CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP LIQUID

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CHLORHEXIDINE GLUCONATE

Tilgjengelig fra:

XTTRIUM LABORATORIES INC.

ATC-kode:

A01AB03

INN (International Name):

CHLORHEXIDINE

Dosering :

0.12%

Legemiddelform:

LIQUID

Sammensetning:

CHLORHEXIDINE GLUCONATE 0.12%

Administreringsrute:

ORAL

Enheter i pakken:

15ML/473ML

Resept typen:

Prescription

Terapeutisk område:

MISCELLANEOUS ANTI-INFECTIVES

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2014-10-10

Preparatomtale

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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