Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Iobitridol
Guerbet
V08AB; V08AB11
Iobitridol
300 milligram(s)/millilitre
Solution for injection
Product subject to Restricted Prescription (C)
Watersoluble, nephrotropic, low osmolar X-ray contrast media; iobitridol
Not marketed
1996-10-10
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER XENETIX 250 (250 MGI/ML), SOLUTION FOR INJECTION XENETIX 300 (300 MGI/ML), SOLUTION FOR INJECTION XENETIX 350 (350 MGI/ML), SOLUTION FOR INJECTION lobitridol 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 or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Xenetix is and what it is used for 2. What you need to know before you use Xenetix 3. How to use Xenetix 4. Possible side effects 5. How to store Xenetix 6. Contents of the pack and other information 1. WHAT XENETIX IS AND WHAT IT IS USED FOR Xenetix belongs to the class of iodinated contrast agents. These medicinal products are used during radiological examinations. Xenetix enhances the contrast of images obtained during these examinations, which improves the visualisation and delineation of the contours of certain parts of the body. This medicinal product is for diagnostic use only. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE XENETIX DO NOT USE XENETIX • if you have previously developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Xenetix. • if you are allergic to the active substance (iobitridol) or any of the other ingredients in Xenetix. See the list of ingredients in Section 6. 'Further information'. • if you have had an allergic reaction to a medicinal product containing the same active substance (iobitridol) (also see Section 4. 'Possible side effects'). • if you have excessive levels of thyroid hormones (thyrotoxicosis). • if you are pregnant, or if you think you are pregnant, and if you are scheduled Read the complete document
Health Products Regulatory Authority 22 May 2023 CRN00D4L8 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xenetix 300mg I/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per ml 20 ml 50 ml 60 ml 75 ml 100 ml 150 ml 200 ml 500 ml Iobitridol corresponding to Iodine 658.1 mg 300 mg 13.16 g 6 g 32.90 g 15 g 39.49 g 18 g 49.36 g 22.5 g 65.81 g 30 g 98.71 g 45 g 131.6 g 60 g 329 g 150 g Excipient with known effect: Sodium (up to 3.5mg per 100mL). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adults and children undergoing: Intravenous urography Brain and whole body CT Intravenous digital subtraction angiography Arteriography Angiocardiography. Arthrography Hysterosalpingography This medicinal product is for diagnostic use only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and Children: The dosage may vary depending on the type of examination, the age, weight, cardiac output and general condition of the patient and the techniques used. As with all contrast media, the lowest dose necessary to obtain visualisation should be used. Adequate hydration should be assessed before and after administration. The dosage guidelines are based on the dosages used in low molecular weight contrast media in current use, and on the dosages used during clinical trials with Xenetix. Health Products Regulatory Authority 22 May 2023 CRN00D4L8 Page 2 of 10 As a guideline, the dosages observed during the clinical trials were as follows: Indications Recommended dosage Urography Adults Minimum dose: 1 ml/kg. It may be necessary to increase the dose in individual cases e.g. obesity or impaired renal function. Children The poor concentrating ability of immature nephron of infantile kidneys necessitates the use of relatively high doses of contrast medium, i.e.: Neonates: 4.0 ml/kg Babies: 3.0 ml/kg Small children: 1.5 m Read the complete document