VABLYS VAGINAL TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

DEQUALINIUM CHLORIDE

Verfügbar ab:

DUCHESNAY INC

ATC-Code:

G01AC05

INN (Internationale Bezeichnung):

DEQUALINIUM

Dosierung:

10MG

Darreichungsform:

VAGINAL TABLET

Zusammensetzung:

DEQUALINIUM CHLORIDE 10MG

Verabreichungsweg:

VAGINAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

ANTIBIOTICS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0107638003; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2021-07-28

Fachinformation

_Vablys (dequalinium chloride vaginal tablets) Product Monograph _
_Page 1 of 20_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
VABLYS
TM
Dequalinium chloride vaginal tablets
Tablets, 10 mg, Vaginal
Anti-infective and Antiseptic Agent
Duchesnay Inc.
950 boul. Michèle-Bohec
Blainville, Quebec
Canada, J7C 5E2
Date of Initial Approval:
September 1, 2021JUL 27,
2021
Submission Control No: 227886
Annotated Product Monograph - EN
Pg. 1
_ _
_Vablys (dequalinium chloride vaginal tablets) Product Monograph _
_Page 2 of 20_
TABLE OF CONTENTS
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATION
...................................................................................................................
4
1.1
Pediatrics
.............................................................................................................
4
1.2
Geriatrics
.............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
DOSAGE AND ADMINISTRATION
................................................................................
4
3.1
Dosing Considerations
.........................................................................................
4
3.2
Recommended Dose and Dosage Adjustment
..................................................... 5
3.3
Administration
......................................................................................................
5
3.4
Missed Dose
........................................................................................................
5
4
OVERDOSAGE
...............................................................................................................
6
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACK