ISOVUE MULTIPACK-370 LIQUID

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

IOPAMIDOL

Tilgjengelig fra:

BRACCO IMAGING CANADA

ATC-kode:

V08AB04

INN (International Name):

IOPAMIDOL

Dosering :

76%

Legemiddelform:

LIQUID

Sammensetning:

IOPAMIDOL 76%

Administreringsrute:

INTRAVASCULAR

Enheter i pakken:

200/500 ML

Resept typen:

Ethical

Terapeutisk område:

ROENTGENOGRAPHY

Produkt oppsummering:

Active ingredient group (AIG) number: 0116899001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2000-04-19

Preparatomtale

_Product Monograph _
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_ISOVUE_
_®_
_ _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ISOVUE®
Iopamidol Injection
ISOVUE-200
Solution, 41% w/v,
200 mg I/mL, Subarachnoid/Intravascular
ISOVUE-300
Solution, 61% w/v,
300 mg I/mL, Intravascular
ISOVUE MULTIPACK-300
Solution, 61% w/v,
300 mg I/mL, Intravascular
ISOVUE-370
Solution, 76% w/v, 370 mg I/mL, Intravascular
ISOVUE MULTIPACK-370
Solution, 76% w/v,
370 mg I/mL, Intravascular
USP
NON-IONIC RADIOGRAPHIC CONTRAST AGENT
(ATC: V08AB04)
Bracco Imaging Canada
11065 boul. Louis-H.-Lafontaine
Montreal, Quebec
Canada H1J 2Z4
Date of Initial Authorization:
July 15, 2002
Date of Revision:
December 21, 2022
Submission Control Number: 264222
_ _
_Product Monograph _
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_ISOVUE_
_®_
_ (iopamidol) _
_Page 2 of 45_
RECENT MAJOR LABEL CHANGES
Not applicable
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
...................................................................................................................
5
1.2
Geriatrics
...................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 6
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosi