Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
gadoversetamide
Mallinckrodt Deutschland GmbH
V08CA06
gadoversetamide
Contrast media
Magnetic Resonance Imaging
This medicinal product is for diagnostic use only.Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.
Revision: 14
Withdrawn
2007-07-23
32 B. PACKAGE LEAFLET Medicinal product no longer authorised 33 PACKAGE LEAFLET: INFORMATION FOR THE USER OPTIMARK 500 MICROMOL/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Gadoversetamide This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE BEING GIVEN 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. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Optimark is and what it is used for 2. What you need to know before you are given Optimark 3. How Optimark is given 4. Possible side effects 5. How to store Optimark 6. Contents of the pack and other information 1. WHAT OPTIMARK IS AND WHAT IT IS USED FOR Optimark contains the active substance gadoversetamide. Gadoversetamide is used as a ‘contrast agent’ in magnetic resonance imaging. Optimark is for diagnostic use, only. It is used in adult patients and children of two years and older, who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken. Optimark is used to obtain a clearer scan in patients who have or are thought to have abnormalities in the brain, spine or liver. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN OPTIMARK DO NOT USE OPTIMARK if you are allergic • to the active substance gadoversetamide or • to any of the other ingredients of Optimark (see section 6), or • to other gadolinium contrast agents. You must not be given Optimark if • you suffer from severe and/or acute kidney impairment, or • if you are a patient who is about to have or has had a liver transplant as use of Optimark in patients with Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Optimark 500 micromol/ml solution for injection in pre-filled syringe Optimark 500 micromol/ml solution for injection in vial 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol. Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5 millimol. Each 15 ml syringe contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol. Each 20 ml syringe contains 6618 mg gadoversetamide equivalent to 10 millimol. Each 30 ml syringe contains 9927 mg gadoversetamide equivalent to 15 millimol. Excipient(s) with known effect: 20 ml of the solution contain 28.75 mg sodium. 30 ml of the solution contain 43.13 mg sodium. For the full list of excipients, see section 6.1. Vial 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol. Each 10 ml vial contains 3309 mg gadoversetamide equivalent to 5 millimol. Each 15 ml vial contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol. Each 20 ml vial contains 6618 mg gadoversetamide equivalent to 10 millimol. Excipient(s) with known effect: 20 ml of the solution contain 28.75 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pre-filled syringe Solution for injection in pre-filled syringe. Vial Solution for injection in vial. Clear, colourless to pale yellow solution. pH: 6.0 – 7.5 Osmolality (37°C): 1000 – 1200 mOsm/kg Medicinal product no longer authorised 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It pro Прочетете целия документ