Roniskan^®

Roniscan® (Gadodiamides) used in MRI of the central nervous system, the thoracic cavity (non-cardiac), the abdomen, the pelvis, and the retroperitoneal space to improve the visibility of lesions.

• Magnetic resonance imaging (MRI) of the central nervous system, thoracic cavity (non-cardiac) abdomen, pelvis, and retroperitoneal space
• Magnetic resonance angiography (MRA)
• Musculoskeletal imaging

Vial containing 15 mL injectable solution — 287 mg/mL.

Roniscan® is a ready-to-inject solution and does not require preparation.

Roniscan® is for intravenous injection only. Strictly avoid intrathecal injection of this product, as it may cause sensory and motor nerve disorders, seizure, and coma.

Roniscan® solution is colorless to pale yellow. Before injection, inspect the vial contents for color, precipitate, or foreign particles. Do not inject if particles or discoloration are observed.

Inject the medicine immediately after drawing it into the syringe and discard any remaining amount.

To ensure complete administration of Roniscan®, 5 mL of 0.9% sodium chloride may be injected afterward.

The imaging procedure should be completed within one hour after Roniscan® injection.

• Signs of hypersensitivity reactions during and for several hours after Gadodiamide injection
• Kidney function before contrast-agent injection
• Short- and long-term signs of nephrogenic systemic fibrosis (NSF) including itching, swelling, skin hardening, joint stiffness, pain in the pelvic bone or ribs, and muscle weakness
• Pregnancy status before use

• History of hypersensitivity to Gadodiamide or any other component of the formulation
• Acute or chronic severe kidney failure (creatinine clearance below 30 mL/min)
• Infants younger than 4 weeks old

• In patients with kidney failure or inflammatory diseases, pregnant women, and children, the medicine may remain longer in different parts of the body. Therefore, Gadodiamide-enhanced imaging in these patients should be performed as few times as possible.
• Gadolinium-containing contrast agents may increase the risk of nephrogenic systemic fibrosis (NSF). Use of these agents is recommended only when essential diagnostic information is needed and cannot be obtained through non-contrast MRI or other methods.
• During Gadodiamide injection and for several hours afterward, the patient should be closely monitored, especially people with a history of drug hypersensitivity, asthma, or allergy. If severe hypersensitivity reactions occur with skin, respiratory, or cardiovascular manifestations, Gadodiamide injection should be stopped immediately and appropriate treatment should be started.
• Creatinine clearance should be calculated for patients at risk of reduced kidney function (such as people over 60 years old, patients with high blood pressure, or patients with diabetes) and decisions should be made based on the results.

• Consult your physician before using Gadodiamide during pregnancy or breastfeeding.
• Gadodiamide may cross the placenta. It should be used only in a limited manner and at the discretion of a specialist physician when the benefits of injection outweigh the possible risks to the fetus.
• Gadodiamide may be excreted in breast milk. The decision to use this medicine during pregnancy or breastfeeding should be made by weighing the benefits of treatment for the mother against the risk of adverse effects in the fetus or infant.

Like all medicines, Gadodiamide may cause unwanted side effects along with its desired effects, although not everyone experiences them. Possible side effects include:

• Headache and dizziness
• Abdominal pain, nausea, or vomiting
• Local injection-site reactions
• Shortness of breath

Consult your physician or pharmacist about using Gadodiamide together with other medicines or supplements.

Each package contains 1 vial of Roniscan®.

• Store below 25°C, protected from light and moisture.
• Protect the medicine from freezing.
• The medicine may be used until the end of the month stated in the expiry date on the package. Do not use or store expired medicines.
• Keep the medicine out of the reach of children.
• Keep the medicine in its original packaging until use.

1. Gadodiamide: Drug information, UpToDate 2025
2. Drugs.com Gadodiamide information.