Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Iodised oil 38%{relative} (eqv to 48% w/v iodine);
Obex Medical Ltd
Iodised oil 38% w/w
38% w/w
Solution for injection
Active: Iodised oil 38%{relative} (eqv to 48% w/v iodine)
Ampoule, 1 x 10mL, 10 mL
General sale
General sale
Simafex
In diagnostic radiology LIPIODOL ULTRA FLUID is used in lymphography, hysterosalpingography in women undergoing infertility workup and sialography.
Package - Contents - Shelf Life: Ampoule, glass, 1 x 10mL - 10 mL - 36 months from date of manufacture stored at or below 30°C
1965-11-15
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME LIPIODOL ULTRA FLUID (480 mg iodine/mL), solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Corresponding to an iodine content of .................................................................................... 480 mg/mL in the form of ethyl esters of iodised fatty acids of poppy seed oil per ...............................................1 mL One 10 mL ampoule contains ....................................................................................... 4800 mg of iodine Viscosity at 15°C: 70 cP (centipoise) Viscosity at 37°C: 25 cP Relative density at 15°C: 1.280 This medicinal product does not contain any excipients. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS In diagnostic radiology LIPIODOL ULTRA FLUID is used in lymphography, hysterosalpingography in women undergoing infertility workup and sialography. In interventional radiology Visualisation and localisation during Trans-Arterial Chemo Embolisation (TACE) of hepatocellular carcinoma (HCC) at intermediate stage in adults. 4.2. DOSE AND METHOD OF ADMINISTRATION LIPIODOL ULTRA FLUID must be administered by slow injection or by catheter, using glass syringes or other devices which have studies demonstrating the compatibility with LIPIODOL ULTRA FLUID. Instructions for use applicable to those devices should be followed (see Section 6.2). In diagnostic radiology: • Lymphography Administer via a catheter inserted into a lymph duct. A dye can first be injected to locate the lymph ducts. The usual dose is 5 to 7 mL via the strict lymphatic route to enhance contrast in an extremity (depending on the height of the patient), i.e. 10 to 14 mL for bilateral lymphography of the feet. The dose must be reduced proportionally in children. In infants 1 to 2 years of age, a dose of 1 mL per extremity is sufficient. • Hysterosalpingography Inject increments of 2 mL of LIPIODOL ULTRA FLUID into the endometrial cavity under fluoroscopic control until tu Διαβάστε το πλήρες έγγραφο