Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Possible adverse reactions of atosiban were described for the mother during the use of Atosiban-Ferring in clinical trials. In total 48% of the patients treated with atosiban experienced adverse reactions during clinical trials. The observed adverse reactions were generally of a mild severity. The most commonly reported adverse reaction in the mother is nausea (14%).
For the newborn, the clinical trials did not reveal any specific undesirable effects of atosiban. The infant adverse reactions were in the range of normal variation and were comparable with both placebo and beta- mimetic group incidences.
The frequency of adverse reactions listed below 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
MedDRA System              Very common           Common                Uncommon             Rare Organ Class
(SOC)
Immune system                                                                           Allergic reaction disorders
Metabolism and                              Hyperglycemia
nutrition disorders
Psychiatric                                                       Insomnia
disorders
Nervous system                              Headache
disorders                                   Dizziness
Cardiac disorders                           Tachycardia
Vascular disorders                          Hypotention
Hot flush
Gastrointestinal      Nausea                Vomiting
disorders
Skin and                                                          Pruritis
subcutaneous                                                      Rash
tissue disorders
Reproductive                                                                            Uterine system and breast                                                                       haemorrage, cancer disorder                                                                         Uterine atony General disorders                           Injection site        pyrexia
and administration                          reaction
site conditions
Post-marketing experience


Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and beta- mimetics, and/or in women with multiple pregnancy, have been reported post-marketing.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorization 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/