Country: Malta
Language: English
Source: Medicines Authority
GADOBUTROL
Bayer Public Limited Company
V08CA09
GADOBUTROL
SOLUTION FOR INJECTION
GADOBUTROL 1 millimole(s)/millilitre
POM
CONTRAST MEDIA
Authorised
2019-07-09
Page 1 of 10 PACKAGE LEAFLET for Gadograf 1.0 mmol/ml solution for injection Page 2 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GADOGRAF 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 Gadograf (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 Gadograf is and what it is used for 2. What you need to know before you are given Gadograf 3. How Gadograf will be given 4. Possible side effects 5. How to store Gadograf 6. Contents of the pack and other information 1. WHAT GADOGRAF IS AND WHAT IT IS USED FOR Gadograf is a contrast medium for magnetic resonance imaging (MRI) used for diagnostics of the brain, spine and vessels. Gadograf can also help the doctor find out the kind (benign or malignant) of known or suspected abnormalities in the liver and kidneys. Gadograf 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 GADOGRAF 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. Gadograf 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 GADOGRAF DO NOT USE GADOGRAF IF YOU • Read the complete document
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 13 1. NAME OF THE MEDICINAL PRODUCT Gadograf 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 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. Gadograf 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). Gadograf 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. Gadograf should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI). Page 3 of 13 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GADOGRAF SHOULD ONLY BE ADMINISTERED BY HEALTHCARE PROFESSIONALS_ _EXPERIENCED IN THE FIELD OF CLINICAL MRI PRACTICE. Method of administration This medicinal product is for intravenous administration only. The dose required is administered intravenously as a bolus inject Read the complete document