PRIMOVIST SOLUTION FOR INJECTION IN VIAL 0.25 mmol/ml

INJECTION, SOLUTION

**4.2 Dosage and method of administration** **4.2.1 Method of administration** This medicinal product is for intravenous administration. The dose is administered undiluted as a bolus injection. After the injection of the contrast medium the intravenous cannula/line should be flushed using physiological saline solution. After bolus injection of Primovist, dynamic imaging during arterial, portovenous, and equilibrium phases utilizes the different temporal enhancement pattern of different liver lesion types to obtain information about their classification (benign/malignant) and the specific characterization. It further improves visualization of hypervascular liver lesions. The delayed (hepatocyte) phase starts at about 10 minutes post injection (in confirmatory studies most of the data were obtained at 20 minutes post injection) with an imaging window lasting at least 120 minutes. The imaging window is reduced to 60 minutes in patients requiring hemodialysis and in patients with elevated bilirubin values (> 3 mg/dl) (see also section “Interaction with other medicinal products and other forms of interaction” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The enhancement of liver parenchyma during the hepatocyte phase assists in the identification of the number, segmental distribution, visualization, and delineation of liver lesions, thus improving lesion detection. The different enhancement/ washout patterns of liver lesions contribute to the information from the dynamic phase. Hepatic excretion of Primovist results in enhancement of biliary structures. The usual safety rules for magnetic resonance imaging must be observed, e.g. exclusion of cardiac pacemakers and ferromagnetic implants. For additional instructions see section “Instructions for use/handling” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **4.2.2 Dosage regimen** Adults: 0.1 ml per kg body weight Primovist (equivalent to 25 micromole per kg body weight) **4.2.3 Additional information on special populations** 4.2.3.1 Pediatric population Primovist is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy. 4.2.3.2 Elderly population (aged 65 years and above) No dosage adjustment is necessary. In clinical studies, no overall differences in safety or efficacy were observed between elderly (aged 65 years and above) and younger patients, and other reported clinical experience has not identified differences between the elderly and younger patients (see also section “Pharmacokinetic properties” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 4.2.3.3 Patients with hepatic impairment No dosage adjustment is necessary. In clinical studies, no overall differences in safety or efficacy were observed between patients with and without hepatic impairment, and other reported clinical experience has not identified differences in patients with hepatic impairment and healthy subjects (see also section “Pharmacokinetic properties” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 4.2.3.4 Patients with renal impairment In clinical studies, no overall differences in safety and efficacy were observed between patients with renal impairment and patients with normal kidney function. The elimination of gadoxetate disodium is prolonged in renally impaired patients. To ensure diagnostically useful images, no dosage adjustment is recommended (see also section “Special warnings and precautions for use” and section “Pharmacokinetic properties” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).