Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Kesimpta

Kesimpta 20 mg solution for injection in pre-filled syringe Kesimpta 20 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-147272 · Präparat HOS-099626

Infections and infestations Very common Upper respiratory tract infections1 Urinary tract infections2 Common Oral herpes Immune system disorders Not known Hypersensitivity reactions3 Gastrointestinal disorders Common Nausea, vomiting4 Hepatobiliary disorders Common Hepatic enzymes increased5 General disorders and administration site conditions Very common Injection-site reactions (local) Investigations Common Blood immunoglobulin M decreased Injury, poisoning and procedural complications Very common Injection-related reactions (systemic) 1 Grouping of preferred terms (PTs) was considered for ADR frequency determination and includes the following: nasopharyngitis, upper respiratory tract infection, influenza, sinusitis, pharyngitis, rhinitis, viral upper respiratory infection, tonsillitis, acute sinusitis, pharyngotonsillitis, laryngitis, pharyngitis streptococcal, viral rhinitis, sinusitis bacterial, tonsillitis bacterial, viral pharyngitis, viral tonsillitis, chronic sinusitis, nasal herpes, tracheitis. 2 Grouping of preferred terms (PTs) was considered for ADR frequency determination and includes the following: urinary tract infection, cystitis, escherichia urinary tract infection, asymptomatic bacteriuria, bacteriuria. 3 Reported during post-marketing experience (see section 4.4). 4 Nausea and vomiting have been reported in association with systemic injection-related reactions (see below and section 4.4) 5 Grouping of PTs was considered for ADR frequency determination and includes the following: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzymes increased, transaminases increased, liver function test increased, hepatic function abnormal, liver function test abnormal

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