Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Fingolimod Accord

Fingolimod Accord 0.5 mg hard capsules · Abschnitt 4.3 · PDF-Seite 3–4

HOS-145236 · Präparat HOS-099320

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Immunodeficiency syndrome. - Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies). - Suspected or confirmed progressive multifocal leukoencephalopathy (PML) (see section 4.4). - Severe active infections, active chronic infections (hepatitis, tuberculosis). 3 - Active malignancies. - Severe liver impairment (Child-Pugh class C). - Patients who in the previous 6 months had myocardial infarction (MI), unstable angina pectoris, stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure (see section 4.4). - Patients with severe cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or class III anti-arrhythmic medicinal products (see section 4.4). - Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV block, or sick-sinus syndrome, if they do not wear a pacemaker (see section 4.4). - Patients with a baseline QTc interval ≥ 500 msec (see section 4.4). - During pregnancy and in women of childbearing potential not using effective contraception (see sections 4.4 and 4.6).

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