RESTASIS MULTIDOSE EMULSION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CYCLOSPORINE

Dostupno od:

ABBVIE CORPORATION

ATC koda:

S01XA18

INN (International ime):

CICLOSPORIN

Doziranje:

0.05%

Farmaceutski oblik:

EMULSION

Sastav:

CYCLOSPORINE 0.05%

Administracija rute:

OPHTHALMIC

Jedinice u paketu:

5.5ML

Tip recepta:

Prescription

Područje terapije:

ANTI-INFLAMMATORY AGENTS, MISCELLANEOUS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2018-06-01

Svojstava lijeka

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