Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
gadobenate dimeglumine, Quantity: 529 mg/mL
Bracco Pty Ltd
Injection, solution
Excipient Ingredients: water for injections
Intravenous
10 x 20mL vials
Not scheduled. Not considered by committee
MultiHance is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) indicated for: For use in adults for the enhancement of magnetic resonance imaging (MRI) of the liver and Central Nervous System (CNS) for diagnostic use only. For use in adult patients with suspected or known vascular disease for contrast-enhanced magnetic resonance angiography of the abdominal or peripheral arteries where it improves the diagnostic accuracy for detecting clinically significant steno-occlusive vascular disease.
Visual Identification: Clear, colourless to slightly yellow solution, free from visible particulate matter.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2003-07-07
CONSUMER MEDICINE INFORMATION MULTIHANCE® INJECTION 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 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 HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU ARE GIVEN AN INJECTION OF MULTIHANCE® _ _ _WHEN YOU MUST NOT TAKE IT: _ DO NOT TAKE MULTIHANCE® IF YOU HAVE AN Прочетете целия документ
1 of 19 AUSTRALIAN PRODUCT INFORMATION - MULTIHANCE ® (DIMEGLUMINE GADOBENATE) 1 NAME OF THE MEDICINE Dimeglumine gadobenate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MultiHance contains 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). 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]. MultiHance ® contains dimeglumine gadobenate 0.529g per mL (0.5M). MultiHance ® has a pH of 6.5 to 7.3. Pertinent physicochemical data follow: 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. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Sterile, non-pyrogenic, clear colourless to slightly yellow, aqueous solution for intravenous injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MultiHance ® is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) indicated for: For use in adults for the enhancement of magnetic resonance imaging (MRI) of the liver and Central Nervous System (CNS) for diagnostic use only. For use in adult patients with suspected or known vascular disease for contrast-enhanced magnetic resonance angiography of the abdominal or peripheral arteries where it improves the diagnostic accuracy for detecting clinically significant steno-occlusive vascular disease. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS MRI 2 of 19 Imaging of the liver The recommended dose of MultiHance ® in adult patients is 0.05 mmol/kg body weight. This corresponds to 0.1 mL/kg of the 0.5 M solution. The product should be administered intravenously either as a bolus or as an infusi Прочетете целия документ