CYSTO-CONRAY II SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IOTHALAMATE MEGLUMINE

Available from:

LIEBEL-FLARSHEIM COMPANY LLC

ATC code:

V08AA04

INN (International Name):

IOTALAMIC ACID

Dosage:

172MG

Pharmaceutical form:

SOLUTION

Composition:

IOTHALAMATE MEGLUMINE 172MG

Administration route:

URETHRAL

Units in package:

250/500ML

Prescription type:

Ethical

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

Active ingredient group (AIG) number: 0102763004; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-12-02

Summary of Product characteristics

_ _
_Page 1 of 14_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CYSTO-CONRAY
® II
Iothalamate Meglumine Injection USP
17.2 % w/v
Solution
IONIC IODINATED RADIOGRAPHIC CONTRAST MEDIUM FOR INSTILLATION OF THE
URINARY TRACT.
Liebel-Flarsheim Company LLC Date of Revision:
8800 Durant Road November 26, 2021
Raleigh, North Carolina
27616 USA
Importer:
Liebel-Flarsheim Canada Inc.
7500 Trans-Canada Highway
Pointe-Claire, Quebec
H9R 5H8
Submission Control No.: 255550
_ _
_ _
_Page 2 of 14_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................5
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................9
PART II: SCIENTIFIC INFORMATION
...............................................................................10
PHARMACEUTICAL INFORMATION
..........................................................................10
DETAILED PHARMACOLOGY
.....................................................................................10
REFER