MAGNEVIST SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

GADOPENTETATE DIMEGLUMINE

Предлага се от:

BAYER INC

АТС код:

V08CA01

INN (Международно Name):

GADOPENTETIC ACID

дозиране:

469MG

Лекарствена форма:

SOLUTION

Композиция:

GADOPENTETATE DIMEGLUMINE 469MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

10ML/15ML/20ML

Вид предписание :

Ethical

Терапевтична област:

OTHER DIAGNOSTIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2007-02-22

Данни за продукта

_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