Land: Zweden
Taal: Zweeds
Bron: Läkemedelsverket (Medical Products Agency)
gadoterinsyra
GE Healthcare AS
V08CA02
gadoteric acid
0,5 mmol/ml
Injektionsvätska, lösning i förfylld spruta
gadoterinsyra 279,32 mg Aktiv substans
Receptbelagt
Förpacknings: Förfylld spruta, 10 ml; Förfylld spruta, 10 x 20 ml; Förfylld spruta, 15 ml; Förfylld spruta, 20 ml; Förfylld spruta, 10 x 10 ml; Förfylld spruta, 10 x 15 ml
Godkänd
2017-02-20
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CLARISCAN 0.5 MMOL/MLSOLUTION FOR INJECTION CLARISCAN 0.5 MMOL/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 radiologist or pharmacist. ● If you get any of the side effects, talk to your doctor, radiologist or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET : 1. What Clariscan is and what it is used for 2. What you need to know before you are given Clariscan 3. How you will be given Clariscan 4. Possible side effects 5. How to store Clariscan 6. Contents of the pack and other information 1. WHAT CLARISCAN IS AND WHAT IT IS USED FOR WHAT CLARISCAN IS Clariscan contains the active substance gadoteric acid. It belongs to a group called “contrast agents” used for magnetic resonance imaging” (MRI). WHAT CLARISCAN IS USED FOR Clariscan is used to enhance the contrast of the images obtained during MRI examinations. In adults and in children and adolescents 0-18 years old: - MRI of the CNS including of defects (lesions) in brain, spine, and surrounding tissues In adults and in children and adolescents 6 months – 18 years old: - Whole body MRI including defects (lesions) In adults only: - MR angiography including defects (lesions) or narrowing (stenosis) in arteries, except in coronary arteries. This medicine is for diagnostic use only HOW CLARISCAN WORKS Clariscan makes the pictures on an MRI scanner easier to see. It does this by increasing the contrast between the part of the body being looked at and the rest of the body. This allows doctors or radiologists to see different areas of the body better. 2 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CLARISCAN YOU SHOULD NOT BE GIVEN CLARISCAN : • if you are allergic to gadoteric acid or any of the other ingr Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Clariscan 0.5 mmol/ mL solution for injection Clariscan 0.5 mmol/ mL solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL solution for injection contains 279.32 mg gadoteric acid*(as gadoterate meglumine) equivalent to 0.5 mmol Tetraxetan (DOTA) 202.46 mg Gadolinium oxide 90.62 mg * Gadoteric acid: gadolinium complex with1,4,7,10 tetraazacyclododecane N,N’,N”,N’’’ tetraacetic acid (tetraxetan (DOTA)) For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Solution for injection in prefilled syringe Clear, colourless to slightly yellow solution Contrast medium concentration 279.32 mg/mL equivalent to 0.5 mmol/mL Osmolality at 37 °C 1350 mOsm.kg -1 Viscosity at 20 °C 3.0 mPa.s Viscosity at 37 °C 2.1 mPa.s pH value 6.5 – 8.0 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Clariscan should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI). Clariscan is a contrast agent indicated for enhancement of the contrast in Magnetic Resonance Imaging for a better visualization/delineation. Adult population and paediatric population (0-18 years): - lesions of the brain, spine, and surrounding tissues - whole body MRI (see section 4.2) Use for whole body is not recommended in children less than 6 months In adults only: - lesions or stenoses of the non-coronary arteries (MR Angiography). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should only be administered by trained healthcare professionals with technical expertise in performing and interpreting gadolinium enhanced MRI. 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 Lees het volledige document