PERIOGARD ALCOHOL FREE SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CHLORHEXIDINE GLUCONATE

Tilgjengelig fra:

COLGATE-PALMOLIVE CANADA INC

ATC-kode:

A01AB03

INN (International Name):

CHLORHEXIDINE

Dosering :

0.12%

Legemiddelform:

SOLUTION

Sammensetning:

CHLORHEXIDINE GLUCONATE 0.12%

Administreringsrute:

BUCCAL

Enheter i pakken:

470ML

Resept typen:

Prescription

Terapeutisk område:

MISCELLANEOUS ANTI-INFECTIVES

Produkt oppsummering:

Active ingredient group (AIG) number: 0107629007; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2013-04-15

Preparatomtale

1
PRODUCT MONOGRAPH
PR
PERIOGARD
TM ALCOHOL FREE
CHLORHEXIDINE GLUCONATE ORAL RINSE 0.12% W/W, USP
Antigingivitis Oral Rinse
COLGATE-PALMOLIVE CANADA INC.
Toronto, ON M3C 1W3
CONTROL #: 218608
DATE OF REVISION:
March 8, 2019
PREVIOUS APPROVAL DATE:
December 19, 2017
2
PRODUCT MONOGRAPH
PR
PERIOGARD
TM ALCOHOL FREE
THERAPEUTIC CLASSIFICATION
Antigingivitis Oral Rinse
ACTIONS AND CLINICAL PHARMACOLOGY
Pr
PERIOGARD
TM
ALCOHOL FREE (0.12% Chlorhexidine Gluconate Oral Rinse, USP)
provides antimicrobial activity during oral rinsing which is sustained
between rinsings.
Microbiological sampling of plaque has shown reduction of bacterial
counts of certain
assayed species, both aerobic and anaerobic, ranging from 54% - 97%
through six
months’ use with a Chlorhexidine containing mouthrinse. The activity
of Chlorhexidine in
the oral cavity is promoted by binding to plaque, salivary pellicle,
oral mucosa, and hard
structures that may result in sustained release of up to 24 hours.
Use of a 0.12% chlorhexidine gluconate oral rinse in a six month
clinical study did not
result in any significant changes in bacterial resistance, overgrowth
or potentially
opportunistic organisms or other adverse changes in the oral microbial
ecosystem. Three
months after the use of a 0.12% Chlorhexidine Gluconate oral rinse was
discontinued, the
number of bacteria in plaque had returned to baseline levels and
resistance of plaque
bacteria to chlorhexidine gluconate was equal to that at baseline.
Studies conducted on human subjects and animals demonstrate that
chlorhexidine
gluconate is poorly absorbed from the gastrointestinal tract.
Excretion of chlorhexidine
gluconate occurred primarily through feces (~90%). Less than 1% of the
chlorhexidine
gluconate ingested by these subjects was excreted in the urine.
INDICATIONS AND CLINICAL USE
PERIOGARD ALCOHOL FREE is indicated for use as part of a professional
program for
the treatment of moderate to severe gingivitis, and in addition for
management of
associated gingival bleeding and inflammation betwe