Individual Participant Data (IPD) Sharing Statement: Related Info Layout table for additonal information A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).Patients with no clinical signs of bleeding.epistaxis, hematuria) who can be managed with standard supportive care. Emergency is defined as within the following 8 hours. Group B: A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required.Group A: Overt bleeding judged by the physician to require a reversal agent.Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.A list of contraception methods meeting these criteria is provided in the patient information. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
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