Currently, according to the current information on the safety of medical use of drugs enoxaparin sodium, the company Sanofi-Aventis Trup AO - Moscow Representative Office,Russia makes significant changes to the sections on "Contraindications", "Application during pregnancy and during breastfeeding", "Method of administration and dose" and "Special instructions" for instructions for the use of the reference drug Clexane, injection 2000 anti-Ha IU / 0.2 ml , 4000 anti-Xa IU / 0.4 ml, 6000 anti-Ha IU / 0.6 ml, 8000 anti-Ha IU / 0.8 ml, 10,000 anti-Ha IU / 1 ml.
In this regard, we consider it advisable to give instructions on the use of medicines containing sodium enoxaparin, registered in the territory of the Russian Federation, in accordance with updated information on the experience of its clinical application, and in particular:
- from the section "Contraindications" to exclude the information "It is not recommended to use the drug for the purpose of preventing thrombosis in pregnant women with mechanical heart valves (lack of clinical experience of use)," current information on the experience with sodium enoxaparin is given in the section "Special instructions".
- in the section "Application during pregnancy and during breast-feeding", the section "Breastfeeding Period" shall be revised to read:
"It is not known whether the unchanged sodium enoxaparin in human milk. Absorption of enoxaparin sodium in the digestive tract in a newborn is unlikely. However, as a precaution, lactating women receiving treatment with enoxaparin sodium should be advised to interrupt breastfeeding "; - under "Dosage and Administration" lead subsection "Prevention of venous thrombosis and embolism during surgery, especially orthopedic and general surgical operations" as follows: "Patients with moderate risk of thrombosis and embolism (e.g., abdominal surgery), the recommended dose is 20 mg once a day subcutaneously. The first injection should be given 2 hours before surgery.
Patients with high risk for thrombosis and embolism (e.g., orthopedic surgery, surgical operations in oncology patients with additional risk factors not related to the operation, such as congenital or acquired thrombophilia, malignancy, bed rest more than three days, obesity, venous a history of thrombosis,varicose veins of the lower extremities, pregnancy) the drug is recommended in a dose of 40 mg once a day subcutaneously, with the administration of the first dose 12 hours before surgery, or at a dose of 30 mg twice a day with the onset of administration 12-24 hours after surgery .
The duration of treatment with the drug on average is 7-10 days. If necessary, therapy can be continued as long as there is a risk of developing thrombosis and embolism, and until the patient goes into an outpatient setting.In orthopedic operations, it may be advisable after the initial therapy to continue treatment by administering the drug at a dose of 40 mg once daily for 3 weeks.
The specific application of the drug for spinal / epidural anesthesia, as well as for procedures of coronary revascularization, is described in the section "Special instructions." "; - in the "Special instructions" section, add the section "Application in pediatrics", containing the following information: "The safety and efficacy of sodium enoxaparin in children under the age of 18 years are not established."