Pays: Malte
Langue: anglais
Source: Medicines Authority
IOHEXOL
GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norway
V08AB02
IOHEXOL 350 mg I/ml
SOLUTION FOR INJECTION
IOHEXOL 350 mg I/ml
POM
CONTRAST MEDIA
Authorised
2006-09-20
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OMNIPAQUE 300 MG I/ML SOLUTION FOR INJECTION OMNIPAQUE 350 MG I/ML SOLUTION FOR INJECTION Iohexol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING OMNIPAQUE 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. See section 4. WHAT IS IN THIS LEAFLET : 1. What Omnipaque is and what it is used for 2. What you need to know before you use Omnipaque 3. How to use Omnipaque 4. Possible side effects 5. How to store Omnipaque 6. Contents of the pack and other information 1. WHAT OMNIPAQUE IS AND WHAT IT IS USED FOR Omnipaque contains the active substance iohexol. This medicine is for diagnostic use only. It is used only to help identify an illness and not in connection with treatment. Omnipaque is a ‘contrast medium’. It is given before an X-ray to make the picture that your doctor takes clearer. • Once injected, it can help your doctor tell apart normal or abnormal appearance and shape of some organs in your body. • It can be used for X-rays of your urinary system, spine or blood vessels, including blood vessels of your heart. • Some other people are given this medicine before or during a scan of their head or body using ‘computed tomography’ (also called a CAT scan). This type of scan uses X-rays. • It can also be used to look at your salivary glands, stomach and intestine, or for looking in body cavities, such as in your joints or womb and ovarian tubes. Your doctor will explain which part of your body will be scanned. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OMNIPAQUE DO NOT USE OMNIPAQUE: • If you suffer from severe thyroid problems • If you are allergic (hypersensiti Lire le document complet
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT OMNIPAQUE injection, 300 mg I/ml, 350 mg I/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Strength Content per. ml. Iohexol (INN) Iohexol (INN) 300 mg I/ml 350 mg I/ml 647 mg equiv. 300 mg I 755 mg equiv. 350 mg I Iohexol is a non-ionic, monomeric, triiodinated, water-soluble X-ray contrast medium. The osmolality and viscosity values of Omnipaque are as follows: Concentration Osmolality * Osm/kg H2O 37°C 20°C 37°C 300 mg I/ml 350 mg I/ml 0.64 0.78 11.6 23.3 6.1 10.6 * Method: Vapour - pressure osmometry. This medicinal product contains 0.012mg sodium per ml, i.e. essentially sodium free. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Omnipaque injection is supplied ready to use as clear, colourless to pale yellow, sterile aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. X-ray contrast medium for use in adults and children for cardioangiography, arteriography, urography, phlebography and CT-enhancement. Cervical myelography, following subarachnoid injection. Arthrography, hysterosalpingography, sialography and studies of the gastrointestinal tract. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage varies depending on the type of examination, age, weight, cardiac output and general condition of the patient and the technique used. Usually the same iodine concentration and volume is used as with other iodinated X-ray contrast media in current use. Adequate hydration should be assured before and after administration as for other Page 2 of 18 contrast media. For intravenous, intra-arterial and intrathecal use, and use in body cavities. The following dosages may serve as a guide. GUIDES FOR INTRAVENOUS USE Indication Concentration Volume Comments UROGRAPHY adults: children < 7 kg 300 mg I/ml or 350 mg I/ml 300 mg I/ml 40 - 80 ml 40 - 80 ml 3 ml/kg b.w. 80 ml may be exceeded in selected cases children > Lire le document complet