Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Undesirable effects can result from the solution used or the treatment.
Bicarbonate-buffered haemofiltration and haemodialysis solutions are generally well tolerated.
The following undesirable effects have been reported from post-marketing experience. The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies cannot be estimated from the available data.

MedDra System       Preferred Term                                 Frequency Organ Class
Metabolism and      Electrolyte imbalances, e.g.:                  not known nutrition           hyperphosphataemia disorders           Fluid imbalance, e.g.: hypervolaemia,          not known hypovolaemia
Acid-base balance disorders, e.g. metabolic    not known acidosis, metabolic alkalosis
Vascular disorder      Hypotension*                                   not known Gastrointestinal       Nausea*                                        not known disorder               Vomiting*                                      not known Musculoskeletal        Muscle cramps*                                 not known and connective tissue disorders
* undesirable effects related generally to dialysis treatments.

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 in the home page: www.health.gov.il by using an online form: https://sideeffects.health.gov.il