Pays: Canada
Langue: anglais
Source: Health Canada
GADOPENTETATE DIMEGLUMINE
BAYER INC
V08CA01
GADOPENTETIC ACID
469MG
SOLUTION
GADOPENTETATE DIMEGLUMINE 469MG
INTRAVENOUS
10ML/15ML/20ML
Ethical
OTHER DIAGNOSTIC AGENTS
Active ingredient group (AIG) number: 0123846001; AHFS:
APPROVED
2007-02-22
_MAGNEVIST Product Monograph_ _Page 1 of 37 _ PRODUCT MONOGRAPH MAGNEVIST ® Gadopentetate Dimeglumine Injection Bayer Standard 469 mg/mL (0.5 mmol/mL) For Intravenous Use THERAPEUTIC CLASSIFICATION Contrast Enhancement Agent for Magnetic Resonance Imaging (MRI) For Professional Use Only Bayer Inc. Date of Revision: 2920 Matheson Boulevard East April 12, 2018 Mississauga, Ontario L4W 5R6 http://www.bayer.ca Submission Control No.: 212849 © 2018, Bayer Inc. ® TM see www.bayer.ca/tm-mc. All other trademarks are the property of their respective owners. _MAGNEVIST Product Monograph_ _Page 2 of 37 _ PRODUCT MONOGRAPH MAGNEVIST ® Gadopentetate Dimeglumine Injection Bayer Standard 469 mg/mL (0.5 mmol/mL) For Intravenous Use THERAPEUTIC CLASSIFICATION Contrast Enhancement Agent for Magnetic Resonance Imaging (MRI) ACTION AND CLINICAL PHARMACOLOGY MAGNEVIST (gadopentetate dimeglumine) was developed as a contrast agent for diagnostic use in magnetic resonance imaging (MRI). Gadolinium is a rare earth element. Its ion (Gd +++ ) has seven unpaired electrons and, therefore, shows paramagnetic properties. Gd +++ has a strong effect on the hydrogen-proton spin-lattice relaxation time (T 1 ), which causes the observed contrast enhancement in MRI scans. By chelation of Gd+++ with diethylenetriamine pentaacetic acid (DTPA), a strongly paramagnetic, well-tolerated, stable complex (gadopentetate dimeglumine salt) is obtained. The paramagnetic efficacy at a magnetic field strength of 1.5 T and at 37°C, as indicated by the relaxivity (r 1 ) (determined from the influence on the T1 relaxation time of the water protons in plasma) and the relaxivity (r 2 ) (determined from the influence on the T2 relaxation time), is about 4.1 ± 0.2 L/(mmol•sec) and 4.6 ± 0.8 L/(mmol•sec), respectively. The relaxivities display only slight dependency on the strength of the magnetic field. The free gadolinium ion is unsuitable for clinical use due to high toxicity; however, the metal chelate is metabolically inert and does not display significan Lire le document complet