Summary of the safety profile: In clinical studies in individuals who received Hexaxim, the most frequently reported reactions include injection-site pain, irritability, crying, and injection-site erythema.
Slightly higher solicited reactogenicity was observed after the 1st dose compared to subsequent doses.
The safety of Hexaxim in children over 24 months of age has not been studied in clinical trials.
Tabulated list of adverse reactions: The following convention has been used for the classification of adverse reactions: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from available data). (See Table 5.)
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Description of selected adverse reactions: Extensive limb swelling: Large injection-site reactions (>50 mm), including extensive limb swelling from the injection site beyond one or both joints, have been reported in children. These reactions start within 24-72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3-5 days. The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4th and 5th doses.
Potential adverse events: (i.e. adverse events which have been reported with other vaccines containing one or more of the components or constituents of Hexaxim and not directly with Hexaxim).
Nervous system disorders: Brachial neuritis and Guillain-Barre Syndrome have been reported after administration of a tetanus toxoid containing vaccine.
Peripheral neuropathy (polyradiculoneuritis, facial paralysis), optic neuritis, central nervous system demyelination (multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine.
Respiratory, thoracic and mediastinal disorders: Apnoea in very premature infants (≤ 28 weeks of gestation) (see Precautions).
General disorders and administration site conditions: Oedematous reaction affecting one or both lower limbs may occur following vaccination with Haemophilus influenzae type b containing vaccines. If this reaction occurs, it is mainly after primary injections and within the first few hours following vaccination. Associated symptoms may include cyanosis, redness, transient purpura and severe crying. All events should resolve spontaneously without sequel within 24 hours.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.