Flenox (enoxaparin sodium) solution for injections 2000ME/0.2 ml. №10 syringe

Description

Flenox 0.2 ml Storage
active substance: enoxaparin sodium;

1 ml of solution contains: 10000 anti-Xa MO, which is equivalent to 100 mg of enoxaparin sodium;

2000 anti-Xa IU / 0.2 ml, equivalent to enoxaparin sodium 20 mg;

4000 anti-Xa IU / 0.4 ml, equivalent to enoxaparin sodium 40 mg;

6000 anti-Xa IU / 0.6 ml, equivalent to enoxaparin sodium 60 mg;

8000 anti-Xa IU / 0.8 ml, equivalent to enoxaparin sodium 80 mg;

Excipient: water for injections.

Flenox 0.2 ml Dosage form
Solution for injection.

Main physical and chemical properties: clear colorless or light yellow liquid.

Flenox 0.2 ml Pharmacotherapeutic group
Antithrombotic drugs. Heparin group. Enoxaparins.

ATX code B01A B05.

Pharmacological properties

Pharmacodynamics.

Enoxaparin is a low molecular weight heparin (LMWH) that separates the antithrombotic and anticoagulant activity of standard heparin. It has higher anti-Xa activity than anti-IIa and antithrombin activity (for enoxaparin the ratio is 3.6).

When used in prophylactic doses, enoxaparin has no significant effect on APTT (activated partial thromboplastin time).

When using therapeutic doses of the drug APTT can be prolonged and 1.5-2.2 times higher than the control time of maximum activity. This prolongation reflects residual antithrombin activity.

Treatment of acute myocardial infarction with ST-segment elevation in combination with a thrombolytic agent in patients undergoing subsequent coronary angioplasty, as well as in patients not undergoing this procedure.

In a large-scale multicenter clinical trial, 20,479 patients with acute ST-segment elevation myocardial infarction after receiving fibrinolytic therapy were randomized to receive either enoxaparin as a bolus intravenous injection of 3,000 anti-Xa IUs, followed immediately by administered a dose of 100 anti-Xa IU / kg, then performed subcutaneous injections of 100 anti-Xa IU / kg every 12 hours, or for the introduction of intravenous unfractionated heparin as a bolus injection of 60 IU / kg (maximum 4000 IU / kg ) followed by continuous infusion at a dose that was adjusted depending on the rate of activated partial thromboplastin time. Subcutaneous injections of enoxaparin were given before discharge from the hospital or no more than 8 days (in 75% of cases – no less than 6 days). Half of the patients receiving heparin received the drug for at least 48 hours (in 89.5% of cases ≥ 36 hours). All patients also received acetylsalicylic acid for at least 30 days. The dose of enoxaparin for patients ≥75 years of age was adjusted: 0.75 mg / kg (75 anti-Xa IU / kg) as a subcutaneous injection every 12 hours without an initial bolus intravenous injection.

Indication
Prevention of venous thromboembolism during surgery, which is accompanied by moderate and high thrombogenic risk;
prevention of deep vein thrombosis in patients in bed due to acute therapeutic diseases: heart failure class III or IV according to the NYHA classification, acute respiratory failure, acute infectious or rheumatic disease, in the presence of at least one other risk factor for venous thromboembolism ;
prevention of thrombosis in the extracorporeal circulation during hemodialysis (the procedure lasts on average up to about 4 hours);
treatment of diagnosed deep vein thrombosis, which is accompanied or not accompanied by pulmonary embolism and has no severe clinical symptoms, except for pulmonary embolism, which requires treatment with thrombolytic agent or surgery;
treatment of unstable angina and acute myocardial infarction without Q wave in combination with acetylsalicylic acid;
treatment of acute myocardial infarction with elevation / elevation of the ST segment in combination with a thrombolytic agent in patients who may continue to use coronary angioplasty, as well as in patients who do not undergo this procedure.

Contraindication
For doses of 2000 anti-Xa IU / 0.2 ml, equivalent to enoxaparin sodium 20 mg;

4000 anti-Xa IU / 0.4 ml, equivalent to enoxaparin sodium 40 mg;

6000 anti-Xa IU / 0.6 ml, equivalent to enoxaparin sodium 60 mg;

8000 anti-Xa IU / 0.8 ml, equivalent to enoxaparin sodium 80 mg;

This medicine is generally not recommended in the following cases:

Hypersensitivity to enoxaparin, heparin or its derivatives, including other low molecular weight heparins.

Presence of a history of severe heparin-induced thrombocytopenia (GIT) type II caused by non-fractional heparin or low molecular weight heparin (see section 4.4).

Bleeding or bleeding tendency associated with haemostasis may be a possible exception to disseminated intravascular coagulation if it is not associated with heparin therapy (see section 4.4).