OPTIRAY® is a sterile, non-pyrogenic, aqueous solution intended for intravascular and subarachnoid administration. 

Composition:(*) OPTIRAY® 240 Ioversol, 509 mg/ml, which is equivalent to 240 mg/ ml of organically bound iodine. OPTIRAY® 300 Ioversol, 636 mg/ml, which is equivalent to 300 mg/ml of organically bound iodine. OPTIRAY® 320 Ioversol, 678 mg/ml, which is equivalent to 320 mg/ml of organically bound iodine. OPTIRAY® 350 Ioversol, 741 mg/ml, which is equivalent to 350 mg/ml of organically bound iodine. 

Indications (*): OPTIRAY® non-ionic X-ray contrast medium for diagnostic use only. 

OPTIRAY® 350 is indicated in adults for angiography, including intra-arterial, digital subtraction angiography (IA-DSA), throughout the cardiovascular system, except selective cerebral angiography. OPTIRAY® 350 is also indicated for contrast enhanced computed tomographic imaging of the head and body, intravenous excretory urography, intravenous digital subtraction angiography and venography. OPTIRAY® 350 is indicated in children for angiocardiography. 

OPTIRAY® 320 is indicated in adults for angiography, including digital subtraction angiography (DSA), throughout the cardiovascular system. The uses include but are not limited to cerebral, coronary, peripheral, visceral and renal arteriography, venography, aortography, and left ventriculography. OPTIRAY® 320 is also indicated for contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography. OPTIRAY® 320 is indicated in children for angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography. 

OPTIRAY® 300 is indicated for cerebral, peripheral, and abdominal arteriography, including digital subtraction angiography (DSA), in adults. OPTIRAY® 300 is also indicated for contrast enhanced computed tomographic imaging of the head and body, venography, and intravenous excretory urography. OPTIRAY® 300 is indicated in children for cerebral, peripheral and abdominal angiography, including digital subtraction angiography (DSA), computed tomography of the head and body, and intravenous excretory urography. 

OPTIRAY® 240 is indicated for cerebral, peripheral, and abdominal angiography, including intra-arterial, digital subtraction angiography (IA-DSA), and venography in adults. OPTIRAY® 240 is also indicated for contrast enhanced computed tomographic imaging of the head and body and intravenous excretory urography. OPTIRAY® 240 is indicated in children for cerebral, peripheral and abdominal angiography, including digital subtraction angiography (DSA), computed tomography of the head and body, and intravenous excretory urography. OPTIRAY® 240 is indicated for subarachnoid administration in adults for lumbar, thoracic and cervical myelography, in some countries. 

Posology and Method of Administration (*): The dosage may vary between 1 ml and 150 ml, maximum total dose 250 ml or less depending on the indications, the composition of OPTIRAY®, the patient’s factors and other technical factors. Please refer to the Summary of Product Characteristics for the recommended dosage schedule. 

