OPTIMARK SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

GADOVERSETAMIDE

から入手可能:

LIEBEL-FLARSHEIM CANADA INC

ATCコード:

V08CA06

INN（国際名）:

GADOVERSETAMIDE

投薬量:

330.9MG

医薬品形態:

SOLUTION

構図:

GADOVERSETAMIDE 330.9MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

15ML

処方タイプ:

Ethical

治療領域:

OTHER DIAGNOSTIC AGENTS

製品概要:

Active ingredient group (AIG) number: 0142281001; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2018-03-23

製品の特徴

_ _
_Page 1 of 37 _
PRODUCT MONOGRAPH
OPTIMARK
®
Gadoversetamide Injection
5, 10, 15, 20 mL in glass vials for injection and
pharmacy bulk package: 50 mL vial for injection
330.9 mg/mL of Gadoversetamide
Paramagnetic, intravascular, contrast agent for magnetic resonance
imaging (MRI)
Liebel-Flarsheim Canada Inc.
Pointe-Claire, QC, H9R 5H8
CANADA
Date of Revision: June 15, 2017
Control No.: 204201
_ _
_Page 2 of 37_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................22
SPECIAL HANDLING INSTRUCTIONS
.......................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
.........................................................