Enoxaparin solution for injections 10000 anti-Cha IU/ml. 0.6 ml. syringe

Description

Enoxaparin 0.6 ml. syringe Storage
active substance: enoxaparin sodium;

1 ml of solution contains 10,000 anti-Xa MO, which is equivalent to 100 mg of enoxaparin sodium;

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

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

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

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

Enoxaparin 0.6 ml. Excipient: water for injections.

Enoxaparin 0.6 ml. Dosage form
Solution for injection.

Main physical and chemical properties: clear colorless or yellowish solution.

Pharmacotherapeutic group
Antithrombotic drugs. Heparin group.

ATX code B01A B05.

Pharmacological properties

Pharmacodynamics.

Enoxaparin is a low molecular weight heparin in which the antithrombotic and anticoagulant activities of standard heparin are not related. The active substance is presented in the form of sodium salt.

In a purified in vitro system, enoxaparin sodium exhibits high anti-Xa activity (approximately 100 IU / mg) and low anti-IIa (or antithrombin) activity (approximately 28 IU / mg), the ratio of which is 3.6. These anticoagulant activities are mediated by antithrombin III (ATIII), which causes antithrombotic effects in humans.

In addition to anti-Xa / IIa activity, additional antithrombotic and anti-inflammatory properties of enoxaparin have been identified in healthy volunteers and patients, as well as in experimental models in preclinical studies. These include ATIII-dependent inhibition of other coagulation factors, such as factor VIIa, induction of endogenous tissue factor pathway inhibitor (TFPI), and reduction of von Willebrand factor (vWF) release from the vascular endothelium into the circulatory system. These factors contribute to the overall antithrombotic effect of enoxaparin sodium.

When used for prophylaxis, enoxaparin sodium does not significantly affect the rate of activated partial thromboplastin time (APTT). When used for treatment, APTT can be prolonged by 1.5–2.2 times compared to the control time against the background of maximum activity of the drug.

Indication
The drug is indicated for use by adults for:

Prevention of venous thromboembolic complications in surgical patients at moderate and high risk, especially in patients undergoing orthopedic or general surgical intervention, including surgery for cancer.
Prevention of venous thromboembolic complications in therapeutic patients with acute diseases (such as acute heart failure, respiratory failure, severe infections or rheumatic diseases) and reduced mobility who have an increased risk of venous thromboembolism.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (pulmonary embolism), except in cases of pulmonary embolism, which may require thrombolytic therapy or surgery.
Prevention of thrombus formation in the extracorporeal circulation during hemodialysis.
In acute coronary syndrome:
for the treatment of unstable angina and myocardial infarction without ST-segment elevation (NSTEMI), in combination with oral acetylsalicylic acid;
for the treatment of acute ST-segment elevation myocardial infarction (STEMI), including in patients undergoing medical treatment or subsequent percutaneous coronary intervention (PCI).

Contraindication
Enoxaparin sodium is contraindicated in patients with the following conditions:

Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins, or to any of the excipients (see section “Composition”).
Presence of a history of immune-mediated heparin-induced thrombocytopenia (GIT) within the last 100 days in the presence of circulating antibodies (see also section “Special warnings and precautions for use”).
Active clinically significant bleeding and conditions with a high risk of bleeding, including a recent hemorrhagic stroke, gastrointestinal ulcer, the presence of a malignancy with a high risk of bleeding, a recent surgery on the brain or spinal cord, spinal cord, spinal cord varicose veins of the esophagus, arteriovenous malformations, vascular aneurysms or serious malformations of intraspinal or intracerebral vessels.
Spinal or epidural anesthesia or locoregional anesthesia if enoxaparin sodium has been used for treatment within the previous 24 hours (see section 4.4).