Land: Canada
Sprog: engelsk
Kilde: Health Canada
METHOTREXATE (METHOTREXATE SODIUM)
ACCORD HEALTHCARE INC
L04AX03
METHOTREXATE
25MG
SOLUTION
METHOTREXATE (METHOTREXATE SODIUM) 25MG
SUBCUTANEOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0107545005; AHFS:
APPROVED
2019-08-07
_METHOTREXATE SUBCUTANEOUS (Methotrexate Injection BP) _ _Page 1 of 45 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR METHOTREXATE SUBCUTANEOUS Methotrexate Injection Solution, 7.5 mg / 0.15 mL (50 mg / mL) methotrexate (as methotrexate sodium), single- use pre-filled syringe for subcutaneous injection Solution, 10 mg / 0.2 mL (50 mg / mL) methotrexate (as methotrexate sodium), single- use pre-filled syringe for subcutaneous injection Solution, 12.5 mg / 0.25 mL (50 mg / mL) methotrexate (as methotrexate sodium), single- use pre-filled syringe for subcutaneous injection Solution, 15 mg / 0.3 mL (50 mg / mL) methotrexate (as methotrexate sodium), single- use pre-filled syringe for subcutaneous injection Solution, 17.5 mg / 0.35 mL (50 mg / mL) methotrexate (as methotrexate sodium), single- use pre-filled syringe for subcutaneous injection Solution, 20 mg / 0.4 mL (50 mg / mL) methotrexate (as methotrexate sodium), single- use pre-filled syringe for subcutaneous injection Solution, 22.5 mg / 0.45 mL (50 mg / mL) methotrexate (as methotrexate sodium), single- use pre-filled syringe for subcutaneous injection Solution, 25 mg / 0.5 mL (50 mg / mL) methotrexate (as methotrexate sodium), single- use pre-filled syringe for subcutaneous injection BP Immunosuppressant Accord Healthcare Inc. 3535 boul. St-Charles, Suite 704 Kirkland, QC, H9H 5B9 Canada Submission Control Number: 263562 Date of Initial Approval: August 2, 2019 Date of Revision: October 3, 2022 _METHOTREXATE SUBCUTANEOUS (Methotrexate Injection BP) _ _Page 2 of 45 _ RECENT MAJOR LABEL CHANGES 7. Warnings and Precautions 10/2022 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................................... 4 1 INDICATIONS .......................................................................................................................... 4 1.1 Pediatrics ........................................................................................................................... 4 1.2 Geriatrics Læs hele dokumentet