OPTIRAY

Adverse Drug Reaction Overview Optiray is an iodinated contrast agent with an adverse reaction profile similar to other non-ionic contrast media. Adverse events associated with the use of any contrast agent may occur with Optiray. Most adverse reactions following the use of Optiray are of mild or moderate intensity, however, serious, life-threatening and fatal adverse reactions, mostly of cardiovascular origin, have been reported.

Although most adverse reactions occur soon after the administration of t he contrast medium, some adverse reactions can be delayed and can be of long -lasting nature. The reported incidence of adverse reactions to contrast media in patients with a history of allergy is twice that of the general population.

Patients with a histo ry of previous reactions to a contrast medium are three times more susceptible to adverse reactions than other patients. The incidence of serious adverse reactions is higher with coronary arteriography than with other procedures.

Cardiac decompensation, serious arrhythmias, myocardial ischemia, or myocardial infarction, may occur during coronary arteriography and left ventriculography. Adverse reactions to specific procedures are also discussed under DOSAGE AND ADMINISTRATION.

Injection of Optiray, as with other contrast media, is commonly associated with sensations of warmth and pain. Clinical Trial Adverse Drug Reactions Table 1 lists reactions based upon phase II and III clinical trials with Optiray formulations in 1506 adult patients to support the marketing authorization application.

These adverse reactions are listed regardless of their direct attributability to the drug or the procedure and are coded according to the MedDRA (ver. 1) system organ classes. Table 1 - Clinical Trial Adverse Drug Reactions Supporting Marketing Authorization System Adverse Reactions* Cardiac disorders angina pectoris arrhythmia Page 14 of 55 System Adverse Reactions* atrioventricular block complete bradycardia vascular trauma** Ear and labyrinth disorders vertigo Eye disorders periorbital oedema vision blurred Gastrointestinal disorders nausea vomiting General disorders and administration site conditions chills extravasation face oedema injection site haematoma malaise Injury, poisoning and procedural complications vascular pseudoaneurysm Musculoskeletal and connective tissue disorders muscle spasms Nervous system disorders aphasia cerebral infarction dizziness dysgeusia headache paresthesia presyncope Psychiatric disorders disorientation visual hallucination Respiratory, thoracic and mediastinal disorders coughing dyspnoea hypoxia laryngeal oedema nasal congestion pulmonary oedema sneezing Skin and subcutaneous tissue disorders pruritus urticaria Vascular disorders arterial spasm flushing hypertension hypotension * Less Common Adverse Drug Reactions with a frequency of less than or equal to 1%.