PHARIXIA ALCOHOL FREE MOUTHWASH/GARGLE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

BENZYDAMINE HYDROCHLORIDE

Commercializzato da:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Codice ATC:

A01AD02

INN (Nome Internazionale):

BENZYDAMINE

Dosaggio:

0.15%

Forma farmaceutica:

MOUTHWASH/GARGLE

Composizione:

BENZYDAMINE HYDROCHLORIDE 0.15%

Via di somministrazione:

BUCCAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

MOUTHWASHES AND GARGLES

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2019-11-27

Scheda tecnica

_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
.....................................................