Држава: Малта
Језик: Енглески
Извор: Medicines Authority
GADOBUTROL
Bayer Hellas S.A 6-8 Agisilaou Street 151 23 Marousi Attiki, , Greece
V08CA09
GADOBUTROL 1 mmol/ml
SOLUTION FOR INJECTION
GADOBUTROL 1 mmol/ml
POM
CONTRAST MEDIA
Authorised
2016-07-04
1 PACKAGE LEAFLET for Gadovist 1.0 mmol/ml solution for injection 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GADOVIST 1.0 MMOL/ML SOLUTION FOR INJECTION Gadobutrol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE 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, please ask your doctor or the person giving you Gadovist (the radiologist) or the hospital/MRI-centre personnel. - If you get any side effects talk to your doctor or radiologist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gadovist is and what it is used for 2. What you need to know before you are given Gadovist 3. How Gadovist will be given 4. Possible side effects 5. How to store Gadovist 6. Contents of the pack and other information 1. WHAT GADOVIST IS AND WHAT IT IS USED FOR Gadovist is a contrast medium for magnetic resonance imaging (MRI) used for diagnostics of the brain, spine and vessels. Gadovist can also help the doctor find out the kind (benign or malignant) of known or suspected abnormalities in the liver and kidneys. Gadovist can also be used for MRI of abnormalities of other body regions. It facilitates visualisation of abnormal structures or lesions and helps in the differentiation between healthy and diseased tissue. It is for use in adults and children of all ages (including term newborn infants). HOW GADOVIST WORKS MRI is a form of medical diagnostic imaging that uses the behaviour of water molecules in normal and abnormal tissues. This is done by a complex system of magnets and radio waves. Computers record the activity and translate that into images. Gadovist is given as an injection into your vein. This medicine is for diagnostic use only and will only be administered by healthcare professionals experienced in the field of clinical MRI practice. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GADOVIST DO NOT USE GADOVIST IF YOU • are allergic to gadob Прочитајте комплетан документ
1 SUMMARY OF PRODUCT CHARACTERISTICS, FOR GADOVIST 1.0 MMOL/ML SOLUTION FOR INJECTION 2 SUMMARY OF PRODUCT CHARACTERISTICS 3 1. NAME OF THE MEDICINAL PRODUCT Gadovist 1.0 mmol/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains 604.72 mg gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium). 1 vial with 2 ml contains 1209.44 mg gadobutrol, 1 vial with 7.5 ml contains 4535.4 mg gadobutrol, 1 vial with 15 ml contains 9070.8 mg gadobutrol, 1 vial with 30 ml contains 18141.6 mg gadobutrol. 1 bottle with 65 ml contains 39306.8 mg gadobutrol. Excipient with known effect: 1 ml contains 0.00056 mmol (equivalent to 0.013 mg) of sodium (see section 4.4). _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless to pale yellow liquid. Physico-chemical properties: Osmolality at 37 °C: 1603 mOsm/kg H 2 O Viscosity at 37 °C: 4.96 mPa·s 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Gadovist is indicated in adults and children of all ages (including term neonates) for: • Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI). • Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant. • Contrast enhancement in magnetic resonance angiography (CE-MRA). Gadovist can also be used for MR Imaging of pathologies of the whole body. It facilitates visualisation of abnormal structures or lesions and helps in the differentiation between healthy and pathological tissue. Gadovist should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI). 4 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GADOVIST SHOULD ONLY BE ADMINISTERED BY HEALTHCARE PROFESSIONALS_ _EXPERIENCED IN THE FIELD OF CLINICAL MRI PRACTICE. Method of administration This medicinal product is Прочитајте комплетан документ