Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Gadoteric acid (as meglumine salt)
FARMACO HEALTHCARE SDN. BHD.
Gadoteric acid (as meglumine salt)
1 x 15 ml Vials; 10 x 10 ml Vials; 1 x 10 ml Vials; 10 x 15 ml Vials; 1 x 20 ml Vials; 10 x 20 ml Vials
Sanochemia Pharmazeutika GmbH
CYCLOLUX 0.5 MMOL/ML SOLUTION FOR INJECTION 1. NAME OF THE MEDICINAL PRODUCT CYCLOLUX 0.5 mmol/ml solution for injection 2. QUALITATIVE AND QUANTI- TATIVE COMPOSITION 1 ml solution for injection contains 279.32 mg gadoteric acid (as me- glumine salt) corresponding to Gad- olinium (III) oxide 90.62mg, DOTA 202.21mg, Meglumine 97.6mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gadoteric acid (as meglumine salt) is a clear, colourless to pale yellowish solution, free from visible particulates. Contrast medium concentration 279.32 mg/ml 0.5 mmol/ml Osmolality at 37°C 1.35 Osm/kg H 2 O Viscosity at 37°C 1.8 mPas pH value 6.5 – 8.0 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Cyclolux should be used only when diagnos- tic information is essential and not available with unenhanced magnetic resonance imag- ing (MRI). Magnetic resonance imaging for: • Cerebral and spinal disease • Disease of the vertebral column • and other whole-body pathologies (in- cluding Angiography) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The lowest dose that provides sufficient en- hancement 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 Cyclolux should always be administered by med- ically qualified personnel. The doses are determined by the physician and are adapted to each individual’s needs. The recommended dose is 0.2ml/kg (0.1mmol/kg) in adult, children and infant. In angiography, depending on the result of ex- amination being performed, a second injection may be administered during the same session if necessary. In some exceptional cases, as in the confirma- tion of isolated metastasis or the detection of leptomeningeal tumours, a second injection of 0.4ml/kg (0.2mmol/kg) can be administered. SPECIAL POPULATIONS Impaired renal function The adult dose applies to patients Lesen Sie das vollständige Dokument