Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
IODINE AS ETHYL ESTERS OF IODIZED FATTY ACIDS OF POPPY SEED OIL
PROMEDICO LTD
V08AD
SOLUTION FOR INJECTION
IODINE AS ETHYL ESTERS OF IODIZED FATTY ACIDS OF POPPY SEED OIL 480 MG/ML
INTRA-LYMPHATIC, INTRA-ARTERIAL
Required
GUERBET, FRANCE
NON WATERSOLUBLE X-RAY CONTRAST MEDIA
Lymphography.- Visualisation, localisation and vectorisation during Trans-Arterial Chemo-Embolisation (TACE) of hepatocellular carcinoma, in adults.
2013-02-19
THE FORMAT OF THIS LEAFLET HAS BEEN DEFINED BY THE MOH AND ITS CONTENT HAS BEEN CHECKED AND APPROVED, JULY 2013 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT LIPIODOL ULTRA-FLUID (480 mg I/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 iodized 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 - Lymphography 4.2. POSOLOGY AND METHOD OF ADMINISTRATION LIPIODOL ULTRA-FLUID must be administered by slow injection or by catheter, using an appropriate glass syringe and a catheter (see Section 6.2 – Incompatibilities). 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 subject), i.e. 10 to 14 mL for bilateral lymphography of the feet. Patients with low weight The dose must be reduced proportionally in this population. Elderly The product must be administered with special care in patients over 65 years of age with underlying diseases of the cardiovascular, respiratory or nervous systems. Keeping in mind that part of the product temporarily embolises the pulmonary capillaries, the dose must be adjusted in elderly patients with cardiorespiratory failure or the examination must be cancelled. 4.3. CONTRAINDIC Citiți documentul complet