ACULAR LS SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

KETOROLAC TROMETHAMINE

Disponible desde:

ABBVIE CORPORATION

Código ATC:

S01BC05

Designación común internacional (DCI):

KETOROLAC

Dosis:

0.4%

formulario farmacéutico:

SOLUTION

Composición:

KETOROLAC TROMETHAMINE 0.4%

Vía de administración:

OPHTHALMIC

Unidades en paquete:

5ML

tipo de receta:

Prescription

Área terapéutica:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0121995005; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2022-11-08

Ficha técnica

_ACULAR / ACULAR LS (ketorolac tromethamine) _
_Page 1 of 20 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACULAR®
ketorolac tromethamine ophthalmic solution
Solution, 0.5% w/v, for ophthalmic use
with benzalkonium chloride 0.01% w/v as preservative
Pr
ACULAR LS®
ketorolac tromethamine ophthalmic solution
Solution, 0.4% w/v, for ophthalmic use
with benzalkonium chloride 0.006% w/v as preservative
Topical Non-Steroidal Anti-Inflammatory Agent
ATC code: S01BC05
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
Submission Control Number: 268269
Date of Initial Authorization:
FEB 12, 1992
Date of Revision:
NOV
8, 2022
_ACULAR / ACULAR LS (ketorolac tromethamine) _
_Page 2 of 20 _
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 Dosa