Primovist Injection

Adult administration

Administer this drug at a bolus intravenous injection of 0.1mL/kg at a speed of approximately 2mL/sec. After administration, additional normal saline should be infused.

Child administration

The safety and efficacy of this drug have not been established in patients under 18 years of age.

Administration of this drug to patients with acute or chronic severe renal impairment may increase the risk of nephrogenic systemic fibrosis, a serious condition affecting the skin, muscles, and internal organs. Therefore, it should be used with extreme caution in patients with severely impaired kidney function, patients with hepatorenal syndrome, and patients before and after liver transplantation, and should be avoided if not necessary. This drug should never be administered via epidural injection due to the risk of serious side effects. Cases of gadolinium accumulation have been reported in brain scans of patients receiving multiple doses, necessitating careful judgment during repeated administration. This drug should not be used in patients with hypersensitivity to gadobutrol or those with artificial pacemakers, ferromagnetic implants, or persistent hypokalemia. Particular caution should be exercised when administering to patients with severe renal impairment or cardiovascular diseases, as well as to those with a history of allergies or asthma, as the risk of hypersensitivity reactions is heightened. After administration, side effects such as vomiting, headache, elevated blood pressure, and dizziness may occur, and rare but serious allergic reactions like anaphylaxis can occur. This drug may remain in the body for an extended time in patients with decreased kidney function, so renal function tests should be performed prior to administration, and this drug can be removed by hemodialysis. Use during pregnancy is only recommended if necessary, as its effects on the fetus are unclear, and breastfeeding should be suspended for 24 hours after administration. Since adverse reactions frequently occur within 30 minutes after the administration of this drug, patients should be monitored closely for at least 30 minutes post-administration. This drug should not be mixed with other medications, and discoloration or foreign materials must be checked before administration. In case of suspected overdose, there is a risk of cardiac arrhythmia, so immediate patient observation and enhanced cardiac monitoring should be conducted. Before administration, it is essential to carefully review the patient's medical history and clinical test results, and prepare medications and equipment needed for treating allergic reactions in case of emergencies. Finally, this drug should be opened immediately before use without dilution, as it is single-use, and any remaining solution must be disposed of.

Serious side effects

Hives, severe swelling (edema), chest discomfort, difficulty breathing, cold sweat, pallor, anaphylactic reaction, respiratory distress, jaundice (including yellow spots on the white part of the eyes), severe edema, headache, dizziness, hypotension, elevated blood pressure, vasodilation, fever, chills, bronchial asthma, shock, laryngeal and pharyngeal edema.

Mild side effects

• Vomiting
• headache
• burning sensation
• elevated blood pressure
• dizziness
• light-headedness
• abnormal sensations
• taste disorders
• olfactory disturbances
• inability to sit still

This drug should be stored in a sealed container to avoid contact with air and is best kept at room temperature between 1 to 30 degrees Celsius. This is to maintain the drug's effectiveness and prevent degradation.

Appearance

A clear liquid filling in a glass prefilled syringe or plastic prefilled syringe, which is colorless to light yellow or brownish or yellowish brown or yellow-green.

Package unit

Glass prefilled syringe: 10mL X 1 Plastic prefilled syringe: 10mL X 1