ISOVUE 300 INJECTION LIQUID

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

IOPAMIDOL

Saadav alates:

BRACCO IMAGING CANADA

ATC kood:

V08AB04

INN (Rahvusvaheline Nimetus):

IOPAMIDOL

Annus:

61%

Ravimvorm:

LIQUID

Koostis:

IOPAMIDOL 61%

Manustamisviis:

INTRAVASCULAR

Ühikuid pakis:

15/50/100/150 ML

Retsepti tüüp:

Ethical

Terapeutiline ala:

ROENTGENOGRAPHY

Toote kokkuvõte:

Active ingredient group (AIG) number: 0116899003; AHFS:

Volitamisolek:

MARKETED

Loa andmise kuupäev:

1998-01-08

Toote omadused

_Product Monograph _
_ _
_ISOVUE_
_®_
_ _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ISOVUE®
Iopamidol
ISOVUE-200
(injection, 41% w/v,
200 mg I/mL)
ISOVUE 300
(injection, 61% w/v,
300 mg I/mL)
ISOVUE MULTIPACK 300
(injection, 61% w/v,
300 mg I/mL)
ISOVUE-370
(injection, 76% w/v, 370 mg I/mL)
ISOVUE MULTIPACK-370
(injection, 76% w/v,
370 mg I/mL)
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 17, 2021
Submission Control Number: 254894
_ _
_Product Monograph _
_ _
_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
.............................................................................................................
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
Dosing Considerations
.................................................................