Gadodiamide

Introduction: Gadodiamide is a contrast agent used for cranial and spinal resonance imaging (MRI) and for general MRI of the body after intravenous administration. It provides contrast enhancement and facilitates visualisation of abnormal structures or lesions in various parts of the body including the CNS.

How it works: 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.

Important Information: 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.

• Cranial and spinal resonance imaging (MRI)
• General MRI of the body
• Lesions with abnormal vascularity - in the brain (intracranial lesions), spine and associated tissues

Contrast medium for diagnostic procedures

Gadolinium-based contrast agent

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.

Gadodiamide increases MRI signal intensity by decreasing proton relaxation times in tissues, allowing clear visualization of abnormal tissues and lesions.

Adults and Children Dose:

• Recommended dose: 0.1 mmol/kg body weight (0.2 ml/kg body weight) up to 100 kg.
• Above 100 kg: 20 ml is usually sufficient.
• Administer as a single intravenous injection.

Adults (when brain metastases are suspected):

• 0.3 mmol/kg body weight (0.6 ml/kg body weight) up to 100 kg.
• Above 100 kg: total of 60 ml is usually sufficient.

Children (2-16 years):

• 0.2 mL/kg (0.1 mmol/kg) as a bolus intravenous injection.

* Use as directed by the registered physician

Intravenous (IV) injection. Draw into syringe immediately before use. Vial is intended for one patient only. Use a separate syringe and needle.

If you miss a dose, consult your doctor.

Common Side Effects (>1% and <10%):

• Sensation of warmth, coolness or local pressure or pain at injection site
• Dizziness
• Nausea
• Headache
• Perverted sense of taste or smell

Serious Side Effects: Nephrogenic systemic fibrosis (NSF), anaphylactoid reactions.

Precautions:

• Avoid use in patients with chronic, severe kidney disease (GFR <30 mL/min/1.73m²) or acute kidney injury (risk of NSF).
• Caution in patients with known hypersensitivity or history of asthma/allergic disorders.
• Gadodiamide interferes with serum calcium measurements (do not test for 12-24 hours).
• Safety of repeated injections is not available.

Contraindications:

• Hypersensitivity to Gadodiamide or its constituents
• Chronic, severe kidney disease (GFR <30 mL/min/1.73m²)
• Acute kidney injury

Drug Interactions:

• Should not be directly mixed with other drugs.
• Use a separate syringe and needle.

Food Interactions: No interaction found/established.

Use in Pregnancy: Pregnancy category B3. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in Lactation: It is not known whether Gadodiamide is excreted in human milk. Breast-feeding should be discontinued prior to administration and not recommenced until at least 24 hours after administration.

Pediatric Use: Safety and efficacy have been established for whole body MRI in children from 6 months of age. No experience in children below 6 months with severe disease.

Geriatric Use: Elderly patients are more likely to have decreased renal function - caution in dose selection.

Renal Impairment: Avoid use in severe kidney disease (GFR <30 mL/min/1.73m²). Monitor renal function.

Hepatic Impairment: No known restrictions.

Overdose: Clinical consequences have not been reported. Acute toxicity unlikely with normal renal function. Can be eliminated by hemodialysis.

Storage: Store at room temperature (below 30°C) and protected from light. Vial is intended for one patient only. Discard unused portion.

Gadodiamide Injection