PROHANCE SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

GADOTERIDOL

Tilgjengelig fra:

BRACCO IMAGING CANADA

ATC-kode:

V08CA04

INN (International Name):

GADOTERIDOL

Dosering :

279.3MG

Legemiddelform:

SOLUTION

Sammensetning:

GADOTERIDOL 279.3MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

10/15/17/20/50ML

Resept typen:

Ethical

Terapeutisk område:

OTHER DIAGNOSTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0124199001; AHFS:

Autorisasjon status:

MARKETED

Autorisasjon dato:

1998-09-08

Preparatomtale

_PROHANCE_
_®_
_ (Gadoteridol injection) _
_Page 1 of 32 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PROHANCE®
Gadoteridol injection USP
Solution, 279.3 mg (0.5mmol) per mL, Intravenous
CONTRAST ENHANCEMENT PREPARATION FOR
MAGNETIC RESONANCE IMAGING (MRI)
Bracco Imaging Canada
11065 boul. Louis-H. Lafontaine
Montreal, Quebec
Canada H1J 2Z4
Date of Initial Authorization:
AUG 19, 1996
Date of Revision:
MAR 15, 2024
Submission Control Number: 276177
_ _
_PROHANCE_
_®_
_ (Gadoteridol injection) _
_Page 2 of 32 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
05/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
05/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
09/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
05/2022
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
05/2022
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 Consider