Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · HyQvia

HyQvia 100 mg/mL solution for infusion for subcutaneous use · Abschnitt 4.8 · PDF-Seite 15

HOS-126386 · Präparat HOS-096247

The most common local reactions observed during the pivotal clinical studies include infusion site pain, infusion site erythema and infusion site oedema. Most of the local reactions were mild in severity and self-limited. In the PID studies, 2 instances of local adverse reactions were severe (infusion site pain and infusion site swelling) and in the CIDP studies 4 instances were severe (infusion site extravasation, infusion site inflammation, infusion site pruritus and infusion site reaction). In the PID studies, there were 2 instances of transient genital oedema, one considered severe, that resulted from diffusion of the medicinal product from the infusion site in the abdomen. In the CIDP studies there was one mild instance of genital oedema (penile swelling). No skin changes were observed that did not resolve during the clinical study.

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