GADOPENTETATE DIMEGLUMINE INJECTION SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

GADOPENTETATE DIMEGLUMINE

متاح من:

AVIR PHARMA INC.

ATC رمز:

V08CA01

INN (الاسم الدولي):

GADOPENTETIC ACID

جرعة:

469MG

الشكل الصيدلاني:

SOLUTION

تركيب:

GADOPENTETATE DIMEGLUMINE 469MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Ethical

المجال العلاجي:

MISCELLANEOUS THERAPEUTIC AGENTS

ملخص المنتج:

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

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2021-06-23

خصائص المنتج

_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