GADOPENTETATE DIMEGLUMINE INJECTION SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

GADOPENTETATE DIMEGLUMINE

Commercializzato da:

AVIR PHARMA INC.

Codice ATC:

V08CA01

INN (Nome Internazionale):

GADOPENTETIC ACID

Dosaggio:

469MG

Forma farmaceutica:

SOLUTION

Composizione:

GADOPENTETATE DIMEGLUMINE 469MG

Via di somministrazione:

INTRAVENOUS

Confezione:

100

Tipo di ricetta:

Ethical

Area terapeutica:

MISCELLANEOUS THERAPEUTIC AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0123846001; AHFS:

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2021-06-23

Scheda tecnica

_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