OPTIMARK SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

GADOVERSETAMIDE

제공처:

LIEBEL-FLARSHEIM CANADA INC

ATC 코드:

V08CA06

INN (International Name):

GADOVERSETAMIDE

복용량:

330.9MG

약제 형태:

SOLUTION

구성:

GADOVERSETAMIDE 330.9MG

관리 경로:

INTRAVENOUS

패키지 단위:

20ML

처방전 유형:

Ethical

치료 영역:

OTHER DIAGNOSTIC AGENTS

제품 요약:

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

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2018-03-23

제품 특성 요약

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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
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_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
.........................................................