Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Gadoteridol
Bracco International B.V.
V08CA; V08CA04
Gadoteridol
279.3 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Paramagnetic contrast media; gadoteridol
Marketed
1993-02-23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PROHANCE 279.3 MG/ML SOLUTION FOR INJECTION Gadoteridol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What ProHance is and what it is used for 2. Before you use ProHance 3. How to use ProHance 4. Possible side effects 5. How to store ProHance 6. Further information 1. WHAT PROHANCE IS AND WHAT IT IS USED FOR ProHance is a magnetic resonance contrast medium in the form of a solution for injection. It is used for Magnetic Resonance Examinations to provide a better picture of the brain, spine and surrounding tissues in case of lesions involving the blood flow. 2. BEFORE YOU USE PROHANCE DO NOT USE PROHANCE • if you are allergic (hypersensitive) to Gadoteridol or any of the other ingredients of ProHance (see section 6) or other gadolinium based contrast media. • if you are under 18 years of age TAKE SPECIAL CARE WITH PROHANCE • In some cases ProHance may cause changes in serum iron (the amount of iron in your blood) with no significant effects. • The allergic reactions which have been seen occasionally after the administration of similar products might also happen with ProHance. Therefore emergency measures must be readily available. Tell your doctor if: - If you have a history of allergy - your KIDNEYS do not work properly - you have recently had, or soon expect to have, a LIVER TRANSPLANT - You have a history of epilepsy or brain lesions YOUR DOCTOR MAY DECIDE TO TAKE A BLOOD TEST TO CHECK HOW WELL YOUR KIDNEYS ARE WORKING BEFORE MAKING THE DECISION TO USE PROHANCE ESPECIALLY IF YOU ARE 65 YEARS OF AGE OR OLDER. TA read_full_document
Health Products Regulatory Authority 07 November 2018 CRN008JWP Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ProHance, 279.3 mg/ml, solution for injection, 20 ml vial 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gadoteridol 279.3 mg per ml (0.5 mmol), 5586 mg per 20 ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear colourless to pale yellow sterile solution for intravenous use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Using Magnetic Resonance Imaging (MRI), ProHance provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualisation (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood-brain barrier. ProHance 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 _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. _Adults_ The recommended dose of ProHance for imaging most brain and spinal pathologies is 0.1 mmol/kg (0.2 ml/kg). However, in patients suspected of having cerebral metastases or other poorly enhancing lesions 0.3 mmol/kg (0.6 ml/kg) is recommended. Health Products Regulatory Authority 07 November 2018 CRN008JWP Page 2 of 10 To ensure complete injection of the contrast medium, the injection should be followed by a 5ml normal saline flush. The imaging procedure should be completed within 1 hour after injecting ProHance. CAUTION DURING INJECTION OF ANY CONTRAST MEDIA IS NECESSARY TO AVOID EXTRAVASATION. _Paediatric population _ _Children_ The safety and effectiveness of ProHance in children have not been established. SP read_full_document