GADOPENTETATE DIMEGLUMINE INJECTION, USP SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

GADOPENTETATE DIMEGLUMINE

Disponible depuis:

JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA

Code ATC:

V08CA01

DCI (Dénomination commune internationale):

GADOPENTETIC ACID

Dosage:

469MG

forme pharmaceutique:

SOLUTION

Composition:

GADOPENTETATE DIMEGLUMINE 469MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

5/10/15/20ML

Type d'ordonnance:

Ethical

Domaine thérapeutique:

OTHER DIAGNOSTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2022-05-17

Résumé des caractéristiques du produit

JUBILANT DRAXIMAGE INC.
MODULE 1 ADMINISTRATIVE
GADOPENTETATE DIMEGLUMINE INJECTION, USP
1.3.1 PRODUCT MONOGRAPH
1
PRODUCT MONOGRAPH
GADOPENTETATE DIMEGLUMINE INJECTION, USP
469 mg/mL (0.5 mmol/mL)
For Intravenous Use
THERAPEUTIC CLASSIFICATION
Contrast Enhancement Agent
for Magnetic Resonance Imaging (MRI)
Jubilant DraxImage Inc.
Date of Preparation:
16751 Trans Canada Hwy
September 12, 2014
Kirkland, Quebec
H9H 4J4
Canada
http://www. draximage.com
Submission Control No.: 160553
JUBILANT DRAXIMAGE INC.
MODULE 1 ADMINISTRATIVE
GADOPENTETATE DIMEGLUMINE INJECTION, USP
1.3.1 PRODUCT MONOGRAPH
2
TABLE OF CONTENTS
1.3.1
PRODUCT MONOGRAPH – NON-ANNOTATED ....... ERROR! BOOKMARK NOT
DEFINED.
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 4
ACTION
AND
CLINICAL
PHARMACOLOGY
......................................................................
4
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
5
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS
...............................................................................................................................
6
_General
...................................................................................................................................
7_
_Nephrogenic Systemic Fibrosis (NSF)
....................................................................................
7_
_Hypersensitivity Reactions
......................................................................................................
8_
_Injection Site
Reactions...........................................................................................................
8_
_Sickle
Erythrocytes..................................................................................................................
9_
_Renal
Impairment....................................................................