CYSVIEW KIT

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

HEXAMINOLEVULINATE HYDROCHLORIDE

Fáanlegur frá:

PHOTOCURE ASA

ATC númer:

V04CX

INN (Alþjóðlegt nafn):

OTHER DIAGNOSTIC AGENTS

Skammtar:

100MG

Lyfjaform:

KIT

Samsetning:

HEXAMINOLEVULINATE HYDROCHLORIDE 100MG

Stjórnsýsluleið:

INTRAVESICAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

OTHER DIAGNOSTIC AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0156451001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2022-01-12

Vara einkenni

_Product Monograph _
_ _
_CYSVIEW (hexaminolevulinate hydrochloride) _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CYSVIEW®
Hexaminolevulinate hydrochloride for intravesical solution
Powder for Solution (kit), 100 mg/vial, Intravesical
Kit for the preparation of intravesical solution
Other diagnostic agents
Photocure ASA
Hoffsveien 4
0275 Oslo
Norway
Imported by: Innomar Strategies Inc.
3470 Superior Court,
Oakville, ON L6L 0C4
Date of Initial Authorization:
JAN 23, 2015
Date of Revision:
MAR 21, 2024
Submission Control Number: 273436
_ _
_Product Monograph _
_ _
_CYSVIEW (hexaminolevulinate hydrochloride) _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
03/2024
4 DOSAGE AND ADMINISTRATION
03/2024
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
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
..............................................................................................................
4
1.2
Geriatrics
..............................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
.............................................................................