Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Iodixanol
GE Healthcare AS
V08AB; V08AB09
Iodixanol
270 mg I/ millilitre(s)
Solution for injection
Product subject to Restricted Prescription (C)
Watersoluble, nephrotropic, low osmolar X-ray contrast media; iodixanol
Marketed
1995-09-19
PACKAGE LEAFLET: INFORMATION FOR THE USER VISIPAQUE 270 MG I/ML SOLUTION FOR INJECTION GLASS CONTAINER VISIPAQUE 320 MG I/ML SOLUTION FOR INJECTION GLASS CONTAINER VISIPAQUE 270 MG I/ML SOLUTION FOR INJECTION POLYPROPYLENE CONTAINER VISIPAQUE 320 MG I/ML SOLUTION FOR INJECTION POLYPROPYLENE CONTAINER iodixanol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • Ask your doctor if you need more information or advice. • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Visipaque is and what it is used for 2. What you need to know before you use Visipaque 3. How to use Visipaque 4. Possible side effects 5. How to store Visipaque 6. Contents of the pack and other information 1. WHAT VISIPAQUE IS AND WHAT IT IS USED FOR Visipaque is a “contrast agent” for diagnostic use in adults and children. It is used only to help identify an illness and not in connection with treatment. • Once injected, it can help your doctor tell apart normal or abnormal appearance and shape of some organs in your body. • You can have Visipaque before examination of your urinary system, joints, ovarian tubes, spinal cord, blood vessels, including blood vessels of your heart and the gullet, stomach and the intestine. • This medicine can also be given to you before or during a scan of your head or body using “computed tomography” (CT-scan). Your doctor might give you Visipaque for something else. Ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VISIPAQUE DO NOT USE VISIPAQUE: • If you suffer from severe thyroid gland problems. • If you are allergic (hypersensitive) to iodixanol or any of the other ingredients of Visipaque (listed in section 6). • If you have acute pelvic inflammatory disease you should not have X-ray examination of your uterus and ovarian tubes. If you are uncert Perskaitykite visą dokumentą
HealthProductsRegulatoryAuthority 20October2023 CRN00DQVN Page1of12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT VISIPAQUE270mgI/mlSolutionforInjection,polypropylenecontainer 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Activeingredient Strength Contentpr.ml. Iodixanol(INN) 270mgI/ml 550mgequiv.270mgI Iodixanol(INN) 320mgI/ml 652mgequiv.320mgI Iodixanolisanon‐ionic,dimeric,hexaiodinated,water‐solubleX‐raycontrastmedium.Pureaqueoussolutionsofiodixanolin allclinicalrelevantconcentrationshavealowerosmolalitythanwholebloodandthecorrespondingstrengthsofthenon‐ionic monomericcontrastmedia.VISIPAQUEismadeisotonicwithnormalbodyfluidsbyadditionofelectrolytes.Theosmolalityand viscosityvaluesofVISIPAQUEareasfollows: Concentration Osmolality* mOsm/kgH2O 37°C Viscosity(mPas) 20°C 37°C 270mgI/ml 290 11.3 5.8 320mgI/ml 290 25.4 11.4 *Method:Vapour‐pressureosmometry. ThepHoftheproductis6.8‐7.6. 270mgI/ml:Thismedicinalproductcontains0.76mg(0.03mmol)sodiumperml.Tobetakenintoconsiderationbypatients onacontrolledsodiumdiet. 320mgI/ml:Thismedicinalproductcontains0.45mg(0.02mmol)sodiumperml.Tobetakenintoconsiderationbypatients onacontrolledsodiumdiet(SEESECTION4.4). Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Solutionforinjection. VISIPAQUEissuppliedreadytouseasclear,colourlesstopaleyellowaqueoussolutions. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Thismedicinalproductisfordiagnosticuseonly. X‐ Perskaitykite visą dokumentą