Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
GADOPENTETATE DIMEGLUMINE
Bayer Limited
V08CA01
GADOPENTETATE DIMEGLUMINE
469 Micromol
Solution for Injection
Product subject to Restricted Prescription (C)
Paramagnetic contrast media
Authorised
2008-07-25
Bayer Limited The Atrium Blackthorn Road Dublin 18 Telephone: +353 1 2999313 Fax: +353 1 2061456 www.bayer.ie 15158 PATIENT LEAFLET: Information for the user MAGNEVIST ® 0.5 MMOL/ML SOLUTION FOR INJECTION, IN PRE-FILLED SYRINGE Gadopentetate dimeglumine 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 7. INFORMATION FOR HEALTHCARE PROFESSIONALS ONLY 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 to help make an MRI scan of the area of your body that your doctor wants to investigate 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 radiowaves 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 to see and investigate the difference Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Magnevist 0.5mmol/ml Solution for Injection, in pre-filled syringe. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 0.5 mmol gadopentetate dimeglumine (equivalent to 469.01 mg gadopentetate dimeglumine). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale yellow solution. The physico-chemical properties of Magnevist listed below are: 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. • Cranial and spinal magnetic resonance imaging (MRI) In particular for the demonstration of tumours and for further differential-diagnostic clarification in suspected meningioma, (acoustic) neurinoma, invasive tumours (e.g. glioma) and metastases; for the demonstration of small and/or isointense tumours; in suspected recurrence after surgery or radiotherapy; for the differentiated demonstration of rare neoplasms such as haemangioblastomas, ependymomas and small pituitary adenomas; for improved determination of the spread of tumours not of cerebral origin. Additionally in spinal MRI: Differentiation of intra- and extramedullary tumours; demonstration of solid tumour areas in known syrinx; determination of intramedullary tumour spread. • Whole body MRI Including the facial skull, the neck region, the thoracic space including the heart and abdominal space, the female breast, the pelvis and the active and passive musculoskeletal system, and imaging of vessels throughout the body. In particular, Magnevist permits diagnostic information: For the demonstration or exclusion of tumours, inflammation and vascular lesions; For determination of the spread and demarcation of these lesions; For the differentiation of the internal structure of lesions; OSMOLALITY (OSM/KG H 2 O) At 37ºC 1.96 VISCOSITY (MPA·S) At 20ºC 4.9 At 37ºC 2.9 PH-VALUE 7.0 – 7.9 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ __ Прочитать полный документ