ODAN-BENZYDAMINE MOUTHWASH/GARGLE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

BENZYDAMINE HYDROCHLORIDE

Verfügbar ab:

ODAN LABORATORIES LTD

ATC-Code:

A01AD02

INN (Internationale Bezeichnung):

BENZYDAMINE

Dosierung:

0.15%

Darreichungsform:

MOUTHWASH/GARGLE

Zusammensetzung:

BENZYDAMINE HYDROCHLORIDE 0.15%

Verabreichungsweg:

BUCCAL

Einheiten im Paket:

250ML

Verschreibungstyp:

Prescription

Therapiebereich:

MOUTHWASHES AND GARGLES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0113801001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2017-04-13

Fachinformation

_Product Monograph –ODAN-BENZYDAMINE_
_Page 1 of 13_
PRODUCT MONOGRAPH
PR
ODAN-BENZYDAMINE
Benzydamine Mouthwash, BP
benzydamine hydrochloride 1.5 mg/mL (0.15% w/v)
LOCAL ANALGESIC
Odan Laboratories Limited
325 Stillview Avenue
Pointe-Claire, QC,
Canada, H9R 2Y6
Date of Preparation:
April 13, 2017
Submission Control No: 189026
_Product Monograph –ODAN-BENZYDAMINE_
_Page 2 of 13_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
DOSAGE AND ADMINISTRATION
................................................................................4
OVERDOSAGE
..................................................................................................................4
ACTION AND CLINICAL PHARMACOLOGY
..............................................................5
STORAGE AND STABILITY
............................................................................................5
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................5
PART II: SCIENTIFIC INFORMATION
.................................................................................6
PHARMACEUTICAL
INFORMATION............................................................................6
CLINICAL TRIALS
............................................................................................................7
DETAILED PHARMACOLOGY
.......................................................................................7
TOXICOLOGY
.......................................................................................................