Država: Kanada
Jezik: angleščina
Source: Health Canada
CHLORHEXIDINE GLUCONATE
3M CANADA COMPANY
A01AB03
CHLORHEXIDINE
0.12%
MOUTHWASH
CHLORHEXIDINE GLUCONATE 0.12%
BUCCAL
15G/50G
Prescription
MISCELLANEOUS ANTI-INFECTIVES
Active ingredient group (AIG) number: 0107629007; AHFS:
APPROVED
1998-03-05
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 ( Preberite celoten dokument