Avaxim Adverse Reactions

AVAXIM 80 U PEDIATRIC: Summary of the safety profile: More than 6200 children aged from 12 months to 15 years were vaccinated with AVAXIM 80 U PEDIATRIC during clinical trials.
Most undesirable effects were moderate and limited to the first few days following vaccination with spontaneous recovery. Reactions were more rarely reported after the booster dose than after the first dose.
However, as with all pharmaceuticals, expanded commercial use of the vaccine might reveal rarer undesirable effects.
Tabulated list of adverse reactions: The undesirable effects are derived from clinical studies and worldwide post-marketing experience.
In each System Organ Class, the undesirable effects are ranked under headings of frequency, the most common reactions coming first, using the following convention: Very common (≥ 1/10), Common (≥ 1/100, < 1/10), Uncommon (≥ 1/1 000, < 1/100), Rare (≥ 1/10 000, < 1/1000), Very rare (< 1/10 000), Not known: cannot be estimated from the available data.
The table as follows summarize the frequencies of the adverse reactions that were recorded after the first dose, after the booster dose or after any dose of AVAXIM 80 U PEDIATRIC. (See Table 1.)

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AVAXIM 160 U: 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 reactions: 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 2.)

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Reporting of suspected adverse reactions: AVAXIM 80 U Pediatric and AVAXIM 160 U: 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.