Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Bekemv

BEKEMV 300 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11–12

HOS-148442 · Präparat HOS-099910

11 MedDRA Very Common Uncommon Rare Not known system organ common (≥ 1/100 to (≥ 1/1 000 to (≥ 1/10 000 to (cannot be class (≥ 1/10) < 1/10) < 1/100) < 1/1 000) estimated from the available data) Reproductive Spontaneous penile Menstrual system and erection disorder breast disorders General Pyrexia, Oedema, Extravasation, disorders and Fatigue, Chest discomfort, Infusion site administration Influenza-like Asthaenia, paraesthesia, site conditions illness Chest pain, Feeling hot Infusion site pain, Chills Investigations Haematocrit Coombs test decreased, positivec Haemoglobin decreased Injury, Infusion related poisoning and reaction procedural complications Included studies: asthma (C07-002), aHUS (C08-002, C08-003, C10-003, C10-004), dermatomyositis (C99- 006), refractory gMG (C08-001, ECU-MG-301, ECU-MG-302, ECU-MG-303), Neuromyelitis Optica Spectrum Disorder (ECU-NMO-301, ECU-NMO-302), IMG (C99-004, E99-004), PNH (C02-001, C04-001, C04-002, C06-002, C07-001, E02-001, E05-001, E07-001, M07-005, X03-001, X03-001A), psoriasis (C99-007), RA (C01-004, C97-001, C99-001, E01-004, E99-001), STEC-HUS (C11-001), SLE (C97-002). MedDRA version 26.1. * See ‘Description of selected adverse reactions.’ a Abscess includes the following group of preferred terms (PTs): abscess limb, colonic abscess, renal abscess, subcutaneous abscess, tooth abscess, liver abscess, perirectal abscess, rectal abscess. b Meningococcal infection includes the following group of PTs: meningococcal infection, meningococcal sepsis, meningitis meningococcal. c ADRs identified in post marketing reports. d Frequency cannot be estimated from the available post marketing data.

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