Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of the safety profile
The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection).

Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (see section 4.4).

Thromboembolism may occur very rarely (see section 4.4).

Ovaleap solution for injection                                                      8.2.2018     ME Tabulated list of adverse reactions

The following definitions apply to the frequency terminology used hereafter: 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;
Not known         cannot be estimated from the available data.

Treatment in women

Table 1: Adverse reactions in women
System organ class               Frequency                           Adverse reaction Immune system disorders          Very rare                           Mild to severe hypersensitivity reactions, including anaphylactic reactions and shock
Nervous system disorders              Very common                    Headache Vascular disorders                    Very rare                      Thromboembolism (both in association with and separate from OHSS)
Respiratory, thoracic and             Very rare                      Exacerbation or aggravation of mediastinal disorders                                                asthma Gastrointestinal disorders            Common:                        Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting,
diarrhoea
Reproductive system and breast        Very common                    Ovarian cysts disorders                             Common                         Mild or moderate OHSS (including associated symptomatology)
Uncommon                       Severe OHSS (including associated symptomatology)
(see section 4.4)
Rare                           Complication of severe OHSS
General disorders and                 Very common                    Injection site reactions (e.g.
administration site conditions                                       pain, erythema, haematoma, swelling and/or irritation at the site of injection)



Ovaleap solution for injection                                                      8.2.2018     ME Treatment in men

Table 2: Adverse reactions in men
System organ class                Frequency                             Adverse reaction Immune system disorders           Very rare                             Mild to severe hypersensitivity reactions, including anaphylactic reactions and shock
Respiratory, thoracic and           Very rare                           Exacerbation or aggravation of mediastinal disorders                                                   asthma Skin and subcutaneous tissue        Common:                             Acne disorders
Reproductive system and breast      Common                              Gynaecomastia, varicocele disorders
General disorders and               Very common                         Injection site reactions (e.g.
administration site conditions                                          pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Investigations                      Common                              Weight gain 
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 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il.