国家: 加拿大
语言: 英文
来源: Health Canada
KETOROLAC TROMETHAMINE
ATNAHS PHARMA UK LIMITED
M01AB15
KETOROLAC
10MG
SOLUTION
KETOROLAC TROMETHAMINE 10MG
INTRAMUSCULAR
1 ML
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0121995001; AHFS:
APPROVED
2015-11-10
_Product Monograph _ _ _ TORADOL IM (ketorolac tromethamine injection) _Page 1 of 56_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TORADOL ® IM ketorolac tromethamine injection Solution, 10 mg/mL, intramuscular Non-Steroidal Anti-Inflammatory Drug (NSAID) Atnahs Pharma UK Limited Sovereign House, Miles Gray Road Basildon, Essex SS14 3FR United Kingdom Date of Initial Authorization: November 3, 2015 Date of Revision: April 3, 2023 Distributed by: Methapharm Inc. Brantford, Ontario N3S 7X6 Canada Submission Control Number: 267937 TORADOL ® is a registered trademark of Atnahs Pharma UK Limited, used under license. _ _ _Product Monograph _ _ _ TORADOL IM (ketorolac tromethamine injection) _Page 2 of 56_ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNING AND PRECAUTIONS BOX [03/2022] 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests [03/2022] 7 WARNINGS AND PRECAUTIONS, Skin [03/2022] 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women [03/2022] 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 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 ........................................................................ 阅读完整的文件