Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The following undesirable effects are reported from post-marketing experience. The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Frequencies: Not known (cannot be estimated from the available data).


System Organ Class           Preferred Term                         Frequency Metabolism and               Electrolyte imbalances,                Not known nutrition disorders          e.g.:hypophosphataemia,
hypokalaemia
Acid-base balance disorders            Not known
Fluid imbalance                        Not known
Vascular disorders           Hypotension                            Not known Gastrointestinal             Nausea                                 Not known disorders                    Vomiting                               Not known Musculoskeletal and          Muscle spasms                          Not known connective tissue disorders

Special attention must be taken for patients with hypokalaemia as this solution is potassium- free (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