KETOROLAC SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

KETOROLAC TROMETHAMINE

Tilgjengelig fra:

AA PHARMA INC

ATC-kode:

S01BC05

INN (International Name):

KETOROLAC

Dosering :

0.5%

Legemiddelform:

SOLUTION

Sammensetning:

KETOROLAC TROMETHAMINE 0.5%

Administreringsrute:

OPHTHALMIC

Enheter i pakken:

5ML/10ML

Resept typen:

Prescription

Terapeutisk område:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2012-07-06

Preparatomtale

_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
..........