Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
GADOPENTATE DIMEGLUMINE
Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom
V08CA01
GADOPENTATE DIMEGLUMINE
SOLUTION FOR INJECTION
GADOPENTATE DIMEGLUMINE
POM
CONTRAST MEDIA
Withdrawn
2008-09-15
81853312 PACK AGING T ECHNOLOGY BERLIN PEWI page 1 Bayer Pharma AG client: 0021 itemno.: 81853312 PZ: 2663O-3 code-no.: 0 name: LF-OUTS-MAGNEVIST VL countr y: GB BPH colors: BLACK version: 03.04.2014/03 approval: READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, please ask the doctor giving you Magnevist (the radiologist) or the hospital/MRI-centre staff. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, radiologist or the hospital/MRI-centre staff. IN THIS LEAFLET: 1. What Magnevist is and what it is used for 2. Before you are given Magnevist 3. How you will be given Magnevist 4. Possible side effects 5. How to store Magnevist 6. Further information 1. WHAT MAGNEVIST IS AND WHAT IT IS USED FOR Magnevist is used together with a technique called Magnetic Resonance Imaging (MRI) to create artificial contrast or enhancement, this can help make the MRI scan of the brain, spine, vessels, or other area of your body that your doctor wants to investigate look clearer. MRI is a modern scanning technique which produces very high quality pictures of various parts of your body without using X-rays. The use of MRI can provide a quick, early and accurate diagnosis. The scanner uses a strong magnetic field and radio waves to measure the magnetic properties of body tissues. Using a computer, this information is converted into a black and white picture which can help your doctor see and investigate the differences between normal and abnormal tissue. Sometimes MRI is used in areas where it cannot produce a clear black and white picture. This is when Magnevist is used. Magnevist produces a clearer image and allows the doctor to see the area of interest better. Sometimes several scans will be taken b Perskaitykite visą dokumentą
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF MEDICINAL PRODUCT Magnevist ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 0.5 mmol gadopentetate dimeglumine (equivalent to 469.01 mg gadopentetate dimeglumine). For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only as a paramagnetic contrast medium in cranial, spinal and whole body magnetic resonance imaging (MRI). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION Magnevist is to be administered only be intravenous injection. Nausea and vomiting are known possible adverse reactions of all extracellular MRI contrast media. The patient should therefore refrain from eating for 2 hours prior to investigation to avoid aspiration. The usual precautions for MRI (e.g. exclusion of cardiac pacemakers and other ferro-magnetic objects including vascular clips etc) must be observed. INSTRUCTIONS FOR USE/HANDLING Magnevist should only be drawn up into the syringe immediately before use. The rubber stopper should never be pierced more than once. Any contrast medium not used in one examination must be discarded. Contrast-enhanced MRI can start immediately after administration of the medium. T 1 - weighted scanning sequences are particularly suitable for contrast-enhanced examinations with Magnevist. Ideally the patient should be recumbent during administration, and should be kept under supervision for at least 30 minutes after the injection. POSOLOGY The recommended doses are given in ml of Magnevist per kg body weight. Page 2 of 11 ADULTS: CRANIAL AND SPINAL MRI In general, the administration of 0.2ml Magnevist per kg body weight (equivalent to 0.1mmol gadopentetate dimeglumine per kg body weight) is sufficient to provide diagnostically adequate contrast. If a strong clinical suspicion of a lesion persists despite a normal scan, a further injection of 0.2ml or even 0.4ml Magnevist per kg b Perskaitykite visą dokumentą