Avaxim 160 Adverse Reactions

Summary of tolerance profile: During clinical studies, adverse reactions were generally moderate and limited to the first days following vaccination with spontaneous regression.
The reactions were less frequently reported after administration of the booster dose than after the first dose.
In subjects seropositive against hepatitis A virus, Avaxim was as well tolerated as in seronegative subjects.
Tabulated list of adverse reaction: The adverse reactions are derived from clinical studies and worldwide post-marketing experience. The adverse reactions are ranked under headings of frequency using the following convention: 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). Adverse reactions were spontaneously reported after the marketing of Avaxim 160 U. Given that these reactions were reported voluntarily by a population of unknown size, it is not possible to accurately estimate their frequency. (See table.)

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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 via the national reporting system.