The paramagnetic properties of Gadodiamide provides contrast enhancement during MRI. There were no clinically significant deviations from pre-injection values in haemodynamic and blood and urine laboratory parameters following intravenous injection of gadodiamide in healthy volunteers. However, a minor transient change in serum iron levels 8 to 48 hours after gadodiamide injection was observed.

Gadodiamide does not cross the intact blood-brain barrier. Administration of Gadodiamide causes signal enhancement from areas where blood-brain barrier dysfunction has been induced by pathological processes, and may provide greater diagnostic yield than unenhanced MRI. Lack of enhancement need not indicate absence of pathology since some types of low grade malignancies or inactive MS-plaques fail to enhance; it can be used for differential diagnosis between different pathologies.

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.

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)

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.

Nephrogenic systemic fibrosis, Hypersensitivity reactions

Overdose Effects

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. There is no antidote for this contrast medium. 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.

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.

Use in Special Populations

Use in Children: The safety and effectiveness of Gadodiamide have been established for whole body magnetic resonance imaging in children from 6 months of age.The safety and effectiveness in infants and neonates have been established in the evaluation of lesions within the brain and spine.

There is no experience with Gadodiamide in children below 6 months of age with severe hepatic or renal disease, or with premature infants below 4 weeks, or those with a post-conceptional age of less than 30 weeks.

Use in elderly patients: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

Pregnancy & Lactation

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.