Adverse reactions : תופעות לוואי

4.8.   Undesirable effects

Adverse event data are derived from clinical trials and worldwide post- marketing experience.
Within each system organ class, the adverse events are ranked under headings of frequency, most frequent reactions first, using the following convention:
Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10000, <1/1000), Very rare (<1/10000).

Clinical Studies
In clinical trials, adverse reactions were usually mild and confined to the first few days after vaccination with spontaneous recovery. The adverse reactions observed with AVAXIM 160 U were:
Nervous system disorders
Common: headache
Gastrointestinal disorders
Common: nausea, vomiting, decreased appetite, diarrhoea, abdominal pain 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: transaminases increased (mild and reversible) Reactions were less frequently reported after the booster dose than after the first dose.
In subjects seropositive against hepatitis A virus, AVAXIM 160 U was as well tolerated as in seronegative subjects.

Post marketing experience
Based on spontaneous reporting, the following additional adverse events have been reported during the commercial use of AVAXIM. These events have been very rarely reported, however exact incidence rates are not known (cannot be estimated from the available data).
Nervous system disorders
Vasovagal syncope in response to injection
Skin and subcutaneous tissue disorders
Urticaria, rashes associated or not with pruritus

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.
Any suspected adverse events should be reported to the Ministry of Health (www.health.gov.il) according to the National Regulation by using an online form https://sideeffects.health.gov.il