Active Ingredient: Gadoversetamide
Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualization and helps with the characterization of focal lesions and abnormal structures in the CNS and liver in adult patients and in children of two years and older with known or highly suspected pathology.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
0.2 - 0.2 mL per kg of body weight
From 0.2 To 0.2 mL per kg of body weight once every day
The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/kg (100 micromol/kg) body weight. To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ml (0.9%) solution for injection. The imaging procedure should be completed within 1 hour of administration of the contrast medium.
In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrast-enhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.2ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
The safety of repeat doses has not been established in children and adolescents (2 years and older), in patients with renal impairment, or the elderly. The repeat dose is not recommended in these populations.
Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of the dose of 300 micromol/kg body weight of gadoversetamide may lead to higher diagnostic confidence.
No dose adjustment is considered necessary in children more than 2 years of age.
Gadoversetamide is contraindicated in neonates up to 4 weeks of age.
Use of gadoversetamide is not recommended in children less than 2 years of age because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
No dose adjustment is considered necessary. Caution should be exercised in elderly patients.
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