Arixtra solution for injection 2.5 mg/0.5 ml syringe No. 10




Arixtra injection solution is indicated for:
For the prevention of venous thromboembolic complications in patients after major orthopedic surgery on the lower extremities, including hip fracture (including extended prophylaxis) and hip and knee arthroplasty. For the prevention of venous thromboembolic complications in patients after abdominal surgery who are at high risk of thromboembolic complications, for example in patients after abdominal surgery for cancer. For the prevention of venous thromboembolic complications in patients at high risk of such complications due to prolonged limitation of mobility during the acute phase of the disease, such as heart failure and/or acute respiratory disorders and/or acute infectious or inflammatory diseases. In the treatment of unstable angina or non-ST segment elevation myocardial infarction in patients for whom urgent (<120 min) invasive intervention (percutaneous coronary intervention - PCI) is not indicated. In the treatment of ST-segment elevation myocardial infarction in patients treated with thrombolytics or in those who have not initially received other forms of reperfusion therapy.Composition
Active ingredient: fondaparinux sodium;
1 syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium;
Excipients: sodium chloride, water for injection, hydrochloric acid or sodium hydroxide.
Contraindication
Known allergy to the active substance or to any of the excipients of the drug. Active clinically significant bleeding. Acute bacterial endocarditis. Severe renal failure (creatinine clearance <20 ml/min).
Method of application
Arixtra is for subcutaneous or intravenous injection. Do not administer intramuscularly. Arixtra is for use only under the supervision of a physician.
Application features
Pregnant women
Not recommended for use.
Drivers
With caution.
Overdose
Exceeding the recommended doses of the drug may lead to an increased risk of bleeding. There is no known antidote to fondaparinux.
In case of overdose accompanied by hemorrhagic complications, treatment should be discontinued and the underlying cause of bleeding should be investigated. Appropriate therapy, such as surgical hemostasis, blood replacement, fresh plasma transfusion, plasmapheresis, should be considered.
Side effects
The most frequently reported serious adverse reactions with fondaparinux are haemorrhagic complications (at various sites, including isolated cases of intracranial/intracerebral and retroperitoneal haemorrhage) and anaemia. Fondaparinux should be used with caution in patients at increased risk of bleeding.
Interaction
Drugs that increase the risk of bleeding should not be used concomitantly with Arixtra, with the exception of vitamin K antagonists used to treat venous thromboembolism. If such co-administration is necessary, it should be carried out under close supervision.
Storage conditions
Store below 25°C.
Keep out of reach of children.
Shelf life - 3 years.
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