Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Twinrix Adult

Twinrix Adult, 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-085935 · Präparat HOS-083226

5  System Organ Class Frequency Adverse reactions Clinical trials Infections and infestations Uncommon Upper respiratory tract infection Blood and lymphatic system disorders Rare Lymphadenopathy Metabolism and nutrition disorders Rare Decreased appetite Nervous system disorders Very common Headache Uncommon Dizziness Rare Hypoaesthesia, paraesthesia Vascular disorders Rare Hypotension Gastrointestinal disorders Common Gastrointestinal symptoms, diarrhoea, nausea Uncommon Vomiting, abdominal pain* Skin and subcutaneous tissue disorders Rare Rash, pruritus Very rare Urticaria Musculoskeletal and connective tissue Uncommon Myalgia disorders Rare Arthralgia General disorders and administration Very common Pain and redness at the injection site, site conditions fatigue Common Swelling at the injection site, injection site reactions (such as haematoma, pruritus and bruising), malaise Uncommon 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 paediatric formulation

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