GADOPENTETATE DIMEGLUMINE INJECTION, USP SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
08-10-2014
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Aktiv bestanddel:
GADOPENTETATE DIMEGLUMINE
Tilgængelig fra:
JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA
ATC-kode:
V08CA01
INN (International Name):
GADOPENTETIC ACID
Dosering:
469MG
Lægemiddelform:
SOLUTION
Sammensætning:
GADOPENTETATE DIMEGLUMINE 469MG
Indgivelsesvej:
INTRAVENOUS
Enheder i pakken:
5/10/15/20ML
Recept type:
Ethical
Terapeutisk område:
OTHER DIAGNOSTIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0123846001; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2022-05-17
Produktets egenskaber
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....................................................................
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