CNS (Central Nervous System): Gadodiamide is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues. Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic And Retroperitoneal Regions): Gadodiamide is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space.
Contrast medium for diagnostic procedures
This is a clear, colourless to slightly yellow aqueous solution containing Gadodiamide USP 287 mg/ml equivalent to 0.5 mmol/ml. For Magnetic resonance imaging, visualization of normal and pathological brain and spinal tissue depends, in part, on variations in the radiofrequency signal intensity. Gadodiamide decreases both the T1 and T2 relaxation times in tissues where it is distributed. At clinical doses, the effect is primarily on the T1 relaxation time, and produces an increase in signal intensity.
No special preparation of the patient is required. Gadodiamide should be drawn into the syringe immediately before use.The vial is intended for one patient only. Contrast medium not used in one examination must be discarded. CNS (Central Nervous System): Adults: The recommended dose of Gadodiamide is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. Pediatric Patients (2-16 years): The recommended dose of Gadodiamide is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic And Retroperitoneal Regions): Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of Gadodiamide is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of Gadodiamide is 0.2 mL/kg (0.1 mmol/kg)
Asymptomatic transitory increases in serum iron and bilirubin have been reported in patients receiving Gadodiamide. Gadodiamide should not be directly mixed with other drugs. A separate syringe and needle should be used.
Chronic, severe kidney disease (glomerular filtration rate < 30 ml/ min/1.73 m2), or acute kidney injury prior hypersensitivity reaction, should not be used in patients known to have hypersensitivity to Gadodiamide or its constituents. Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m2) as well as patients with acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function.
Nephrogenic systemic fibrosis, Hypersensitivity reactions.
Pregnancy category B3. No effects of Gadodiamide on reproductive performance were seen in rats at doses up to 1.0 mmol/kg. In rabbits, there is an increased incidence of litters with skeletal or visceral abnormalities at doses up to 0.5 and 1.0 mmol/kg. However, these effects are possibly attributable to maternal toxicity rather than a direct effect of the drug. There are no adequate and well-controlled studies of Gadodiamide in pregnant women. Gadodiamide should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus. Use in Lactation: It is not known whether Gadodiamide is excreted in human milk. Breast-feeding should be discontinued prior to administration and should not be recommenced until at least 24 hours after the administration of Gadodiamide.
Clinical consequences of overdose have not been reported and acute symptoms of toxicity are unlikely in patients with a normal renal function. Treatment is symptomatic. In patients with delayed elimination due to renal insufficiency and in patients who have received excessive doses, the contrast medium can be eliminated by haemodialysis.
Gadodiamide should be stored at room temperature (below 30°C) and protected from light. The vial is intended for one patient only. Any unused portion must be discarded.
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