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FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation. Exanta (ximelagatran) is an investigational oral direct thrombin inhibitor (oral DTI) intended for use in the prevention of strokes in patients with atrial fibrillation, for the prevention ...
For the full list of all side effects reported with Micardis, see the package leaflet. Micardis must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. Micardis must not be used in people who have severe liver problems or bile problems.
Side effects. Ximelagatran was generally well tolerated in the trial populations, but a small proportion (5–6%) developed elevated liver enzyme levels, which prompted the FDA to reject an initial application for approval in 2004. The further development was discontinued in 2006 following reports of hepatotoxicity.
approval for the use of EXANTA® (ximelagatran) Tablets as: œ An oral 24-mg twice daily (bid) fixed dose for the long-term secondary prevention of venous thromboembolism (VTE) after standard treatment for an episode of acute
As of September 13, 2004, ximelagatran was deemed not approvable by the FDA Cardiovascular and Renal Drugs Advisory Committee. Collection of further data to support the approval of this potentially hepatotoxic oral direct thrombin inhibitor is recommended .
The most common side effect with MicardisPlus (seen in between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with MicardisPlus, see the package leaflet. MicardisPlus must not be used in women who are more than three months pregnant.
The most common side effect with MicardisPlus (seen in between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with MicardisPlus, see the Package Leaflet.
