Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Infanrix Hexa

Infanrix hexa, Powder and suspension for suspension for injection. Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 8

HOS-091128 · Präparat HOS-084201

System Organ Class Frequency Adverse reactions Infections and infestations Uncommon Upper respiratory tract infection Blood and lymphatic system disorders Rare Lymphadenopathy2, thrombocytopenia2 Immune system disorders Rare Anaphylactic reactions2, anaphylactoid reactions (including urticaria)2 Allergic reactions (including pruritus)2 Metabolism and nutrition disorders Very common Loss of appetite Psychiatric disorders Very common Crying abnormal, irritability, restlessness Common Nervousness Nervous system disorders Very common Somnolence Rare Collapse or shock-like state (hypotonic- hyporesponsive episode)2 Very rare Convulsions (with or without fever) Respiratory, thoracic and mediastinal Uncommon Cough disorders Rare Bronchitis, apnoea2 [see section 4.4 for apnoea in very preterm infants (≤ 28 weeks of gestation)] Gastrointestinal disorders Common Diarrhoea, vomiting Skin and subcutaneous tissue disorders Rare Rash, Angioedema2 Very rare Dermatitis General disorders and administration site Very common Fever ≥ 38°C, pain, redness, local conditions swelling at the injection site (≤ 50 mm) Common Fever >39.5°C, injection site reactions, including induration, local swelling at the injection site (> 50 mm)1 Uncommon Diffuse swelling of the injected limb, sometimes involving the adjacent joint1, fatigue Rare Swelling of the entire injected limb1, 2, extensive swelling reactions2, injection site mass2, injection site vesicles2 1 Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines. These reactions resolve over an average of 4 days. 2 Adverse reactions from spontaneous reporting.

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