Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
GADOPENTETATE DIMEGLUMINE
Sanochemia Pharmazeutika AG
GADOPENTETATE DIMEGLUMINE
500 Micromol
Solution for Injection
Product subject to Restricted Prescription (C)
Withdrawn
2014-07-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Magnetolux 500 micromol/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains 469 mg of gadopentetate dimeglumine equivalent to 500 micromol, equivalent to 78.63 mg gadolinium. 5 ml solution for injection contain 2,345 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 393.15 mg gadolinium. 10 ml of solution for injection contain 4,690 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 786.30 mg gadolinium. 15 ml of solution for injection contain 7,035 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 1179.45 mg gadolinium. 20 ml of solution for injection contain 9,380 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 1572.60 mg gadolinium. 30 ml of solution for injection contain 14,070 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 2358.90 mg gadolinium. 100 ml of solution for injection contain 46,900 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 7863.00 mg gadolinium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Magnetolux is a contrast medium for cranial and spinal magnetic resonance imaging (MRI). Magnetolux is also indicated for whole body MRI including head and neck region, thoracic space including the heart, female breast, abdomen (pancreas and liver), retroperitoneal space (kidney), pelvis (prostate, bladder and uterus) and musculoskeletal system by intravenous administration. Gadopentetate dimeglumine facilitates visualisation of abnormal st Прочитайте повний документ