TORADOL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

KETOROLAC TROMETHAMINE

Available from:

AA PHARMA INC

ATC code:

M01AB15

INN (International Name):

KETOROLAC

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

KETOROLAC TROMETHAMINE 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2015-11-10

Summary of Product characteristics

_ _
_TORADOL_
_® _
_(Ketorolac Tromethamine Tablets) _
_Page 1 of 56_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TORADOL
®
Ketorolac Tromethamine Tablets
Tablets, 10 mg, For Oral Use
House Standard
Non-Steroidal Anti-Inflammatory Drug (NSAID)
AA Pharma Inc.
1165 Creditstone Road, Unit#1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
JUN 16, 2017
Date of Revision:
APRIL 4, 2023
Submission Control Number: 267475
TORADOL

is a registered trademark used under license by AA Pharma Inc.
_ _
_TORADOL_
_® _
_(Ketorolac Tromethamine Tablets) _
_Page 2 of 56_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
04/2023
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
04/2023
7 WARNINGS AND PRECAUTIONS, Skin
04/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant women
04/2023
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 Con