Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
GADOTERIDOL
Bracco International B.V.
279.3 mg/m Mg/Ml
Solution for Injection
1993-02-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ProHance, 279.3 mg/ml, Solution for Injection, 5 ml vial 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gadoteridol 279.3 mg per ml (0.5 mmol) 1396.5 mg per 5 ml. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Using Magnetic Resonance Imaging (MRI), ProHance provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualisation (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood-brain barrier. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults The recommended dose of ProHance for imaging most brain and spinal pathologies is 0.1 mmol/kg (0.2 ml/kg). However, in patients suspected of having cerebral metastases or other poorly enhancing lesions 0.3 mmol/kg (0.6 ml/kg) is recommended. To ensure complete injection of the contrast medium, the injection should be followed by a 5ml normal saline flush. The imaging procedure should be completed within 1 hour after injecting ProHance. Children The safety and effectiveness of ProHance in children have not been established. Special Populations Impaired renal function ProHance should only be used in patients with severe renal impairment (GFR < 30 ml/min/1.73m 2 ) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non contrast enhanced MRI (see section 4.4). If it is necessary to use Prohance, the dose should not exceed 0.1mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information Baca dokumen lengkapnya