OMNISCAN SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

GADODIAMIDE

Tilgjengelig fra:

GE HEALTHCARE CANADA INC

ATC-kode:

V08CA03

INN (International Name):

GADODIAMIDE

Dosering :

287MG

Legemiddelform:

SOLUTION

Sammensetning:

GADODIAMIDE 287MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

5/10/15/20/50 ML

Resept typen:

Ethical

Terapeutisk område:

OTHER DIAGNOSTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0126095001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2003-03-04

Preparatomtale

_ _
_OMNISCAN (gadodiamide injection) _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
OMNISCAN
TM
gadodiamide injection USP
Solution, 287 mg/mL (0.5 mmol/mL), intravenous injection
Contrast Enhancement Agent for Magnetic Resonance Imaging (MRI)
GE Healthcare Canada Inc.
1919 Minnesota Court
Mississauga, Ontario
L5N 0C9
Date of Initial Authorization:
MAY 18, 1994
Date of Revision:
NOV 30, 2023
Submission Control Number: 274137
_ _
_OMNISCAN (gadodiamide injection) _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
2023-11
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
...........................................................................
2
TABLE OF CONTENTS
.............................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 4
1
INDICATIONS
..............................................................................................
4
1.1
Pediatrics
.............................................................................................
4
1.2
Geriatrics
..............................................................................................
4
2
CONTRAINDICATIONS
................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................ 5
4.1
Dosing
Considerations..........................................................................
6
4.2
Recommended Dose and Dosage Adjustment
..................................... 6
4.4
Administration
.....................................................................................
7
5
OVERDOSAGE
............................................................................................
7
6
DOSAG