Land: Israel
Språk: engelsk
Kilde: Ministry of Health
GADOTERIC ACID
PROMEDICO LTD
V08CA02
SOLUTION FOR INJECTION
GADOTERIC ACID 27.932 G / 100 ML
I.V
Required
GUERBET, FRANCE
GADOTERIC ACID
GADOTERIC ACID
Enhancement of contrast in magnetic resonance imaging. Aencephalic and spinal pathologies: brain tumours tumours of the spine and the surrounding tissue intervertebral disk prolapse infectious diseases. Abdominal pathologies: primary and secondary liver tumours. Osteo-articular pathology: bone and soft tissue tumours synovial diseases. Magnetic resonance imaging for angiography.
2013-02-28
_ _ _ _ 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCTS DOTAREM - VIALS, SOLUTION FOR INJECTION DOTAREM PRE-FILLED SYRINGES - SOLUTION FOR INJECTION IN PREFILLED SYRINGE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 100 mL of solution: Gadoteric acid* ........................................................................................................ 27.932 g corresponding to DOTA ................................................................................. 20.246 g corresponding to gadolinium oxide .................................................................. 9.062 g *Gadoteric acid: complex of gadolinium with 1,4,7,10-tetraazacyclododecane- N, N’,N’’,N’’’-tetraacetic acid. Concentration in the contrast agent: 0.5 mmol/mL For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for I.V injection in prefilled syringe or vial . Clear, colourless to pale yellow solution. Osmolality: 1350 mOsm.kg -1 Viscosity at 20°C: 3.2 mPa.s Viscosity at 37°C: 2.0 mPa.s pH: 6.5 to 8.0. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Enhancement of contrast in magnetic resonance imaging. Aencephalic and spinal pathologies: brain tumours tumours of the spine and the surrounding tissue intervertebral disk prolapse infectious diseases. Abdominal pathologies: primary and secondary liver tumours. Osteo-articular pathology: bone and soft tissue tumours synovial diseases. Magnetic resonance imaging for angiography. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg, in adults, children and infants. In angiography, depending on the results of the examination being performed, a second injection may be administered during the same session if necessary. In some exceptional cases, as in the confirmation of isolated metastasis or the detection of leptomeningeal tumours, a second injection of Les hele dokumentet