GUM PAROEX MOUTHWASH

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CHLORHEXIDINE GLUCONATE

Disponible des:

SUNSTAR AMERICAS INC

Codi ATC:

A01AB03

Designació comuna internacional (DCI):

CHLORHEXIDINE

Dosis:

0.12%

formulario farmacéutico:

MOUTHWASH

Composición:

CHLORHEXIDINE GLUCONATE 0.12%

Vía de administración:

BUCCAL

Unidades en paquete:

16 OZ-473ML

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANTI-INFECTIVES

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2012-05-01

Fitxa tècnica

PRODUCT MONOGRAPH
PR
G•U•M
® PAROEX
® ORAL RINSE
CHLORHEXIDINE GLUCONATE 0.12%
Chlorhexidine Gluconate USP, 0.12%
Antigingivitis Oral Rinse
Sunstar Americas, Inc.
515 Governors Road
Guelph, Ontario
N1K 1C7
Date of Revision:
June 17, 2014
Submission Control No: 173508
2
G•U•M®
PAROEX
®
ORAL
RINSE
(CHLORHEXIDINE
GLUCONATE 0.12%)
ANTIGINGIVITIS ORAL RINSE
ACTIONS, CLINICAL PHARMACOLOGY:
GUM
Paroex
Oral
Rinse
(0.12%
Chlorhexidine
Gluconate) provides antimicrobial activity during oral
rinsing
which
is
maintained
between
rinsings.
Microbiologic sampling of plaque has shown a general
reduction of both aerobic and anaerobic bacterial counts
ranging from 54-97% through six months’ clinical use.
Rinsing with chlorhexidine gluconate inhibits the buildup
and maturation of plaque by reducing certain microbes
regarded
as
gingival
pathogens,
thereby
reducing
gingivitis
1,4,5
.
Chlorhexidine
gluconate
provided
antimicrobial
activity
during
rinsing
and
for
several
hours thereafter.
No
significant
changes
in
bacterial
sensitivity,
overgrowth
of
potentially
opportunistic
organisms
or
other adverse changes in the oral microbial flora were
observed following the use of chlorhexidine gluconate
for
six
months.
Three
months
after
chlorhexidine
gluconate use was discontinued, the number of bacteria
in
plaque
had
returned
to
pre-treatment
levels
and
sensitivity of plaque bacteria to chlorhexidine gluconate
remained unchanged.
Studies
conducted
with
human
subjects
and
animals
demonstrate that any ingested chlorhexidine gluconate is
poorly absorbed from the gastrointestinal tract. Excretion
of chlorhexidine gluconate occurred primarily through
the feces (approximately 90%). Less than 1% of the
chlorhexidine gluconate ingested by these subjects was
excreted in the urine.
INDICATIONS AND CLINICAL USE:
GUM
Paroex
(0.12%
chlorhexidine
gluconate)
is
indicated for use as part of a professional program for the
treatment
of
moderate
to
severe
gingivitis,
and
for
management
of
associated
gingival
bleeding
and
inflammation between denta