CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP LIQUID

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CHLORHEXIDINE GLUCONATE

متاح من:

XTTRIUM LABORATORIES INC.

ATC رمز:

A01AB03

INN (الاسم الدولي):

CHLORHEXIDINE

جرعة:

0.12%

الشكل الصيدلاني:

LIQUID

تركيب:

CHLORHEXIDINE GLUCONATE 0.12%

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15ML/473ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS ANTI-INFECTIVES

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2014-10-10

خصائص المنتج

_ _
_ _
_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
_ _
_ _
_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