País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
organically combined iodine.
Guerbet
V08AD
organically combined iodine.
38 percent weight/weight
Solution for injection
Product subject to Restricted Prescription (C)
Non-watersoluble X-ray contrast media
Marketed
1996-05-07
PACKAGE LEAFLET: INFORMATION FOR THE USER LIPIODOL ULTRA FLUID 38% W/W, SOLUTION FOR INJECTION Iodised ethyl-esters of fatty acids of poppy seed oil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET : 1. What Lipiodol Ultra Fluid is and what it is used for 2. What you need to know before you use Lipiodol Ultra Fluid 3. How to use Lipiodol Ultra Fluid 4. Possible side effects 5. How to store Lipiodol Ultra Fluid 6. Contents of the pack and other information 1. WHAT LIPIODOL ULTRA FLUID IS AND WHAT IT IS USED FOR Lipiodol Ultra Fluid is a diagnostic agent. It belongs to the group of contrast agents used for radiological examinations. Lipiodol Ultra Fluid is used to enhance the contrast of the images obtained during radiological examinations. This contrast enhancement improves the visualisation and outline of certain body parts. Lipiodol Ultra Fluid is used in radiological examinations of the uterus and Fallopian tubes when searching for causes of infertility. When mixed with certain medicines used to treat liver cancer, Lipiodol Ultra Fluid carries and delivers the anti-cancer medicine into the area to be treated as part of a TACE procedure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIPIODOL ULTRA FLUID You should read the information in this section carefully. You and your doctor should take the information into consideration before you are given Lipiodol Ultra Fluid. DO NOT USE LIPIODOL ULTRA FLUID: If you are allergic to iodised ethyl-esters of the fatty acids of poppy seed oil (the active substance), If you have an overactive thyroi Leer el documento completo
Health Products Regulatory Authority 09 June 2022 CRN00C437 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipiodol Ultra Fluid 38% w/w Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 100% iodised ethyl-esters of the fatty acids of poppy-seed oil containing approximately 38% w/w organically combined iodine. This product does not contain any excipient. 3 PHARMACEUTICAL FORM Solution for injection. A pale yellow, clear oily liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In diagnostic radiology: Lipiodol Ultra Fluid is an X-ray contrast medium for use in certain radiological investigations where it is desired to outline a viscous or other structure with directly instilled radio-opaque material. Lipiodol Ultra Fluid is used in hysterosalpingography in women undergoing infertility workup. From most sites in the body it is slowly absorbed, but from the peritoneal cavity (after hysterosalpingography) absorption is relatively rapid. On account of its low viscosity Lipiodol ultra Fluid is suitable for introduction into narrow channels and may therefore be used in ducts and sinuses. In interventional radiology: Visualisation, localisation and carrier of cytotoxic medicine during Trans-Arterial Chemo-Embolisation (TACE) of hepatocellular carcinoma at intermediate stage, in adults (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION IN DIAGNOSTIC RADIOLOGY: The volume to be administered depends on the particular requirements of the technique and the size of the patient. Recommended dosages - Lymphography: 3 to 10 mL (maximum 20 mL) - Hysterosalpingography: Inject increments of 2 mL of Lipiodol Ultra Fluid into the endometrial cavity under fluoroscopic control until tubal patency is determined. The total volume to be injected depends on the volume of the uterine cavity, usually not exceeding 15 mL. The dose of Lipiodol Ultra Fluid for hysterosalpingography should be kept as low as possible to minimize the potential risk of thyroid dysfunction; thi Leer el documento completo