Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of safety profile
During clinical trials over 1.4 million capsules of Vivotif were administered. Since initial registration the number of doses distributed exceeds 100 million. The most frequent adverse reactions have been abdominal pain, nausea, headache, fever, diarrhoea, vomiting, and skin rash. Most adverse reactions have been mild. One isolated, non-fatal anaphylactic shock considered to be an allergic reaction to the vaccine was reported.

The adverse reaction frequency classification used is as follows: 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 the available data).

Tabulated summary of adverse reactions

Adverse reactions occurring in clinical trials were as follows:
Adverse Reactions                                     Frequency
Nervous system disorders
Headache                                              Common
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, diarrhoea           Common
Skin and subcutaneous tissue disorders
Rash                                                  Common
General disorders and administration site conditions
Pyrexia                                               Common
Adverse reactions reported during post-marketing surveillance are as follows: Adverse Reactions*
Immune system disorders
Hypersensitivity, anaphylactic reaction, including shock
Metabolism and nutrition disorders
Decreased appetite
Nervous system disorders
Paraesthesia, dizziness
Gastrointestinal disorders
Flatulence, abdominal distension
Skin and subcutaneous tissue disorders
Dermatitis, pruritus, urticaria
Musculoskeletal and connective tissue disorders
Arthralgia, myalgia, back pain
General disorders and administration site conditions
Asthenia, malaise, fatigue, chills, influenza-like illness
*Because these reactions are reported spontaneously during post-marketing from a population of unknown size, it is not possible to establish their frequency. Therefore, the frequency of these reactions is not known.

Paediatric Population

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
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 according to the National Regulation by using an online form: https://sideeffects.health.gov.il/
Additionally, you should also report to Kamada LTD to email address: pharmacovigilance@kamada.com