Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Gadoteric acid
Guerbet
V08CA; V08CA02
Gadoteric acid
279.32 milligram(s)/millilitre
Solution for injection in pre-filled syringe
Product subject to Restricted Prescription (C)
Paramagnetic contrast media; gadoteric acid
Not marketed
1996-06-10
PACKAGE LEAFLET: INFORMATION FOR THE USER DOTAREM 279.32 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Gadoteric acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, ask your doctor or pharmacist. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Dotarem is and what it is used for 2. What you need to know before you are given Dotarem 3. How you will be given Dotarem 4. Possible side effects 5. How to store Dotarem 6. Contents of the pack and other information 1. WHAT DOTAREM IS AND WHAT IS IT USED FOR Dotarem is a diagnostic agent used in adults and children. It belongs to the group of contrast agents used for magnetic resonance imaging (MRI). Dotarem is used to enhance the contrast of the images obtained during MRI examinations. This contrast enhancement improves the examination of some areas of the body. This medicine is for diagnostic use only. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOTAREM YOU SHOULD NOT BE GIVEN DOTAREM • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) • if you are allergic to medicines containing gadolinium (like other contrast agents used for MRI). WARNINGS AND PRECAUTIONS Inform your doctor or radiologist if the following applies to you: • you have previously reacted to a contrast agent during an examination • you have asthma • you have a history of allergy (such as seafood allergy, urticaria, hay fever) • you are being treated with a beta-blocker (medicine for heart and blood pressure disorders, such as metoprolol) • your kidneys do not work properly • you have recently had, or soon expect to have, a liver transplant • you have a disease affecting your heart or your blood vessels • you have ha Прочитать полный документ
Health Products Regulatory Authority 15 November 2023 CRN00DYHZ Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dotarem 279.32 mg/ml solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Name of ingredient Formula per ml Gadoteric acid* 279.32 mg (equivalent to 0.5 mmol/ml) *Gadoteric acid is formed in situ during manufacture from DOTA and gadolinium oxide. Gadoteric acid: 1, 4, 7, 10-tetraazacyclododecane-N, N’, N’’, N’’’, tetraacetic acid (or DOTA) gadolinium complex For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless or slightly yellow solution in a prefilled syringe Osmolality: 1350 mOsm/kg -1 Viscosity at 20 °C: 3.2 mPa.s Viscosity at 37 °C: 2.0 mPa.s pH: 6.5 to 8.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Dotarem should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI). Enhancement ofc ontrast in Magnetic Resonance Imaging: In adults and paediatric population (0-18 years): * MRI of the brain and spine: brain tumours, tumours of the spine and the surrounding tissue, intravertebral disk prolapse, infectious diseases. * Wholebody MRI: Abdominal diseases: primary and secondary hepatic tumours, pancreatic tumours. Renal diseases: renal tumours and cysts, follow-up of kidney transplants. Pelvic diseases: uterine and ovarian tumours. Cardiac diseases: follow-up of infarction and heart transplants. Breast diseases: breast tumours, follow-up of implants. Osteo-articular diseases: bone and soft tissue tumours. In adults only: *Vascular pathology (angiography) Health Products Regulatory Authority 15 November 2023 CRN00DYHZ Page 2 of 7 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 n Прочитать полный документ