Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The undesirable effects listed in this section are categorised according to the recommended frequency 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).

List of undesirable effects
System organ class                   Undesirable effect                    Frequency Metabolism and nutrition        Hypertonic dehydration (see              not known disorders                       section 4.9)
Hospital-acquired hyponatraemia*

Nervous system disorders        Hyponatraemic encephalopathy*            not known General disorders and            Irritation at the administration site    not known administration site              Irritation of veins conditions                       Thrombophlebitis
Extravasation
Local pain
*Hospital-acquired hyponatraemia may cause irreversible brain injury and death due to the development of acute hyponatraemic encephalopathy (see 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