Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
GADOTERIC ACID
ELDAN ELECTRONIC INSTRUMENTS CO LTD, ISRAEL
V08CA02
SOLUTION FOR INJECTION
GADOTERIC ACID 279.3 MG / 1 ML
I.V
Required
GE HEALTHCARE AS, NORWAY
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.
2020-02-04
_ _ _ _ 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCTS Clariscan 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of solution: Gadoteric acid* ....................................................................................................... 279.3 mg corresponding to gadoterate meglumine ...................................................... 376.9 mg corresponding to gadolinium oxide ............................................................... 90.62 mg corresponding to tetraxetan…………………………………………………….202.46 mg *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 a full list the excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for I.V injection in pre-filled syringe, vial or bottles (glass and polypropylene). Clear, colourless to slightly yellow solution. Osmolality: 1350 mOsm.kg -1 Viscosity at 20°C: 3.0 mPa.s Viscosity at 37°C: 2.1 mPa.s pH: 6.5 to 8.0. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS • Enhancement of contrast in magnetic resonance imaging. • Encephalic 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 injec Baca dokumen lengkap