KETOROLAC SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

KETOROLAC TROMETHAMINE

Disponible des:

AA PHARMA INC

Codi ATC:

S01BC05

Designació comuna internacional (DCI):

KETOROLAC

Dosis:

0.5%

formulario farmacéutico:

SOLUTION

Composición:

KETOROLAC TROMETHAMINE 0.5%

Vía de administración:

OPHTHALMIC

Unidades en paquete:

5ML/10ML

tipo de receta:

Prescription

Área terapéutica:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0121995003; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2012-07-06

Fitxa tècnica

_KETOROLAC (ketorolac tromethamine ophthalmic solution) _
_Page 1 of 21 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
KETOROLAC
Ketorolac Tromethamine Ophthalmic Solution
Solution, 0.5% w/v, for ophthalmic use
with benzalkonium chloride 0.01% w/v as preservative
Topical Non-Steroidal Anti-Inflammatory Agent
ATC code: S01BC05
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
May 27, 2002
Date of Revision:
August 28, 2023
Submission Control Number.: 273938
_KETOROLAC (ketorolac tromethamine ophthalmic solution) _
_Page 2 of 21 _
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
4.4
Administration
..........