Name of the medicinal product: Ultravist^® 300/370 solution for injection / infusion

Composition: Ultravist^® 300, 370: 1 mL contains 0.623 g/ 0.769 g iopromide (equivalent to 300 mg / 370 mg iodine).

Each mL contains 0.000534 mmol (equivalent to 0.0123 mg) of sodium.

Indications: This medicinal product is for diagnostic use only.

Ultravist^® 300/370: For intravascular use and use in body cavities. Contrast enhancement in computerized tomography (CT), arteriography and venography, intravenous/intraarterial digital subtraction angiography (DSA); intravenous urography, use for ERCP, arthrography and examination of other body cavities.

Ultravist^® 370: Especially for angiocardiography.

Contraindications

• Ultravist^® is contraindicated for use in myelography, cerebral ventriculography, and cisternography.
• Ultravist^® is contraindicated in patients with manifest hyperthyroidism.
• Ultravist^® should not be administered to patients with known hypersensitivity to the drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
• Ultravist^® 300 and Ultravist^® 370 are contraindicated for intrathecal use.
• Preparatory dehydration, including prolonged fasting, restriction of fluids and the administration of a laxative before Ultravist^® Injection, is contraindicated in pediatric patients because of the risk of renal failure (see 7.1.3 Pediatrics).

Warnings

Nonionic iodinated contrast media (ICM) inhibit blood coagulation less than ionic contrast media. Clotting has been reported in vivo and in vitro when blood remains in contact with syringes, catheters or tubes containing nonionic contrast media. Nonionic contrast media are not suitable flush solutions.

Ultravist^® has been associated with serious and fatal reactions. Therefore, clear indication and evaluation of the benefit/risk ratio for every patient should precede each examination with contrast media. Also, it is of utmost importance that adequate facilities and appropriate personnel be readily available and a course of action be planned in advance for the immediate treatment of any serious untoward reaction. Diagnostic procedures utilizing a radiopaque contrast agent should be conducted only by a physician with the requisite training and a thorough knowledge of the particular procedure to be performed. The physician must also be thoroughly familiar with the emergency treatment of all adverse effects.

As with other iodinated contrast agents, the use of Ultravist^® contrast enhancement may obscure some lesions which were seen on previously unenhanced CT scans.

Because unenhanced scanning may provide adequate diagnostic information in the individual patient, the decision to employ contrast enhancement, which may be associated with risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological, and unenhanced CT findings. Careful optimization of contrast and radiation parameters can decrease radiation exposure.

Caution is advised in patients with cardiac and circulatory insufficiency, hypertension, pheochromocytoma, cerebral arteriosclerosis, latent hyperthyroidism, severe impairment of hepatic or renal function, pulmonary emphysema, diabetes with renal dysfunction requiring treatment, cerebral arterial spasm, bland nodular goiter, multiple myeloma or other paraproteinemias, and renal transplant.

Avoid angiography whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism.

Pronounced states of excitement, anxiety and pain may increase the risk of side effects or intensify contrast medium-related reactions. Care should be taken to minimize the state of anxiety in such patients.

Sensitivity testing using a small test dose of contrast medium is not recommended as it has no predictive value. Furthermore, sensitivity testing itself has occasionally led to serious and even fatal hypersensitivity/anaphylactoid reactions.

Dosage and Administration

• Solutions of Ultravist^®, like those of other radiopaque contrast agents, should be at or close to body temperature when injected. As with other sterile parenteral products, Ultravist^® should not be withdrawn from the vial except immediately prior to use (see 7 WARNINGS AND PRECAUTIONS, General). Ultravist^® should not be mixed with other medicinal products to avoid the risk of possible incompatibilities. Any unused portion should be discarded.
• For additional instructions see 11 STORAGE, STABILITY AND DISPOSAL.
• Vials containing contrast medium solutions are not intended for the withdrawal of multiple doses, with the exception of Ultravist^® Pharmacy Bulk Vials (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING, and 4.4 Administration, DIRECTIONS FOR MULTIPLE DISPENSING FROM PHARMACY BULK VIALS). The rubber stopper should never be pierced more than once. The use of a cannula or needle with a long tip and a maximum diameter of 18 G is recommended for piercing the stopper and drawing up the contrast medium. With the exception of Ultravist^® Pharmacy Bulk Vials (see 4.4 Administration, DIRECTIONS FOR MULTIPLE DISPENSING FROM PHARMACY BULK VIALS), any contrast solution not used in one examination for a given patient is to be discarded.
• In the case of abdominal angiography and urography, the diagnostic yield is increased if the bowels are empty of fecal matter and gas. It may be necessary to administer an enema or laxative in the evening prior to examination, provided purging of the bowels is not contraindicated.
• In infants and young children, prolonged fasting, restriction of fluids and the administration of a laxative before the examination are contraindicated. See 7.1.3 Pediatrics.
• Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be kept under observation for at least 30 minutes, since experience shows that the majority of all severe incidents occur within this time.
• The recommended dosages of Ultravist^® should not be exceeded. The volume of each individual injection is a more important consideration than the total dose used.
• Determine the volume and concentration of Ultravist^® to be used, taking into account factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel; consider also extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. As with all iodinated contrast agents, lower doses may have less risk. The efficacy of Ultravist^® below doses recommended has not been established.

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