Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
Dimeglumine gadobenate
Bracco Pty Ltd
Medicine Registered
MULTIHANCE ® INJECTION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MultiHance ® . It does not contain all the available information. It does not take the place of talking with your radiologist, your doctor or your pharmacist. All products of this type have risks and benefits. Your radiologist and your doctor have weighed the risk of you being given MultiHance ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS PREPARATION, ASK YOUR RADIOLOGIST, DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You might need to read it again. WHAT MULTIHANCE ® IS USED FOR MultiHance ® is a substance known as a paramagnetic contrast medium. It is used in magnetic resonance imaging (MRI) for adults; in particular: • For the enhancement of Magnetic Resonance Imaging (MRI) in order to improve the scans or images (pictures) of certain parts of the body (in particular, the brain, spine and surrounding tissue) and liver. • In adult patients with suspected or known vascular disease for contrast-enhanced Magnetic Resonance Angiography (MRA) of the abdominal or peripheral arteries where it improves the diagnostic accuracy for detecting vascular diseases This medicine belongs to a group of medicines called contrast agents. MultiHance ® is given by injection into a vein. MRI and MRA are relatively new medical technologies which use magnetic fields and radio waves to produce images of parts of the body, which a doctor can then use to make a diagnosis. MRI and MRA examinations are carried out by specialist doctors called radiologists, using sophisticated medical equipment. MRI and MRA do not use X-rays and therefore the minor risks associated with X-rays are avoided. ASK YOUR DOCTOR IF YOU Pročitajte cijeli dokument
MultiHance ® PI Page 1 PRODUCT INFORMATION NAME OF THE MEDICINE: MultiHance ® (dimeglumine gadobenate) DESCRIPTION MultiHance ® is supplied as a sterile, non-pyrogenic, clear colourless to slightly yellow, aqueous solution at neutral pH (6.5-7.3) for intravenous injection. MultiHance ® contains no preservatives. 1 mL of solution for injection contains: gadobenic acid 334 mg (0.5M) as the dimeglumine salt. [dimeglumine gadobenate 529 mg = gadobenic acid 334 mg + meglumine 195 mg]. Chemical name Gadolinate(2 - ),(4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)-1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato-(5 - )- N 5 ,N 8 ,N 11 ,O 4 ,O 5 ,O 8 ,O 11 ,O 13 ]- dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol (1:2). Laboratory name B19036/7 Gd-BOPTA/dimeg The structural formula of dimeglumine gadobenate is: MOLECULAR FORMULA MOLECULAR WEIGHT C 36 H 62 N 5 O 21 Gd 1058.17 CAS Number: 127000-20-8 PARAMETER Osmolality (mOsmol/kg water) @ 37°C: 1970 Viscosity (cP) @ 37°C: 5.3 Density @ 20°C: 1.220g/mL MultiHance ® has an osmolality 6.9 times that of plasma (285 mOsm/kg water) and is hypertonic under conditions of use. PHARMACOLOGY Pharmacodynamic properties Dimeglumine gadobenate is an octadentatate chelate of gadolinium salified with meglumine. As a paramagnetic contrast agent, it shortens longitudinal (T1), and, to a lesser extent, transversal (T2) relaxation times of tissue water protons. The relaxivities of dimeglumine gadobenate in aqueous solution (r 1 = 4.39 and r 2 = 5.56 mM -1 s -1 at 20 MHz), are only slightly higher than those of other paramagnetic contrast agents already in clinical use. However, unlike MultiHance ® PI Page 2 other contrast agents, dimeglumine gadobenate experiences strong increase in relaxivity on going from aqueous solution to solutions containing serum protei Pročitajte cijeli dokument