PHARIXIA ALCOHOL FREE MOUTHWASH/GARGLE

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

BENZYDAMINE HYDROCHLORIDE

Beschikbaar vanaf:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC-code:

A01AD02

INN (Algemene Internationale Benaming):

BENZYDAMINE

Dosering:

0.15%

farmaceutische vorm:

MOUTHWASH/GARGLE

Samenstelling:

BENZYDAMINE HYDROCHLORIDE 0.15%

Toedieningsweg:

BUCCAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutisch gebied:

MOUTHWASHES AND GARGLES

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2019-11-27

Productkenmerken

_Product Monograph – PHARIXIA_
_®_
_, PHARIXIA_
_®_
_ ALCOHOL FREE Page 1 of 14 _
PRODUCT MONOGRAPH
PR
PHARIXIA
®
PR
PHARIXIA
®
ALCOHOL FREE
Benzydamine Mouthwash, BP
Benzydamine hydrochloride 1.5 mg/mL (0.15% w/v)
Buccal
LOCAL ANALGESIC
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Avenue Suite #100
Montreal, Québec,
H4P 2T4
Date of Revision:
November 27, 2019
Submission Control No: 226851
®
Registered Trademark of Pharmascience Inc.
_Product Monograph – PHARIXIA_
_®_
_, PHARIXIA_
_®_
_ ALCOHOL FREE Page 2 of 14 _
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
....................................................................................................4
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
.................................................................................7
PHARMACEUTICAL INFORMATION
............................................................................7
CLINICAL TRIALS
.....................................................