CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP LIQUID

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CHLORHEXIDINE GLUCONATE

זמין מ:

XTTRIUM LABORATORIES INC.

קוד ATC:

A01AB03

INN (שם בינלאומי):

CHLORHEXIDINE

כמות:

0.12%

טופס פרצבטיות:

LIQUID

הרכב:

CHLORHEXIDINE GLUCONATE 0.12%

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15ML/473ML

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTI-INFECTIVES

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2014-10-10

מאפייני מוצר

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_Page 1 of 19_
PRODUCT MONOGRAPH
CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP
Chlorhexidine Gluconate 0.12% Oral Rinse
Liquid, 0.12% Chlorhexidine Gluconate
Antigingivital Oral Rinse
Xttrium Laboratories, Inc.
1200 East Business Center Drive
Mount Prospect, IL 60056
USA
Date of Preparation:
October 09, 2014
Submission Control No: 168915
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_Page 2 of 19_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................6
OVERDOSAGE
..................................................................................................................7
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................9
SPECIAL HANDLING INSTRUCTIONS
.........................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
...............................................................................11
PHARMACEUTICAL INFORMATION
..........................................................................11
CLINICAL TRIALS
..........................................................................................................12
DETAILED PHARMACO