Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
ascorbic acid,calcium hydrogen phosphate dihydrate,calcium pantothenate,colecalciferol,dolomite,retinol palmitate,zinc amino acid chelate
Vitex Pharmaceuticals Pty Ltd
Ascorbic acid,calcium hydrogen phosphate dihydrate,colecalciferol,Calcium pantothenate,Dolomite,retinol palmitate,zinc amino aci
Medicine Listed
Listed
1710 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 Magnevist • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. YOU MUST NOT BE GIVEN MAGNEVIST IF YOU HAVE SEVERE DISTURBANCES O Baca dokumen lengkap
1710 Magnevist PI 1 PRODUCT INFORMATION MAGNEVIST ® NAME OF THE MEDICINE Magnevist ® (dimeglumine gadopentetate) 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). Magnevist Injection is a 0.5 mmol/mL 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 DESCRIPTION Magnevist Injection is a sterile, clear, colourless to slightly yellow aqueous solution for intravenous administration. Each mL 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 has a pH of 7.0-7.9. Magnevist Injection is hypertonic under conditions of use. N N O N O O O O O O O O O Gd C H 3 NH 2 + O H O H H O H H OH H H OH 2 1710 Magnevist PI 2 PHARMACOLOGY PHARMACODYNAMICS Mechanism of Action Dimeglumine gadopentetate is a paramagnetic agent and, as such, it develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment produced by the paramagnetic agent results in a relatively large local magnetic field, which can enhance the relaxation rates of water protons in the vicinity of the paramagnetic agent. In MRI, visualisation of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occur with 1) changes in proton density; 2) alteration of the spin lattice or longitudinal relaxation time (T 1 ); and 3) variation of the spin-spin or transverse relaxation time (T 2 ). When placed in a magnetic field, dimeglumine gadopentetate decreases the T 1 and T 2 relaxation time in tissues wh Baca dokumen lengkap