appoint in a combination with antithrombocytic therapy. Treatment should be performed within at least two days and to continue before clinical stabilization of the patient. The usual duration of treatment is from 2nd to 8 days.

For all patients who have no complications recommends use of acetylsalicylic acid inside in an initial load dose of 150-300 mg (patients who did not receive acetylsalicylic acid yet) and a maintenance dose of 75-325 mg/days dolgosrochno irrespective of the strategy of treatment.

For treatment of sharp STEMI the recommended dose of an enoksaparin of sodium - single intravenous (in / c) introduction bolyusno 3000 ME (30 mg) plus a dose of 100 ME/kg (1 mg/kg) p / to with the subsequent administration of medicament in a dose of 100 ME/kg (1 mg/kg) p / to each 12 hours (at most 10000 ME (100 mg) for each of the first two doses entered p / j). It is necessary to appoint at the same time the corresponding antithrombocytic therapy, for example acetylsalicylic acid orally (75-325 mg once a day), in the absence of contraindications. The recommended duration of treatment is 8 days or to the patient's extract from a hospital, depending on what will occur earlier. At use with thrombolytic therapy (fibrinspetsifichesky or I nefibrinspetsifichnoit) enoksaparin sodium it is necessary to enter in an interval of 15 minutes prior to fibrinolytic therapy and 30 minutes after the beginning of fibrinolytic therapy.

any more. If the last p / to administration of medicament was more than in 8 hours prior to inflating of a cylinder, it is necessary to enter in into bolyusno 30 ME/kg (0.3 mg/kg) of an enoksaparin of sodium.

Feature of use

Pregnant women

At people are absent proofs that enoksaparin gets through a placental barrier during the second and third trimesters of pregnancy. Information concerning the first trimester is absent so far. Enoksaparin of sodium it is necessary to appoint pregnant only in case of establishment by the doctor of the accurate need for such treatment. For pregnant women who receive enoksaparin sodium it is necessary to carry out careful observation about emergence of symptoms of bleeding or excessive anticoagulating action and also it is necessary to inform such patients on risk of the hemorrhagic phenomena. In general the available data indicate lack of any proofs of the increased risk of bleedings, thrombocytopenia or osteoporosis at such patients in comparison with this risk at not pregnant women, except risk which is observed at pregnant women with artificial valves of heart.

If plans epidural anesthesia, it is recommended to cancel before performance treatments enoksapariny sodium.

whether it is removed enoksaparin in breast milk at the person. At rats in the period of a lactation of penetration of an enoksaparin or its metabolites in milk is very low. Absorptions of an enoksaparin of sodium at oral administration it is improbable therefore it can be applied during feeding by a breast.

Clinical data on influence of an enoksaparin of sodium on fertility are absent so far. Researches on animals did not show any influence of medicament on fertility.

Safety and efficiency of use of an enoksaparin of sodium are not established to pediatric patients by

yet.

Drivers

Influence of an enoksaparin of sodium on ability to run vehicles and to work with other mechanisms is absent or is insignificant.

Overdose

Inadvertent overdose of an enoksaparin of sodium as a result in/in, extracorporal or p / to introduction can lead to hemorrhagic complications. After reception even enough high doses absorption of an enoksaparin of sodium is improbable.

Anticoagulating effects of medicament can be substantially neutralized by

slow in/in administration of protamin. The dose of protamin depends on the entered dose of an enoksaparin of sodium:

• 1 mg of protamin the anticoagulating effect 100 ME (1 mg) neutralizes an enoksaparin of sodium if enoksaparin sodium it was entered within the last 8 hours;
• can use infusional administration of protamin in a dose of 0.5 mg on everyone 100 ME (1 mg) an enoksaparina of sodium if enoksaparin sodium it was entered more than 8 hours prior to use of protamin or if need of purpose of the second dose of protamin was defined;
• in 12 hours after introduction of an enoksaparin of sodium the use of protamin can be not necessary.

However even at use of high doses of protamin anti-Xa the activity of an enoksaparin of sodium is never neutralized by

fully (at most approximately for 60%).

Side effects

In clinical trials by undesirable reactions about which it was reported most often were the hemorrhagic phenomena, thrombocytopenia and a thrombocytosis.

Subcutaneous injection - not to mix

with other medicines.

Storage conditions

to Store

in original packing at a temperature not above 25 °C, out of children's reach. Not to freeze.

Expiration date - 3 years.