APO-KETOROLAC TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

KETOROLAC TROMETHAMINE

Available from:

APOTEX INC

ATC code:

M01AB15

INN (International Name):

KETOROLAC

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

KETOROLAC TROMETHAMINE 10MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0121995001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-10-04

Summary of Product characteristics

_APO-KETOROLAC (Ketorolac Tromethamine Tablets) _
_Page 1 of 59_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-KETOROLAC
Ketorolac Tromethamine Tablets
Tablets, 10 mg, For Oral Use
Apotex Standard
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
June 22, 1998
Date of Revision:
October 05, 2023
Submission Control Number: 276972
_APO-KETOROLAC (Ketorolac Tromethamine Tablets) _
_Page 2 of 59_
_ _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
03/2023
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory
Tests
03/2023
7 WARNINGS AND PRECAUTIONS, Skin
03/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant women
03/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................... 6
4
DOSAGE AND ADMINISTRATION ........................................................................................
7
4.1 Dosing Considerations
......................