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 appropriate treatment should be initiated.

Tabulated list of adverse reactions

Adverse reactions reported from post-marketing use of Zenalb 20 are classified according to system organ class and frequency. Frequency groupings are defined according to 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); very rare (<1/10,000), not known (cannot be estimated from the available data).

MedDRA Standard System Organ Class                                  Not known 
Nervous system disorders                                              Tremor Cardiac disorders                                                   Tachycardia Dyspnoea
Dizziness
Vascular disorders                                                  Hypertension Hypotension
Respiratory, thoracic and mediastinal disorders                       Stridor Bronchospasm
General disorders and administration site                           Feeling cold conditions                                                         Chest tightness Rigors

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