RESTASIS MULTIDOSE EMULSION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CYCLOSPORINE

Mevcut itibaren:

ABBVIE CORPORATION

ATC kodu:

S01XA18

INN (International Adı):

CICLOSPORIN

Doz:

0.05%

Farmasötik formu:

EMULSION

Kompozisyon:

CYCLOSPORINE 0.05%

Uygulama yolu:

OPHTHALMIC

Paketteki üniteler:

5.5ML

Reçete türü:

Prescription

Terapötik alanı:

ANTI-INFLAMMATORY AGENTS, MISCELLANEOUS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2018-06-01

Ürün özellikleri

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