MULTIHANCE INJECTION 15 ML

INJECTION

**4.2 Posology and method of administration** Posology MRI of the liver: the recommended dose of MultiHance injection in adult patients is 0.05 mmol/kg body weight. This corresponds to 0.1 mL/kg of the 0.5 M solution. MRI of the brain and spine: the recommended dose of MultiHance injection in adult and in paediatric patients greater than 2 years of age is 0.1 mmol/kg body weight. This corresponds to 0.2 mL/kg of the 0.5 M solution. MRA: the recommended dose of MultiHance injection in adult patients is 0.1 mmol/kg body weight. This corresponds to 0.2 mL/kg of the 0.5 M solution. MRI of the breast: the recommended dose of MultiHance in adult patients is 0.1 mmol/kg body weight. This corresponds to 0.2 mL/kg of the 0.5 M solution. Method of administration MultiHance should be drawn up into the syringe immediately before use and should not be diluted. Any unused product should be discarded and not be used for other MRI examinations. To minimise the potential risks of soft tissue extravasation of MultiHance, it is important to ensure that the i.v. needle or cannula is correctly inserted into a vein. Liver and Brain and Spine: the product should be administered intravenously either as a bolus or slow injection (10 mL/min.). MRA: the product should be administered intravenously as a bolus injection, either manually or using an automatic injector system. The injection should be followed by a saline flush. Post-contrast imaging acquisition:  Special Populations Impaired renal function Use of MultiHance should be avoided in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If use of MultiHance cannot be avoided, the dose should not exceed 0.1 mmol/kg body weight when used for MR of the brain and spine, MR-angiography or breast MRI and should not exceed 0.05 mmol/kg body weight when used for MR of the liver. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, MultiHance 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 (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Pediatric population No dosage adjustment is considered necessary. Use for MRI of the brain and spine is not recommended in children less than 2 years of age. Use for MRI of the liver, MRI of the breast or MRA is not recommended in children less than 18 years of age.