PMS-BENZYDAMINE MOUTHWASH/GARGLE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

BENZYDAMINE HYDROCHLORIDE

Commercializzato da:

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:

100ML/250ML

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:

1999-01-25

Scheda tecnica

PRODUCT MONOGRAPH
PR
PMS-BENZYDAMINE
Benzydamine Mouthwash, BP
Benzydamine Hydrochloride 1.5 mg/mL (0.15% w/v)
LOCAL ANALGESIC
PHARMASCIENCE INC.
6111 Royalmount Avenue Suite #100
Montreal, QC, CANADA, H4P 2T4
www.pharmascience.com
Date of Preparation:
October 26, 2017
Submission Control No: 210244
_Product Monograph pms-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
.............................................................. 4
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
...................................................................................................................
7
REFERENCES