AVAXIM 80 U PEDIATRIC: Summary of the safety profile: More than 6200 children aged from 12 months to 15 years (around 7000 administered doses) 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.)
Click on icon to see table/diagram/image
AVAXIM 160 U: The undesirable effects are derived from clinical studies and worldwide post-marketing experience. The undesirable effects are ranked under headings of frequency using the following convention: Very common (≥ 1/10); Common (≥ 1/100 and < 1/10); Uncommon (≥ 1/1,000 and < 1/100); Rare (≥ 1/10,000 and < 1/1,000); Very rare (< 1/10,000), including isolated cases; Not known: cannot be estimated from available data.
Nervous system disorders: Common: cephalalgia. Not known: vasovagal syncope in response to injection.
Gastrointestinal disorders: Common: nausea, vomiting, appetite decrease, diarrhoea, abdominal pain.
Skin and subcutaneous tissue disorders: Not known: urticaria, rash associated or not with pruritus.
Musculoskeletal and connective tissue disorders: Common: myalgia, arthralgia.
General disorders and administration site conditions: Very common: asthenia, mild injection site pain. Common: mild fever. Uncommon: injection site erythema. Rare: injection site nodule.
Investigations: Rare: increase in serum transaminases (mild and transient).
The reactions were less frequently reported after the booster injection than after the first dose.
In subjects seropositive against hepatitis A virus, this vaccine was as well tolerated as in seronegative subjects.
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.