CYSTO-CONRAY II SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IOTHALAMATE MEGLUMINE

Saatavilla:

LIEBEL-FLARSHEIM COMPANY LLC

ATC-koodi:

V08AA04

INN (Kansainvälinen yleisnimi):

IOTALAMIC ACID

Annos:

172MG

Lääkemuoto:

SOLUTION

Koostumus:

IOTHALAMATE MEGLUMINE 172MG

Antoreitti:

URETHRAL

Kpl paketissa:

250/500ML

Prescription tyyppi:

Ethical

Terapeuttinen alue:

ROENTGENOGRAPHY

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2021-12-02

Valmisteyhteenveto

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_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
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_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