Երկիր: Նոր Զելանդիա
Լեզու: անգլերեն
Աղբյուրը: Medsafe (Medicines Safety Authority)
Gadobenate dimeglumine 0.529 g/mL equivalent to to 0.5 M gadobenic acid
Regional Health Ltd
Gadobenate dimeglumine 0.529 g/mL (equiv. to 0.5 M gadobenic acid)
0.529 g/mL
Solution for injection
Active: Gadobenate dimeglumine 0.529 g/mL equivalent to to 0.5 M gadobenic acid Excipient: Water for injection
Vial, glass, single dose, 5 mL
General sale
General sale
Bracco SpA.
MultiHance is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) of the liver and Central Nervous System (CNS). MultiHance is indicated, for the detection of focal liver lesions in patients with known or suspected primary liver cancer (eg. hepatocellular carcinoma) or metastatic disease. MultiHance is also indicated for the MRI of the brain and spine where it improves the detection of lesions and provides diagnostic information additional to that obtained with unenhanced MRI. MultiHance is indicated for contrast enhance Magnetic Resonance Angiography to improve the diagnostic accuracy of detecting clinical significant steno-occlusive vascular diseases in patients with known vascular diseases of the abdominal, supra-aortic or peripheral arteries.
Package - Contents - Shelf Life: Vial, glass, single dose, - 5 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, - 10 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, - 15 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, - 20 mL - 36 months from date of manufacture stored at or below 25°C
2002-05-30
1 of 19 NEW ZEALAND DATASHEET - 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 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. 2 of 19 The product should be administered intravenously either as a bolus or as an infusion (10 m Կարդացեք ամբողջական փաստաթուղթը