Posology : מינונים

4.2     Posology and method of administration
      Posology

The lowest dose that provides sufficient enhancement for diagnostic purposes should be used.
The recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg, in adults, children and infants.
In angiography, depending on the results of the 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 0.2 mmol/kg can be administered.

Special populations

Impaired renal function
Cyclolux should only be used in patients with severe renal impairment (GFR < 30 mL/min/1.73m2) 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 section 4.4).

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.

Pediatric population

Neonates up to 4 weeks of age and infants up to 1 year of age
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. 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.

Cyclolux is not recommended for angiography in children under the age of 18 because of insufficient data on the efficacy and safety in this indication.

Elderly (aged 65 years and above)
No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4).

Method of administration
The product must be administered by strict intravenous injection.