VABLYS VAGINAL TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
01-09-2021
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Aktiv bestanddel:
DEQUALINIUM CHLORIDE
Tilgængelig fra:
DUCHESNAY INC
ATC-kode:
G01AC05
INN (International Name):
DEQUALINIUM
Dosering:
10MG
Lægemiddelform:
VAGINAL TABLET
Sammensætning:
DEQUALINIUM CHLORIDE 10MG
Indgivelsesvej:
VAGINAL
Enheder i pakken:
15G/50G
Recept type:
Prescription
Terapeutisk område:
ANTIBIOTICS
Produkt oversigt:
Active ingredient group (AIG) number: 0107638003; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2021-07-28
Produktets egenskaber
_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
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