Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Iodixanol 305 mg/mL equivalent to 150 mg/mL Iodine
GE Healthcare Limited t/a GE Healthcare - Medical Diagnostics
Iodixanol 305 mg/mL (=150 mg/mL Iodine)
150 mg/mL
Solution for injection
Active: Iodixanol 305 mg/mL equivalent to 150 mg/mL Iodine Excipient: Calcium chloride dihydrate Hydrochloric acid Sodium calcium edetate Sodium chloride Trometamol Water for injection
Bottle, glass, 50, 200, 500 mL,
General sale
General sale
GE Healthcare AS
Package - Contents - Shelf Life: Bottle, glass, 50, 200, 500 mL - - 36 months from date of manufacture stored at or below 30°C - Vial, glass, - 20 mL - 36 months from date of manufacture stored at or below 30°C
1998-10-21
1 1 NEW ZEALAND DATASHEET 1 PRODUCT NAME VISIPAQUE™ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION lodixanol Injection 270 mg I/ml, 320 mg I/ml 3 PHARMACEUTICAL FORM VISIPAQUE injectable solution is provided as a ready-to-use sterile, pyrogen-free, colourless to pale yellow solution, in concentrations of 270 and 320 mg of organically bound iodine per ml (550 and 652 mg of iodixanol per ml, respectively). All solutions of iodixanol are hypotonic to blood. Sodium chloride and calcium chloride have been added resulting in an isotonic solution for injection. VISIPAQUE (270 mg I/ml) contains 0.07 mg calcium chloride dihydrate per ml and 1.87 mg sodium chloride per ml, and VISIPAQUE (320 mg I/ml) contains 0.04 mg calcium chloride dihydrate per ml and 1.10 mg sodium chloride per ml providing for both concentrations a sodium/calcium ratio equivalent to blood. In addition, each millilitre contains 1.2 mg trometamol and 0.1 mg sodium calcium edetate; the pH is adjusted between 6.8 and 7.7 with hydrochloric acid and/or sodium hydroxide at 22ºC. All solutions are terminally sterilised by autoclaving and contain no preservatives. PHYSICAL PROPERTIES OF VISIPAQUE The two concentrations of VISIPAQUE, 270 mg I/ml and 320 mg I/ml have the following physical properties: Parameter Concentration (mg I/ml) 270 320 Osmolality (mOsm/kg water) (vapour pressure at 37ºC) 290 290 Viscosity (mPa-s) at 20ºC at 37ºC 11.3 5.8 25.4 11.4 Density (g/ml) at 20°C 1.369 1.356 At 37°C 1.314 1.303 4 CLINICAL PARTICULARS 4.1 Therapeutic indications This medicinal product is for diagnostic use only. VISIPAQUE is indicated, in adult patients, for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, VISIPAQUE may be used for both conventional radiography and digital subtraction angiography (DSA). In children, VISIPAQUE is indicated for cardioangiography, urography, CT-enhancement and studies of the u Read the complete document