Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-123111 · Präparat HOS-095645

• Presence or risk of venous thromboembolism (VTE) o Venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]). o Known hereditary or acquired predisposition for venous thromboembolism, such as activated protein C (APC)-resistance (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency. o Major surgery with prolonged immobilisation (see section 4.4). o A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4). • Presence or risk of arterial thromboembolism (ATE) o Arterial thromboembolism - current ATE, history of ATE (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris). o Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack [TIA]). o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant). o History of migraine with focal neurological symptoms. o A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as: • diabetes mellitus with vascular symptoms; • severe hypertension; • severe dyslipoproteinaemia. • Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia. • Presence or history of severe hepatic disease as long as liver function values have not returned to normal. • Presence or history of liver tumours (benign or malignant). • Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the breasts). • Meningioma or history of meningioma. • Undiagnosed vaginal bleeding. • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): protein S (HOS-110298) protein C (HOS-091603)