Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Puregon

Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-085464 · Präparat HOS-083121

The table below lists the adverse reactions with follitropin beta reported in clinical trials and post- marketing surveillance in females, according to system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from available data). SOC Frequency Adverse reaction Immune system disorders Not known Anaphylactic reactions Nervous system disorders Common Headache Gastrointestinal disorders Common Abdominal distension Abdominal pain Uncommon Abdominal discomfort Constipation Diarrhoea Nausea Reproductive system and breast Common OHSS disorders Pelvic pain Uncommon Breast complaints1 Metrorrhagia Ovarian cyst Ovarian enlargement Ovarian torsion Uterine enlargement Vaginal haemorrhage General disorders and Common Injection site reaction2 administration site conditions Uncommon Generalised hypersensitivity reaction3 1. Breast complaints include tenderness, pain and/or engorgement and nipple pain. 2. Local reactions at the site of injection include: bruising, pain, redness, swelling and itching. 3. Generalised hypersensitivity reaction include erythema, urticaria, rash and pruritus.

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