מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
CHLORHEXIDINE GLUCONATE
SUNSTAR AMERICAS INC
A01AB03
CHLORHEXIDINE
0.12%
MOUTHWASH
CHLORHEXIDINE GLUCONATE 0.12%
BUCCAL
16 OZ-473ML
Prescription
MISCELLANEOUS ANTI-INFECTIVES
Active ingredient group (AIG) number: 0107629007; AHFS:
APPROVED
2012-05-01
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 קרא את המסמך השלם