Arixtra (fondaparinux natrium) solution for injections 12.5 mg/ml. 0.6 ml. (7.5 mg.) №10 in syringe

Description

Ingredients:

active substance:  fondaparinux sodium;

1 syringe (0.6 ml) contains 7.5 mg of fondaparinux sodium;

excipients: sodium chloride, water for injections, sodium hydroxide or hydrochloric acid.

Medicinal form. Solution for injections.

Main physico-chemical properties: pre-filled glass syringe containing a clear or almost clear liquid, from colorless to slightly yellow in color, which practically does not contain visible particles.

Pharmacotherapeutic group. Antithrombotic agents. ATX code B01A X05.

Pharmacological properties.

Pharmacodynamics.

Fondaparinux is a synthetic selective inhibitor of activated factor X (Xa). The antithrombotic activity of fondaparinux is the result of selective inhibition of factor Xa, mediated by antithrombin III (AT III). By selectively binding to AT III, fondaparinux potentiates (approximately 300 times) the initial neutralization of factor Xa by antithrombin III. Neutralization of factor Xa interrupts the coagulation chain in the blood and inhibits both thrombin formation and thrombus formation. The drug does not inactivate thrombin (activated factor IIa) and does not affect platelets.

At recommended therapeutic doses, fondaparinux does not clinically significantly affect the results of conventional coagulation tests such as activated partial thromboplastin time (aPT), activated clotting time (ACT), or plasma prothrombin time (PT)/international normalized ratio (INR), and nor does it alter bleeding time or fibrinolytic activity. However, there have been occasional spontaneous reports of aPTT prolongation. When using the drug in higher doses, moderate changes in aPTT are possible. At the 10 mg dose used in interaction studies, fondaparinux had no significant effect on the anticoagulant activity (ANC) of warfarin.

Fondaparinux does not cross-react with the serum of patients with heparin-induced thrombocytopenia.

Indications.

Treatment of acute deep vein thrombosis, treatment of acute pulmonary embolism, except in hemodynamically unstable patients or patients requiring thrombolysis or pulmonary embolectomy.

Contraindications.

Established allergy to the active substance or to any of the auxiliary substances of the drug. Intense clinically significant bleeding. Acute bacterial endocarditis. Severe renal failure (creatinine clearance < 30 ml/min).

Dosage and Administration.

Treatment of acute deep vein thrombosis and acute pulmonary embolism.

The recommended dose of Arixtra (fondaparinux) for subcutaneous administration is:

– 5 mg – for patients with a body weight of less than 50 kg;

– 7.5 mg – for patients with a body weight of 50-100 kg;

– 10 mg – for patients with body weight over 100 kg.

The injection should be given once a day. The duration of treatment should be at least 5 days, and it can be stopped no earlier than it is possible to transfer to adequate therapy with oral anticoagulants (the value of the international normalized ratio (INR) from 2 to 3). Concomitant therapy with oral anticoagulants should be started as early as possible, usually within 72 hours. The average duration of use of the drug in clinical trials was 7 days, clinical experience of using the drug for more than 10 days is limited.

Application method.

Arixtra (fondaparinux) should be used in the form of a deep subcutaneous injection, the patient should be in a supine position. The injection sites should be alternately left and right anterolateral or left and right posterolateral abdominal wall. To avoid the loss of the drug, do not remove the air bubble from the pre-filled syringe before injection. The needle should be inserted along its entire length perpendicularly into the fold of skin, pinched between the thumb and forefinger; during the entire introduction, the fold of skin must be kept clamped.

Arixtra (fondaparinux) should be used only under the supervision of a doctor.

Subcutaneous injection should be administered in the same way as in the case of using a classic syringe.

Before using the solution for injections, it is necessary to visually control the absence of visible particles and a change in color.

Arixtra (fondaparinux) pre-filled syringes have been designed with an automatic needle protection system to prevent damage after drug injection.