Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · HBVaxPro

HBVAXPRO 10 micrograms, suspension for injection Hepatitis B vaccine (recombinant DNA) · Abschnitt 4.8 · PDF-Seite 21–22

HOS-109209 · Präparat HOS-093119

21  Adverse reactions Frequency General disorders and administration site conditions Common Local reactions (injection site): Transient soreness, Erythema, Induration (≥1/100 to, <1/10) Fatigue, Fever, Malaise, Influenza-like symptoms Very rare (<1/10,000) Blood and the lymphatic system disorders Thrombocytopaenia, Lymphadenopathy Very rare (<1/10,000) Immune system disorders Serum sickness, Anaphylaxis, Polyarteritis nodosa Very rare (<1/10,000) Nervous system disorders Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Very rare (<1/10,000) Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope Eye disorders Uveitis Very rare (<1/10,000) Vascular disorders Hypotension, Vasculitis Very rare (<1/10,000) Respiratory, thoracic and mediastinal disorders Bronchospasm-like symptoms Very rare (<1/10,000) Gastrointestinal disorders Vomiting, Nausea, Diarrhoea, Abdominal pain Very rare (<1/10,000) Skin and subcutaneous tissue disorders Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Very rare (<1/10,000) Eczema Musculoskeletal, connective tissue and bone disorders Arthralgia, Arthritis, Myalgia, Pain in extremity Very rare (<1/10,000) Investigations Elevation of liver enzymes Very rare (<1/10,000)

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