UniRay Pre-Filled Injection

Adult administration

Adults and children (including infants) should be administered this drug at 0.1 mmol/kg (0.2 mL/kg) intravenously. In exceptional cases for adults, such as diagnosing meningeal tumors and confirming solitary metastatic lesions, an additional intravenous administration of 0.2 mmol/kg (0.4 mL/kg) may be considered. For angiography, an additional administration of 0.1 mmol/kg (0.2 mL/kg) may be given depending on the imaging results.

Child administration

Adults and children (including infants) should be administered this drug at 0.1 mmol/kg (0.2 mL/kg) intravenously.

This drug should be used with caution in patients with severely impaired renal function or those with simultaneous severe damage to both liver and kidney functions, as it can cause serious side effects in the body. In particular, patients with very low kidney function are at a higher risk of developing severe diseases affecting the skin, muscles, and internal organs due to the use of this drug. This drug must not be used for intrathecal administration as serious adverse reactions may occur. Additionally, there may be residual components of this drug in the brain of patients who have been administered this drug multiple times, therefore it should be used cautiously only when necessary. This drug should not be used in patients who have had allergic reactions to this drug or its components, or in patients for whom MRI is contraindicated. Special caution should be exercised when using this drug in specific patient groups such as those with severe systemic weakness, asthma, severe liver dysfunction, severe kidney dysfunction, allergic constitution, seizure disorders, heart disease, elderly individuals, and pediatric patients. This drug may commonly cause temporary and mild side effects such as injection site pain, nausea, headache, and rarely serious allergic reactions or risks like seizures or shock. Patients should be monitored for at least 30 minutes post-administration for adverse reactions. This drug should only be administered by qualified professionals in appropriate facilities, and premedication may be considered to reduce allergic reactions in patients with a history of allergies. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of using this drug, and breastfeeding should be paused for a while after administration. Pediatric patients should be used more cautiously as their renal function is immature, and the safety and efficacy have not been sufficiently established in children under 18 years. Elderly patients should be particularly monitored due to the possibility of decreased renal function. In the case of overdose, ensuring adequate hydration and electrolyte supplementation is necessary, and blood dialysis can be used to remove the drug. This drug should only be administered intravenously, and local reactions should be observed and appropriately managed in the case of extravasation. Any remaining drug after use should be disposed of, and infection prevention should be taken seriously in multiple uses.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by coughing and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination abnormalities.

Mild side effects

• Nausea
• headache
• injection site reactions
• cold sensation
• hypotension
• drowsiness
• dizziness
• warmth sensation
• heat sensation
• rash

This drug should be stored in a sealed container to prevent exposure to air or moisture, ideally at room temperature between 1 degree and 30 degrees Celsius. Therefore, avoid storing in places that are too hot or too cold.

Appearance

A colorless to light yellow slightly viscous solution in a colorless and transparent pre-filled injection.

Package unit

10ml/ vial x 5 vials, 15ml/ vial x 5 vials, 20ml/ vial x 5 vials