Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
One case of hypersensitivity was observed in clinical trials with Ruconest. The most common adverse reaction observed after administration of Ruconest is nausea .

Tabulated lists of adverse reactions
Adverse reactions reported with Ruconest in the treatment of acute HAE attacks obtained from clinical trials and post-marketing surveillance are tabulated below.
In clinical trials, the incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administration.

The frequency of adverse reactions listed below is defined 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 the available data).
System Organ Class                    Adverse reaction                Frequency Nervous system disorders              Headache                        Uncommon 
Vertigo                         Uncommon

Hypoaesthesia                   Uncommon
Dizziness                       Uncommon
Ear and labyrinth disorders           Auricular swelling              Uncommon Respiratory, thoracic and             Throat irritation               Uncommon mediastinal disorders
Gastrointestinal disorders            Nausea                          Common 
Diarrhoea                       Uncommon

Abdominal discomfort            Uncommon
Oral paraesthesia               Uncommon
Skin and subcutaneous tissue          Urticaria                       Uncommon disorders
Immune system disorders               Anaphylaxis*                    Uncommon Hypersensitivity reactions*     Not known
*Further information is found in section 4.4


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