Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
METHOTREXATE (METHOTREXATE SODIUM)
MEDEXUS PHARMACEUTICALS INC.
L04AX03
METHOTREXATE
10MG
SOLUTION
METHOTREXATE (METHOTREXATE SODIUM) 10MG
SUBCUTANEOUS
0.2 ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0107545005; AHFS:
APPROVED
2016-05-17
_METOJECT_ _® _ _SUBCUTANEOUS_ (_Methotrexate Injection) _ _Page 1 of _45_ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR METOJECT ® 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 House Standard Immunosuppressant Medexus Inc. 35 Nixon Road, Unit 1 Bolton, Ontario L7E 1K1 Submission Control Number: 251944 Date of Initial Approval: May 17, 2016 Date of Revision: December 7, 2021 _METOJECT_ _® _ _SUBCUTANEOUS_ (_Methotrexate Injection) _ _Page 2 of _45_ _ RECENT MAJOR LABEL CHANGES 7. Warnings and Precautions 12/2021 8. Adverse Reactions 12/2021 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS .................................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics...................................... Belgenin tamamını okuyun