Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
IRINOTECAN HYDROCHLORIDE
PFIZER CANADA ULC
L01CE02
IRINOTECAN
20MG
SOLUTION
IRINOTECAN HYDROCHLORIDE 20MG
INTRAVENOUS
2/5/25ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0132910001; AHFS:
APPROVED
2007-06-07
_Product Monograph _ _ _ _Irinotecan Hydrochloride Injection USP _ _Page 1 of 71_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr IRINOTECAN HYDROCHLORIDE INJECTION USP (Irinotecan Hydrochloride Injection) Solution, 20 mg / mL, Intravenous USP Antineoplastic Agent ATC: L01XX19 Pfizer Canada ULC 17,300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Date of Initial Authorization: APR 20, 2005 Date of Revision: SEP 14, 2022 Submission Control Number: 262849 _ _ _Product Monograph _ _ _ _Irinotecan Hydrochloride Injection USP _ _Page 2 of 71_ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, 7.1.1 Pregnant Women 07/2021 7 Warnings and Precautions, 7.1.2 Breast-feeding 07/2021 7 Warnings and Precautions, General, Patients with reduced UGT1A1 activity 09/2022 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 ........................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................ 5 4.1 Dosing Considerations ............................................... Izlasiet visu dokumentu