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               Hypertonic dehydration                  not known nutrition disorders          (see section 4.9)
Hospital-acquired hyponatraemia*

Nervous system           Hyponatraemic encephalopathy*           not known disorders
General disorders            Irritation at the administration site   not known and administration           Irritation of veins site 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