Maa: Kanada
Kieli: englanti
Lähde: Health Canada
CHLORHEXIDINE GLUCONATE
BAJAJ MEDICAL, LLC
A01AB03
CHLORHEXIDINE
0.12%
MOUTHWASH
CHLORHEXIDINE GLUCONATE 0.12%
BUCCAL
475ML
Prescription
MISCELLANEOUS ANTI-INFECTIVES
Active ingredient group (AIG) number: 0107629007; AHFS:
APPROVED
2000-06-06
- 1 - PRODUCT MONOGRAPH PR CHLORHEXIDINE CHLORHEXIDINE GLUCONATE ORAL RINSE USP 0.12% ANTIGINGIVITIS Manufactured By: Bajaj Medical, LLC 415 W Pershing Road Chicago, Illinois 60609-2760, USA DATE OF REVISION: Imported By: February 19, 2021 Quality & Compliance Services Inc. 2000 Argentia Road, Plaza 2, Suite 220 Mississauga, ON L5N 1V8, Canada SUBMISSION CONTROL NUMBER: 247515 - 2 - PRODUCT MONOGRAPH Pr CHLORHEXIDINE Chlorhexidine Gluconate Oral Rinse USP 0.12% ACTIONS, CLINICAL PHARMACOLOGY: Chlorhexidine gluconate oral rinse 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 oral rinse inhibits the buildup and maturation of plaque by reducing certain microbes regarded as gingival pathogens, thereby reducing gingivitis 1,4,5 . Chlorhexidine gluconate oral rinse 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 oral rinse for six months. Three months after chlorhexidine gluconate oral rinse use was discontinued, the number of bacteria in plaque had returned to pretreatment 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: CHLORHEXIDINE (Chlorhexidine Gluconate) Oral Rinse USP is indicated for use as part of a professional progra Lue koko asiakirja