Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Gadoxetic acid, disodium
Bayer Limited
V08CA; V08CA10
Gadoxetic acid, disodium
0.25 millimole(s)/millilitre
Solution for injection in pre-filled syringe
Product subject to Restricted Prescription (C)
Paramagnetic contrast media; gadoxetic acid
Marketed
2004-11-19
BP22036_REC30610 1 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. If you get any side effects talk to your doctor. 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 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 radio waves. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PRIMOVIST DO NOT USE PRIMOVIST - if you are allergic to gadoxetate disodium or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before you are given Primovist if you have: - or have had asthma or an allergy such as hay fever, nettle rash - had a previous reaction to contrast media - reduced kidney function. The use of some gadolinium-containing contrast agents in patients with these conditions has been associated with a di Прочитајте комплетан документ
Health Products Regulatory Authority 10 November 2022 CRN00D61K Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 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 0.25mmol 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 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 recommended dose of Primovist is: Adults 0.1 ml per kg bod Прочитајте комплетан документ