Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of safety profile:
The most commonly reported adverse drug reactions in placebo-controlled and active comparator efficacy clinical trials (N=1116) were “foetal heart rate disorder” (6.9%), “uterine contractions abnormal” (6.2%) and “abnormal labour affecting foetus” (2.6 %).
The table below displays the main ADRs distributed by system organ classes (SOC) and frequency.
Further, the ADRs seen during post-marketing experience are mentioned with unknown frequency.
Adverse reactions observed in clinical studies are presented according to their incidence, post authorisation reported adverse reactions are presented in the column frequency unknown.

System organ class        Common                     Uncommon               Not known: frequency (≥ 1/100 and < 1/10)       (≥ 1/1000 and ≤ 1/100) cannot be estimated from the available data
Blood and lymphatic                                                            Disseminated system disorders                                                               intravascular coagulation
Immune system                                                                  Anaphylactic reaction disorders                                                                      Hypersensitivity Nervous system                                       Headache disorders
Cardiac disorders         Foetal heart rate disorder 1*
Vascular disorders                                   Hypotension
Respiratory, thoracic                                Neonatal respiratory and mediastinal                                      distress related disorders                                            conditions
Gastrointestinal                                                               Abdominal pain, disorders                                                                      Nausea, vomiting, diarrhoea
Hepatobiliary disorders                              Neonatal hyperbilirubinaemia
Skin and subcutaneous                                Pruritus tissue disorders
Pregnancy, puerperium Abnormal labour                Postpartum                Anaphylactoid and perinatal conditions affecting foetus 2*         haemorrhage,              syndrome of pregnancy Uterine contractions        Premature separation of   Foetal distress abnormal, uterine           placenta,                 syndrome 3* tachysystole, uterine       Apgar score low           Fetal death, stillbirth, hyperstimulation,                                     neonatal death 4* Arrested labour uterine hypertonus
Chorioamnionitis
Meconium in amniotic fluid                       Uterine atony
Reproductive system                                  Vulvovaginal burning      Genital oedema and breast disorders                                 sensation
General disorders and                                Febrile disorders administration site conditions
Injury, poisoning and                                                          Uterine rupture procedural complications

1* “Foetal heart rate disorder” was in clinical studies reported as “foetal heart rate abnormalities”, “foetal bradycardia”, “foetal tachycardia”, “unexplained absence of normal variability”, “foetal heart 

rate decreased”, “foetal heart rate deceleration”, “early or late decelerations”, “variable decelerations”, “prolonged decelerations”.
2* “Abnormal labour affecting foetus” as expression for hyperstimulation syndrome was in clinical studies reported as “uterine tachysystole” combined with “late decelerations”, “foetal bradycardia”, or “prolonged decelerations”
3* “Foetal distress syndrome” was also reported as “foetal acidosis” , “pathological CTG”, “foetal heart rate abnormalities”, “intrauterine hypoxia” or “threatening asphyxia”. The term itself is unspecific, has a low positive predictive value and is often associated with an infant who is in good condition at birth.
4* Fetal death, stillbirth, and neonatal death have been reported after application of dinoprostone,
especially following the occurrence of serious events such as uterine rupture (see sections 4.2, 4.3 and 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/