देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
GADOPENTETATE DIMEGLUMINE
AVIR PHARMA INC.
V08CA01
GADOPENTETIC ACID
469MG
SOLUTION
GADOPENTETATE DIMEGLUMINE 469MG
INTRAVENOUS
100
Ethical
MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0123846001; AHFS:
CANCELLED PRE MARKET
2021-06-23
_GADOPENTETATE DIMEGLUMINE INJECTION - Product Monograph _ _Page 1 of 32_ PRODUCT MONOGRAPH GADOPENTETATE DIMEGLUMINE INJECTION 469 mg / mL (0.5 mmol / mL) USP For Intravenous Use THERAPEUTIC CLASSIFICATION Contrast Enhancement Agent for Magnetic Resonance Imaging (MRI) For Professional Use Only AVIR PHARMA INC. 660 Boul. Industriel Blainville, Quebec Canada, J7C 3V4 www.avirpharma.com Date of Preparation: April 3, 2020 Submission Control No: 217936 _GADOPENTETATE DIMEGLUMINE INJECTION - Product Monograph _ _Page 2 of 32_ PRODUCT MONOGRAPH GADOPENTETATE DIMEGLUMINE INJECTION 469 mg / mL (0.5 mmol / mL) USP For Intravenous Use THERAPEUTIC CLASSIFICATION Contrast Enhancement Agent for Magnetic Resonance Imaging (MRI) ACTION AND CLINICAL PHARMACOLOGY 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 T 1 relaxation time of the water protons in plasma) and the relaxivity (r 2 ) (determined from the influence on the T 2 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 significant inhibitory interaction with enzymes (e.g. acetylcholinesterase and lysozyme) at clinically relevant con पूरा दस्तावेज़ पढ़ें