PHARIXIA ALCOHOL FREE MOUTHWASH/GARGLE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

BENZYDAMINE HYDROCHLORIDE

제공처:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC 코드:

A01AD02

INN (국제 이름):

BENZYDAMINE

복용량:

0.15%

약제 형태:

MOUTHWASH/GARGLE

구성:

BENZYDAMINE HYDROCHLORIDE 0.15%

관리 경로:

BUCCAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

MOUTHWASHES AND GARGLES

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2019-11-27

제품 특성 요약

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