PERIDEX ORAL RINSE MOUTHWASH

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CHLORHEXIDINE GLUCONATE

Dostupno od:

3M CANADA COMPANY

ATC koda:

A01AB03

INN (International ime):

CHLORHEXIDINE

Doziranje:

0.12%

Farmaceutski oblik:

MOUTHWASH

Sastav:

CHLORHEXIDINE GLUCONATE 0.12%

Administracija rute:

BUCCAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

MISCELLANEOUS ANTI-INFECTIVES

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

1998-03-05

Svojstava lijeka

PRODUCT MONOGRAPH
PR
PERIDEX® ORAL RINSE
Chlorhexidine Gluconate 0.12%
Antigingivitis Oral Rinse
3M Canada Company
Dental Products
300 Tartan Drive
London, Ontario
N5V 4M9
Control#: 118710
Date of Preparation:
December 12, 2007
PR PERIDEX® ORAL RINSE
(CHLORHEXIDINE GLUCONATE 0.12%)
ANTIGINGIVITIS ORAL RINSE
ACTIONS, CLINICAL PHARMACOLOGY:
Peridex
Oral
Rinse
(0.12%
Chlorhexidine
Gluconate)
or
Peridex
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 Peridex inhibits the buildup
and
maturation
of
plaque
by
reducing
certain
microbes
regarded as gingival pathogens, thereby reducing gingivitis
1,4,5
. Peridex 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
Peridex for six months. Three months after Peridex 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:
Peridex (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
dental visits. For patients having coexisting gingivitis and
periodontitis, see PRECAUTIONS.
CONTRAINDICATIONS
Peridex (