Cyclolux Dosage/Direction for Use

Posology: 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: Cyclolux should always be administered by medically qualified personnel.
The doses are determined by the physician and are adapted to each individual's needs.
The recommended dose is 0.2ml/kg (0.1mmol/kg) in adult, children and infant.
In angiography, depending on the result of examination being performed, a second injection may be administered during the same session if necessary.
In some exceptional cases, as in the confirmation of isolated metastasis or the detection of leptomeningeal tumours, a second injection of 0.4ml/kg (0.2mmol/kg) can be administered.
Special populations: Impaired renal function: The adult dose applies to patients with mild to moderate renal impairment (GFR ≥ 30 ml/min/1.73 m²).
Cyclolux 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 Cyclolux, 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, Cyclolux 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.
Impaired hepatic function: The adult dose applies to these patients. Caution is recommended, especially in the case of perioperative liver transplantation period.
Paediatric population (0-18 years): MRI of brain and spine/whole-body MRI: the recommended and maximum dose of Gadoteric acid 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, Cyclolux should only be used in these patients after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. Because of the lack of information on repeated administration, Cyclolux injections should not be repeated unless the interval between injections is at least 7 days.
Angiography: Cyclolux is not recommended for angiography in children under 18 years of age due to insufficient data on efficacy and safety in this indication.
Method of administration: This product must be administered by intravenous injection only.
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.
Paediatric population (0-18 years): Depending on the amount of gadoteric acid to be given to the child, it is preferable to use gadoteric acid 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.
This product is for single-use.