OPTIMARK SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

GADOVERSETAMIDE

Fáanlegur frá:

LIEBEL-FLARSHEIM CANADA INC

ATC númer:

V08CA06

INN (Alþjóðlegt nafn):

GADOVERSETAMIDE

Skammtar:

330.9MG

Lyfjaform:

SOLUTION

Samsetning:

GADOVERSETAMIDE 330.9MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

15ML

Gerð lyfseðils:

Ethical

Lækningarsvæði:

OTHER DIAGNOSTIC AGENTS

Vörulýsing:

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

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2018-03-23

Vara einkenni

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