Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gadobutrol
Bayer Plc
V08CA09
Gadobutrol
1mmol/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5016703008248
Version 030_0 Page 1 of 10 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. _ _ _ _ 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 transla Baca dokumen lengkapnya
OBJECT 1 GADOVIST 1.0MMOL/ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 16-Jan-2018 | Bayer plc 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). 4.2 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 for intravenou Baca dokumen lengkapnya