Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following adverse reactions are based on post marketing experience as well as scientific literature. The following standard categories of frequency are used:

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 (including reported single cases)

Undesired reactions with Berinert are rare.
Organ class        Very        Common Uncommon            Rare               Very rare common
Vascular                                                  Development disorders                                                 of thrombosis* General                                                   Rise in disorders and                                             temperature, administration                                            reactions at the site conditions                                           injection site Immune                                                    Allergic or        Shock system                                                    anaphylactic- disorders                                                 type reactions (e.g.
tachycardia,
hyper- or hypotension,
flushing, hives,
dyspnoea,
headache,
dizziness,
nausea)
* In treatment attempts with high doses of Berinert for prophylaxis or therapy of Capillary Leak Syndrome (CLS) before, during or after cardiac surgery under extracorporal circulation (unlicensed indication and dose), in single cases with fatal outcome.

For safety with respect to transmissible agents, see section 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/
 and emailed to the Registration Holder’s Patient Safety Unit at: PV-IL@cslbehring.com