OPTIMARK SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

GADOVERSETAMIDE

Tersedia dari:

LIEBEL-FLARSHEIM CANADA INC

Kode ATC:

V08CA06

INN (Nama Internasional):

GADOVERSETAMIDE

Dosis:

330.9MG

Bentuk farmasi:

SOLUTION

Komposisi:

GADOVERSETAMIDE 330.9MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

15ML

Jenis Resep:

Ethical

Area terapi:

OTHER DIAGNOSTIC AGENTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2018-03-23

Karakteristik produk

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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
.........................................................