CYSTO-CONRAY II SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

IOTHALAMATE MEGLUMINE

Dostopno od:

LIEBEL-FLARSHEIM COMPANY LLC

Koda artikla:

V08AA04

INN (mednarodno ime):

IOTALAMIC ACID

Odmerek:

172MG

Farmacevtska oblika:

SOLUTION

Sestava:

IOTHALAMATE MEGLUMINE 172MG

Pot uporabe:

URETHRAL

Enote v paketu:

250/500ML

Tip zastaranja:

Ethical

Terapevtsko območje:

ROENTGENOGRAPHY

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2021-12-02

Lastnosti izdelka

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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