1. Dotarem Injection 2. Dotarem Prefilled Syringe

Adult administration

For adults, administer 0.1 mmol/kg (0.2 mL/kg) intravenously. In cases of meningeal tumor diagnosis or confirmation of solitary metastatic lesions, an additional 0.2 mmol/kg (0.4 mL/kg) can be administered intravenously. During angiography, an additional 0.1 mmol/kg (0.2 mL/kg) can be administered based on imaging results.

Child administration

For children (ages 0 to under 18), administer 0.1 mmol/kg (0.2 mL/kg) intravenously.

This medicine has the risk of causing a serious side effect called nephrogenic systemic fibrosis if administered to patients with severely impaired kidney function or those with combined liver and kidney dysfunction. It is advisable to avoid using this medication in such patients, and if necessary, it should be used with caution. This drug should not be injected into the spinal canal, as it may lead to serious adverse reactions. Repeated administration may result in abnormal signals in specific areas of the brain, although the clinical significance of this is not yet clear. It should not be given to patients with allergies to this drug or its components or those with metallic foreign bodies contraindicated for MRI. Particularly frail patients, those with asthma, severe liver or kidney disorders, allergic individuals, those with a history of convulsive disorders, cardiovascular diseases, the elderly, and children should use this medication with caution. Common side effects include injection site reactions, nausea, headache, and rare cases of severe allergic reactions, convulsions, and shock; patients must be monitored for at least 30 minutes after administration. The risk of side effects may increase with repeated dosing or high doses, so strict dosage limits must be adhered to, and kidney function should be assessed to ensure patient safety. In preparation for emergencies, appropriate medications and emergency equipment should be available, and administration should be performed by experienced professionals. Pregnant or breastfeeding women should carefully consider the potential effects on the fetus or infant before using this medication, and breastfeeding should preferably be paused for a period after administration. The safety and efficacy for children have not been sufficiently demonstrated, so if necessary, the minimum dose should be used with adequate intervals between doses. The elderly may have decreased kidney function, so kidney function should be confirmed before administration. In cases of overdose, fluids and electrolytes should be replenished, and kidney function monitored, with blood dialysis considered to remove this drug if needed. This medication must be administered only intravenously, and care should be taken to avoid local reactions in case of leakage at the injection site. Any leftover medication should be discarded, and prefilled syringes are for single use only and should not be reused.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, cough with fever and breathing difficulties, yellowing of skin or eyes (jaundice), extreme fatigue, sudden severe headache, thunderclap headache, seizures, disorientation, visual disturbances, paralysis, urination

Mild side effects

• Nausea
• headache
• injection site reaction
• cold sensation
• hypotension
• drowsiness
• dizziness
• warm sensation
• heat sensation
• rash

This drug should be stored in a sealed container that prevents air entry and kept at room temperature between 1°C and 30°C for optimal effect.

Appearance

Dotarem Injection: A colorless, slightly viscous liquid in a colorless vial, Dotarem Prefilled Syringe: A colorless glass or plastic tube (part of the prefilled syringe system) with both ends sealed.

Package unit

Dotarem Injection - 5 milliliters/vial [X manufacturer packaging unit], Dotarem Injection - 10 milliliters/vial [X manufacturer packaging unit], Dotarem Injection - 15 milliliters/vial [X manufacturer packaging unit], Dotarem Injection - 20 milliliters/vial [X manufacturer packaging unit], Dotarem Prefilled Syringe - 10 milliliters/prefilled syringe [X manufacturer packaging unit], Dotarem Prefilled Syringe - 15 milliliters/prefilled syringe [X manufacturer packaging unit], Dotarem P