Adverse reactions : תופעות לוואי

4.8   Undesirable effects

In clinical studies at a dose of 500 micrograms (total 161 patients) the most frequently observed adverse reaction, at least possibly related to Paloxi, was headache (3.7 %).



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In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to Paloxi. These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100).

System Organ Class                 Common ARs                    Uncommon ARs 
Psychiatric disorders                                                            Insomnia Nervous system disorders                         Headache
Eye disorders                                                                  Eye swelling Cardiac disorders                                                    Atrioventricular block first degree, atrioventricular block second degree
Respiratory, thoracic and mediastinal                                            Dyspnoea disorders
Gastrointestinal disorders                                                 Constipation, nausea Musculoskeletal and connective tissue                                             Myalgia disorders
Investigations                                                            Blood bilirubin increased In post marketing very rare cases (<1/10,000) of hypersensitivity reactions occurred with palonosetron solution for injection for intravenous use.
Adverse reactions with unknown frequency: dizziness, somnolence, fatigue.

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