Clariscan Dosage/Direction for Use

This medicinal product should only be administered by trained healthcare professionals with technical expertise in performing and interpreting gadolinium enhanced MRI.
Dosage: The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patient's body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section.
Adults: MRI of brain and spine: The recommended dose is 0.1 mmol/kg BW, i.e. 0.2 mL/kg BW. In patients with brain tumors, an additional dose of 0.2 mmol/kg BW, i.e. 0.4 mL/kg BW, may improve tumor characterisation and facilitate therapeutic decision making.
Whole body MRI (including lesions of the liver, kidneys, pancreas, pelvis, lungs, heart, breast, and musculoskeletal system): The recommended dose is 0.1 mmol/kg BW, i.e. 0.2 mL/kg BW to provide diagnostically adequate contrast.
For angiography: The recommended dose for intravenous injection is 0.1 mmol/kg BW, i.e. 0.2 mL/kg BW to provide diagnostically adequate contrast.
In exceptional circumstances (e.g. failure to gain satisfactory images of an extensive vascular territory) administration of a second consecutive injection of 0.1 mmol/kg BW, i.e. 0.2 mL/kg BW may be justified. However, if the use of 2 consecutive doses of Gadoteric Acid (Clariscan) are anticipated prior to commencing angiography, the use of 0.05 mmol/kg BW (i.e. 0.1 mL/kg BW) for each dose may be of benefit, depending on the imaging equipment available.
Special populations: Impaired renal function: The adult dose applies to patients with mild to moderate renal impairment (GFR ≥ 30 ml/min/1.73 m²).
Gadoteric Acid (Clariscan) should only be used in patients with severe renal impairment (GFR < 30 mL/min/1.73 m²) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI (see Precautions). If it is necessary to use Gadoteric Acid (Clariscan) the dose should not exceed 0.1 mmol/kg body weight.
More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Gadoteric Acid (Clariscan) injections should not be repeated unless the interval between injections is at least 7 days.
Elderly (aged 65 years and above): No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see Precautions).
Impaired hepatic function: The adult dose applies to these patients. Caution is recommended, especially in the case of perioperative liver transplantation period (see Impaired renal function as previously mentioned).
Paediatric population (aged 0-18 years): Encephalic and Spinal MRI, Whole body MRI: The recommended and maximum dose of Gadoteric Acid (Clariscan) is 0.1 mmol/kg body weight. More than one dose should not be used during a scan.
Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Gadoteric Acid (Clariscan) should only be used in these patients after careful consideration, at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Gadoteric Acid (Clariscan) injections should not be repeated unless the interval between injections is at least 7 days. Use for whole body MRI is not recommended in children less than 6 months of age.
Angiography: Gadoteric Acid (Clariscan) is not recommended for angiography in children under 18 years of age due to insufficient data on its efficacy and safety in this indication (see Precautions).
Method of administration: The product is indicated for intravenous administration only. Infusion rate: 3-5 mL/min (higher infusion rates up to 120 mL/min, i.e. 2 mL/sec, may be used for angiographic procedures).
Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be kept under observation for at least half an hour, since experience shows that the majority of undesirable effects occur within this time.
For single patient use only, any unused solution should be discarded.
Paediatric population (0-18 years): Depending on the amount of Gadoteric Acid (Clariscan) to be given to the child, it is preferable to use Gadoteric Acid (Clariscan) vials with a single use syringe of a volume adapted to this amount in order to have a better precision of the injected volume.
In neonates and infants the required dose should be administered by hand.
Image acquisition: Contrast enhanced MRI may be initiated immediately after administration of the agent. Optimal imaging: within 45 minutes after injection. Optimal image sequence: T1-weighted.