OPTIMARK SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

GADOVERSETAMIDE

Mevcut itibaren:

LIEBEL-FLARSHEIM CANADA INC

ATC kodu:

V08CA06

INN (International Adı):

GADOVERSETAMIDE

Doz:

330.9MG

Farmasötik formu:

SOLUTION

Kompozisyon:

GADOVERSETAMIDE 330.9MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

15ML

Reçete türü:

Ethical

Terapötik alanı:

OTHER DIAGNOSTIC AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2018-03-23

Ürün özellikleri

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