Safety


Adverse reactions in most patients receiving Rapiscan in clinical trials were mild, transient (usually resolving within 30 minutes after receiving Rapiscan), and required no medical intervention. Adverse reactions occurred in approximately 80% of patients. The most common adverse reactions reported during clinical development in a total of 1,651 patients/subjects were: dyspnoea (29%), headache (27%), flushing (23%), chest pain (19%), electrocardiogram ST segment changes (18%), gastrointestinal discomfort (15%) and dizziness (11%)

Please see Summary of Product Characteristics (SPC) for details of Adverse Events

Adverse events should be reported to your local regulatory authority

In Denmark

Reporting forms and information can be found at http://laegemiddelstyrelsen.dk/da/topics/bivirkninger-og-forsoeg.
Adverse events should also be reported by phone +45 32 50 66 10,
fax +45 52 52 18 48, or by email to dupharma(at)dupharma.dk

Elsewhere in Europe

Adverse events should be reported to your local regulatory authority.
Adverse events should also be reported to safety@rapiscan-mpi.com