Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Twinrix Paediatric

Twinrix Paediatric, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 5–6

HOS-086554 · Präparat HOS-083298

5  site conditions Common Swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise, fever ( 37.5°C) Rare Influenza like illness*, chills* Post-marketing surveillance The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines: Infections and infestations Meningitis Blood and lymphatic system disorders Thrombocytopenia, thrombocytopenic purpura Immune system disorders Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness Nervous system disorders Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions Vascular disorders Vasculitis Skin and subcutaneous tissue disorders Angioneurotic oedema, lichen planus, erythema multiforme Musculoskeletal and connective tissue Arthritis, muscular weakness disorders General disorders and administration Immediate injection site pain site conditions Following widespread use of the monovalent hepatitis A and/or hepatitis B vaccines, the following undesirable events have additionally been reported in temporal association with vaccination: Nervous system disorders Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), optic neuritis General disorders and administration Stinging and burning sensation site conditions Investigations Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the adult formulation

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