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Ondexxya
Eintrag öffnenOndexxya · 4.1 Therapeutic indications · 1
Eintrag öffnenOndexxya · 4.3 Contraindications · 1
Eintrag öffnenOndexxya · 4.3 · Hypersensitivity to the active substance or to any other ingredients listed in section 6.1.
Eintrag öffnenOndexxya · 4.3 · Known allergic reaction to hamster proteins.
Eintrag öffnenOndexxya · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenOndexxya · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenOndexxya · 4.5 · In vitro data suggest interaction of andexanet alfa with the heparin-anti-thrombin III (ATIII) complex and neu
Eintrag öffnenOndexxya · 4.5 · No interaction studies with andexanet alfa have been performed.
Eintrag öffnenOndexxya · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenOndexxya · 4.8 Undesirable effects · 1
Eintrag öffnenOndexxya · 4.8 · 6 System Organ Class Common Uncommon ≥ 1/100 to < 1/10 ≥ 1/1 000 to < 1/100
Eintrag öffnenOndexxya · 4.8 · Cardiac disorders Myocardial infarctionc Cardiac arrest
Eintrag öffnenOndexxya · 4.8 · Description of selected adverse reactions
Eintrag öffnenOndexxya · 4.8 · In clinical studies including patients with acute major bleeding and who were under treatment with a FXa inhib
Eintrag öffnenOndexxya · 4.8 · Nervous system disorders Ischaemic strokeb Transient ischaemic attack
Eintrag öffnenOndexxya · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenOndexxya · 4.8 · Respiratory, thoracic and Pulmonary embolism mediastinal disorders General disorders and Pyrexia administrativ
Eintrag öffnenOndexxya · 4.8 · Reversing FXa inhibitor therapy exposes patients to the thrombotic risk of their underlying disease. In additi
Eintrag öffnenOndexxya · 4.8 · Summary of the safety profile The most frequently observed adverse reactions in healthy volunteers were mild o
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