Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
IOPAMIDOL
DEXCEL LTD, ISRAEL
V08AB04
SOLUTION FOR INJECTION
IOPAMIDOL 612.4 MG/ML
I.V
Required
BRACCO IMAGING S.P.A., ITALY
IOPAMIDOL
IOPAMIDOL
X-ray contrast medium in neuroradiology, angiography, urography, ct scanning, arthrography and fistulography
2021-09-30
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Iopamiro 300 mg/ml solution for injection Iopamiro 370 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Iopamiro 300 mg/mL Solution for Injection Iopamiro 370 mg/mL Solution for Injection Active ingredient IOPAMIDOL equal to IODINE 612.4 mg/mL 300.0 mg/mL 755.3 mg/mL 370.0 mg/mL For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear aqueous solution filled into colourless glass ampoules or bottles. Iodine concentratio n Iopamidol concentration PH Viscosity cP Density Osmometric values at 37° C mg l/mL mg l/mL 20° C 37° C 20° C 37° C Osmolality (osmol.kg -1 ) Π (atm) 300 _ _ 612.4 _ _ 7±0.5 _ _ 8.8 _ _ 4.7 _ _ 1.335 _ _ 1.328 _ _ 0.616 15.7 370 _ _ 755.3 _ _ 7±0.5 _ _ 20.9 _ _ 9.4 _ _ 1.415 _ _ 1.405 _ _ 0.796 20.3 4. CLINICAL PARTICULARS 4.1 Therapeutic indications This medicinal product is for diagnostic use only. X-ray contrast medium in neuroradiology, angiography, urography, CT scanning, arthrography and fistulography. 4.2 Posology and method of administration Neuroradiology Concentration(mg I/ml) Recommended Dose (ml) mieloradiculography 300 5 - 15 cisternography and ventriculography 300 5 - 15 2 Angiography Concentration (mg I/ml) Recommended Dosage (ml) Cerebral arteriography 300 5 - 10 per bolus Coronary arteriography 370 8 - 15 per bolus Thoracic aortography 370 1.0 – 1.2/kg Abdominal aortography 370 1.0 – 1.2/kg Angiocardiography 370 1.0 - 1.2/kg Selective visceral arteriography 300-370 depends on the vascular area to be examined Peripheral arteriography 300-370 40 – 50 Digital Subtraction Angiography 150-370 depends on the vascular area to be examined Venography (phlebography) 300 30 - 50 Urography The recommended dosage for this type of investigation is 30-50 ml for adults. The less marked osmotic diuresis induced by the non ionic agent makes Iopamiro ® 370 especially suitable for patients with mild or moderately severe renal insufficiency and for neo Կարդացեք ամբողջական փաստաթուղթը