RESTASIS EMULSION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CYCLOSPORINE

Disponível em:

ABBVIE CORPORATION

Código ATC:

S01XA18

DCI (Denominação Comum Internacional):

CICLOSPORIN

Dosagem:

0.05%

Forma farmacêutica:

EMULSION

Composição:

CYCLOSPORINE 0.05%

Via de administração:

OPHTHALMIC

Unidades em pacote:

0.4ML

Tipo de prescrição:

Prescription

Área terapêutica:

ANTI-INFLAMMATORY AGENTS, MISCELLANEOUS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2022-08-08

Características técnicas

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
RESTASIS®
Cyclosporine Ophthalmic Emulsion
Emulsion, 0.05% w/v, Ophthalmic
Anti-Inflammatory / Immunomodulator
ATC Code: S01XA18
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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) _
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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
..........................