Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Summary of the safety profile
Mild reactions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very rarely, severe reactions such as shock may occur. In these cases, the infusion should be stopped and an appropriate treatment should be initiated.
Tabulated list of adverse reactions
The table presented below is according to the MedDRA system organ classification (SOC) and Preferred Term Level (PT).

MedDRA System Organ              Adverse reactions (MedDRA Preferred              Frequency Class (SOC)                                  Term)

Flushing                                      Rare
Vascular disorders
Shock                                         Very rare

Gastrointestinal disorders       Nausea                                        Rare 
Skin and subcutaneous tissue                                                   Rare Urticaria disorders
General disorders and                                                          Rare Pyrexia administration site conditions


For safety information with respect to transmissible agents, see 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
Additionally, you should also                report   to   Kamada   LTD   to    email      address: pharmacovigilance@kamada.com