Land: Canada
Språk: engelsk
Kilde: Health Canada
OXALIPLATIN
DR REDDY'S LABORATORIES LTD
L01XA03
OXALIPLATIN
5MG
SOLUTION
OXALIPLATIN 5MG
INTRAVENOUS
10/20/40ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0152220003; AHFS:
APPROVED
2016-10-17
_Oxaliplatin Injection, USP – Product Monograph _ _Page 1 of 57 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR OXALIPLATIN INJECTION, USP Oxaliplatin Injection Sterile Solution, 5 mg / mL, for Intravenous Infusion (Available as 50 mg / 10 mL, 100 mg / 20 mL, 200 mg / 40 mL) CONCENTRATE - MUST BE DILUTED BEFORE ADMINISTRATION USP Antineoplastic Agent Manufactured by: Dr. Reddy’s Laboratories Ltd., Bachupally– 500 090 India Imported and Distributed by: DR. REDDY’S LABORATORIES CANADA INC., Mississauga, ON L4W 4Y1 Canada Date of Initial Authorization: October 17, 2016 Date of Revision: December 21 ,2023 Submission Control Number: 277339 _Oxaliplatin Injection, USP – Product Monograph _ _Page 2 of 57 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 12/2023 7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding 12/2023 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 .......................................................... Les hele dokumentet