Land: Armenía
Tungumál: enska
Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
iodixanol
GE Healthcare Ireland Limited
V08AB09
iodixanol
320mg iodine/ml
solution for injection
(10) glass vials 50ml, (10) plastic vials 50ml
Prescription
Registered
2019-11-27
V ISIPAQUE 270 AND 320 MG I/ML SOLUTION FOR INJECTION SPC IRELAND Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT VISIPAQUE 270 mg I/ml and 320 mg I/ml Solution for Injection, glass container and polypropylene container 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Strength Content pr. ml. Iodixanol (INN) 270 mg I/ml 550 mg equiv. 270 mg I Iodixanol (INN) 320 mg I/ml 652 mg equiv. 320 mg I Iodixanol is a non-ionic, dimeric, hexaiodinated, water-soluble X-ray contrast medium. Pure aqueous solutions of iodixanol in all clinical relevant concentrations have a lower osmolality than whole blood and the corresponding strengths of the non-ionic monomeric contrast media. VISIPAQUE is made isotonic with normal body fluids by addition of electrolytes. The osmolality and viscosity values of VISIPAQUE are as follows: Concentration Osmolality * mOsm/kg H 2 O 37°C Viscosity (mPa ⋅ s) 20°C 37°C 270 mg I/ml 290 11.3 5.8 320 mg I/ml 290 25.4 11.4 * Method: Vapour - pressure osmometry. 270 mg I/ml: This medicinal product contains 0.76 mg (0.03 mmol) sodium per ml. To be taken into consideration by patient on a controlled sodium diet. 320 mg I/ml: This medicinal product contains 0.45 mg (0.02 mmol) sodium per ml. To be taken into consideration by patient on a controlled sodium diet (SEE SECTION 4.4). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. VISIPAQUE is supplied ready to use as clear, colourless to pale yellow aqueous solutions. The pH of the product is 6.8-7.6. V ISIPAQUE 270 AND 320 MG I/ML SOLUTION FOR INJECTION SPC IRELAND Page 2 of 17 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. X-ray contrast medium for use in adults for cardioangiography, cerebral angiography (conventional), peripheral angiography, (conventional), abdominal angiography (i.a. DSA),urography, venography, CT-enhancement and studies of the gastrointestinal tract , Lumbar, thoracic and cervical myelograp Lestu allt skjalið