Description

VISIPAQUE is a specialized iodinated contrast medium designed to enhance the clarity of radiographic imaging. With its active ingredient, iodixanol, this non-ionic, dimeric, hexaiodinated solution is both water-soluble and isotonic, ensuring compatibility with the body's natural fluids. It is meticulously formulated to be sterile and free from pyrogens, making it suitable for safe intravascular injection.

Imaging Enhancement

This contrast medium is invaluable in a wide range of diagnostic procedures, significantly improving the visibility of blood vessels and internal structures. It is particularly beneficial in:

• Angiocardiography
• Arteriography (peripheral, visceral, cerebral)
• Contrast-enhanced computed tomography (CT)
• Excretory urography
• Venography

Its applications extend to both adult and pediatric patients, including neonates and infants, providing critical imaging support in cardioangiography, urography, and gastrointestinal studies.

Administration

VISIPAQUE is administered via intra-arterial or intravenous injection, typically within hospital or clinical settings by healthcare professionals. The dosage is tailored to the patient's specific needs, considering factors such as age, weight, and the particular imaging requirements. It is often used with automated injection systems, and strict sterile techniques are employed, as each vial or bottle is intended for single use only.

Concentrations and Packaging

The product is available in two primary concentrations:

• 270 mg iodine/mL
• 320 mg iodine/mL

These are provided in various packaging options, including glass vials, polypropylene bottles, ampoules, and injection bags, accommodating different volume needs from 10 mL to 200 mL.

Chemical Properties

The solution appears clear to slightly yellow, with a pH ranging from 6.8 to 7.7. It contains no preservatives and includes excipients such as trometamol, sodium chloride, and calcium chloride dihydrate to maintain its stability and performance.

Mechanism of Action

The iodine content in VISIPAQUE enhances the contrast of blood vessels and organs in X-ray and CT images, aiding healthcare providers in accurate diagnosis. It is rapidly distributed in the extracellular fluid and primarily excreted unchanged in urine, with minimal interaction with plasma proteins.

Safety and Precautions

While generally safe, VISIPAQUE should be used with caution in patients with specific health conditions, such as renal impairment or a history of allergic reactions. Adequate hydration is recommended around the time of administration to mitigate potential risks, and careful monitoring of renal function is advised, especially in vulnerable groups.

Storage Instructions

Store VISIPAQUE below 30°C, shielded from light, and avoid freezing. It can be kept in a contrast media warmer at 37°C for up to a month if needed. Once opened, the solution should be used within four hours to maintain its integrity, aligning with its designation for single-procedure use.