Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gadoteridol
Bracco UK Ltd
V08CA04
Gadoteridol
.5mmol/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF:
OBJECT 1 PROHANCE SYRINGES Summary of Product Characteristics Updated 21-Dec-2017 | Bracco UK Limited 1. Name of the medicinal product ProHance 279.3 mg/ml, solution for injection in prefilled syringes 2. Qualitative and quantitative composition Gadoteridol 279.3mg/ml (0.5M) 3. Pharmaceutical form Sterile solution for intravenous injection 4. Clinical particulars 4.1 Therapeutic indications This medicinal product is for diagnostic use only. Using Magnetic Resonance Imaging (MRI), ProHance provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualization (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood-brain barrier. ProHance can also be used for whole body MRI including the head, neck, liver, breast, muscoloskeletal system and soft tissue pathologies. ProHance should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI). 4.2 Posology and method of administration Posology The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patient's body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section. _Adults_ The recommended dose of ProHance for imaging most brain and spinal pathologies is 0.1 mmol/kg. However, doses of 0.3 mmol/kg have been shown to be useful in patients suspected of having cerebral metastases or other poorly enhancing lesions. The recommended dose for whole body MRI is 0.1 mmol/kg. _Paediatric population _ _Children (2 years and above)_ The recommended dose of ProHance for brain imaging and spine pathologies is 0.1 mmol/kg (0.2 ml/kg). ProHance has been used in only a limited number of children aged between 6 months and 2 years. If an MRI procedure must be performed in this group, particular caution should be exercised. The safety and efficacy of doses higher than 0.1 mmol/kg and sequent read_full_document