Fragmin solution for injections 2500 IU 0.2 ml. №10

Description

Fragmin 2500 IU Storage:

active substance: 0.2 ml (1 syringe) of solution for injection contains 2,500 IU (anti-Xa) or 5,000 IU (anti-Xa) sodium dalteparin;

1 ml (1 ampoule) of solution for injection contains 10,000 IU of dalteparin sodium (anti-Xa);

Excipients: for dosages 2500 IU (anti-Xa) /0.2 ml and 10,000 IU (anti-Xa) / ml: sodium chloride, water for injections; for a dosage of 5000 IU (anti-Xa) / 0.2 ml – water for injections.

Dosage form.

Solution for injection.

Fragmin 2500 IU Pharmacotherapeutic group.

Antithrombotic drugs. Heparin group.

ATC code B01A B04.

Clinical characteristics.

Indication.

· Prevention of thrombosis in the pre- and postoperative period.

· Prevention of proximal deep vein thrombosis in patients with bed rest, including congestive heart failure (NYHA class III or IV), acute respiratory failure, or acute infections, in the presence of a provoking risk factor for venous thromboembolism (such as age from 75 years, obesity, cancer or venous thromboembolism (VTE) in the anamnesis).

· Treatment of deep vein thrombosis, as well as long-term prevention of recurrent venous thromboembolic processes in cancer patients.

· Prevention of blood clotting in the extracorporeal circulation during hemodialysis or hemofiltration in patients with chronic or acute renal failure.

· Treatment of venous thromboembolism with clinical manifestations of deep vein thrombosis (DVT), pulmonary embolism or both.

· Unstable angina and myocardial infarction without Q wave (unstable course of coronary heart disease), the drug is used simultaneously with aspirin.

Contraindication.

Hypersensitivity to Fragmin® or other low molecular weight heparins and / or heparins, eg history of heparin-induced immune thrombocytopenia (type II) (confirmed or suspected); pork allergy; acute gastroduodenal ulcer; hemorrhage into the brain; hemorrhage into the vitreous; established hemorrhagic diathesis or other active bleeding; severe coagulation disorders, severe diseases of the liver, kidneys, pancreas; severe thrombocytopenia, hypermenorrhea; intestinal ulcer; acute or subacute septic endocarditis; hemorrhagic pericarditis and hemorrhagic pleurisy; injuries or surgical interventions on the organs of the central nervous system, organs of sight and hearing; cerebral vascular aneurysm; uncontrolled severe hypertension; retinopathy; threat of miscarriage; pulmonary hemorrhage or tuberculosis in the active stage.

Patients receiving Fragmin® for treatment rather than prophylaxis are contraindicated under local and / or regional anesthesia during routine surgical procedures (this includes high doses of dalteparin required for the treatment of acute deep vein thrombosis, pulmonary embolism, and unstable ischemic heart disease). ).

The use of epidural anesthesia during childbirth is strictly contraindicated in pregnant women treated with anticoagulants.

Patients with cancer and body weight <40 kg at the time of venous thromboembolism should not use Fragmin® for long-term treatment of symptomatic VTE and prevention of its recurrence due to lack of relevant data.

Dalteparin should not be used in patients who have recently (less than 3 months ago) had a stroke, unless the stroke is due to systemic embolism.