RESTASIS MULTIDOSE EMULSION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CYCLOSPORINE

Commercializzato da:

ABBVIE CORPORATION

Codice ATC:

S01XA18

INN (Nome Internazionale):

CICLOSPORIN

Dosaggio:

0.05%

Forma farmaceutica:

EMULSION

Composizione:

CYCLOSPORINE 0.05%

Via di somministrazione:

OPHTHALMIC

Confezione:

5.5ML

Tipo di ricetta:

Prescription

Area terapeutica:

ANTI-INFLAMMATORY AGENTS, MISCELLANEOUS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2018-06-01

Scheda tecnica

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