Adverse reactions : תופעות לוואי

4.8     Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics. The frequency grouping is defined using the following convention: Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1 000 to <1/100); Rare (≥ 1/10 000 to <1/1 000); Very Rare (< 1/10 000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.


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System Organ        Very           Common           Uncommon           Rare        Very    Frequency Not Class              Common          ≥1/100 to        ≥1/1 000 to     ≥1/10 000 to   Rare    Known (Cannot ≥1/10           <1/10             <1/100         <1/1 000      <1/10    Be Estimated 000    From Available
Data)
Blood and                                                          Disseminated lymphatic                                                          intravascular system disorders                                                   coagulation Immune system                                                                              Hypersensitivity, disorders                                                                                  Anaphylactoid reaction,
Anaphylactic reaction,
Anaphylactic shock
Nervous system                   Vasovagal disorders                        symptoms
(flushing,
shivering,
headache,
dizziness)
Cardiac                                                                                    Cardiac arrest disorders
Vascular                         Hypertension disorders
Respiratory,                                       Bronchospasm                            Asthma thoracic and mediastinal disorders
Gastrointestinal   Diarrhoea,
disorders          Nausea,
Vomiting
Musculoskeletal                                                                            Back pain and connective tissue disorders
Pregnancy,                       Foetal distress   Premature                               Uterine rupture, Puerperium and                   syndrome,         separation of                           Anaphylactoid Perinatal                        Uterine           placenta                                syndrome of conditions                       hypertonus,                                               pregnancy, Rapid Uterine                                                   cervical contractions                                              dilatation, abnormal                                                  Neonatal distress, Death neonatal,
Stillbirth, Foetal death

General            Injection                       Pyrexia                                 Local infections disorders and      site administration     irritation,
site conditions    Injection site erythema
Investigations     Apgar                                                                   White blood cell score low,                                                              count increased Foetal heart rate abnormal


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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/