Contraindications: Hypersensitivity to ioversol or to any of the excipients. Manifest hyperthyroidism. Special Warnings and Precautions for Use: Serious or fatal reactions have been associated with the administration of iodine containing radiopaque media. It is of utmost importance to be completely prepared to treat any contrast medium reaction.  Caution must be exercised in patients with hyperthyroidism or with an autonomously functioning thyroid nodule, severely impaired renal function, renal and hepatic disease, multiple myeloma or other paraproteinemia, anuria, pheochromocytoma, sickle cell disease, cardiovascular disorders (cases of Kounis syndrome). Meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Diagnostic procedures which involve the use of iodinated intravascular contrast agents should be carried out under the direction of personnel skilled and experienced in the particular procedure to be performed. A fully equipped emergency cart, or equivalent supplies and equipment, and personnel competent in recognizing and treating adverse reactions of all types should always be available. Since severe delayed reactions have been known to occur, emergency facilities and competent personnel should be available for at least 30 to 60 minutes after administration. Renal insufficiency: preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients and in susceptible nondiabetic patients (often elderly with pre-existing renal disease). Patients should be well hydrated prior to and following the administration of OPTIRAY®. Intolerance to iodinated contrast agents: the possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered. Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration.  Increased risk is associated with a history of previous reaction to a contrast medium, and known allergies (i.e., bronchial asthma, hay fever and food allergies) or hypersensitivities. The occurrence of severe idiosyncratic reactions has prompted the use of several pre-testing methods. However, pre-testing cannot be relied upon to predict severe reactions and may itself be hazardous to the patient. It is suggested that a thorough medical history with emphasis on allergy and hypersensitivity, prior to the injection of any contrast medium, may be more accurate than pre-testing in predicting potential adverse reactions. A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent when a diagnostic procedure is thought essential, but caution should be exercised. Pre-medication with antihistamines or corticosteroids to avoid or minimize possible allergic reaction in such patients should be considered. Reports indicate that such pre-treatment does not prevent serious life-threatening reactions but may reduce both their incidence and severity. Anaesthetised patient: general anaesthesia may be indicated in the performance of some procedures in selected patients. However, a higher incidence of adverse reactions has been reported in these patients and may be attributable to the inability of the patient to identify untoward symptoms or to the hypotensive effect of anaesthesia. Cardiovascular diseases: in angiographic procedures, the risk of dislodging plaques or damaging or perforating the vessel wall should be considered during catheter manipulations and contrast medium injection. Test injections to ensure proper catheter placement are suggested. Angiography should be avoided whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism. Patients with congestive heart failure should be observed for several hours following the procedure to detect delayed hemodynamic disturbances which may be associated with a transitory increase in the circulating osmotic load. About procedural risks, selective coronary arteriography should be performed only in selected patients and those in whom the expected benefits outweigh the procedural risk. The inherent risks of angiocardiography in patients with chronic pulmonary emphysema must be weighed against the necessity for performing this procedure. Extravasation: caution during injection of a contrast medium is necessary to avoid extravasation. This is especially important in patients with severe arterial or venous disease. Central nervous system disorders: encephalopathy has been reported with the use of ioversol. Paediatric population: Hypothyroidism or transient thyroid suppression may be observed after exposure to iodinated contrast media. This adverse reaction has been more frequently observed in neonates and premature infants, or following diagnostic procedures associated with higher doses. It may also be observed in new-borns whose mothers have received an iodinated contrast medium during pregnancy. Younger age, very low birth weight, prematurity, and the presence of other conditions, such as, admission to neonatal or pediatric intensive care units, and cardiac conditions are associated with an increased risk. Pediatric patients with cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures, such as catheterization, and computed tomography (CT). Thyroid function should be evaluated in all pediatric patients after exposure to iodinated contrast media, especially in premature infants and neonates. If hypothyroidism is detected, thyroid function should be monitored as appropriate even when replacement treatment is given.

Subarachnoid administration: myelography should not be performed when lumbar puncture is contraindicated as in the presence of local or systemic infection where bacteremia is likely. Myelography should be performed only in hospitalized patients under close medical observation, which is to be continued for 24 hours following the procedure. Caution must be exercised in patients with history of seizure, epilepsy, and elderly patients. Please refer to the Summary of Product Characteristics for complete information. 

Interactions with other medicinal products and other forms of interaction: metformine, interleukin, diuretics, vasopressors. The results of protein-bound iodine (PBI) and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast media. Please refer to the Summary of Product Characteristics for complete information. 

Pregnancy and Breastfeeding: There are no adequate and well controlled studies in pregnant women. 

Literature reports show that ioversol crosses the placenta, reaches foetal tissues in small amounts, and is visualized in the digestive tract of exposed infants after birth. Many injectable contrast agents cross the placental barrier in humans and appear to enter fetal tissue passively. This drug should be used during pregnancy only if clearly needed. The transient iodine overload following administration to the mother may induce foetal dysthyroidism if the examination takes place after more than 14 weeks of amenorrhoea. However, in view of the reversibility of the effect and expected benefit to the mother, the isolated administration of an iodinated contrast agent is justifiable if the indication for the radiological examination in a pregnant woman has been carefully evaluated. Thyroid function of neonates should be closely monitored if iodinated contrast was administered to the mother during pregnancy.

