IZBA SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TRAVOPROST

제공처:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC 코드:

S01EE04

INN (국제 이름):

TRAVOPROST

복용량:

0.003%

약제 형태:

SOLUTION

구성:

TRAVOPROST 0.003%

관리 경로:

OPHTHALMIC

패키지 단위:

2.5ML/5ML

처방전 유형:

Prescription

치료 영역:

PROSTAGLANDIN ANALOGS

제품 요약:

Active ingredient group (AIG) number: 0145801002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2017-03-13

제품 특성 요약

_IZBA* Product monograph _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
IZBA*
(travoprost ophthalmic solution) 0.003% w/v
Manufacturer Standard
Elevated Intraocular Pressure Therapy
Prostaglandin F
2α
analogue
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.,
Dorval, Québec
H9S 1A9
www.novartis.ca
Date of Preparation:
September 23, 2016
Date of Revision:
March 10, 2017
Submission Control No.: 202529
*a trademark of Novartis
_IZBA* Product monograph _
_Page 2 of 36_
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
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................12
SPECIAL HANDLING INSTRUCTIONS
.......................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
........................................................................