PERICHLOR MOUTHWASH

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

CHLORHEXIDINE GLUCONATE

Доступна з:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Код атс:

A01AB03

ІПН (Міжнародна Ім'я):

CHLORHEXIDINE

Дозування:

0.12%

Фармацевтична форма:

MOUTHWASH

Склад:

CHLORHEXIDINE GLUCONATE 0.12%

Адміністрація маршрут:

BUCCAL

Одиниць в упаковці:

475ML

Тип рецепту:

Prescription

Терапевтична области:

MISCELLANEOUS ANTI-INFECTIVES

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2018-09-04

Характеристики продукта

_ _
_PERICHLOR and PERICHLOR WITHOUT ALCOHOL-Product Monograph _
_Page 1 of 14_
PRODUCT MONOGRAPH
PR
PERICHLOR
®
PR
PERICHLOR
®
WITHOUT ALCOHOL
Chlorhexidine Gluconate Mouthwash
0.12%
BP
ANTIGINGIVITIS ORAL RINSE
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
October 10, 2019
PERICHLOR
®
is a registered trademark of Pharmascience Inc.
Submission Control No: 223243
_ _
_PERICHLOR and PERICHLOR WITHOUT ALCOHOL-Product Monograph _
_Page 2 of 14_
PR
PERICHLOR
®
PR
PERICHLOR
® WITHOUT ALCOHOL
Chlorhexidine Gluconate Mouthwash
0.12%
BP
ACTIONS, CLINICAL PHARMACOLOGY
PERICHLOR and PERICHLOR WITHOUT ALCOHOL (0.12% Chlorhexidine
Gluconate Mouthwash) provide 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 PERICHLOR and PERICHLOR
WITHOUT
ALCOHOL inhibits the buildup and maturation of plaque by reducing
certain microbes
regarded as gingival pathogens, thereby reducing gingivitis
1,4,5
. Chlorhexidine Gluconate
Mouthwash 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 Mouthwash for six months. Three
months after
Chlorhexidine Gluconate Mouthwash 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 glucona