RESTASIS MULTIDOSE EMULSION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CYCLOSPORINE

제공처:

ABBVIE CORPORATION

ATC 코드:

S01XA18

INN (International Name):

CICLOSPORIN

복용량:

0.05%

약제 형태:

EMULSION

구성:

CYCLOSPORINE 0.05%

관리 경로:

OPHTHALMIC

패키지 단위:

5.5ML

처방전 유형:

Prescription

치료 영역:

ANTI-INFLAMMATORY AGENTS, MISCELLANEOUS

제품 요약:

Active ingredient group (AIG) number: 0115996006; AHFS:

승인 상태:

APPROVED

승인 날짜:

2018-06-01

제품 특성 요약

_RESTASIS MULTIDOSE (cyclosporine ophthalmic emulsion) _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RESTASIS MULTIDOSE®
Cyclosporine Ophthalmic Emulsion
Emulsion, 0.05% w/v, Ophthalmic
Anti-Inflammatory / Immunomodulator
(ATC Code: S01XA18)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, QC H4S 1Z1
Date of Initial Authorization:
JUN 01, 2018
Date of Revision:
FEB 16, 2022
Submission Control Number: 264826
_RESTASIS MULTIDOSE (cyclosporine ophthalmic emulsion) _
_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
.......................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment..................................................... 4
4.3
Reconstitution
...................................................................................................
5
4.4
Administration...........