KETOROLAC TROMETHAMINE INJECTION, USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

KETOROLAC TROMETHAMINE

Available from:

JUNO PHARMACEUTICALS CORP.

ATC code:

M01AB15

INN (International Name):

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

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2015-07-10

Summary of Product characteristics

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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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6
4
DOSAGE AND ADMINISTRATION
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7
4.1
Dosing Considerations
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