Nebenwirkungen · HyQvia
HyQvia 100 mg/mL solution for infusion for subcutaneous use · Abschnitt 4.8 · PDF-Seite 13–14
HOS-126381 · Präparat HOS-096247
13 MedDRA Frequency Frequency System Organ Adverse drug reactions per patient per infusion Class (SOC) N=228 N=7,287 Local reactions (Total) Very Common Very Common - Infusion site discomfort, Infusion site pain, Injection site pain, Very Common Common Puncture site pain and Tenderness - Infusion site erythema and Injection site Very Common Common erythema - Infusion site oedema, Injection site oedema, Infusion site swelling, Very Common Common Injection site swelling and Swelling (local) - Infusion site pruritus, Injection site pruritus, Puncture site pruritus Very Common Common and Vulvovaginal pruritus - Infusion related reaction Common Uncommon - Infusion site bruising, Injection site bruising, Infusion site haematoma, Injection site Common Uncommon General haematoma, Infusion site disorders and haemorrhage and Vessel administration puncture site bruise site conditions - Infusion site reaction, Injection site reaction Common Uncommon and Puncture site reaction - Infusion site mass, Injection site mass and Common Uncommon Infusion site nodule - Infusion site Common Uncommon discoloration - Infusion site rash and Common Uncommon Injection site rash - Infusion site induration and Injection site Common Uncommon induration - Infusion site warmth Common Rare - Infusion site paraesthesia and Injection site Common Rare paraesthesia - Infusion site Common Rare inflammation - Infusion site leakage* Not Known Not Known
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-27T11:30:00Z · SHA-256 82c2d181906f7f26df4b044c3162c2753297176713b9df6564f85902166acac6 · Passage 24fec40d2b20c3eb4750a06903f57a82ec40dd7a8bcecf8da46b83637286713b · Zeichen 6985–9845 im Abschnitt