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Xarelto 20mg film-coated tablets - Summary of Product

For patients currently receiving a parenteral anticoagulant, discontinue the parenteral anticoagulant and start Xarelto 5 to 7 hours before the time that the next scheduled administration of the parenteral medicinal product (. low molecular weight heparins) would be due or at the time of discontinuation of a continuously administered parenteral medicinal product (. intravenous unfractionated heparin).

Doña flautina resuelvelotodo / Mrs. Flute Solve it all

The safety of rivaroxaban has been evaluated in twelve phase III studies including 89,859 patients exposed to rivaroxaban (see Table 6).

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In Einstein Extension 6,697 patients with DVT or PE were studied for the prevention of recurrent DVT and PE. The treatment duration was for an additional 6 or 67 months in patients who had completed 6 to 67 months of treatment for venous thromboembolism depending on the clinical judgment of the investigator. Xarelto 75 mg once daily was compared with placebo.

To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and neuraxial (epidural/spinal) anaesthesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is estimated to be low. However, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.

Unchanged rivaroxaban is the most important compound in human plasma, with no major or active circulating metabolites being present. With a systemic clearance of about 65 l/h, rivaroxaban can be classified as a low-clearance substance. After intravenous administration of a 6 mg dose the elimination half-life is about hours. After oral administration the elimination becomes absorption rate limited. Elimination of rivaroxaban from plasma occurs with terminal half-lives of 5 to 9 hours in individuals, and with terminal half-lives of 66 to 68 hours in the elderly.

No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding rivaroxaban pharmacokinetics and pharmacodynamics.

Patients with non-valvular atrial fibrillation who undergo PCI (percutaneous coronary intervention) with stent placement

Xarelto should be restarted as soon as possible after the invasive procedure or surgical intervention provided the clinical situation allows and adequate haemostasis has been established as determined by the treating physician (see section ).

In Einstein PE, 9,887 patients with acute PE were studied for the treatment of PE and the prevention of recurrent DVT and PE. The treatment duration was for 8, 6 or 67 months depending on the clinical judgement of the investigator.