Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Adult population - Intravenous use
The safety of SonoVue after intravenous administration was evaluated in 4653 adult patients who participated in 58 clinical trials. The undesirable effects reported with SonoVue after intravenous administration were, in general, non-serious, transient and resolved spontaneously without residual effects. In clinical trials, the most commonly reported adverse reactions after intravenous administration are: headache, injection site reaction, and nausea.

The adverse reactions are classified by System Organ Class and frequency, using 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)

Adverse Drug Reactions
System Organ Class                                         Frequency Category Not known
Uncommon                         Rare
Cannot be estimated
(≥ 1/1,000 to < 1/100)       (≥ 1/10,000 to < 1/1000) from available data
Immune system
Hypersensitivity* disorders
Nervous system                 Headache, paraesthesia,                                      Vasovagal reaction disorders                      dizziness, dysgeusia
Eye disorders                                                Vision blurred Myocardial infarction**
Cardiac disorders
Myocardial ischemia**
Kounis syndrome***
Vascular disorders             Flushing                      Hypotension 

Gastrointestinal                                                                           Vomiting Nausea, abdominal pain disorders
Skin and subcutaneous
Rash                          Pruritus tissue disorders
Musculoskeletal,                                             Back pain connective tissue and bone disorders
General disorders and          Chest discomfort,
administration site            injection site reaction,      Chest pain, pain, fatigue conditions                     feeling hot


*       Cases suggestive of hypersensitivity may include: skin erythema, bradycardia, hypotension, dyspnoea, loss of consciousness, cardiac/cardio-respiratory arrest, anaphylactic reaction, anaphylactic shock.
**      In some of the cases of hypersensitivity, in patients with underlying coronary artery disease, myocardial ischemia and/or myocardial infarctions were also reported.
***     Allergic acute coronary syndrome

In very rare cases, fatal outcomes have been reported in temporal association with the use of SonoVue.
In all these patients there was a high underlying risk for major cardiac complications, which could have led to the fatal outcome.

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