Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gadoxetate disodium
Bayer Plc
V08CA10
Gadoxetate disodium
.25mmol/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5016703008699
V027 Page 1 of 9 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 USER PRIMOVIST 0.25 MMOL/ML, SOLUTION FOR INJECTION, PRE-FILLED SYRINGE Gadoxetate, disodium 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 giving you Primovist (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 Primovist is and what it is used for 2. What you need to know before you are given Primovist 3. How to use Primovist 4. Possible side effects 5. How to store Primovist 6. Contents of the pack and other information 1. WHAT PRIMOVIST IS AND WHAT IT IS USED FOR Primovist is a contrast medium for magnetic resonance imaging (MRI) of the liver. It is used to help detect and diagnose changes that may be found in the liver. Abnormal signs within the liver can be better evaluated (as to number, size, and distribution). Primovist can also help the doctor determine the nature of any abnormalities, thereby increasing the confidence one can have in the diagnosis. It is provided as a solution for intravenous injection. This medicine is for diagnostic use only. MRI is a form of medical diagnostic imaging that forms pictures after water molecules have been detected in normal and abnormal tissues. This is done using a complex system of magnets and radiowaves. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PRIMOVIST DO NOT USE PRIMOVIST - if yo Đọc toàn bộ tài liệu
OBJECT 1 PRIMOVIST 0.25 MMOL/ML, SOLUTION FOR INJECTION, PREFILLED SYRINGE Summary of Product Characteristics Updated 16-Jan-2018 | Bayer plc 1. Name of the medicinal product Primovist 0.25 mmol/ml, solution for injection, pre-filled syringe 2. Qualitative and quantitative composition Each ml contains 0.25 mmol gadoxetate disodium (Gd-EOB-DTPA disodium), equivalent to 181.43 mg gadoxetate disodium. 1 prefilled syringe with 5.0 ml contains 907 mg gadoxetate disodium, 1 prefilled syringe with 7.5 ml contains 1361 mg gadoxetate disodium, 1 prefilled syringe with 10.0 ml contains 1814 mg gadoxetate disodium. Excipients with known effect: 11.7 mg sodium/ ml For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection, prefilled syringe: Clear, colourless to pale yellow liquid free from visible particles. 4. Clinical particulars 4.1 Therapeutic indications Primovist is indicated for the detection of focal liver lesions and provides information on the character of lesions in T1-weighted magnetic resonance imaging (MRI). Primovist should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI) and when delayed phase imaging is required. This medicinal product is for diagnostic use by intravenous administration only_._ 4.2 Posology and method of administration METHOD OF ADMINISTRATION Primovist is a ready-to-use aqueous solution to be administered undiluted as an intravenous bolus injection at a flow rate of about 2 ml/sec. After the injection of the contrast medium the intravenous cannula/ line should be flushed using sterile 9 mg/ml (0.9 %) saline solution. For detailed imaging information refer to section 5.1. For additional instructions see section 6.6. POSOLOGY The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patient's body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section. The rec Đọc toàn bộ tài liệu