RESTASIS EMULSION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CYCLOSPORINE

Disponibil de la:

ABBVIE CORPORATION

Codul ATC:

S01XA18

INN (nume internaţional):

CICLOSPORIN

Dozare:

0.05%

Forma farmaceutică:

EMULSION

Compoziție:

CYCLOSPORINE 0.05%

Calea de administrare:

OPHTHALMIC

Unități în pachet:

0.4ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTI-INFLAMMATORY AGENTS, MISCELLANEOUS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-08-08

Caracteristicilor produsului

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
RESTASIS®
Cyclosporine Ophthalmic Emulsion
Emulsion, 0.05% w/v, Ophthalmic
Anti-Inflammatory / Immunomodulator
ATC Code: S01XA18
_Page_
_1_
_of_
_26_
Submission Control Number: 266000
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
_RESTASIS (cyclosporine)_ _ _
Date of Initial Authorization:
AUG 19, 2010
Date of Revision:
AUG 4, 2022
_RESTASIS (cyclosporine) _
_ _ _Page 2_ _of 26_
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.
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.......................................................................................................
5
4.5
Missed Dose
..........................