Active Ingredient: Gadopiclenol
Gadopiclenol is for diagnostic use only.
Gadopiclenol is indicated in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:
It should be used only when diagnostic information is essential and not available with unenhanced MRI.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient age in years is ≥ 2, intravenous, 0.05 moles gadopiclenol per kilogram of body weight, one dose.
The recommended dose is 0.05 mmol/kg body weight (BW) to provide diagnostically adequate contrast for all indications.
The dose should be calculated based on the patient’s BW and should not exceed the recommended dose per kilogram of BW detailed in this section.
The recommended and maximum dose is 0.05 mmol/kg BW for all indications. More than one dose should not be used during a scan.
No dose adjustment is necessary. Caution should be exercised in elderly patients.
Contrast-enhanced MRI can start after the injection depending on the pulse sequences used and the protocol for the examination. Optimal signal enhancement is generally observed during arterial phase and within a period of about 15 minutes after injection. Longitudinal relaxation times (T1)-weighted sequences are particularly suitable for contrast-enhanced examinations.
Intravenous administration of contrast agent should, if possible, be done with the patient lying down. Since experience shows that most undesirable effects occur within minutes after administration, the patient should be kept under observation during and following administration for at least half an hour.
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