PHARIXIA MOUTHWASH/GARGLE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

BENZYDAMINE HYDROCHLORIDE

Mevcut itibaren:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC kodu:

A01AD02

INN (International Adı):

BENZYDAMINE

Doz:

0.15%

Farmasötik formu:

MOUTHWASH/GARGLE

Kompozisyon:

BENZYDAMINE HYDROCHLORIDE 0.15%

Uygulama yolu:

BUCCAL

Paketteki üniteler:

100ML/250ML

Reçete türü:

Prescription

Terapötik alanı:

MOUTHWASHES AND GARGLES

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2013-10-10

Ürün özellikleri

_Product Monograph –PHARIXIA_
_TM_
_ Page 1 of 13 _
_ _
PRODUCT MONOGRAPH
PR
PHARIXIA
TM
Benzydamine Mouthwash, BP
benzydamine hydrochloride 1.5 mg/mL (0.15% w/v)
LOCAL ANALGESIC
PENDOPHARM, Division of Pharmascience Inc.
6111 Royalmount Avenue Suite #100
Montreal, QC, Canada, H4P 2T4
Date of Preparation:
October 11, 2013
Submission Control No: 166685
TM
Trademark of Pharmascience Inc.
_Product Monograph –PHARIXIA_
_TM_
_ 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
......................................