Although it has not been established that adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast media are administered to nursing women because of potential adverse reactions, and consideration should be given to temporarily discontinuing nursing. There are no adequate and well controlled clinical studies on fertility.

Effects on ability to drive and use machines: There is no known effect on the ability to drive and operate machines. However, because of the risk of early reactions, driving or operating machinery is not advisable for 30 to 60 min following administration.

Undesirable effects: Adverse reactions following the use of OPTIRAY® are generally independent of the dose administered. Usually, they are mild to moderate, of short duration and resolve spontaneously (without treatment). However, even mild adverse reactions may be the first indication of a serious, generalized reaction that can occur rarely after iodinated contrast media.  Such serious reactions may be life-threatening and fatal, and usually affect the cardiovascular system.  Most adverse drug reactions to OPTIRAY® formulations occur within minutes after administration, however, contrast related hypersensitivity reactions may occur with a delay of some hours up to several days. Injections of contrast media are very commonly associated with sensations of warmth, and commonly associated with pain. 

Adverse reactions may be classified as follows: • Hypersensitivity or anaphylactoid reactions are mostly mild to moderate with symptoms like rash, pruritus, urticaria, rhinitis and blister. These symptoms may occur independent of dose and route of administration and may be the first signs of an evolving shock with symptoms like pronounced decrease in blood pressure, tachycardia, dyspnoea, pallor and decrease in consciousness. Fatal cases were reported. • Vasovagal reactions with symptoms ranging from dizziness and hypotension to syncope. Vasovagal reactions may be caused either by the contrast media or by the procedure. • Cardiologic side effects during cardiac catheterization may include ECG changes, arrhythmia, conductivity disorders as well as coronary spasm. Such reactions may be caused by the contrast media or by the procedure. • Nephrotoxic reactions with acute renal failure may occur in patients with pre-existing renal damage. • Neurotoxic reactions after intra-arterial injection of the contrast medium like confusion, visual disorders, convulsions, or fits. The symptoms are generally transient and abate spontaneously within several hours or days. Patients with pre-existing damage of the blood-brain barrier are at increased risk of developing neurotoxic reactions. • Local reactions at the injection site may occur and include rashes, swelling, inflammation and oedema. Such reactions occur probably in most cases due to extravasation of the contrast agent. Extended paravasation may necessitate surgical treatment. For Paediatric population: Thyroid dysfunction has been observed in younger children following the administration of iodinated radiopaque agents. For subarachnoid administration: Any adverse reactions known to occur with the intravascular use of OPTIRAY® can also occur during myelography, especially those which originate in the CNS. The most commonly observed adverse reaction was headache, which had an incidence of 8.6%. Please refer to the Summary of Product Characteristics for complete information. 

Overdose: The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular system. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. 

Pharmacological properties: Pharmacotherapeutic group: water-soluble, nephrotropic, low-osmolar X-ray contrast media ATC code: V08AB07. 

Incompatibilities: No medicinal product should be mixed with OPTIRAY®. 

Nature and content of container: (*) OPTIRAY® is supplied in glass bottles and plastic pre-filled syringes. 

Marketing authorization holder: (*) Information: Guerbet – BP 57400 – F-95943 Roissy CdG cedex - France. Tel: 33 (0) 1 45 91 50 00. Date of revision: 19/02/2026

For current and complete prescribing information refer to the local Summary of Product Characteristics (SmPC) and /or contact your local Guerbet organization.

(*) Marketing Authorization Information: The marketing authorization holder, number and date of approval may differ from one country to another. Volume, presentation, indication and Posology and Method of Administration may also differ. 

Reporting of suspected adverse reactions is important as it helps to continuously assess the benefit-risk balance. Therefore, Guerbet encourages you to report any adverse reactions to your health authorities or to our local Guerbet representative.