Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Dimeglumine gadopentetate
Bayer Australia Ltd
Medicine Registered
1210 MAGNEVIST ® CMI 1 MAGNEVIST ® (MAG·NE ⋅VIST) _DIMEGLUMINE GADOPENTETATE _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Magnevist. It does not contain all the available information. It does not take the place of talking to your doctor. All diagnostic agents have risks and benefits. Your doctor has weighed the risks of you using Magnevist against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS DIAGNOSTIC AGENT, ASK YOUR DOCTOR OR RADIOLOGIST. KEEP THIS LEAFLET. You may need to read it again. WHAT MAGNEVIST IS USED FOR Magnevist is used at the same time as magnetic resonance imaging (MRI) to aid in the detection of abnormalities in the brain, spinal cord, neck, chest, abdomen, pelvis, bones and muscles in adults; and in the brain and spinal cord in children and babies. MRI is a form of medical diagnostic imaging that forms pictures after detecting water molecules in normal and abnormal tissues. This is done using a complex system of magnets and radiowaves. Magnevist is a liquid that alters the way in which the MRI machine detects certain tissues within the body. Magnevist often makes the pictures clearer and often shows things that may not have been visible using MRI alone. Magnevist is only available at MRI units for use in conjunction with MRI. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MAGNEVIST IS BEING USED IN YOU. Your doctor may be using it for another reason. BEFORE YOU ARE GIVEN MAGNEVIST _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU MUST NOT BE GIVEN MAGNEVIST IF YOU HAVE AN ALLERGY TO: • dimeglumine gadopentetate, the active ingredient in Læs hele dokumentet
- 1 - MAGNEVIST ® PRODUCT INFORMATION NAME OF THE MEDICINE Magnevist ® (dimeglumine gadopentetate) 0.5 mmol/mL solution for intravenous injection is the N-methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). DESCRIPTION Dimeglumine gadopentetate is to be administered by intravenous injection or infusion. Each mL of Magnevist solution for injection or infusion contains 469 mg dimeglumine gadopentetate, 530 micrograms meglumine, 1.02 mg meglumine pentetate and water for injections. Magnevist Injection contains no antimicrobial preservative. Magnevist Injection is provided as a sterile, clear, colourless to slightly yellow aqueous solution. Magnevist Injection is a 0.5 mol/L solution of 1-deoxy-1-(methylamino)-D-glucitol dihydrogen [_N,N_-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato-(5-)]gadolinate (2-) (2:1) with a molecular weight of 938 and has the following structural formula: Dimeglumine Gadopentetate (USAN) Gadopentetate Dimeglumine (INN) Molecular Formula: C 28 H 54 GdN 5 O 20 CAS Registry No.: 86050-77-3 N N O N O O O O O O O O O Gd 3+ C H 3 NH 2 + O H O H H O H H OH H H OH 2 - 2 - Magnevist Injection has a pH of 7.0-7.9. Magnevist Injection is hypertonic under conditions of use. PHARMACOLOGY The pharmacokinetics of intravenously administered dimeglumine gadopentetate in normal subjects conforms to a two compartment open-model with mean distribution and elimination half-lives (reported as mean ± SD) of about 0.2 ± 0.13 hours and 1.6 ± 0.13 hours, respectively. Dimeglumine gadopentetate does not cross the intact blood-brain barrier and, therefore, does not accumulate in normal brain or in lesions that do not have an abnormal blood-brain barrier, e.g. Læs hele dokumentet