KETOROLAC TROMETHAMINE INJECTION, USP SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

KETOROLAC TROMETHAMINE

MAH:

JUNO PHARMACEUTICALS CORP.

ATC_code:

M01AB15

INN:

KETOROLAC

dosage:

30MG

pharmaceutical_form:

SOLUTION

composition:

KETOROLAC TROMETHAMINE 30MG

administration_route:

INTRAMUSCULAR

units_in_package:

10X1ML

prescription_type:

Prescription

therapeutic_area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0121995002; AHFS:

authorization_status:

APPROVED

authorization_date:

2015-07-10

SPC

Ketorolac Tromethamine Injection, USP
Page 1 of 47
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
KETOROLAC TROMETHAMINE INJECTION, USP
Ketorolac Tromethamine Injection
Solution, 30 mg/mL, Intramuscular
USP
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, ON
L5N 2X7
Date of Initial Authorization:
July 10, 2015
Date of Revision:
October 10, 2023
Submission Control Number: 274319
Ketorolac Tromethamine Injection, USP
Page 2 of 47
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
10/2023
7 WARNING AND PRECAUTIONS, Skin
10/2023
7 WARNING AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2023
7 WARNING AND PRECAUTIONS, Monitoring and Laboratory Tests
10/2023
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
.........