Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
OXALIPLATIN
PFIZER CANADA ULC
L01XA03
OXALIPLATIN
5MG
SOLUTION
OXALIPLATIN 5MG
INTRAVENOUS
10/20/40ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0152220003; AHFS:
APPROVED
2017-06-01
_ _ _Pr_ _Oxaliplatin – Product Monograph_ _ _ _Page 1 of 64_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR OXALIPLATIN Oxaliplatin Injection, 5 mg/mL Sterile concentrate 50 mg / 10 mL, 100 mg / 20 mL, 200 mg / 40 mL for intravenous infusion Antineoplastic Agent Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Initial Authorization: DEC 16, 2015 Date of Revision: MAY 10, 2023 Submission Control Number: 270750 _ _ _Pr_ _Oxaliplatin – Product Monograph_ _ _ _Page 2 of 64_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 05/2023 7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding 05/2023 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 ............................................................ 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations ............................................................................................ 5 4.2 Recommended Dose and Dosage Ad Prečítajte si celý dokument