MINT-KETOROLAC TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

KETOROLAC TROMETHAMINE

Available from:

MINT PHARMACEUTICALS 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:

2017-02-07

Summary of Product characteristics

_MINT-KETOROLAC_
_ _
_(Ketorolac Tromethamine Tablets) _
_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MINT-KETOROLAC
Ketorolac Tromethamine Tablets
Tablets, 10 mg, For Oral Use
House Standard
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
FEB 07, 2017
Date of Revision:
November 3, 2023
Submission Control Number: 275488
_Page 2 of 55 _
_MINT-KETOROLAC_
_ _
_(Ketorolac Tromethamine Tablets) _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
11/2023
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
11/2023
7 WARNINGS AND PRECAUTIONS, Skin
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant women
11/2023
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
.............................................