Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: 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).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness 

Investigations               Uncommon: increased transaminases

Skin and                     Common: increased sweating subcutaneous tissue          Not known: rash disorders

‐   Undesirable effects in organic acidaemia


Cardiac disorders           Uncommon: bradycardia


Gastrointestinal            Uncommon:             diarrhoea,
disorders                   vomiting


General disorders           Uncommon: pyrexia and Administration site conditions


Skin and                    Not known: rash subcutaneous tissue disorders



Reporting suspected adverse reaction after authorization 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/