País: Canadá
Idioma: inglés
Fuente: Health Canada
KETOROLAC TROMETHAMINE
FRESENIUS KABI CANADA LTD
M01AB15
KETOROLAC
30MG
LIQUID
KETOROLAC TROMETHAMINE 30MG
INTRAMUSCULAR
24X1ML PFS
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0121995002; AHFS:
APPROVED
2018-09-25
_KETOROLAC TROMETHAMINE INJECTION, USP (Ketorolac Tromethamine Injection) _ _Page 1 of 49_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR KETOROLAC TROMETHAMINE INJECTION, USP Ketorolac Tromethamine Injection Liquid, 30 mg / mL per Vial, Intramuscular Liquid, 30 mg / mL per Simplist® Prefilled Syringe, Intramuscular Non-Steroidal Anti-Inflammatory Drug (NSAID) Fresenius Kabi Canada Ltd. 165 Galaxy Blvd, Suite 100 Toronto, ON M9W 0C8 Date of Initial Authorization: NOV 30, 2001 Date of Revision: DEC 02, 2022 Submission Control Number: 265131 _KETOROLAC TROMETHAMINE INJECTION, USP (Ketorolac Tromethamine Injection) _ _Page 2 of 49_ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 12/2022 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 12/2022 7 WARNINGS AND PRECAUTIONS, Skin 12/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 12/2022 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 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 ..................... Leer el documento completo