Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Anaphylactic reactions including anaphylactic shock that are very rare but clinically severe, and potentially lethal, systemic allergic reactions, can occur following Rabipur vaccination. Mild allergic reactions to Rabipur (i.e. hypersensitivity), including rashes (very common) and urticaria (common) may occur after vaccination. These reactions are usually mild in nature and typically resolve within a few days.

Very rare cases with symptoms of Encephalitis and Guillain-Barré Syndrome have been reported following Rabipur vaccination.

In clinical trials, the most commonly reported solicited adverse reactions were injection site pain (30-85%) or injection site induration (15-35%). Most injection site reactions were not severe and resolved within 24 to 48 hours.

Tabulated list of adverse reactions

Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
Frequencies are defined as follows:
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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)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
In addition to reports in clinical trials, worldwide voluntary reports of adverse reactions received for Rabipur since market introduction are included in the list. These reactions are reported voluntarily from a population of uncertain size and have been chosen for inclusion due to their seriousness, frequency of reporting, causal relationship to Rabipur, or a combination of these factors.
Table 5: Adverse reactions reported in clinical trials and in postmarketing surveillance 

System Organ Class                    Frequency            Adverse events Blood and lymphatic system            Common               Lymphadenopathy disorders
Immune system disorders               Rare                 Hypersensitivity Very rare            Anaphylaxis including anaphylactic shock*
Metabolism and nutrition              Common               Decreased appetite disorder
Nervous system disorders              Very common          Headache, Dizziness Rare                 Paraesthesia
Very rare            Encephalitis*, Guillain-Barré syndrome*, Presyncope*, Syncope*,
Vertigo*
Gastrointestinal disorders            Common               Nausea, Vomiting, Diarrhoea, Abdominal pain/ discomfort
Skin and subcutaneous tissue          Very common          Rash disorders                             Common               Urticaria
Rare                 Hyperhidrosis (sweating)
Very rare            Angioedema*
Musculoskeletal and                   Common               Myalgia, Arthralgia connective tissue disorders
General disorder and                  Very common          Injection site reactions, Malaise, administration site conditions                             Fatigue, Asthenia, Fever Rare                      Chills
*Additional adverse reactions from spontaneous reporting

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.

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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 GSK Israel (il.safety@gsk.com).