Nazione: Canada
Lingua: inglese
Fonte: Health Canada
METHOTREXATE (METHOTREXATE SODIUM)
PHARMASCIENCE INC
L04AX03
METHOTREXATE
20MG
SOLUTION
METHOTREXATE (METHOTREXATE SODIUM) 20MG
SUBCUTANEOUS
100
Prescription
Active ingredient group (AIG) number: 0107545005; AHFS:
APPROVED
2023-07-18
_pms-METHOTREXATE INJECTION page 1 of 51 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATIO N PR PMS-METHOTREXATE INJECTION Methotrexate 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 PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Quebec, H4P 2T4 Submission Control Number: 268544 Date of Initial Authorization: July 14, 2023 _pms-METHOTREXATE INJECTION page 2 of 51 _ RECENT MAJOR LABEL CHANGES _None at the time of authorization _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................................. 4 1 INDICATIONS ............................................................................................................................................. 4 1.1 PEDIATRICS ..................................................................................................................................... 4 1.2 GERIATRICS ..................................................................................................................................... 4 2 CONTRAINDICATIONS ...................................... Leggi il documento completo