OPTIMARK SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

GADOVERSETAMIDE

Disponible desde:

LIEBEL-FLARSHEIM CANADA INC

Código ATC:

V08CA06

Designación común internacional (DCI):

GADOVERSETAMIDE

Dosis:

330.9MG

formulario farmacéutico:

SOLUTION

Composición:

GADOVERSETAMIDE 330.9MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

30ML

tipo de receta:

Ethical

Área terapéutica:

OTHER DIAGNOSTIC AGENTS

Resumen del producto:

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

Estado de Autorización:

CANCELLED PRE MARKET

Fecha de autorización:

2018-03-23

Ficha técnica

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