Gadoteric acid is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Each 1 ml solution for injection contains 279.32 mg of gadoteric acid (as meglumine salt), equivalent to 0.5 mmol of gadoteric acid (as meglumine salt).

Gadoterate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues. When placed in a magnetic field, gadoterate shortens the T1 and T2 relaxation times in target tissues.

For adult and pediatric patients (including term neonates), the recommended dose of this preparation is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1-2 mL/second for pediatric patients. To ensure complete injection, the injection may be followed by a normal saline flush. Contrast MRI can begin immediately following injection.

The most frequent adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and burning sensation.

Pregnancy Category C. There are no adequate and well-controlled studies with this preparation conducted in pregnant women. Limited published human data on exposure to other GBCAs during pregnancy did not show adverse effects in exposed neonates. No effects on embryo-fetal development were observed in rats or rabbits at doses up to 10 mmol/kg/day in rats or 3 mmol/kg/day in rabbits. The doses in rats and rabbits were respectively 16 and 10 times the recommended human dose based on body surface area. This preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Gadoteric Acid is excreted in human milk. Limited case reports on the use of GBCAs in nursing mothers indicate that 0.01 to 0.04% of the maternal gadolinium dose is excreted in human breast milk. Because many drugs are excreted in human milk, exercise caution when Gadoteric Acid is administered to a nursing woman. Nonclinical data show that gadoterate meglumine is excreted into breast milk in very small amounts (0.1% of the dose intravenously administered), and absorption via the gastrointestinal tract is poor.

Nephrogenic Systemic Fibrosis has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeat dosing appears to increase the risk. Hypersensitivity: Anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred. Monitor patients closely for the need for emergency cardiorespiratory support.

In the case of actual overdose, this preparation can be removed from the body by haemodialysis (blood cleaning).

Store at 25°C. Should solidification occur in the vial because of exposure to the cold, Gadoteric Acid should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, Gadoteric Acid should return to a clear, colourless to yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. Should solids persist, discard the vial.