Adverse reactions : תופעות לוואי

4.8     Undesirable effects

The assessment of undesirable effects is based on the following grades of frequency: Very common (>1/10)
Common (>1/100 bis <1/10)
Uncommon (>1/1,000 bis <1/100)
Rare (>1/10,000 bis <1/1,000)
Very rare (<1/10,000)

System organ          Very           Common           Uncommon       Rare (≥     Very rare class                 common         (>1/100 to       (>1/1,000 to   1/10,000    (<1/10,000) (>1/10)        <1/10)           <1/100)        to <
1/1,000)
Gastrointestinal                     Nausea,
disorders                            Abdominal pain, emesis
General disorders     Reactions*     Flu-like         Fever and                   and pain at    symptoms administration site   the site of conditions            injection
Immune system                                                                    Hypersensitivity disorders
Nervous system                       Headache disorders
Reproductive                         Mild,
system and                           moderate breast disorders                     and severe
OHSS
Skin and                             Rash subcutaneous tissue disorders


* Reactions at the site of injection have been observed in 55 – 60 % of the participants in clinical studies on local tolerability. In about 12 %, the reaction has been assessed as severe.
In most cases, the reaction occurred following subcutaneous administration. After intramuscular administration, reactions at the site of injection have been observed in up to 13% of the study participants.

Menogon treatment has shown single cases of anaphylactic reactions.

In connection with ovarian hyperstimulation, the use of gonadotropins has shown single cases of thromboembolic complications and ovarian torsions.

Pregnancy commencing subsequent to infertility treatment with gonadotropins such as Menogon can end up in spontaneous abortion more frequently than normal pregnancy.

Men: In connection with treatment with gonadotropins, gynecomastia, acne and increase in weight have been reported.
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/