KETOROLAC SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

KETOROLAC TROMETHAMINE

Disponibil de la:

AA PHARMA INC

Codul ATC:

S01BC05

INN (nume internaţional):

KETOROLAC

Dozare:

0.5%

Forma farmaceutică:

SOLUTION

Compoziție:

KETOROLAC TROMETHAMINE 0.5%

Calea de administrare:

OPHTHALMIC

Unități în pachet:

5ML/10ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2012-07-06

Caracteristicilor produsului

_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
..........