Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The adverse events observed with carbetocin during the clinical trials were of the same type and frequency as the adverse events observed with oxytocin Intravenous administration* – Tabulated summary of adverse reactions

System Organ Class            Very common             Common                  Not known ≥ 1/10                  ≥ 1/100 and < 1/10      (cannot be estimated from the available data)
Blood and lymphatic                                   Anaemia system disorders
Nervous system disorders      Headache, tremor        Dizziness
Cardiac disorders                                                             Tachycardia, bradycardia***,
arrhythmia***,
myocardial ischaemia***,
and QT prolongation***
Vascular disorders            Hypotension, flushing
Respiratory, thoracic and                             Chest pain, dyspnoea mediastinal disorders
Gastrointestinal disorders    Nausea, abdominal       Metallic taste, pain                    vomiting
Skin and subcutaneous         Pruritus tissue disorders
Musculosceletal and                                   Back pain connective tissue disorders
General disorders and         Feeling of warmth       Chills, pain administration site conditions
* Based on studies in caesarean section
*** Reported with oxytocin (closely related in structure to carbetocin) In the clinical trials sweating and tachycardia were reported as sporadic cases.


Intramuscular administration** – Tabulated summary of adverse reactions System Organ Class                Uncommon                         Rare                Not known (cannot be ≥ 1/1,000 and <1/100             ≥ 1/10,000 and <    estimated from the available 1/1,000             data)
Blood and lymphatic system Anaemia disorders
Nervous system disorders          Headache, dizziness              Tremor Cardiac disorders                 Tachycardia                                          Bradycardia***, arrhythmia***, myocardial ischaemia***, and QT prolongation***
Vascular disorders                Hypotension                      Flushing Respiratory, thoracic and         Chest pain                       Dyspnoea mediastinal disorders
Gastrointestinal disorders        Nausea, abdominal pain,
vomiting
Skin and subcutaneous tissue                                       Pruritus disorders
Musculoskeletal and               Back pain, muscular connective tissue disorders       weakness
Renal and urinary disorders                                        Urinary retention General disorders and          Chills, pyrexia, pain administration site conditions
* Based on studies in vaginal delivery
*** Reported with oxytocin (closely related in structure to carbetocin) 
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/