Country: Canada
Language: English
Source: Health Canada
METHOTREXATE (METHOTREXATE SODIUM)
PFIZER CANADA ULC
L01BA01
METHOTREXATE
25MG
SOLUTION
METHOTREXATE (METHOTREXATE SODIUM) 25MG
INTRACEREBROVENTRICULAR
2ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0107545002; AHFS:
APPROVED
2017-06-06
_Pr_ _METHOTREXATE INJECTION USP (methotrexate sodium) – Product Monograph _ _Page 1 of 54_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR METHOTREXATE INJECTION USP Methotrexate Injection Solution (Preservative-Free), 10 mg/mL and 25 mg/mL methotrexate (as methotrexate sodium), for intravenous, intramuscular, intra-arterial, intrathecal and intracerebroventricular use Solution (with Preservative), 25 mg/mL methotrexate (as methotrexate sodium), for intravenous, intramuscular, intra-arterial use USP Antimetabolite and Antirheumatic Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Initial Authorization: [JAN 07, 1985] Date of Revision: MAR 01, 2024 Submission Control Number: 280068 _Pr_ _METHOTREXATE INJECTION USP (methotrexate sodium) – Product Monograph _ _Page 2 of 54_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Neurologic 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ................................................................................................................ 4 1.2 Geriatrics ................................................................................................................ 5 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 4.1 Dosing Considerations ............. Read the complete document